Spaces:
Sleeping
Sleeping
Chain Update
Browse files- .gitignore +2 -1
- HBV_Eligibility_Results_23-11_Last_Update.csv +2071 -0
- api/routers/hbv_assessment.py +13 -15
- core/assessment_chain.py +840 -0
- core/hbv_assessment.py +27 -31
.gitignore
CHANGED
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@@ -209,4 +209,5 @@ __marimo__/
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*.ipynb
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*.docx
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*.pptx
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*.ipynb
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*.docx
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*.pptx
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/docs
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HBV_Eligibility_Results_23-11_Last_Update.csv
ADDED
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@@ -0,0 +1,2071 @@
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| 1 |
+
Case ID,Age,Sex,Pregnancy Status,HBsAg,HBV DNA (IU/mL),HBeAg,ALT (U/L),Fibrosis/Cirrhosis Stage,Necroinflammation,Extrahepatic Manifestations,Immunosuppressive Therapy,Coinfections,Family History of HCC/Cirrhosis,Smoking,Comorbidities,Eligibility,Rationale,Column1,Eligibility from ACTIVATE 2,Eligibility from ACTIVATE2 OBSOLETE,Rationale from ACTIVATE,Eligibility-chain-23/11,recommendations-chain-23/11
|
| 2 |
+
Case22,33,F,Yes (12 weeks),Positive,300000,Positive,40,F1,Mild,No,,,No,No,,(Not) Eligible,Pregnancy early trimester β initiate prophylaxis only in 3rd trimester.,,eligible,Eligible,"Eligibility and Rationale:
|
| 3 |
+
- Eligible: HBV DNA > 100,000 IU/mL during pregnancy warrants antiviral prophylaxis (Grade D) [SASLT 2021, Page 10]
|
| 4 |
+
- ALT > ULN and HBeAg-positive status further support treatment initiation (Grade A) [SASLT 2021, Page 6]
|
| 5 |
+
|
| 6 |
+
Treatment Recommendations:
|
| 7 |
+
- Start antiviral prophylaxis with TDF or TAF at 24-28 weeks of pregnancy (Grade D) [SASLT 2021, Page 10]
|
| 8 |
+
- Preferred regimens include TDF or TAF as monotherapy (Grade A) [SASLT 2021, Page 8]
|
| 9 |
+
|
| 10 |
+
Monitoring and Follow-up:
|
| 11 |
+
- Monitor HBV DNA and ALT levels every 3 months during treatment (Grade D) [SASLT 2021, Page 7]
|
| 12 |
+
- Postpartum follow-up to assess treatment continuation or cessation [SASLT 2021, Page 10]
|
| 13 |
+
|
| 14 |
+
Special Considerations:
|
| 15 |
+
- Breastfeeding is permitted while on TDF therapy (Grade B) [SASLT 2021, Page 10]
|
| 16 |
+
|
| 17 |
+
References:
|
| 18 |
+
- Pages 6, 7, 8, 10: Treatment criteria, drugs, monitoring, pregnancy considerations",eligible,"**Patient Summary**
|
| 19 |
+
- 33-year-old pregnant female
|
| 20 |
+
- HBsAg positive for 6 months, HBV DNA 300,000 IU/mL
|
| 21 |
+
- HBeAg positive, ALT 40 IU/L, mild fibrosis (F1), mild necroinflammation (A1)
|
| 22 |
+
|
| 23 |
+
|
| 24 |
+
**Treatment Eligibility Analysis**
|
| 25 |
+
|
| 26 |
+
*Absolute Indications Check (Priority):*
|
| 27 |
+
|
| 28 |
+
- β No HIV coinfection
|
| 29 |
+
- β No cirrhosis (F4)
|
| 30 |
+
- β No immunosuppression
|
| 31 |
+
- β
Pregnancy with high viral load (HBV DNA > 100,000 IU/mL)
|
| 32 |
+
|
| 33 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 34 |
+
- HBV DNA >2000 IU/mL: β
|
| 35 |
+
- ALT >ULN (40 IU/L): β
|
| 36 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
|
| 37 |
+
|
| 38 |
+
*Special Considerations:*
|
| 39 |
+
- Pregnancy is a key factor for eligibility due to risk of mother-to-child transmission
|
| 40 |
+
- SASLT 2021 guidelines recommend treatment for pregnant women with HBV DNA > 100,000 IU/mL in the late second trimester (Grade D) [Page 10]
|
| 41 |
+
|
| 42 |
+
|
| 43 |
+
**Clinical Recommendation**
|
| 44 |
+
|
| 45 |
+
*Decision:* ELIGIBLE
|
| 46 |
+
|
| 47 |
+
*Rationale:*
|
| 48 |
+
- The patient meets the absolute indication for treatment due to pregnancy with a high viral load (HBV DNA > 100,000 IU/mL).
|
| 49 |
+
- This is supported by SASLT 2021 guidelines, which recommend antiviral prophylaxis in pregnant women with HBV DNA > 100,000 IU/mL in the late second trimester (Grade D) [Page 10].
|
| 50 |
+
|
| 51 |
+
*Key Factors:*
|
| 52 |
+
- Pregnancy with HBV DNA 300,000 IU/mL (above the 100,000 IU/mL threshold)
|
| 53 |
+
- HBeAg positive status, increasing risk of vertical transmission
|
| 54 |
+
- ALT within normal limits, no significant fibrosis or necroinflammation
|
| 55 |
+
- No other comorbidities or contraindications
|
| 56 |
+
|
| 57 |
+
*Management Approach:*
|
| 58 |
+
|
| 59 |
+
|
| 60 |
+
**If ELIGIBLE (Standard Criteria):**
|
| 61 |
+
- Initiate Tenofovir Disoproxil Fumarate (TDF) as the drug of choice during pregnancy [SASLT 2021, Page 10, Grade D].
|
| 62 |
+
- Alternatively, Tenofovir Alafenamide (TAF) may be considered based on safety profile [Page 10].
|
| 63 |
+
- Monitor HBV DNA and ALT levels every 3 months during pregnancy and postpartum.
|
| 64 |
+
- Ensure newborn receives HBV immunoglobulin (HBIG) and HBV vaccine within 12 hours of birth.
|
| 65 |
+
|
| 66 |
+
|
| 67 |
+
**If NOT ELIGIBLE:**
|
| 68 |
+
- Not applicable as the patient is eligible.
|
| 69 |
+
|
| 70 |
+
*Final Recommendation:*
|
| 71 |
+
- The patient is eligible for antiviral treatment due to pregnancy with a high viral load (HBV DNA > 100,000 IU/mL). Initiate TDF or TAF in the late second trimester to reduce the risk of mother-to-child transmission. Monitor closely during pregnancy and postpartum."
|
| 72 |
+
Case12,50,F,No,Positive (3 months),450,Negative,32,F0,Mild,No,Yes (tacrolimus),,No,No,Post-transplant,Eligible,Immunosuppressed post-transplant β prophylaxis required.,,eligible,Not Eligible,"Eligibility and Rationale:
|
| 73 |
+
- Not eligible: HBV DNA < 2,000 IU/mL, ALT Γ’β°Β€ ULN, no significant fibrosis or necroinflammation [SASLT 2021, Page 6].
|
| 74 |
+
|
| 75 |
+
Treatment Recommendations:
|
| 76 |
+
- Treatment not indicated at this time [SASLT 2021, Page 6].
|
| 77 |
+
|
| 78 |
+
Monitoring and Follow-up:
|
| 79 |
+
- Monitor every 6-12 months (HBeAg-negative, HBV DNA < 2,000 IU/mL) (Grade B) [SASLT 2021, Page 7].
|
| 80 |
+
|
| 81 |
+
Special Considerations:
|
| 82 |
+
- Immunosuppression: Consider prophylaxis if undergoing immunosuppressive therapy (Grade A) [SASLT 2021, Page 9].
|
| 83 |
+
|
| 84 |
+
References:
|
| 85 |
+
- Pages 6, 7, 9: Treatment criteria, monitoring protocols, immunosuppression considerations",eligible,"**Patient Summary**
|
| 86 |
+
- Female, 50 years old, post-transplant
|
| 87 |
+
- HBsAg positive for 3 months, HBV DNA 450 IU/mL (<2000 IU/mL)
|
| 88 |
+
- ALT 32 IU/L (normal), Fibrosis stage F0, Necroinflammatory activity A1
|
| 89 |
+
- On immunosuppressive therapy (Tacrolimus)
|
| 90 |
+
|
| 91 |
+
|
| 92 |
+
**Treatment Eligibility Analysis**
|
| 93 |
+
|
| 94 |
+
*Absolute Indications Check (Priority):*
|
| 95 |
+
|
| 96 |
+
- β No HIV coinfection
|
| 97 |
+
- β No cirrhosis (F0)
|
| 98 |
+
- β
Immunosuppression: Patient is on Tacrolimus
|
| 99 |
+
- β Pregnancy with high viral load: Not pregnant, HBV DNA <100,000 IU/mL
|
| 100 |
+
|
| 101 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 102 |
+
- HBV DNA >2000 IU/mL: β
|
| 103 |
+
- ALT >ULN (40 IU/L): β
|
| 104 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
|
| 105 |
+
|
| 106 |
+
*Special Considerations:*
|
| 107 |
+
- Immunosuppression overrides standard criteria per SASLT guidelines [Page 9]
|
| 108 |
+
- No family history of HCC or cirrhosis
|
| 109 |
+
- No extrahepatic manifestations
|
| 110 |
+
|
| 111 |
+
|
| 112 |
+
**Clinical Recommendation**
|
| 113 |
+
|
| 114 |
+
*Decision:* ELIGIBLE
|
| 115 |
+
|
| 116 |
+
*Rationale:*
|
| 117 |
+
- The patient meets the absolute indication for treatment due to immunosuppression (Tacrolimus use) and positive HBsAg status [SASLT 2021, Page 9, Grade A].
|
| 118 |
+
- Immunosuppression is a high-risk condition for HBV reactivation, requiring prophylaxis irrespective of HBV DNA level, ALT, or fibrosis stage.
|
| 119 |
+
|
| 120 |
+
*Key Factors:*
|
| 121 |
+
- Immunosuppression with Tacrolimus
|
| 122 |
+
- Positive HBsAg status
|
| 123 |
+
- Post-transplant status
|
| 124 |
+
- HBV DNA detectable (450 IU/mL)
|
| 125 |
+
- No cirrhosis or significant fibrosis
|
| 126 |
+
|
| 127 |
+
*Management Approach:*
|
| 128 |
+
|
| 129 |
+
|
| 130 |
+
**If ELIGIBLE (Absolute Indication):**
|
| 131 |
+
- Initiate prophylactic antiviral therapy with a potent nucleos(t)ide analog (NA) with a high barrier to resistance: Tenofovir Alafenamide (TAF), Tenofovir Disoproxil Fumarate (TDF), or Entecavir (ETV) [SASLT 2021, Page 8, Grade A].
|
| 132 |
+
- Monitor HBV DNA and ALT every 3 months for the first year, then every 6-12 months [SASLT 2021, Page 7].
|
| 133 |
+
|
| 134 |
+
|
| 135 |
+
**Final Recommendation:**
|
| 136 |
+
- The patient is eligible for HBV treatment based on immunosuppression criteria. Prophylactic antiviral therapy is strongly recommended to prevent HBV reactivation and potential complications. TAF is preferred due to its superior renal and bone safety profile."
|
| 137 |
+
Case15,33,M,No,Positive,25000,Negative,30,F1,Mild,No,,HIV positive,No,No,,Eligible,Treat all HIV/HBV coinfected patients.,,eligible,Not Eligible,"Eligibility and Rationale:
|
| 138 |
+
- Not eligible: HBV DNA > 2,000 IU/mL but ALT Γ’β°Β€ ULN and no significant fibrosis or necroinflammation (Grade A) [SASLT 2021, Page 6].
|
| 139 |
+
|
| 140 |
+
Treatment Recommendations:
|
| 141 |
+
- Treatment not indicated at this time [SASLT 2021, Page 6].
|
| 142 |
+
|
| 143 |
+
Monitoring and Follow-up:
|
| 144 |
+
- Monitor every 3 months for the first year, then every 6 months (HBeAg-negative, HBV DNA Γ’β°Β₯ 2,000 IU/mL) (Grade D) [SASLT 2021, Page 7].
|
| 145 |
+
|
| 146 |
+
Special Considerations:
|
| 147 |
+
- HBV-HIV coinfection: ensure ART includes TDF- or TAF-based regimen (Grade A) [SASLT 2021, Page 9].
|
| 148 |
+
|
| 149 |
+
References:
|
| 150 |
+
- Pages 6, 7, 9: Treatment criteria, monitoring protocols, HIV coinfection",eligible,"**Patient Summary**
|
| 151 |
+
- 33-year-old male with chronic HBV (HBsAg positive for 6 months)
|
| 152 |
+
- HBV DNA: 25,000 IU/mL, ALT: 30 IU/L (normal), Fibrosis: F1, Necroinflammation: A1
|
| 153 |
+
- **CRITICAL: HIV coinfection present - absolute treatment indication**
|
| 154 |
+
|
| 155 |
+
|
| 156 |
+
**Treatment Eligibility Analysis**
|
| 157 |
+
|
| 158 |
+
*Absolute Indications Check (Priority):*
|
| 159 |
+
- β
**HBV-HIV coinfection: ABSOLUTE INDICATION** [SASLT 2021, Page 9, Grade A]
|
| 160 |
+
- Cirrhosis (F4): β
|
| 161 |
+
- Immunosuppression: β
|
| 162 |
+
- Pregnancy with high viral load: β
|
| 163 |
+
|
| 164 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 165 |
+
- HBV DNA >2000 IU/mL: β
|
| 166 |
+
- ALT >ULN (40 IU/L): β
|
| 167 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
|
| 168 |
+
|
| 169 |
+
*Special Considerations:*
|
| 170 |
+
- HIV coinfection is an absolute treatment indication regardless of ALT, HBV DNA, or fibrosis stage
|
| 171 |
+
- No family history of HCC or cirrhosis
|
| 172 |
+
- No extrahepatic manifestations
|
| 173 |
+
|
| 174 |
+
|
| 175 |
+
**Clinical Recommendation**
|
| 176 |
+
|
| 177 |
+
*Decision:* ELIGIBLE
|
| 178 |
+
|
| 179 |
+
*Rationale:*
|
| 180 |
+
- The patient has HIV coinfection, which is an absolute Grade A indication for HBV treatment per SASLT 2021 guidelines [Page 9].
|
| 181 |
+
- This indication overrides all other parameters, including normal ALT, mild fibrosis (F1), and mild necroinflammation (A1).
|
| 182 |
+
- SASLT emphasizes the increased risk of rapid fibrosis progression, HCC, and liver-related mortality in HBV-HIV coinfected patients.
|
| 183 |
+
|
| 184 |
+
*Key Factors:*
|
| 185 |
+
- HIV coinfection (absolute treatment indication)
|
| 186 |
+
- HBV DNA >20,000 IU/mL
|
| 187 |
+
- Normal ALT (30 IU/L)
|
| 188 |
+
- Mild fibrosis (F1) and necroinflammation (A1)
|
| 189 |
+
|
| 190 |
+
*Management Approach:*
|
| 191 |
+
|
| 192 |
+
|
| 193 |
+
**HBV-HIV Coinfection Treatment (Grade A):**
|
| 194 |
+
- All HIV-positive patients with HBV coinfection should start ART immediately, irrespective of CD4 count [SASLT 2021, Page 9]
|
| 195 |
+
- Regimen MUST include TDF or TAF (preferably TAF for better renal/bone safety) [SASLT 2021, Page 9]
|
| 196 |
+
- Include Emtricitabine or Lamivudine as part of ART regimen
|
| 197 |
+
- Monitor for immune reconstitution syndrome (may cause HBV flare in first 3-6 months)
|
| 198 |
+
- HBV DNA and ALT at 3, 6, 12 months, then every 6-12 months
|
| 199 |
+
- HIV viral load every 3-6 months
|
| 200 |
+
- Annual HCC surveillance (ultrasound Β± AFP)
|
| 201 |
+
|
| 202 |
+
|
| 203 |
+
**If ELIGIBLE (Standard Criteria):**
|
| 204 |
+
- Preferred agents: Entecavir (ETV), Tenofovir (TDF), or Tenofovir Alafenamide (TAF) [SASLT 2021, Page 8, Grade A]
|
| 205 |
+
- Monitor HBV DNA and ALT at 3, 6, 12 months, then every 6-12 months
|
| 206 |
+
|
| 207 |
+
|
| 208 |
+
**If NOT ELIGIBLE:**
|
| 209 |
+
- Monitor ALT every 3-6 months, HBV DNA every 6-12 months, fibrosis yearly [SASLT 2021, Page 7]
|
| 210 |
+
- Reassess if ALT rises >ULN, fibrosis progresses, or HBV DNA increases
|
| 211 |
+
|
| 212 |
+
*Final Recommendation:*
|
| 213 |
+
- The patient is el"
|
| 214 |
+
Case29,40,M,No,Positive (24 Months),1800,Negative,60,F2,Moderate,No,,,No,No,,Not Eligible,"The guidelines specify that for HBeAg-negative, non-cirrhotic patients, treatment is indicated when HBV DNA is > 2,000 IU/mL. Since this patient's viral load is below that 2,000 IU/mL threshold, they do not meet the criteria for initiating antiviral therapy and should continue to be monitored.",,,,"Eligibility and Rationale:
|
| 215 |
+
- Not eligible: HBV DNA < 2,000 IU/mL, ALT Γ’β°Β€ ULN, no significant fibrosis or necroinflammation (Grade A) [SASLT 2021, Page 6].
|
| 216 |
+
|
| 217 |
+
Treatment Recommendations:
|
| 218 |
+
- Treatment not indicated at this time [SASLT 2021, Page 6].
|
| 219 |
+
|
| 220 |
+
Monitoring and Follow-up:
|
| 221 |
+
- Monitor every 6-12 months (HBeAg-negative, HBV DNA < 2,000 IU/mL) (Grade B) [SASLT 2021, Page 7].
|
| 222 |
+
|
| 223 |
+
References:
|
| 224 |
+
- Pages 6, 7: Treatment criteria, monitoring protocols",not eligible,"**Patient Summary**
|
| 225 |
+
- Male, 40 years old
|
| 226 |
+
- HBsAg positive for 6 months
|
| 227 |
+
- HBV DNA: 1800 IU/mL (<2000 IU/mL)
|
| 228 |
+
- ALT: 60 IU/L (>ULN)
|
| 229 |
+
- Fibrosis stage: F2 (moderate)
|
| 230 |
+
- Necroinflammatory activity: A2 (moderate)
|
| 231 |
+
|
| 232 |
+
|
| 233 |
+
**Treatment Eligibility Analysis**
|
| 234 |
+
|
| 235 |
+
*Absolute Indications Check (Priority):*
|
| 236 |
+
|
| 237 |
+
- β No HIV coinfection
|
| 238 |
+
- β Cirrhosis (F4): Patient has F2 fibrosis
|
| 239 |
+
- β Immunosuppression: None
|
| 240 |
+
- β Pregnancy with high viral load: Not pregnant
|
| 241 |
+
|
| 242 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 243 |
+
- HBV DNA >2000 IU/mL: β
|
| 244 |
+
- ALT >ULN (40 IU/L): β
|
| 245 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
|
| 246 |
+
|
| 247 |
+
*Special Considerations:*
|
| 248 |
+
- No family history of HCC or cirrhosis
|
| 249 |
+
- No extrahepatic manifestations
|
| 250 |
+
- Patient is HBeAg-negative
|
| 251 |
+
|
| 252 |
+
|
| 253 |
+
**Clinical Recommendation**
|
| 254 |
+
|
| 255 |
+
*Decision:* NOT ELIGIBLE
|
| 256 |
+
|
| 257 |
+
*Rationale:*
|
| 258 |
+
- The patient does not meet the SASLT 2021 standard criteria for treatment initiation due to HBV DNA being below the required threshold of >2000 IU/mL [SASLT 2021, Page 6].
|
| 259 |
+
- Although ALT is elevated (>ULN) and moderate fibrosis (F2) and necroinflammation (A2) are present, HBV DNA >2000 IU/mL is mandatory for eligibility unless cirrhosis or absolute indications are present.
|
| 260 |
+
|
| 261 |
+
*Key Factors:*
|
| 262 |
+
- HBV DNA level is below the threshold for treatment initiation.
|
| 263 |
+
- ALT is elevated, indicating liver inflammation.
|
| 264 |
+
- Moderate fibrosis and necroinflammation are present but do not override the HBV DNA threshold requirement.
|
| 265 |
+
- No absolute indications such as cirrhosis, HIV coinfection, or immunosuppression.
|
| 266 |
+
|
| 267 |
+
*Management Approach:*
|
| 268 |
+
|
| 269 |
+
|
| 270 |
+
**If NOT ELIGIBLE:**
|
| 271 |
+
- Monitor ALT every 3-6 months, HBV DNA every 6-12 months, and fibrosis yearly [SASLT 2021, Page 7].
|
| 272 |
+
- Reassess eligibility if ALT rises >ULN, fibrosis progresses, or HBV DNA increases above 2000 IU/mL.
|
| 273 |
+
|
| 274 |
+
*Final Recommendation:*
|
| 275 |
+
- The patient is not eligible for HBV treatment at this time due to HBV DNA being below the required threshold. Regular monitoring is recommended to track disease progression and reassess eligibility in the future."
|
| 276 |
+
Case29,40,M,No,Positive (24 Months),1800,Negative,60,F1,Moderate,No,,,No,No,,Not Eligible,,,,,,not eligible,"**Patient Summary**
|
| 277 |
+
- 40-year-old male, HBsAg-positive for 6 months
|
| 278 |
+
- HBV DNA: 1800 IU/mL (<2000 IU/mL), ALT: 60 IU/L (>ULN)
|
| 279 |
+
- Fibrosis stage: F1 (mild), Necroinflammatory activity: A2 (moderate)
|
| 280 |
+
- No cirrhosis, no extrahepatic manifestations, no family history of HCC/cirrhosis
|
| 281 |
+
|
| 282 |
+
|
| 283 |
+
**Treatment Eligibility Analysis**
|
| 284 |
+
|
| 285 |
+
*Absolute Indications Check (Priority):*
|
| 286 |
+
- β No HIV coinfection
|
| 287 |
+
- β Cirrhosis (F4): Not present (F1)
|
| 288 |
+
- β Immunosuppression: None
|
| 289 |
+
- β Pregnancy with high viral load: Not applicable
|
| 290 |
+
|
| 291 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 292 |
+
- HBV DNA >2000 IU/mL: β
|
| 293 |
+
- ALT >ULN (40 IU/L): β
|
| 294 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
(A2 present, but F1 fibrosis)
|
| 295 |
+
|
| 296 |
+
*Special Considerations:*
|
| 297 |
+
- No family history of HCC or cirrhosis
|
| 298 |
+
- No extrahepatic manifestations
|
| 299 |
+
- Patient is HBeAg-negative, age >30 years
|
| 300 |
+
|
| 301 |
+
|
| 302 |
+
**Clinical Recommendation**
|
| 303 |
+
|
| 304 |
+
*Decision:* NOT ELIGIBLE
|
| 305 |
+
|
| 306 |
+
*Rationale:*
|
| 307 |
+
- The patient does not meet the SASLT 2021 standard treatment criteria as HBV DNA is below the required threshold of >2000 IU/mL for non-cirrhotic patients.
|
| 308 |
+
- Although ALT is elevated (>ULN) and moderate necroinflammation (A2) is present, the HBV DNA level is insufficient to meet the treatment threshold.
|
| 309 |
+
- No absolute indications (e.g., cirrhosis, immunosuppression, HIV coinfection) are present.
|
| 310 |
+
|
| 311 |
+
*Key Factors:*
|
| 312 |
+
- HBV DNA: 1800 IU/mL (<2000 IU/mL)
|
| 313 |
+
- ALT: 60 IU/L (>ULN)
|
| 314 |
+
- Fibrosis stage: F1 (mild)
|
| 315 |
+
- Necroinflammatory activity: A2 (moderate)
|
| 316 |
+
- No family history of HCC or cirrhosis
|
| 317 |
+
|
| 318 |
+
*Management Approach:*
|
| 319 |
+
|
| 320 |
+
|
| 321 |
+
**If NOT ELIGIBLE:**
|
| 322 |
+
- Monitor ALT every 3-6 months, HBV DNA every 6-12 months, fibrosis yearly [SASLT 2021, Page 7]
|
| 323 |
+
- Reassess if ALT rises >ULN, fibrosis progresses, or HBV DNA increases
|
| 324 |
+
|
| 325 |
+
*Final Recommendation:*
|
| 326 |
+
- The patient is not eligible for HBV treatment at this time due to HBV DNA levels below the treatment threshold. Regular monitoring of ALT, HBV DNA, and fibrosis is recommended to reassess eligibility if clinical parameters change."
|
| 327 |
+
Case13,27,M,No,Positive (36 months),1700,Negative,55,F1,Mild,No,,,No,No,,Not Eligible,"HBV DNA <2,000; borderline ALT β monitor.","While HBV DNA is <2,000 IU/mL, the ALT is clearly elevated (55 U/L, >ULN). This represents active hepatitis with evidence of liver inflammation and fibrosis. The guidelines recommend treatment for chronic hepatitis B with ALT >ULN and at least moderate necroinflammation or fibrosis. This case warrants closer evaluation and likely treatment.",not eligible,Not Eligible,"Eligibility and Rationale:
|
| 328 |
+
- Not eligible: HBV DNA < 2,000 IU/mL, ALT > ULN but mild fibrosis and necroinflammation (Grade A) [SASLT 2021, Page 6]
|
| 329 |
+
|
| 330 |
+
Treatment Recommendations:
|
| 331 |
+
- Treatment not indicated at this time [SASLT 2021, Page 6]
|
| 332 |
+
|
| 333 |
+
Monitoring and Follow-up:
|
| 334 |
+
- Monitor every 6-12 months (HBeAg-negative, HBV DNA < 2,000 IU/mL) (Grade B) [SASLT 2021, Page 7]
|
| 335 |
+
|
| 336 |
+
Special Considerations:
|
| 337 |
+
- None applicable to this patient [SASLT 2021, Pages 6-10]
|
| 338 |
+
|
| 339 |
+
References:
|
| 340 |
+
- Pages 6, 7: Treatment criteria, monitoring protocols",not eligible,"**Patient Summary**
|
| 341 |
+
- Male, 27 years old
|
| 342 |
+
- HBsAg positive for 36 months
|
| 343 |
+
- HBV DNA: 1700 IU/mL (<2000 IU/mL)
|
| 344 |
+
- ALT: 55 IU/L (>ULN)
|
| 345 |
+
- Fibrosis: F1 (mild)
|
| 346 |
+
- Necroinflammatory activity: A1 (mild)
|
| 347 |
+
|
| 348 |
+
|
| 349 |
+
**Treatment Eligibility Analysis**
|
| 350 |
+
|
| 351 |
+
*Absolute Indications Check (Priority):*
|
| 352 |
+
|
| 353 |
+
- β No HIV coinfection
|
| 354 |
+
- β Cirrhosis (F4): Patient has F1 fibrosis
|
| 355 |
+
- β Immunosuppression: None
|
| 356 |
+
- β Pregnancy with high viral load: Not pregnant
|
| 357 |
+
|
| 358 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 359 |
+
- HBV DNA >2000 IU/mL: β
|
| 360 |
+
- ALT >ULN (40 IU/L): β
|
| 361 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
|
| 362 |
+
|
| 363 |
+
*Special Considerations:*
|
| 364 |
+
- No family history of HCC or cirrhosis
|
| 365 |
+
- No extrahepatic manifestations
|
| 366 |
+
- Age <30 years
|
| 367 |
+
|
| 368 |
+
|
| 369 |
+
**Clinical Recommendation**
|
| 370 |
+
|
| 371 |
+
*Decision:* NOT ELIGIBLE
|
| 372 |
+
|
| 373 |
+
*Rationale:*
|
| 374 |
+
- The patient does not meet the SASLT 2021 standard criteria for treatment initiation due to HBV DNA being below the required threshold of >2000 IU/mL.
|
| 375 |
+
- Mild fibrosis (F1) and mild necroinflammatory activity (A1) do not meet the criteria for moderate liver disease severity.
|
| 376 |
+
- No absolute indications such as cirrhosis, immunosuppression, or pregnancy are present.
|
| 377 |
+
|
| 378 |
+
*Key Factors:*
|
| 379 |
+
- HBV DNA level is below the treatment threshold.
|
| 380 |
+
- ALT is elevated but does not meet criteria without HBV DNA >2000 IU/mL.
|
| 381 |
+
- Fibrosis and necroinflammatory activity are mild.
|
| 382 |
+
- No family history or extrahepatic manifestations.
|
| 383 |
+
|
| 384 |
+
*Management Approach:*
|
| 385 |
+
|
| 386 |
+
|
| 387 |
+
**If NOT ELIGIBLE:**
|
| 388 |
+
- Monitor ALT every 3-6 months, HBV DNA every 6-12 months, fibrosis yearly [SASLT 2021, Page 7]
|
| 389 |
+
- Reassess if ALT rises >ULN, fibrosis progresses, or HBV DNA increases
|
| 390 |
+
|
| 391 |
+
*Final Recommendation:*
|
| 392 |
+
- The patient is not eligible for HBV treatment at this time based on SASLT 2021 guidelines.
|
| 393 |
+
- Regular monitoring is recommended to track disease progression and reassess eligibility if clinical parameters change."
|
| 394 |
+
Case19,56,M,No,Positive,10,Negative,30,F4 (compensated),Mild,No,,,No,No,,Eligible,Cirrhosis requires lifelong antiviral therapy.,,eligible,Eligible,"Eligibility and Rationale:
|
| 395 |
+
- Eligible: Patient has cirrhosis (F4 fibrosis) with detectable HBV DNA, regardless of ALT levels (Grade A) [SASLT 2021, Page 6].
|
| 396 |
+
|
| 397 |
+
Treatment Recommendations:
|
| 398 |
+
- Start monotherapy with ETV, TDF, or TAF as first-line treatment (Grade A) [SASLT 2021, Page 8].
|
| 399 |
+
|
| 400 |
+
Monitoring and Follow-up:
|
| 401 |
+
- Monitor treatment response per SASLT protocol every 3-6 months (Grade A) [SASLT 2021, Page 7].
|
| 402 |
+
|
| 403 |
+
Special Considerations:
|
| 404 |
+
- None applicable to this patient.
|
| 405 |
+
|
| 406 |
+
References:
|
| 407 |
+
- Pages 6, 7, 8: Treatment criteria, drugs, monitoring protocols",eligible,"**Patient Summary**
|
| 408 |
+
- Male, 56 years old
|
| 409 |
+
- HBsAg positive for 6 months
|
| 410 |
+
- HBV DNA: 10.0 IU/mL (<2000 IU/mL)
|
| 411 |
+
- ALT: 30.0 IU/L (normal)
|
| 412 |
+
- Fibrosis stage: F4 (cirrhosis)
|
| 413 |
+
|
| 414 |
+
|
| 415 |
+
**Treatment Eligibility Analysis**
|
| 416 |
+
|
| 417 |
+
*Absolute Indications Check (Priority):*
|
| 418 |
+
|
| 419 |
+
- β No HIV coinfection
|
| 420 |
+
- β
Cirrhosis (F4): Patient has cirrhosis and detectable HBV DNA
|
| 421 |
+
- β No immunosuppression
|
| 422 |
+
- β Not pregnant
|
| 423 |
+
|
| 424 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 425 |
+
- HBV DNA >2000 IU/mL: β
|
| 426 |
+
- ALT >ULN (40 IU/L): β
|
| 427 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
(F4 cirrhosis)
|
| 428 |
+
|
| 429 |
+
*Special Considerations:*
|
| 430 |
+
- No family history of HCC or cirrhosis
|
| 431 |
+
- No extrahepatic manifestations
|
| 432 |
+
- Age >30 years
|
| 433 |
+
|
| 434 |
+
|
| 435 |
+
**Clinical Recommendation**
|
| 436 |
+
|
| 437 |
+
*Decision:* ELIGIBLE
|
| 438 |
+
|
| 439 |
+
*Rationale:*
|
| 440 |
+
- The patient meets the absolute indication for treatment due to cirrhosis (F4) and detectable HBV DNA, regardless of ALT level or HBV DNA threshold [SASLT 2021, Page 6, Grade A].
|
| 441 |
+
|
| 442 |
+
*Key Factors:*
|
| 443 |
+
- Cirrhosis (F4) confirmed
|
| 444 |
+
- Detectable HBV DNA (10.0 IU/mL)
|
| 445 |
+
- Normal ALT (30.0 IU/L)
|
| 446 |
+
- No other comorbidities or contraindications
|
| 447 |
+
|
| 448 |
+
*Management Approach:*
|
| 449 |
+
|
| 450 |
+
|
| 451 |
+
**If ELIGIBLE (Standard Criteria):**
|
| 452 |
+
- Preferred agents: Entecavir (ETV), Tenofovir (TDF), or Tenofovir Alafenamide (TAF) [SASLT 2021, Page 8, Grade A]
|
| 453 |
+
- Monitor HBV DNA and ALT at 3, 6, 12 months, then every 6-12 months
|
| 454 |
+
|
| 455 |
+
|
| 456 |
+
**If NOT ELIGIBLE:**
|
| 457 |
+
- Monitor ALT every 3-6 months, HBV DNA every 6-12 months, fibrosis yearly [SASLT 2021, Page 7]
|
| 458 |
+
- Reassess if ALT rises >ULN, fibrosis progresses, or HBV DNA increases
|
| 459 |
+
|
| 460 |
+
*Final Recommendation:*
|
| 461 |
+
- The patient is eligible for HBV treatment based on the presence of cirrhosis (F4) and detectable HBV DNA. Treatment should be initiated with a potent nucleos(t)ide analog such as TDF, TAF, or ETV. Regular monitoring of HBV DNA and liver function is essential."
|
| 462 |
+
Case21,70,M,No,Positive (30 Month),1800,Negative,27,F2,Mild,No,,,No,Yes (smoker),Hypertension,Not Eligible,"Older age and fibrosis β₯F2 does not warrant treatment even with low DNA. Monitor (ALT 6β12 mo, HBV DNA and fibrosis yearly).",,Not Eligible,Not Eligible,"Eligibility and Rationale:
|
| 463 |
+
- Not eligible: HBV DNA < 2,000 IU/mL, ALT Γ’β°Β€ ULN, moderate fibrosis but does not meet treatment thresholds [SASLT 2021, Page 6].
|
| 464 |
+
|
| 465 |
+
Treatment Recommendations:
|
| 466 |
+
- Treatment not indicated at this time [SASLT 2021, Page 6].
|
| 467 |
+
|
| 468 |
+
Monitoring and Follow-up:
|
| 469 |
+
- Monitor every 6-12 months (HBeAg-negative, HBV DNA < 2,000 IU/mL) (Grade B) [SASLT 2021, Page 7].
|
| 470 |
+
|
| 471 |
+
References:
|
| 472 |
+
- Pages 6, 7: Treatment criteria, monitoring protocols",not eligible,"**Patient Summary**
|
| 473 |
+
- 70-year-old male with chronic HBV infection (HBsAg positive for 6 months)
|
| 474 |
+
- HBV DNA: 1800 IU/mL (<2000 IU/mL), ALT: 27 IU/L (normal)
|
| 475 |
+
- Fibrosis stage: F2 (moderate), Necroinflammatory activity: A1 (mild)
|
| 476 |
+
- No cirrhosis, no extrahepatic manifestations, no family history of HCC/cirrhosis
|
| 477 |
+
|
| 478 |
+
|
| 479 |
+
**Treatment Eligibility Analysis**
|
| 480 |
+
|
| 481 |
+
*Absolute Indications Check (Priority):*
|
| 482 |
+
- β No HIV coinfection
|
| 483 |
+
- β Cirrhosis (F4): Patient has F2 fibrosis
|
| 484 |
+
- β Immunosuppression: None
|
| 485 |
+
- β Pregnancy with high viral load: Not applicable (male patient)
|
| 486 |
+
|
| 487 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 488 |
+
- HBV DNA >2000 IU/mL: β (1800 IU/mL < 2000 IU/mL)
|
| 489 |
+
- ALT >ULN (40 IU/L): β (27 IU/L < 40 IU/L)
|
| 490 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
(F2 fibrosis, A1 necroinflammation)
|
| 491 |
+
|
| 492 |
+
*Special Considerations:*
|
| 493 |
+
- No family history of HCC or cirrhosis
|
| 494 |
+
- No extrahepatic manifestations
|
| 495 |
+
- Patient is older than 30 years, but HBeAg-negative and HBV DNA <2000 IU/mL
|
| 496 |
+
|
| 497 |
+
|
| 498 |
+
**Clinical Recommendation**
|
| 499 |
+
|
| 500 |
+
*Decision:* NOT ELIGIBLE
|
| 501 |
+
|
| 502 |
+
*Rationale:*
|
| 503 |
+
- The patient does not meet the SASLT 2021 standard treatment criteria as HBV DNA is below the required threshold of >2000 IU/mL, and ALT is within the normal range (<40 IU/L).
|
| 504 |
+
- Absolute indications (e.g., cirrhosis, HIV coinfection, immunosuppression) are not present.
|
| 505 |
+
- While the patient has moderate fibrosis (F2), this alone does not qualify for treatment without HBV DNA >2000 IU/mL.
|
| 506 |
+
|
| 507 |
+
*Key Factors:*
|
| 508 |
+
- HBV DNA: 1800 IU/mL (<2000 IU/mL threshold for treatment)
|
| 509 |
+
- ALT: 27 IU/L (normal, below ULN of 40 IU/L)
|
| 510 |
+
- Fibrosis stage: F2 (moderate)
|
| 511 |
+
- No absolute indications (e.g., cirrhosis, HIV coinfection, immunosuppression)
|
| 512 |
+
|
| 513 |
+
*Management Approach:*
|
| 514 |
+
|
| 515 |
+
|
| 516 |
+
**If NOT ELIGIBLE:**
|
| 517 |
+
- Monitor ALT every 3-6 months, HBV DNA every 6-12 months, and fibrosis progression yearly [SASLT 2021, Page 7]
|
| 518 |
+
- Reassess eligibility if ALT rises >ULN, fibrosis progresses, or HBV DNA increases above 2000 IU/mL
|
| 519 |
+
|
| 520 |
+
*Final Recommendation:*
|
| 521 |
+
- The patient is not eligible for HBV treatment at this time based on SASLT 2021 guidelines. Monitoring is recommended to track disease progression and reassess eligibility if clinical parameters change."
|
| 522 |
+
Case24,58,F,No,Positive,2000,Negative,60,F2,Moderate,No,,,No,No,CKD stage 3,Eligible,"HBV DNA Borderline with comorbidities, ALT >ULN and Fβ₯2 β treat.",,eligible,Eligible,"Eligibility and Rationale:
|
| 523 |
+
- Eligible: HBV DNA > 2,000 IU/mL, ALT > ULN, moderate fibrosis (Grade A) [SASLT 2021, Page 6]
|
| 524 |
+
- Moderate necroinflammation (A2) and fibrosis (F2-F3) support treatment initiation (Grade A) [SASLT 2021, Page 6]
|
| 525 |
+
|
| 526 |
+
Treatment Recommendations:
|
| 527 |
+
- Start monotherapy with ETV, TDF, or TAF (Grade A) [SASLT 2021, Page 8]
|
| 528 |
+
|
| 529 |
+
Monitoring and Follow-up:
|
| 530 |
+
- Monitor treatment response every 3-6 months per SASLT protocol [SASLT 2021, Page 7]
|
| 531 |
+
- Assess HBV DNA, ALT, and fibrosis progression during follow-up [SASLT 2021, Page 7]
|
| 532 |
+
|
| 533 |
+
Special Considerations:
|
| 534 |
+
- CKD stage 3: Prefer TAF over TDF due to better renal safety profile (Grade A) [SASLT 2021, Page 8]
|
| 535 |
+
|
| 536 |
+
References:
|
| 537 |
+
- Pages 6, 7, 8: Treatment criteria, drugs, monitoring protocols",eligible,"**Patient Summary**
|
| 538 |
+
- Female, 58 years old
|
| 539 |
+
- HBsAg positive for 6 months, HBV DNA 2000 IU/mL
|
| 540 |
+
- ALT 60 IU/L (>ULN), moderate fibrosis (F2) and necroinflammation (A2)
|
| 541 |
+
- No pregnancy, immunosuppression, coinfections, or family history of HCC/cirrhosis
|
| 542 |
+
|
| 543 |
+
|
| 544 |
+
**Treatment Eligibility Analysis**
|
| 545 |
+
|
| 546 |
+
*Absolute Indications Check (Priority):*
|
| 547 |
+
- β No HIV coinfection
|
| 548 |
+
- β No cirrhosis (F4)
|
| 549 |
+
- β No immunosuppression
|
| 550 |
+
- β Not pregnant with high viral load
|
| 551 |
+
|
| 552 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 553 |
+
- HBV DNA >2000 IU/mL: β
|
| 554 |
+
- ALT >ULN (40 IU/L): β
|
| 555 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
|
| 556 |
+
|
| 557 |
+
*Special Considerations:*
|
| 558 |
+
- Patient meets standard criteria for treatment initiation: HBV DNA >2000 IU/mL, ALT >ULN, and moderate fibrosis/necroinflammation
|
| 559 |
+
- SASLT 2021 guidelines recommend treatment for non-cirrhotic patients with these parameters [Page 6, Grade A]
|
| 560 |
+
|
| 561 |
+
|
| 562 |
+
**Clinical Recommendation**
|
| 563 |
+
|
| 564 |
+
*Decision:* ELIGIBLE
|
| 565 |
+
|
| 566 |
+
*Rationale:*
|
| 567 |
+
- The patient meets the standard criteria for treatment initiation based on SASLT 2021 guidelines: HBV DNA >2000 IU/mL, ALT >ULN, and moderate fibrosis/necroinflammation (F2/A2).
|
| 568 |
+
- Grade A recommendation for treatment initiation in non-cirrhotic patients with these parameters [Page 6].
|
| 569 |
+
|
| 570 |
+
*Key Factors:*
|
| 571 |
+
- HBV DNA level exceeds 2000 IU/mL
|
| 572 |
+
- ALT is elevated above ULN (60 IU/L vs 40 IU/L)
|
| 573 |
+
- Liver biopsy confirms moderate fibrosis (F2) and necroinflammation (A2)
|
| 574 |
+
- No contraindications or absolute indications overriding standard criteria
|
| 575 |
+
|
| 576 |
+
*Management Approach:*
|
| 577 |
+
|
| 578 |
+
|
| 579 |
+
**If ELIGIBLE (Standard Criteria):**
|
| 580 |
+
- Preferred agents: Entecavir (ETV), Tenofovir (TDF), or Tenofovir Alafenamide (TAF) [SASLT 2021, Page 8, Grade A]
|
| 581 |
+
- Monitor HBV DNA and ALT at 3, 6, 12 months, then every 6-12 months
|
| 582 |
+
|
| 583 |
+
|
| 584 |
+
**If NOT ELIGIBLE:**
|
| 585 |
+
- Not applicable as patient is eligible
|
| 586 |
+
|
| 587 |
+
*Final Recommendation:*
|
| 588 |
+
- The patient is eligible for HBV treatment based on SASLT 2021 guidelines due to elevated HBV DNA, ALT >ULN, and moderate fibrosis/necroinflammation.
|
| 589 |
+
- Initiate treatment with a preferred agent (ETV, TDF, or TAF) and monitor response closely."
|
| 590 |
+
Case29,25,F,No,Positive (2 years),12000000,Positive,95,F1,Moderate,No,,,No,No,,Eligible,HBeAg-positive immune-active phase β treat.,,eligible,Eligible,"Eligibility and Rationale:
|
| 591 |
+
- Eligible: HBV DNA > 20,000 IU/mL and ALT > 2xULN, regardless of fibrosis stage (Grade B) [SASLT 2021, Page 6]
|
| 592 |
+
- Moderate necroinflammatory activity (A2) supports treatment initiation (Grade A) [SASLT 2021, Page 6]
|
| 593 |
+
|
| 594 |
+
Treatment Recommendations:
|
| 595 |
+
- Start monotherapy with ETV, TDF, or TAF (Grade A) [SASLT 2021, Page 8]
|
| 596 |
+
|
| 597 |
+
Monitoring and Follow-up:
|
| 598 |
+
- Monitor treatment response per SASLT protocol every 3-6 months (Grade B) [SASLT 2021, Page 7]
|
| 599 |
+
|
| 600 |
+
Special Considerations:
|
| 601 |
+
- None applicable to this patient [SASLT 2021, Pages 6-10]
|
| 602 |
+
|
| 603 |
+
References:
|
| 604 |
+
- Pages 6, 7, 8: Treatment criteria, drugs, monitoring protocols",eligible,"**Patient Summary**
|
| 605 |
+
- 25-year-old female, HBsAg-positive for 24 months
|
| 606 |
+
- HBV DNA: 12,000,000 IU/mL (very high)
|
| 607 |
+
- ALT: 95 IU/L (>2ΓULN)
|
| 608 |
+
- HBeAg-positive, Fibrosis stage: F1, Necroinflammatory activity: A2
|
| 609 |
+
|
| 610 |
+
|
| 611 |
+
**Treatment Eligibility Analysis**
|
| 612 |
+
|
| 613 |
+
*Absolute Indications Check (Priority):*
|
| 614 |
+
|
| 615 |
+
- β No HIV coinfection
|
| 616 |
+
- β Cirrhosis (F4): Not present (F1)
|
| 617 |
+
- β Immunosuppression: None
|
| 618 |
+
- β Pregnancy with high viral load: Not pregnant
|
| 619 |
+
|
| 620 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 621 |
+
- HBV DNA >2000 IU/mL: β
(12,000,000 IU/mL)
|
| 622 |
+
- ALT >ULN (40 IU/L): β
(95 IU/L)
|
| 623 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
(A2 necroinflammation)
|
| 624 |
+
|
| 625 |
+
*Special Considerations:*
|
| 626 |
+
- No family history of HCC or cirrhosis
|
| 627 |
+
- Age <30 years, but meets criteria due to high HBV DNA and ALT >2ΓULN
|
| 628 |
+
- No extrahepatic manifestations
|
| 629 |
+
|
| 630 |
+
|
| 631 |
+
**Clinical Recommendation**
|
| 632 |
+
|
| 633 |
+
*Decision:* ELIGIBLE
|
| 634 |
+
|
| 635 |
+
*Rationale:*
|
| 636 |
+
- The patient meets the SASLT 2021 treatment criteria for chronic hepatitis B due to HBV DNA >20,000 IU/mL and ALT >2ΓULN (Grade B recommendation).
|
| 637 |
+
- Necroinflammatory activity (A2) further supports treatment initiation.
|
| 638 |
+
|
| 639 |
+
*Key Factors:*
|
| 640 |
+
- HBV DNA: 12,000,000 IU/mL (very high)
|
| 641 |
+
- ALT: 95 IU/L (>2ΓULN)
|
| 642 |
+
- HBeAg-positive status
|
| 643 |
+
- Moderate necroinflammation (A2)
|
| 644 |
+
- No contraindications or absolute exclusions
|
| 645 |
+
|
| 646 |
+
*Management Approach:*
|
| 647 |
+
|
| 648 |
+
|
| 649 |
+
**If ELIGIBLE (Standard Criteria):**
|
| 650 |
+
- Preferred agents: Entecavir (ETV), Tenofovir (TDF), or Tenofovir Alafenamide (TAF) [SASLT 2021, Page 8, Grade A]
|
| 651 |
+
- Monitor HBV DNA and ALT at 3, 6, 12 months, then every 6-12 months
|
| 652 |
+
|
| 653 |
+
|
| 654 |
+
**If NOT ELIGIBLE:**
|
| 655 |
+
- Monitor ALT every 3-6 months, HBV DNA every 6-12 months, fibrosis yearly [SASLT 2021, Page 7]
|
| 656 |
+
- Reassess if ALT rises >ULN, fibrosis progresses, or HBV DNA increases
|
| 657 |
+
|
| 658 |
+
*Final Recommendation:*
|
| 659 |
+
- The patient is eligible for treatment based on SASLT 2021 guidelines due to high HBV DNA levels and ALT >2ΓULN. Treatment initiation with a potent nucleos(t)ide analog (ETV, TDF, or TAF) is recommended to prevent disease progression."
|
| 660 |
+
Case5,22,F,No,Positive (18 months),25000000,Positive,27,F0,,No,,,No,No,,Not Eligible,Immune-tolerant <30 years β monitor.,"While the guidelines state patients >30 years with HBeAg-positive chronic HBV infection may be treated regardless of histology, this patient has HBV DNA >20,000 IU/mL. Although ALT is not >2ΓULN, the extremely high viral load (25 million IU/mL) and moderate necroinflammation warrant treatment consideration. The ""immune tolerant"" label may be premature without confirming truly minimal inflammation.",not eligible,Not Eligible,"Eligibility and Rationale:
|
| 661 |
+
- Not eligible: HBV DNA > 20,000 IU/mL but ALT Γ’β°Β€ 2xULN and age < 30 years (Grade B) [SASLT 2021, Page 6].
|
| 662 |
+
- No significant fibrosis or necroinflammation (F0-F1, A0) and no family history of HCC or cirrhosis [SASLT 2021, Page 6].
|
| 663 |
+
|
| 664 |
+
Treatment Recommendations:
|
| 665 |
+
- Treatment not indicated at this time [SASLT 2021, Page 6].
|
| 666 |
+
|
| 667 |
+
Monitoring and Follow-up:
|
| 668 |
+
- Monitor every 3-6 months for HBeAg-positive patients under 30 years (Grade B) [SASLT 2021, Page 7].
|
| 669 |
+
|
| 670 |
+
Special Considerations:
|
| 671 |
+
- None applicable to this patient.
|
| 672 |
+
|
| 673 |
+
References:
|
| 674 |
+
- Pages 6, 7: Treatment criteria, monitoring protocols",not eligible,"**Patient Summary**
|
| 675 |
+
- 22-year-old female, HBsAg-positive for 18 months
|
| 676 |
+
- HBV DNA: 25,000,000 IU/mL, ALT: 27 IU/L (normal)
|
| 677 |
+
- HBeAg-positive, Fibrosis stage: F0, Necroinflammatory activity: A0
|
| 678 |
+
|
| 679 |
+
|
| 680 |
+
**Treatment Eligibility Analysis**
|
| 681 |
+
|
| 682 |
+
*Absolute Indications Check (Priority):*
|
| 683 |
+
- β No HIV coinfection
|
| 684 |
+
- β Cirrhosis (F4): Not present (F0)
|
| 685 |
+
- β Immunosuppression: None
|
| 686 |
+
- β Pregnancy with high viral load: Not pregnant
|
| 687 |
+
|
| 688 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 689 |
+
- HBV DNA >2000 IU/mL: β
|
| 690 |
+
- ALT >ULN (40 IU/L): β
|
| 691 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
|
| 692 |
+
|
| 693 |
+
*Special Considerations:*
|
| 694 |
+
- No family history of HCC or cirrhosis
|
| 695 |
+
- Age <30 years
|
| 696 |
+
- No extrahepatic manifestations
|
| 697 |
+
|
| 698 |
+
|
| 699 |
+
**Clinical Recommendation**
|
| 700 |
+
|
| 701 |
+
*Decision:* NOT ELIGIBLE
|
| 702 |
+
|
| 703 |
+
*Rationale:*
|
| 704 |
+
- The patient does not meet the SASLT 2021 treatment criteria. While HBV DNA is significantly elevated (>2,000 IU/mL), ALT is normal (27 IU/L, below the ULN of 40 IU/L), and there is no evidence of moderate fibrosis (F2+) or necroinflammation (A2+).
|
| 705 |
+
- No absolute indications for treatment (e.g., cirrhosis, immunosuppression, pregnancy, or HIV coinfection) are present.
|
| 706 |
+
- Per SASLT guidelines, patients with normal ALT and no significant fibrosis or necroinflammation should be monitored rather than treated.
|
| 707 |
+
|
| 708 |
+
*Key Factors:*
|
| 709 |
+
- HBV DNA >20,000 IU/mL but ALT is normal
|
| 710 |
+
- Fibrosis stage F0, necroinflammatory activity A0
|
| 711 |
+
- No family history of HCC or cirrhosis
|
| 712 |
+
- Age <30 years, HBeAg-positive
|
| 713 |
+
|
| 714 |
+
*Management Approach:*
|
| 715 |
+
|
| 716 |
+
|
| 717 |
+
**If NOT ELIGIBLE:**
|
| 718 |
+
- Monitor ALT every 3-6 months, HBV DNA every 6-12 months, and fibrosis yearly [SASLT 2021, Page 7]
|
| 719 |
+
- Reassess eligibility if ALT rises >ULN, fibrosis progresses, or HBV DNA increases
|
| 720 |
+
|
| 721 |
+
*Final Recommendation:*
|
| 722 |
+
- The patient is not eligible for HBV treatment at this time. Monitoring is recommended per SASLT guidelines, with reassessment if clinical parameters change."
|
| 723 |
+
Case1,28,M,No,Positive (36 months),8500000,Positive,120,F1,Moderate,No,,,No,No,,Eligible,"HBV DNA >20,000 and ALT >2ΓULN β treat without biopsy.",,eligible,Eligible,"Eligibility and Rationale:
|
| 724 |
+
- Eligible: HBV DNA > 2,000 IU/mL and ALT > ULN, with moderate necroinflammation (Grade A) [SASLT 2021, Page 6]
|
| 725 |
+
- Meets criteria for treatment due to HBV DNA > 20,000 IU/mL and ALT > 2xULN (Grade B) [SASLT 2021, Page 6]
|
| 726 |
+
|
| 727 |
+
Treatment Recommendations:
|
| 728 |
+
- Start monotherapy with ETV, TDF, or TAF (Grade A) [SASLT 2021, Page 8]
|
| 729 |
+
|
| 730 |
+
Monitoring and Follow-up:
|
| 731 |
+
- Monitor treatment response per SASLT protocol every 3-6 months (Grade B) [SASLT 2021, Page 7]
|
| 732 |
+
|
| 733 |
+
Special Considerations:
|
| 734 |
+
- None applicable as patient has no coinfections, immunosuppression, or extrahepatic manifestations [SASLT 2021, Pages 6-9]
|
| 735 |
+
|
| 736 |
+
References:
|
| 737 |
+
- Pages 6, 7, 8: Treatment criteria, drugs, monitoring protocols",eligible,"**Patient Summary**
|
| 738 |
+
- 28-year-old male, HBsAg-positive for 36 months
|
| 739 |
+
- HBV DNA: 8,500,000 IU/mL (high viral load)
|
| 740 |
+
- ALT: 120 IU/L (>2ΓULN)
|
| 741 |
+
- HBeAg-positive, Fibrosis stage: F1, Necroinflammatory activity: A2
|
| 742 |
+
|
| 743 |
+
|
| 744 |
+
**Treatment Eligibility Analysis**
|
| 745 |
+
|
| 746 |
+
*Absolute Indications Check (Priority):*
|
| 747 |
+
- β No HIV coinfection
|
| 748 |
+
- β Cirrhosis (F4): Not present (F1)
|
| 749 |
+
- β Immunosuppression: None
|
| 750 |
+
- β Pregnancy with high viral load: Not applicable (male patient)
|
| 751 |
+
|
| 752 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 753 |
+
- HBV DNA >2000 IU/mL: β
|
| 754 |
+
- ALT >ULN (40 IU/L): β
|
| 755 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
(A2 necroinflammation present)
|
| 756 |
+
|
| 757 |
+
*Special Considerations:*
|
| 758 |
+
- Age <30 years, but meets criteria for high viral load and elevated ALT
|
| 759 |
+
- No family history of HCC or cirrhosis
|
| 760 |
+
- No extrahepatic manifestations
|
| 761 |
+
|
| 762 |
+
|
| 763 |
+
**Clinical Recommendation**
|
| 764 |
+
|
| 765 |
+
*Decision:* ELIGIBLE
|
| 766 |
+
|
| 767 |
+
*Rationale:*
|
| 768 |
+
- The patient meets the SASLT 2021 standard treatment criteria for chronic hepatitis B: HBV DNA >20,000 IU/mL and ALT >2ΓULN (Grade B recommendation).
|
| 769 |
+
- Additionally, the presence of moderate necroinflammatory activity (A2) supports treatment initiation.
|
| 770 |
+
|
| 771 |
+
*Key Factors:*
|
| 772 |
+
- HBV DNA: 8,500,000 IU/mL (significantly elevated)
|
| 773 |
+
- ALT: 120 IU/L (>2ΓULN)
|
| 774 |
+
- Necroinflammatory activity: A2 (moderate)
|
| 775 |
+
- HBeAg-positive status
|
| 776 |
+
|
| 777 |
+
*Management Approach:*
|
| 778 |
+
|
| 779 |
+
|
| 780 |
+
**If ELIGIBLE (Standard Criteria):**
|
| 781 |
+
- Preferred agents: Entecavir (ETV), Tenofovir (TDF), or Tenofovir Alafenamide (TAF) [SASLT 2021, Page 8, Grade A]
|
| 782 |
+
- Monitor HBV DNA and ALT at 3, 6, and 12 months, then every 6-12 months
|
| 783 |
+
|
| 784 |
+
|
| 785 |
+
**If NOT ELIGIBLE:**
|
| 786 |
+
- Not applicable (patient is eligible)
|
| 787 |
+
|
| 788 |
+
*Final Recommendation:*
|
| 789 |
+
- The patient is eligible for treatment based on SASLT 2021 guidelines due to high HBV DNA levels, elevated ALT, and moderate necroinflammatory activity. Initiate treatment with a potent nucleos(t)ide analog (ETV, TDF, or TAF) and monitor response closely."
|
| 790 |
+
Case10,63,M,No,Positive (300 months),50,Negative,32,F4 (decompensated),Mild,No,,,No,No,,Eligible,Decompensated cirrhosis with any detectable HBV DNA β treat.,,eligible,Eligible,"Eligibility and Rationale:
|
| 791 |
+
- Eligible: Patient has cirrhosis (F4 fibrosis) with detectable HBV DNA, regardless of ALT levels (Grade A) [SASLT 2021, Page 6].
|
| 792 |
+
|
| 793 |
+
Treatment Recommendations:
|
| 794 |
+
- Start monotherapy with ETV, TDF, or TAF as first-line treatment (Grade A) [SASLT 2021, Page 8].
|
| 795 |
+
|
| 796 |
+
Monitoring and Follow-up:
|
| 797 |
+
- Monitor treatment response per SASLT protocol, including HBV DNA and ALT levels every 3-6 months [SASLT 2021, Page 7].
|
| 798 |
+
|
| 799 |
+
Special Considerations:
|
| 800 |
+
- None applicable as patient has no coinfections, immunosuppression, or extrahepatic manifestations [SASLT 2021, Pages 6, 9].
|
| 801 |
+
|
| 802 |
+
References:
|
| 803 |
+
- Pages 6, 7, 8: Treatment criteria, drugs, monitoring protocols",eligible,"**Patient Summary**
|
| 804 |
+
- 63-year-old male with chronic HBV infection (HBsAg positive for 300 months)
|
| 805 |
+
- HBV DNA: 50.0 IU/mL (<2000 IU/mL), ALT: 32.0 IU/L (normal)
|
| 806 |
+
- HBeAg negative, fibrosis stage F4 (cirrhosis), necroinflammatory activity A1 (mild)
|
| 807 |
+
- No extrahepatic manifestations, immunosuppression, or coinfections
|
| 808 |
+
|
| 809 |
+
|
| 810 |
+
**Treatment Eligibility Analysis**
|
| 811 |
+
|
| 812 |
+
*Absolute Indications Check (Priority):*
|
| 813 |
+
|
| 814 |
+
- β No HIV coinfection
|
| 815 |
+
- β
Cirrhosis (F4): Present with detectable HBV DNA (50.0 IU/mL)
|
| 816 |
+
- β No immunosuppression
|
| 817 |
+
- β Not pregnant with high viral load
|
| 818 |
+
|
| 819 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 820 |
+
- HBV DNA >2000 IU/mL: β
|
| 821 |
+
- ALT >ULN (40 IU/L): β
|
| 822 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
(F4 present)
|
| 823 |
+
|
| 824 |
+
*Special Considerations:*
|
| 825 |
+
- Cirrhosis (F4) is an absolute indication for treatment per SASLT 2021 guidelines [Page 6]
|
| 826 |
+
- HBV DNA detectability (50.0 IU/mL) meets the threshold for cirrhotic patients [Page 6]
|
| 827 |
+
- No family history of HCC or cirrhosis, no extrahepatic manifestations
|
| 828 |
+
|
| 829 |
+
|
| 830 |
+
**Clinical Recommendation**
|
| 831 |
+
|
| 832 |
+
*Decision:* ELIGIBLE
|
| 833 |
+
|
| 834 |
+
*Rationale:*
|
| 835 |
+
- The patient meets the absolute indication for treatment due to cirrhosis (F4) with detectable HBV DNA (50.0 IU/mL), regardless of ALT level or HBV DNA threshold [SASLT 2021, Page 6, Grade A].
|
| 836 |
+
- Cirrhosis is a critical factor requiring antiviral therapy to prevent progression to decompensation or HCC.
|
| 837 |
+
|
| 838 |
+
*Key Factors:*
|
| 839 |
+
- Cirrhosis (F4) confirmed
|
| 840 |
+
- Detectable HBV DNA (50.0 IU/mL)
|
| 841 |
+
- Normal ALT (32.0 IU/L)
|
| 842 |
+
- No extrahepatic manifestations or coinfections
|
| 843 |
+
- No family history of HCC or cirrhosis
|
| 844 |
+
|
| 845 |
+
*Management Approach:*
|
| 846 |
+
|
| 847 |
+
|
| 848 |
+
**If ELIGIBLE (Standard Criteria):**
|
| 849 |
+
- Preferred agents: Entecavir (ETV), Tenofovir (TDF), or Tenofovir Alafenamide (TAF) [SASLT 2021, Page 8, Grade A]
|
| 850 |
+
- Monitor HBV DNA and ALT at 3, 6, and 12 months, then every 6-12 months
|
| 851 |
+
- Assess for complications of cirrhosis (e.g., HCC screening with ultrasound every 6 months)
|
| 852 |
+
|
| 853 |
+
|
| 854 |
+
**If NOT ELIGIBLE:**
|
| 855 |
+
- Not applicable as the patient is eligible for treatment
|
| 856 |
+
|
| 857 |
+
*Final Recommendation:*
|
| 858 |
+
- Initiate antiviral therapy with a potent nucleos(t)ide analog (ETV, TDF, or TAF) due to cirrhosis (F4) and detectable HBV DNA.
|
| 859 |
+
- Regular monitoring of HBV DNA, ALT, and cirrhosis-related complications is essential to optimize outcomes and prevent disease progression."
|
| 860 |
+
Case11,68,M,No,Positive (25 years),5800,Negative,41,F2,Mild,No,,,No,No,Diabetes,Eligible,"DNA >2,000 with ALT >ULN and Fβ₯2 β treat.",,eligible,Eligible,"Eligibility and Rationale:
|
| 861 |
+
- Eligible: HBV DNA > 2,000 IU/mL, ALT > ULN, and moderate fibrosis (F2-F3) (Grade A) [SASLT 2021, Page 6]
|
| 862 |
+
- Chronic HBV infection with significant liver disease warrants treatment initiation (Grade A) [SASLT 2021, Page 6]
|
| 863 |
+
|
| 864 |
+
Treatment Recommendations:
|
| 865 |
+
- Start monotherapy with ETV, TDF, or TAF as first-line treatment (Grade A) [SASLT 2021, Page 8]
|
| 866 |
+
|
| 867 |
+
Monitoring and Follow-up:
|
| 868 |
+
- Monitor treatment response per SASLT protocol, including HBV DNA and ALT levels every 3-6 months (Grade A) [SASLT 2021, Page 7]
|
| 869 |
+
|
| 870 |
+
Special Considerations:
|
| 871 |
+
- Patient's age (68 years) and comorbidity (diabetes) may require closer monitoring for treatment-related side effects [SASLT 2021, Page 6]
|
| 872 |
+
|
| 873 |
+
References:
|
| 874 |
+
- Pages 6, 7, 8: Treatment criteria, drugs, monitoring protocols",eligible,"**Patient Summary**
|
| 875 |
+
- 68-year-old male with chronic HBV infection (HBsAg positive for 300 months)
|
| 876 |
+
- HBV DNA: 5800 IU/mL (>2000 IU/mL), ALT: 41 IU/L (~ULN)
|
| 877 |
+
- Fibrosis stage: F2 (moderate), Necroinflammatory activity: A1 (mild)
|
| 878 |
+
- No cirrhosis, no extrahepatic manifestations, no family history of HCC/cirrhosis
|
| 879 |
+
|
| 880 |
+
|
| 881 |
+
**Treatment Eligibility Analysis**
|
| 882 |
+
|
| 883 |
+
*Absolute Indications Check (Priority):*
|
| 884 |
+
- β No HIV coinfection
|
| 885 |
+
- β Cirrhosis (F4): Not present (F2)
|
| 886 |
+
- β Immunosuppression: None
|
| 887 |
+
- β Pregnancy with high viral load: Not applicable
|
| 888 |
+
|
| 889 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 890 |
+
- HBV DNA >2000 IU/mL: β
|
| 891 |
+
- ALT >ULN (40 IU/L): β
|
| 892 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
(F2 present)
|
| 893 |
+
|
| 894 |
+
*Special Considerations:*
|
| 895 |
+
- Age >30 years (68 years old)
|
| 896 |
+
- No family history of HCC or cirrhosis
|
| 897 |
+
- Diabetes as a comorbidity
|
| 898 |
+
- Meets SASLT 2021 standard criteria for treatment initiation (HBV DNA >2000 IU/mL, ALT >ULN, and F2 fibrosis) [SASLT 2021, Page 6, Grade A]
|
| 899 |
+
|
| 900 |
+
|
| 901 |
+
**Clinical Recommendation**
|
| 902 |
+
|
| 903 |
+
*Decision:* ELIGIBLE
|
| 904 |
+
|
| 905 |
+
*Rationale:*
|
| 906 |
+
- The patient meets the SASLT 2021 standard criteria for treatment initiation based on HBV DNA >2000 IU/mL, ALT >ULN, and moderate fibrosis (F2).
|
| 907 |
+
- This recommendation is supported by SASLT 2021 guidelines [Page 6, Grade A].
|
| 908 |
+
|
| 909 |
+
*Key Factors:*
|
| 910 |
+
- HBV DNA: 5800 IU/mL (>2000 IU/mL)
|
| 911 |
+
- ALT: 41 IU/L (~ULN)
|
| 912 |
+
- Fibrosis stage: F2 (moderate)
|
| 913 |
+
- Age >30 years (68 years old)
|
| 914 |
+
- No absolute contraindications or exclusions
|
| 915 |
+
|
| 916 |
+
*Management Approach:*
|
| 917 |
+
|
| 918 |
+
|
| 919 |
+
**If ELIGIBLE (Standard Criteria):**
|
| 920 |
+
- Preferred agents: Entecavir (ETV), Tenofovir (TDF), or Tenofovir Alafenamide (TAF) [SASLT 2021, Page 8, Grade A]
|
| 921 |
+
- Monitor HBV DNA and ALT at 3, 6, 12 months, then every 6-12 months
|
| 922 |
+
|
| 923 |
+
|
| 924 |
+
**If NOT ELIGIBLE:**
|
| 925 |
+
- Monitor ALT every 3-6 months, HBV DNA every 6-12 months, fibrosis yearly [SASLT 2021, Page 7]
|
| 926 |
+
- Reassess if ALT rises >ULN, fibrosis progresses, or HBV DNA increases
|
| 927 |
+
|
| 928 |
+
*Final Recommendation:*
|
| 929 |
+
- The patient is eligible for HBV treatment based on SASLT 2021 guidelines due to HBV DNA >2000 IU/mL, ALT >ULN, and moderate fibrosis (F2).
|
| 930 |
+
- Initiate treatment with a potent nucleos(t)ide analog (ETV, TDF, or TAF) and monitor response regularly."
|
| 931 |
+
Case14,44,F,No,Positive (3 months),3000,Negative,70,F2,Moderate,No,,HCV RNA positive,No,No,,Eligible,Treat HBV in all HBV/HCV coinfected patients.,,eligible,Eligible,"Eligibility and Rationale:
|
| 932 |
+
- Eligible: HBV DNA > 2,000 IU/mL, ALT > ULN, and moderate fibrosis (Grade A) [SASLT 2021, Page 6].
|
| 933 |
+
- HBV-HCV coinfection requires concurrent or prior HBV treatment to prevent reactivation during DAA therapy (Grade A) [SASLT 2021, Page 9].
|
| 934 |
+
|
| 935 |
+
Treatment Recommendations:
|
| 936 |
+
- Start monotherapy with ETV, TDF, or TAF (Grade A) [SASLT 2021, Page 8].
|
| 937 |
+
|
| 938 |
+
Monitoring and Follow-up:
|
| 939 |
+
- Monitor HBV DNA and ALT every 4-8 weeks during DAA therapy and three months post-therapy (Grade D) [SASLT 2021, Page 9].
|
| 940 |
+
- Monitor treatment response per SASLT protocol (Grade A) [SASLT 2021, Page 7].
|
| 941 |
+
|
| 942 |
+
Special Considerations:
|
| 943 |
+
- HBV-HCV coinfection requires close monitoring to prevent HBV reactivation during HCV treatment (Grade A) [SASLT 2021, Page 9].
|
| 944 |
+
|
| 945 |
+
References:
|
| 946 |
+
- Pages 6, 7, 8, 9: Treatment criteria, drugs, monitoring, HBV-HCV coinfection",eligible,"**Patient Summary**
|
| 947 |
+
- 44-year-old female, HBsAg-positive for 3 months
|
| 948 |
+
- HBV DNA: 3000 IU/mL (>2000 IU/mL), ALT: 70 IU/L (>ULN)
|
| 949 |
+
- Fibrosis stage: F2 (moderate), Necroinflammatory activity: A2 (moderate)
|
| 950 |
+
- HBeAg-negative, no extrahepatic manifestations, no family history of HCC/cirrhosis
|
| 951 |
+
|
| 952 |
+
|
| 953 |
+
**Treatment Eligibility Analysis**
|
| 954 |
+
|
| 955 |
+
*Absolute Indications Check (Priority):*
|
| 956 |
+
|
| 957 |
+
- β No HIV coinfection
|
| 958 |
+
- β Cirrhosis (F4): Not present (F2)
|
| 959 |
+
- β Immunosuppression: None
|
| 960 |
+
- β Pregnancy with high viral load: Not pregnant
|
| 961 |
+
|
| 962 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 963 |
+
- HBV DNA >2000 IU/mL: β
|
| 964 |
+
- ALT >ULN (40 IU/L): β
|
| 965 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
|
| 966 |
+
|
| 967 |
+
*Special Considerations:*
|
| 968 |
+
- No family history of HCC or cirrhosis
|
| 969 |
+
- No extrahepatic manifestations
|
| 970 |
+
- Meets SASLT 2021 standard criteria for treatment: HBV DNA >2000 IU/mL, ALT >ULN, and moderate fibrosis (F2) or necroinflammation (A2) [SASLT 2021, Page 6, Grade A]
|
| 971 |
+
|
| 972 |
+
|
| 973 |
+
**Clinical Recommendation**
|
| 974 |
+
|
| 975 |
+
*Decision:* ELIGIBLE
|
| 976 |
+
|
| 977 |
+
*Rationale:*
|
| 978 |
+
- The patient meets the SASLT 2021 standard treatment criteria: HBV DNA >2000 IU/mL, ALT >ULN, and moderate fibrosis (F2) or necroinflammation (A2) [SASLT 2021, Page 6, Grade A].
|
| 979 |
+
- Treatment is recommended to prevent disease progression and reduce the risk of complications.
|
| 980 |
+
|
| 981 |
+
*Key Factors:*
|
| 982 |
+
- HBV DNA: 3000 IU/mL (>2000 IU/mL)
|
| 983 |
+
- ALT: 70 IU/L (>ULN of 40 IU/L)
|
| 984 |
+
- Fibrosis stage: F2 (moderate)
|
| 985 |
+
- Necroinflammatory activity: A2 (moderate)
|
| 986 |
+
- No contraindications or absolute exclusions
|
| 987 |
+
|
| 988 |
+
*Management Approach:*
|
| 989 |
+
|
| 990 |
+
|
| 991 |
+
**If ELIGIBLE (Standard Criteria):**
|
| 992 |
+
- Preferred agents: Entecavir (ETV), Tenofovir (TDF), or Tenofovir Alafenamide (TAF) [SASLT 2021, Page 8, Grade A]
|
| 993 |
+
- Monitor HBV DNA and ALT at 3, 6, 12 months, then every 6-12 months
|
| 994 |
+
|
| 995 |
+
|
| 996 |
+
**If NOT ELIGIBLE:**
|
| 997 |
+
- Not applicable (patient is eligible)
|
| 998 |
+
|
| 999 |
+
*Final Recommendation:*
|
| 1000 |
+
- The patient is eligible for HBV treatment based on SASLT 2021 guidelines due to HBV DNA >2000 IU/mL, ALT >ULN, and moderate fibrosis (F2).
|
| 1001 |
+
- Initiate treatment with a preferred nucleos(t)ide analog (ETV, TDF, or TAF) and monitor response regularly."
|
| 1002 |
+
Case16,30,F,Yes (30 weeks),Positive,40000,Positive,28,F0,,No,,,No,No,,Not Eligible,"Pregnant but DNA <100,000 IU/mL β monitor only.",,not eligible,Not Eligible,"Eligibility and Rationale:
|
| 1003 |
+
- Not eligible: HBV DNA > 2,000 IU/mL but ALT Γ’β°Β€ ULN and no significant fibrosis or necroinflammation [SASLT 2021, Page 6].
|
| 1004 |
+
- Pregnancy alone does not meet treatment criteria unless HBV DNA > 100,000 IU/mL at 24-28 weeks [SASLT 2021, Page 10].
|
| 1005 |
+
|
| 1006 |
+
Treatment Recommendations:
|
| 1007 |
+
- Treatment not indicated at this time [SASLT 2021, Page 6].
|
| 1008 |
+
|
| 1009 |
+
Monitoring and Follow-up:
|
| 1010 |
+
- Monitor every 3-6 months for HBeAg-positive patients under 30 years (Grade B) [SASLT 2021, Page 7].
|
| 1011 |
+
- Assess HBV DNA and ALT levels regularly to evaluate disease progression [SASLT 2021, Page 6].
|
| 1012 |
+
|
| 1013 |
+
Special Considerations:
|
| 1014 |
+
- Consider antiviral prophylaxis with TDF if HBV DNA exceeds 100,000 IU/mL at 24-28 weeks of pregnancy [SASLT 2021, Page 10].
|
| 1015 |
+
|
| 1016 |
+
References:
|
| 1017 |
+
- Pages 6, 7, 10: Treatment criteria, monitoring protocols, pregnancy considerations",not eligible,"**Patient Summary**
|
| 1018 |
+
- Female, 30 years old, pregnant
|
| 1019 |
+
- HBsAg positive for 6 months, HBV DNA 40,000 IU/mL
|
| 1020 |
+
- ALT 28 IU/L (normal), Fibrosis stage F0, Necroinflammatory activity A2
|
| 1021 |
+
|
| 1022 |
+
|
| 1023 |
+
**Treatment Eligibility Analysis**
|
| 1024 |
+
|
| 1025 |
+
*Absolute Indications Check (Priority):*
|
| 1026 |
+
|
| 1027 |
+
- β No HIV coinfection
|
| 1028 |
+
- β No cirrhosis (F0)
|
| 1029 |
+
- β No immunosuppression
|
| 1030 |
+
- β Pregnancy with high viral load: HBV DNA 40,000 IU/mL (<100,000 IU/mL threshold)
|
| 1031 |
+
|
| 1032 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 1033 |
+
- HBV DNA >2000 IU/mL: β
|
| 1034 |
+
- ALT >ULN (40 IU/L): β
|
| 1035 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β (Fibrosis F0, Necroinflammation A2)
|
| 1036 |
+
|
| 1037 |
+
*Special Considerations:*
|
| 1038 |
+
- No family history of HCC or cirrhosis
|
| 1039 |
+
- No extrahepatic manifestations
|
| 1040 |
+
- Patient is HBeAg positive but age is exactly 30 years (does not meet >30 years threshold)
|
| 1041 |
+
|
| 1042 |
+
|
| 1043 |
+
**Clinical Recommendation**
|
| 1044 |
+
|
| 1045 |
+
*Decision:* NOT ELIGIBLE
|
| 1046 |
+
|
| 1047 |
+
*Rationale:*
|
| 1048 |
+
- The patient does not meet any absolute indications for treatment (e.g., HIV coinfection, cirrhosis, immunosuppression, or pregnancy with HBV DNA >100,000 IU/mL).
|
| 1049 |
+
- Standard criteria are not met due to normal ALT levels (28 IU/L < ULN of 40 IU/L) and absence of moderate fibrosis (F0).
|
| 1050 |
+
- SASLT guidelines require HBV DNA >2,000 IU/mL AND ALT >ULN (~40 IU/L) AND moderate necroinflammation/fibrosis (F2+/A2+) for treatment initiation in non-cirrhotic patients [SASLT 2021, Page 6].
|
| 1051 |
+
|
| 1052 |
+
*Key Factors:*
|
| 1053 |
+
- HBV DNA is elevated (>2,000 IU/mL), but ALT is normal.
|
| 1054 |
+
- Fibrosis stage is F0 (no fibrosis).
|
| 1055 |
+
- Pregnancy does not meet the high viral load threshold for treatment (>100,000 IU/mL).
|
| 1056 |
+
- No family history or extrahepatic manifestations.
|
| 1057 |
+
|
| 1058 |
+
*Management Approach:*
|
| 1059 |
+
|
| 1060 |
+
|
| 1061 |
+
**If NOT ELIGIBLE:**
|
| 1062 |
+
- Monitor ALT every 3-6 months, HBV DNA every 6-12 months, fibrosis yearly [SASLT 2021, Page 7].
|
| 1063 |
+
- Reassess eligibility if ALT rises >ULN, fibrosis progresses, or HBV DNA increases.
|
| 1064 |
+
|
| 1065 |
+
*Final Recommendation:*
|
| 1066 |
+
- The patient is not eligible for HBV treatment at this time based on SASLT 2021 guidelines.
|
| 1067 |
+
- Regular monitoring is recommended to assess for changes in ALT, HBV DNA levels, or fibrosis progression."
|
| 1068 |
+
Case17,39,M,No,Positive,4800,Negative,250,F1,Marked,No,,,No,No,,Eligible,"ALT >2ΓULN and DNA >2,000 IU/mL β immune-active.",,eligible,Eligible,"Eligibility and Rationale:
|
| 1069 |
+
- Eligible: HBV DNA > 2,000 IU/mL and ALT > ULN, regardless of HBeAg status (Grade A) [SASLT 2021, Page 6]
|
| 1070 |
+
- ALT > 2x ULN supports treatment initiation (Grade B) [SASLT 2021, Page 6]
|
| 1071 |
+
|
| 1072 |
+
Treatment Recommendations:
|
| 1073 |
+
- Start monotherapy with ETV, TDF, or TAF (Grade A) [SASLT 2021, Page 8]
|
| 1074 |
+
|
| 1075 |
+
Monitoring and Follow-up:
|
| 1076 |
+
- Monitor treatment response per SASLT protocol every 3-6 months (Grade B) [SASLT 2021, Page 7]
|
| 1077 |
+
|
| 1078 |
+
Special Considerations:
|
| 1079 |
+
- None applicable to this patient [SASLT 2021, Pages 6-10]
|
| 1080 |
+
|
| 1081 |
+
References:
|
| 1082 |
+
- Pages 6, 7, 8: Treatment criteria, drugs, monitoring protocols",eligible,"**Patient Summary**
|
| 1083 |
+
- Male, 39 years old
|
| 1084 |
+
- HBsAg positive for 6 months
|
| 1085 |
+
- HBV DNA: 4800 IU/mL (>2000 IU/mL)
|
| 1086 |
+
- ALT: 250 IU/L (>ULN)
|
| 1087 |
+
- Fibrosis stage: F1
|
| 1088 |
+
- Necroinflammatory activity: A3 (severe)
|
| 1089 |
+
|
| 1090 |
+
|
| 1091 |
+
**Treatment Eligibility Analysis**
|
| 1092 |
+
|
| 1093 |
+
*Absolute Indications Check (Priority):*
|
| 1094 |
+
|
| 1095 |
+
- β No HIV coinfection
|
| 1096 |
+
- β Cirrhosis (F4): Fibrosis stage is F1
|
| 1097 |
+
- β Immunosuppression: None
|
| 1098 |
+
- β Pregnancy with high viral load: Not pregnant
|
| 1099 |
+
|
| 1100 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 1101 |
+
- HBV DNA >2000 IU/mL: β
|
| 1102 |
+
- ALT >ULN (40 IU/L): β
|
| 1103 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
(A3 necroinflammation)
|
| 1104 |
+
|
| 1105 |
+
*Special Considerations:*
|
| 1106 |
+
- No family history of HCC or cirrhosis
|
| 1107 |
+
- No extrahepatic manifestations
|
| 1108 |
+
- Meets SASLT 2021 criteria for treatment initiation based on HBV DNA >2000 IU/mL, ALT >ULN, and severe necroinflammation (A3) [SASLT 2021, Page 6]
|
| 1109 |
+
|
| 1110 |
+
|
| 1111 |
+
**Clinical Recommendation**
|
| 1112 |
+
|
| 1113 |
+
*Decision:* ELIGIBLE
|
| 1114 |
+
|
| 1115 |
+
*Rationale:*
|
| 1116 |
+
- The patient meets the SASLT 2021 standard criteria for treatment initiation due to HBV DNA >2000 IU/mL, ALT >ULN (~40 IU/L), and severe necroinflammation (A3).
|
| 1117 |
+
- Grade A recommendation for treatment initiation [SASLT 2021, Page 6].
|
| 1118 |
+
|
| 1119 |
+
*Key Factors:*
|
| 1120 |
+
- HBV DNA level exceeds 2000 IU/mL
|
| 1121 |
+
- ALT significantly elevated at 250 IU/L (>ULN)
|
| 1122 |
+
- Severe necroinflammatory activity (A3)
|
| 1123 |
+
- No contraindications or absolute indications overriding standard criteria
|
| 1124 |
+
|
| 1125 |
+
*Management Approach:*
|
| 1126 |
+
|
| 1127 |
+
|
| 1128 |
+
**If ELIGIBLE (Standard Criteria):**
|
| 1129 |
+
- Preferred agents: Entecavir (ETV), Tenofovir (TDF), or Tenofovir Alafenamide (TAF) [SASLT 2021, Page 8, Grade A]
|
| 1130 |
+
- Monitor HBV DNA and ALT at 3, 6, 12 months, then every 6-12 months
|
| 1131 |
+
|
| 1132 |
+
|
| 1133 |
+
**If NOT ELIGIBLE:**
|
| 1134 |
+
- Not applicable as patient is eligible
|
| 1135 |
+
|
| 1136 |
+
*Final Recommendation:*
|
| 1137 |
+
- The patient is eligible for HBV treatment based on SASLT 2021 guidelines due to elevated HBV DNA, ALT, and severe necroinflammation. Treatment initiation with a potent nucleos(t)ide analog is recommended."
|
| 1138 |
+
Case18,49,F,No,Positive (3 months),2300,Negative,37,F1,Mild,No,,,Yes (mother cirrhosis),No,,Eligible,Borderline case with family history β treat per guideline consideration.,,Eligible,Eligible,"Eligibility and Rationale:
|
| 1139 |
+
- Eligible: HBV DNA > 2,000 IU/mL, ALT > ULN, and family history of HCC or cirrhosis (Grade D) [SASLT 2021, Page 6].
|
| 1140 |
+
|
| 1141 |
+
Treatment Recommendations:
|
| 1142 |
+
- Start monotherapy with ETV, TDF, or TAF (Grade A) [SASLT 2021, Page 8].
|
| 1143 |
+
|
| 1144 |
+
Monitoring and Follow-up:
|
| 1145 |
+
- Monitor treatment response per SASLT protocol, including HBV DNA and ALT levels every 3-6 months [SASLT 2021, Page 7].
|
| 1146 |
+
|
| 1147 |
+
Special Considerations:
|
| 1148 |
+
- Family history of HCC or cirrhosis increases the need for treatment to reduce long-term risks [SASLT 2021, Page 6].
|
| 1149 |
+
|
| 1150 |
+
References:
|
| 1151 |
+
- Pages 6, 7, 8: Treatment criteria, drugs, monitoring protocols",not eligible,"**Patient Summary**
|
| 1152 |
+
- Female, 49 years old
|
| 1153 |
+
- HBsAg positive for 3 months, HBV DNA 2300 IU/mL
|
| 1154 |
+
- ALT 37 IU/L (below ULN), Fibrosis stage F1, Necroinflammatory activity A1
|
| 1155 |
+
- HBeAg negative, family history of cirrhosis/HCC
|
| 1156 |
+
|
| 1157 |
+
|
| 1158 |
+
**Treatment Eligibility Analysis**
|
| 1159 |
+
|
| 1160 |
+
*Absolute Indications Check (Priority):*
|
| 1161 |
+
- β No HIV coinfection
|
| 1162 |
+
- β Cirrhosis (F4): Patient has F1 fibrosis
|
| 1163 |
+
- β Immunosuppression: None
|
| 1164 |
+
- β Pregnancy with high viral load: Not pregnant
|
| 1165 |
+
|
| 1166 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 1167 |
+
- HBV DNA >2000 IU/mL: β
|
| 1168 |
+
- ALT >ULN (40 IU/L): β
|
| 1169 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
|
| 1170 |
+
|
| 1171 |
+
*Special Considerations:*
|
| 1172 |
+
- Family history of cirrhosis/HCC is present, but ALT is below ULN and fibrosis is mild (F1)
|
| 1173 |
+
- SASLT guidelines require ALT >ULN or at least moderate fibrosis (F2+) for treatment eligibility [SASLT 2021, Page 6]
|
| 1174 |
+
|
| 1175 |
+
|
| 1176 |
+
**Clinical Recommendation**
|
| 1177 |
+
|
| 1178 |
+
*Decision:* NOT ELIGIBLE
|
| 1179 |
+
|
| 1180 |
+
*Rationale:*
|
| 1181 |
+
- The patient does not meet the SASLT 2021 standard criteria for treatment initiation. While HBV DNA is >2000 IU/mL, ALT is below ULN, and fibrosis is mild (F1). Family history alone is insufficient for eligibility without elevated ALT or moderate fibrosis.
|
| 1182 |
+
- SASLT guidelines recommend monitoring for patients with HBV DNA >2000 IU/mL and ALT β€ULN unless moderate fibrosis (F2+) or other absolute indications are present [SASLT 2021, Page 6].
|
| 1183 |
+
|
| 1184 |
+
*Key Factors:*
|
| 1185 |
+
- HBV DNA >2000 IU/mL (2300 IU/mL)
|
| 1186 |
+
- ALT below ULN (37 IU/L vs 40 IU/L)
|
| 1187 |
+
- Mild fibrosis (F1) and mild necroinflammation (A1)
|
| 1188 |
+
- Family history of cirrhosis/HCC
|
| 1189 |
+
|
| 1190 |
+
*Management Approach:*
|
| 1191 |
+
|
| 1192 |
+
|
| 1193 |
+
**If NOT ELIGIBLE:**
|
| 1194 |
+
- Monitor ALT every 3-6 months, HBV DNA every 6-12 months, and fibrosis progression yearly [SASLT 2021, Page 7].
|
| 1195 |
+
- Reassess eligibility if ALT rises >ULN, fibrosis progresses to F2+, or HBV DNA increases significantly.
|
| 1196 |
+
|
| 1197 |
+
*Final Recommendation:*
|
| 1198 |
+
- The patient is not currently eligible for HBV treatment under SASLT 2021 guidelines. Regular monitoring is recommended to reassess eligibility if clinical parameters change."
|
| 1199 |
+
Case2,45,F,No,Positive (60 months),15000,Negative,65,F1βF2,Moderate,No,,,No,No,Metabolic syndrome,Eligible,"Chronic hepatitis B (HBV DNA >2,000 and ALT >ULN).",,eligible,Eligible,"Eligibility and Rationale:
|
| 1200 |
+
- Eligible: HBV DNA > 2,000 IU/mL, ALT > ULN, moderate fibrosis (Grade A) [SASLT 2021, Page 6]
|
| 1201 |
+
- Necroinflammatory activity (A2) supports treatment initiation (Grade A) [SASLT 2021, Page 6]
|
| 1202 |
+
|
| 1203 |
+
Treatment Recommendations:
|
| 1204 |
+
- Start monotherapy with ETV, TDF, or TAF (Grade A) [SASLT 2021, Page 8]
|
| 1205 |
+
|
| 1206 |
+
Monitoring and Follow-up:
|
| 1207 |
+
- Monitor treatment response per SASLT protocol every 3-6 months (Grade D) [SASLT 2021, Page 7]
|
| 1208 |
+
|
| 1209 |
+
Special Considerations:
|
| 1210 |
+
- Metabolic syndrome may require additional management alongside HBV treatment [SASLT 2021, Page 6]
|
| 1211 |
+
|
| 1212 |
+
References:
|
| 1213 |
+
- Pages 6, 7, 8: Treatment criteria, drugs, monitoring protocols",eligible,"**Patient Summary**
|
| 1214 |
+
- 45-year-old female, HBsAg-positive for 60 months
|
| 1215 |
+
- HBV DNA: 15,000 IU/mL, ALT: 65 IU/L (>ULN)
|
| 1216 |
+
- Fibrosis stage: F2, Necroinflammatory activity: A2
|
| 1217 |
+
- HBeAg-negative, no extrahepatic manifestations or family history of HCC/cirrhosis
|
| 1218 |
+
|
| 1219 |
+
|
| 1220 |
+
**Treatment Eligibility Analysis**
|
| 1221 |
+
|
| 1222 |
+
*Absolute Indications Check (Priority):*
|
| 1223 |
+
- β No HIV coinfection
|
| 1224 |
+
- β Cirrhosis (F4): Not present (F2)
|
| 1225 |
+
- β Immunosuppression: None
|
| 1226 |
+
- β Pregnancy with high viral load: Not pregnant
|
| 1227 |
+
|
| 1228 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 1229 |
+
- HBV DNA >2000 IU/mL: β
|
| 1230 |
+
- ALT >ULN (40 IU/L): β
|
| 1231 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
|
| 1232 |
+
|
| 1233 |
+
*Special Considerations:*
|
| 1234 |
+
- No family history of HCC or cirrhosis
|
| 1235 |
+
- No extrahepatic manifestations
|
| 1236 |
+
- Meets standard triple criteria for treatment initiation per SASLT 2021 guidelines [Page 6]
|
| 1237 |
+
|
| 1238 |
+
|
| 1239 |
+
**Clinical Recommendation**
|
| 1240 |
+
|
| 1241 |
+
*Decision:* ELIGIBLE
|
| 1242 |
+
|
| 1243 |
+
*Rationale:*
|
| 1244 |
+
- The patient meets the standard triple criteria for treatment initiation: HBV DNA >2000 IU/mL, ALT >ULN, and moderate fibrosis (F2) and necroinflammation (A2) [SASLT 2021, Page 6, Grade A].
|
| 1245 |
+
- Treatment is recommended to prevent disease progression and reduce the risk of complications.
|
| 1246 |
+
|
| 1247 |
+
*Key Factors:*
|
| 1248 |
+
- HBV DNA: 15,000 IU/mL (>2000 IU/mL threshold)
|
| 1249 |
+
- ALT: 65 IU/L (>ULN of 40 IU/L)
|
| 1250 |
+
- Fibrosis stage: F2 (moderate fibrosis)
|
| 1251 |
+
- Necroinflammatory activity: A2 (moderate)
|
| 1252 |
+
|
| 1253 |
+
*Management Approach:*
|
| 1254 |
+
|
| 1255 |
+
|
| 1256 |
+
**If ELIGIBLE (Standard Criteria):**
|
| 1257 |
+
- Preferred agents: Entecavir (ETV), Tenofovir (TDF), or Tenofovir Alafenamide (TAF) [SASLT 2021, Page 8, Grade A]
|
| 1258 |
+
- Monitor HBV DNA and ALT at 3, 6, and 12 months, then every 6-12 months
|
| 1259 |
+
|
| 1260 |
+
*Final Recommendation:*
|
| 1261 |
+
- The patient is eligible for HBV treatment based on SASLT 2021 guidelines due to elevated HBV DNA, ALT >ULN, and moderate fibrosis and necroinflammation.
|
| 1262 |
+
- Initiate treatment with a preferred nucleos(t)ide analog (ETV, TDF, or TAF) and monitor response regularly."
|
| 1263 |
+
Case20,41,F,No,Positive (10 Months),1900,Negative,28,F1,Mild,No,,,No,No,,Not Eligible,Seroconverted with low DNA β continue monitoring only.,,not eligible,Not Eligible,"Eligibility and Rationale:
|
| 1264 |
+
- Not eligible: HBV DNA < 2,000 IU/mL, ALT Γ’β°Β€ ULN, no significant fibrosis or necroinflammation (Grade A) [SASLT 2021, Page 6]
|
| 1265 |
+
|
| 1266 |
+
Treatment Recommendations:
|
| 1267 |
+
- Treatment not indicated at this time [SASLT 2021, Page 6]
|
| 1268 |
+
|
| 1269 |
+
Monitoring and Follow-up:
|
| 1270 |
+
- Monitor every 6-12 months (HBeAg-negative, HBV DNA < 2,000 IU/mL) (Grade B) [SASLT 2021, Page 7]
|
| 1271 |
+
|
| 1272 |
+
Special Considerations:
|
| 1273 |
+
- None applicable to this patient [SASLT 2021, Page 6]
|
| 1274 |
+
|
| 1275 |
+
References:
|
| 1276 |
+
- Pages 6, 7: Treatment criteria, monitoring protocols",not eligible,"**Patient Summary**
|
| 1277 |
+
- Female, 41 years old
|
| 1278 |
+
- HBsAg positive for 6 months
|
| 1279 |
+
- HBV DNA: 1900 IU/mL (<2000 IU/mL)
|
| 1280 |
+
- ALT: 28 IU/L (normal, <40 IU/L)
|
| 1281 |
+
- Fibrosis stage: F1 (mild)
|
| 1282 |
+
- Necroinflammatory activity: A1 (mild)
|
| 1283 |
+
|
| 1284 |
+
|
| 1285 |
+
**Treatment Eligibility Analysis**
|
| 1286 |
+
|
| 1287 |
+
*Absolute Indications Check (Priority):*
|
| 1288 |
+
|
| 1289 |
+
- β No HIV coinfection
|
| 1290 |
+
- β Cirrhosis (F4): Patient has F1 fibrosis
|
| 1291 |
+
- β Immunosuppression: None
|
| 1292 |
+
- β Pregnancy with high viral load: Not pregnant, HBV DNA <100,000 IU/mL
|
| 1293 |
+
|
| 1294 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 1295 |
+
- HBV DNA >2000 IU/mL: β
|
| 1296 |
+
- ALT >ULN (40 IU/L): β
|
| 1297 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
|
| 1298 |
+
|
| 1299 |
+
*Special Considerations:*
|
| 1300 |
+
- No family history of HCC or cirrhosis
|
| 1301 |
+
- No extrahepatic manifestations
|
| 1302 |
+
- Age >30 years, but does not meet other criteria for treatment
|
| 1303 |
+
|
| 1304 |
+
|
| 1305 |
+
**Clinical Recommendation**
|
| 1306 |
+
|
| 1307 |
+
*Decision:* NOT ELIGIBLE
|
| 1308 |
+
|
| 1309 |
+
*Rationale:*
|
| 1310 |
+
- The patient does not meet the SASLT 2021 criteria for HBV treatment initiation. HBV DNA is below the required threshold of >2000 IU/mL, ALT is normal (<40 IU/L), and liver biopsy shows only mild fibrosis (F1) and mild necroinflammation (A1).
|
| 1311 |
+
- No absolute indications such as cirrhosis, immunosuppression, or pregnancy with high viral load apply.
|
| 1312 |
+
|
| 1313 |
+
*Key Factors:*
|
| 1314 |
+
- HBV DNA: 1900 IU/mL (<2000 IU/mL)
|
| 1315 |
+
- ALT: 28 IU/L (normal)
|
| 1316 |
+
- Fibrosis stage: F1 (mild)
|
| 1317 |
+
- Necroinflammatory activity: A1 (mild)
|
| 1318 |
+
- No absolute indications (e.g., cirrhosis, immunosuppression, pregnancy)
|
| 1319 |
+
|
| 1320 |
+
*Management Approach:*
|
| 1321 |
+
|
| 1322 |
+
|
| 1323 |
+
**If NOT ELIGIBLE:**
|
| 1324 |
+
- Monitor ALT every 3-6 months, HBV DNA every 6-12 months, fibrosis yearly [SASLT 2021, Page 7]
|
| 1325 |
+
- Reassess if ALT rises >ULN, fibrosis progresses, or HBV DNA increases
|
| 1326 |
+
|
| 1327 |
+
*Final Recommendation:*
|
| 1328 |
+
- The patient does not currently qualify for HBV treatment based on SASLT 2021 guidelines. Regular monitoring of HBV DNA, ALT, and fibrosis is recommended to reassess eligibility in the future if clinical parameters change."
|
| 1329 |
+
Case23,46,M,No,Positive (8 Months),50000,Negative,48,F2,Moderate,Yes (vasculitis),,,No,No,,Eligible,Presence of extrahepatic manifestation β treat.,,eligible,Eligible,"Eligibility and Rationale:
|
| 1330 |
+
- Eligible: HBV DNA > 2,000 IU/mL, ALT > ULN, moderate fibrosis (Grade A) [SASLT 2021, Page 6]
|
| 1331 |
+
- Extrahepatic manifestations further support treatment initiation (Grade D) [SASLT 2021, Page 6]
|
| 1332 |
+
|
| 1333 |
+
Treatment Recommendations:
|
| 1334 |
+
- Start monotherapy with ETV, TDF, or TAF (Grade A) [SASLT 2021, Page 8]
|
| 1335 |
+
|
| 1336 |
+
Monitoring and Follow-up:
|
| 1337 |
+
- Monitor treatment response every 3-6 months per SASLT protocol (Grade B) [SASLT 2021, Page 7]
|
| 1338 |
+
|
| 1339 |
+
Special Considerations:
|
| 1340 |
+
- None applicable to this patient.
|
| 1341 |
+
|
| 1342 |
+
References:
|
| 1343 |
+
- Pages 6, 7, 8: Treatment criteria, drugs, monitoring protocols",eligible,"**Patient Summary**
|
| 1344 |
+
- Male, 46 years old
|
| 1345 |
+
- HBsAg positive for 6 months
|
| 1346 |
+
- HBV DNA: 50,000 IU/mL (>2,000 IU/mL)
|
| 1347 |
+
- ALT: 48 IU/L (>ULN ~40 IU/L)
|
| 1348 |
+
- Fibrosis stage: F2 (moderate)
|
| 1349 |
+
- Necroinflammatory activity: A2 (moderate)
|
| 1350 |
+
- Extrahepatic manifestations present
|
| 1351 |
+
|
| 1352 |
+
|
| 1353 |
+
**Treatment Eligibility Analysis**
|
| 1354 |
+
|
| 1355 |
+
*Absolute Indications Check (Priority):*
|
| 1356 |
+
|
| 1357 |
+
- β No HIV coinfection
|
| 1358 |
+
- β Cirrhosis (F4): Patient has F2 fibrosis
|
| 1359 |
+
- β Immunosuppression: None
|
| 1360 |
+
- β Pregnancy with high viral load: Not pregnant
|
| 1361 |
+
|
| 1362 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 1363 |
+
- HBV DNA >2000 IU/mL: β
|
| 1364 |
+
- ALT >ULN (40 IU/L): β
|
| 1365 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
|
| 1366 |
+
|
| 1367 |
+
*Special Considerations:*
|
| 1368 |
+
- Extrahepatic manifestations present, which increase risk of complications
|
| 1369 |
+
- Patient meets standard triple criteria: HBV DNA >2,000 IU/mL, ALT >ULN, and moderate fibrosis/necroinflammation
|
| 1370 |
+
- SASLT 2021 guidelines recommend treatment initiation for patients meeting these criteria [Page 6, Grade A]
|
| 1371 |
+
|
| 1372 |
+
|
| 1373 |
+
**Clinical Recommendation**
|
| 1374 |
+
|
| 1375 |
+
*Decision:* ELIGIBLE
|
| 1376 |
+
|
| 1377 |
+
*Rationale:*
|
| 1378 |
+
- The patient meets the standard treatment criteria outlined in SASLT 2021 guidelines: HBV DNA >2,000 IU/mL, ALT >ULN (~40 IU/L), and moderate fibrosis (F2) and necroinflammation (A2).
|
| 1379 |
+
- Extrahepatic manifestations further support the need for treatment initiation.
|
| 1380 |
+
- Grade A recommendation for treatment initiation based on SASLT guidelines [Page 6].
|
| 1381 |
+
|
| 1382 |
+
*Key Factors:*
|
| 1383 |
+
- HBV DNA significantly elevated at 50,000 IU/mL
|
| 1384 |
+
- ALT above ULN at 48 IU/L
|
| 1385 |
+
- Moderate fibrosis (F2) and necroinflammation (A2)
|
| 1386 |
+
- Presence of extrahepatic manifestations
|
| 1387 |
+
|
| 1388 |
+
*Management Approach:*
|
| 1389 |
+
|
| 1390 |
+
|
| 1391 |
+
**If ELIGIBLE (Standard Criteria):**
|
| 1392 |
+
- Preferred agents: Entecavir (ETV), Tenofovir (TDF), or Tenofovir Alafenamide (TAF) [SASLT 2021, Page 8, Grade A]
|
| 1393 |
+
- Monitor HBV DNA and ALT at 3, 6, and 12 months, then every 6-12 months
|
| 1394 |
+
|
| 1395 |
+
|
| 1396 |
+
**If NOT ELIGIBLE:**
|
| 1397 |
+
- Not applicable as patient is eligible
|
| 1398 |
+
|
| 1399 |
+
*Final Recommendation:*
|
| 1400 |
+
- The patient is eligible for treatment initiation based on SASLT 2021 guidelines due to elevated HBV DNA, ALT above ULN, moderate fibrosis, and necroinflammation. Extrahepatic manifestations further support treatment.
|
| 1401 |
+
- Initiate therapy with a potent nucleos(t)ide analog such as TDF, TAF, or ETV."
|
| 1402 |
+
Case25,29,M,No,Positive,2500000,Positive,33,F0,,No,,,No,No,,Not Eligible,"Immune-tolerant phase, <30 years β monitor.",,not eligible,Not Eligible,"Eligibility and Rationale:
|
| 1403 |
+
- Not eligible: HBV DNA > 2,000 IU/mL but ALT Γ’β°Β€ ULN and no significant fibrosis or necroinflammation [SASLT 2021, Page 6].
|
| 1404 |
+
|
| 1405 |
+
Treatment Recommendations:
|
| 1406 |
+
- Treatment not indicated at this time [SASLT 2021, Page 6].
|
| 1407 |
+
|
| 1408 |
+
Monitoring and Follow-up:
|
| 1409 |
+
- Monitor every 3-6 months (HBeAg-positive, HBV DNA > 2,000 IU/mL, ALT Γ’β°Β€ ULN) (Grade B) [SASLT 2021, Page 7].
|
| 1410 |
+
|
| 1411 |
+
Special Considerations:
|
| 1412 |
+
- None applicable to this patient.
|
| 1413 |
+
|
| 1414 |
+
References:
|
| 1415 |
+
- Pages 6, 7: Treatment criteria, monitoring protocols",not eligible,"**Patient Summary**
|
| 1416 |
+
- Male, 29 years old
|
| 1417 |
+
- HBsAg positive for 6 months
|
| 1418 |
+
- HBV DNA: 2,500,000 IU/mL
|
| 1419 |
+
- ALT: 33 IU/L (normal)
|
| 1420 |
+
- Fibrosis stage: F0 (no fibrosis)
|
| 1421 |
+
- Necroinflammatory activity: A0 (none)
|
| 1422 |
+
|
| 1423 |
+
|
| 1424 |
+
**Treatment Eligibility Analysis**
|
| 1425 |
+
|
| 1426 |
+
*Absolute Indications Check (Priority):*
|
| 1427 |
+
|
| 1428 |
+
- β No HIV coinfection
|
| 1429 |
+
- β Cirrhosis (F4): Patient has F0 fibrosis
|
| 1430 |
+
- β Immunosuppression: None reported
|
| 1431 |
+
- β Pregnancy with high viral load: Patient is male
|
| 1432 |
+
|
| 1433 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 1434 |
+
- HBV DNA >2000 IU/mL: β
|
| 1435 |
+
- ALT >ULN (40 IU/L): β
|
| 1436 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
|
| 1437 |
+
|
| 1438 |
+
*Special Considerations:*
|
| 1439 |
+
- Age <30 years: Patient is 29 years old
|
| 1440 |
+
- No family history of HCC or cirrhosis
|
| 1441 |
+
- No extrahepatic manifestations
|
| 1442 |
+
|
| 1443 |
+
|
| 1444 |
+
**Clinical Recommendation**
|
| 1445 |
+
|
| 1446 |
+
*Decision:* NOT ELIGIBLE
|
| 1447 |
+
|
| 1448 |
+
*Rationale:*
|
| 1449 |
+
- The patient does not meet SASLT 2021 standard treatment criteria due to normal ALT levels (33 IU/L, below ULN of 40 IU/L) and absence of moderate fibrosis (F2+) or necroinflammation (A2+).
|
| 1450 |
+
- HBV DNA >2,000 IU/mL is present, but this alone is insufficient for eligibility without additional qualifying factors.
|
| 1451 |
+
- No absolute indications such as cirrhosis, immunosuppression, or pregnancy apply.
|
| 1452 |
+
|
| 1453 |
+
*Key Factors:*
|
| 1454 |
+
- HBV DNA level is high (>2,000 IU/mL), but ALT is normal
|
| 1455 |
+
- Fibrosis stage is F0 (no fibrosis)
|
| 1456 |
+
- Necroinflammatory activity is A0 (none)
|
| 1457 |
+
- Patient is younger than 30 years old
|
| 1458 |
+
|
| 1459 |
+
*Management Approach:*
|
| 1460 |
+
|
| 1461 |
+
|
| 1462 |
+
**If NOT ELIGIBLE:**
|
| 1463 |
+
- Monitor ALT every 3-6 months, HBV DNA every 6-12 months, and fibrosis yearly [SASLT 2021, Page 7]
|
| 1464 |
+
- Reassess eligibility if ALT rises above ULN, fibrosis progresses, or HBV DNA increases further
|
| 1465 |
+
|
| 1466 |
+
*Final Recommendation:*
|
| 1467 |
+
- The patient is not eligible for HBV treatment at this time based on SASLT 2021 guidelines. Regular monitoring is recommended to track disease progression and reassess eligibility in the future."
|
| 1468 |
+
Case26,54,M,No,Positive,750,Negative,18,F4 (compensated),Mild,No,,,No,No,,Eligible,Any detectable DNA in cirrhosis β treat.,,eligible,Eligible,"Eligibility and Rationale:
|
| 1469 |
+
- Eligible: Patient has cirrhosis (F4 fibrosis) with detectable HBV DNA, regardless of ALT levels (Grade A) [SASLT 2021, Page 6].
|
| 1470 |
+
|
| 1471 |
+
Treatment Recommendations:
|
| 1472 |
+
- Start monotherapy with ETV, TDF, or TAF as the preferred treatment options (Grade A) [SASLT 2021, Page 8].
|
| 1473 |
+
|
| 1474 |
+
Monitoring and Follow-up:
|
| 1475 |
+
- Monitor treatment response per SASLT protocol, including HBV DNA and ALT levels every 3-6 months [SASLT 2021, Page 7].
|
| 1476 |
+
|
| 1477 |
+
Special Considerations:
|
| 1478 |
+
- None applicable as the patient has no coinfections, immunosuppression, or other special conditions [SASLT 2021, Pages 6-10].
|
| 1479 |
+
|
| 1480 |
+
References:
|
| 1481 |
+
- Pages 6, 7, 8: Treatment criteria, drugs, monitoring protocols",eligible,"**Patient Summary**
|
| 1482 |
+
- 54-year-old male with chronic HBV infection (HBsAg positive for 6 months)
|
| 1483 |
+
- HBV DNA: 750 IU/mL, ALT: 18 IU/L (normal), HBeAg negative
|
| 1484 |
+
- Fibrosis stage: F4 (cirrhosis), Necroinflammatory activity: A1 (mild)
|
| 1485 |
+
- No extrahepatic manifestations, no coinfections, no family history of HCC/cirrhosis
|
| 1486 |
+
|
| 1487 |
+
|
| 1488 |
+
**Treatment Eligibility Analysis**
|
| 1489 |
+
|
| 1490 |
+
*Absolute Indications Check (Priority):*
|
| 1491 |
+
|
| 1492 |
+
- β No HIV coinfection
|
| 1493 |
+
- β
Cirrhosis (F4): Present with detectable HBV DNA (750 IU/mL)
|
| 1494 |
+
- β Immunosuppression: None
|
| 1495 |
+
- β Pregnancy with high viral load: Not applicable
|
| 1496 |
+
|
| 1497 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 1498 |
+
- HBV DNA >2000 IU/mL: β
|
| 1499 |
+
- ALT >ULN (40 IU/L): β
|
| 1500 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
(F4 present)
|
| 1501 |
+
|
| 1502 |
+
*Special Considerations:*
|
| 1503 |
+
- Cirrhosis (F4) is an absolute indication for treatment per SASLT 2021 guidelines [Page 6]
|
| 1504 |
+
- HBV DNA >2000 IU/mL is not required for cirrhotic patients; any detectable HBV DNA suffices [Page 6]
|
| 1505 |
+
|
| 1506 |
+
|
| 1507 |
+
**Clinical Recommendation**
|
| 1508 |
+
|
| 1509 |
+
*Decision:* ELIGIBLE
|
| 1510 |
+
|
| 1511 |
+
*Rationale:*
|
| 1512 |
+
- The patient meets the absolute indication for treatment due to cirrhosis (F4) with detectable HBV DNA (750 IU/mL), regardless of ALT level or HBV DNA threshold [SASLT 2021, Page 6, Grade A].
|
| 1513 |
+
- Cirrhosis is a critical factor requiring antiviral therapy to prevent progression to decompensation or HCC.
|
| 1514 |
+
|
| 1515 |
+
*Key Factors:*
|
| 1516 |
+
- Cirrhosis (F4) confirmed
|
| 1517 |
+
- Detectable HBV DNA (750 IU/mL)
|
| 1518 |
+
- Normal ALT (18 IU/L)
|
| 1519 |
+
- No extrahepatic manifestations or coinfections
|
| 1520 |
+
|
| 1521 |
+
*Management Approach:*
|
| 1522 |
+
|
| 1523 |
+
|
| 1524 |
+
**If ELIGIBLE (Standard Criteria):**
|
| 1525 |
+
- Preferred agents: Entecavir (ETV), Tenofovir (TDF), or Tenofovir Alafenamide (TAF) [SASLT 2021, Page 8, Grade A]
|
| 1526 |
+
- Monitor HBV DNA and ALT at 3, 6, 12 months, then every 6-12 months
|
| 1527 |
+
|
| 1528 |
+
|
| 1529 |
+
**If NOT ELIGIBLE:**
|
| 1530 |
+
- Monitor ALT every 3-6 months, HBV DNA every 6-12 months, fibrosis yearly [SASLT 2021, Page 7]
|
| 1531 |
+
- Reassess if ALT rises >ULN, fibrosis progresses, or HBV DNA increases
|
| 1532 |
+
|
| 1533 |
+
*Final Recommendation:*
|
| 1534 |
+
- The patient is eligible for antiviral therapy due to cirrhosis (F4) with detectable HBV DNA. Treatment should be initiated with a potent nucleos(t)ide analog (ETV, TDF, or TAF) to prevent disease progression and complications. Close monitoring of HBV DNA, ALT, and liver function is recommended."
|
| 1535 |
+
Case27,38,F,No,Positive,6000,Negative,80,F2,Moderate,No,,,No,No,Obesity,Eligible,"ALT >2ΓULN and DNA >2,000 IU/mL β treat.",,eligible,Eligible,"Eligibility and Rationale:
|
| 1536 |
+
- Eligible: HBV DNA > 2,000 IU/mL, ALT > ULN, and moderate fibrosis (Grade A) [SASLT 2021, Page 6]
|
| 1537 |
+
- Necroinflammatory activity (A2) and fibrosis stage (F2-F3) further support treatment initiation (Grade A) [SASLT 2021, Page 6]
|
| 1538 |
+
|
| 1539 |
+
Treatment Recommendations:
|
| 1540 |
+
- Start monotherapy with ETV, TDF, or TAF as first-line treatment (Grade A) [SASLT 2021, Page 8]
|
| 1541 |
+
|
| 1542 |
+
Monitoring and Follow-up:
|
| 1543 |
+
- Monitor treatment response per SASLT protocol, including HBV DNA and ALT levels every 3-6 months initially (Grade A) [SASLT 2021, Page 7]
|
| 1544 |
+
- Assess fibrosis progression and treatment adherence regularly (Grade A) [SASLT 2021, Page 7]
|
| 1545 |
+
|
| 1546 |
+
Special Considerations:
|
| 1547 |
+
- Obesity may impact liver disease progression; consider lifestyle interventions alongside antiviral therapy [SASLT 2021, Page 6]
|
| 1548 |
+
|
| 1549 |
+
References:
|
| 1550 |
+
- Pages 6, 7, 8: Treatment criteria, drugs, monitoring protocols",eligible,"**Patient Summary**
|
| 1551 |
+
- Female, 38 years old
|
| 1552 |
+
- HBsAg positive for 6 months
|
| 1553 |
+
- HBV DNA: 6000 IU/mL (>2000 IU/mL)
|
| 1554 |
+
- ALT: 80 IU/L (>ULN)
|
| 1555 |
+
- Fibrosis stage: F2 (moderate)
|
| 1556 |
+
- Necroinflammatory activity: A2 (moderate)
|
| 1557 |
+
|
| 1558 |
+
|
| 1559 |
+
**Treatment Eligibility Analysis**
|
| 1560 |
+
|
| 1561 |
+
*Absolute Indications Check (Priority):*
|
| 1562 |
+
|
| 1563 |
+
- β No HIV coinfection
|
| 1564 |
+
- β No cirrhosis (F4)
|
| 1565 |
+
- β No immunosuppression
|
| 1566 |
+
- β Not pregnant with high viral load
|
| 1567 |
+
|
| 1568 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 1569 |
+
- HBV DNA >2000 IU/mL: β
|
| 1570 |
+
- ALT >ULN (40 IU/L): β
|
| 1571 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
|
| 1572 |
+
|
| 1573 |
+
*Special Considerations:*
|
| 1574 |
+
- No family history of HCC or cirrhosis
|
| 1575 |
+
- No extrahepatic manifestations
|
| 1576 |
+
- Age >30 years
|
| 1577 |
+
|
| 1578 |
+
|
| 1579 |
+
**Clinical Recommendation**
|
| 1580 |
+
|
| 1581 |
+
*Decision:* ELIGIBLE
|
| 1582 |
+
|
| 1583 |
+
*Rationale:*
|
| 1584 |
+
- The patient meets the standard triple criteria for treatment initiation: HBV DNA >2000 IU/mL, ALT >ULN (~40 IU/L), and moderate necroinflammation/fibrosis (F2+/A2+).
|
| 1585 |
+
- SASLT 2021 guidelines recommend treatment for non-cirrhotic patients with these parameters (Grade A).
|
| 1586 |
+
|
| 1587 |
+
*Key Factors:*
|
| 1588 |
+
- HBV DNA level exceeds 2000 IU/mL
|
| 1589 |
+
- ALT is elevated above the upper limit of normal
|
| 1590 |
+
- Liver biopsy confirms moderate fibrosis (F2) and necroinflammation (A2)
|
| 1591 |
+
- No absolute contraindications or exclusions
|
| 1592 |
+
|
| 1593 |
+
*Management Approach:*
|
| 1594 |
+
|
| 1595 |
+
|
| 1596 |
+
**If ELIGIBLE (Standard Criteria):**
|
| 1597 |
+
- Preferred agents: Entecavir (ETV), Tenofovir (TDF), or Tenofovir Alafenamide (TAF) [SASLT 2021, Page 8, Grade A]
|
| 1598 |
+
- Monitor HBV DNA and ALT at 3, 6, 12 months, then every 6-12 months
|
| 1599 |
+
|
| 1600 |
+
|
| 1601 |
+
**If NOT ELIGIBLE:**
|
| 1602 |
+
- Not applicable as patient is eligible
|
| 1603 |
+
|
| 1604 |
+
*Final Recommendation:*
|
| 1605 |
+
- The patient is eligible for HBV treatment based on SASLT 2021 guidelines due to elevated HBV DNA, ALT, and moderate fibrosis/necroinflammation.
|
| 1606 |
+
- Initiate treatment with a potent nucleos(t)ide analog (ETV, TDF, or TAF) and monitor response closely."
|
| 1607 |
+
Case28,42,M,No,Positive (6 Months),1200,Negative,25,F1,Mild,No,,,No,No,,Not Eligible,Inactive infection with low DNA and normal ALT β monitor.,,not eligible,Not Eligible,"Eligibility and Rationale:
|
| 1608 |
+
- Not eligible: HBV DNA < 2,000 IU/mL, ALT Γ’β°Β€ ULN, no significant fibrosis or necroinflammation (Grade A) [SASLT 2021, Page 6].
|
| 1609 |
+
|
| 1610 |
+
Treatment Recommendations:
|
| 1611 |
+
- Treatment not indicated at this time [SASLT 2021, Page 6].
|
| 1612 |
+
|
| 1613 |
+
Monitoring and Follow-up:
|
| 1614 |
+
- Monitor every 6-12 months (HBeAg-negative, HBV DNA < 2,000 IU/mL) (Grade B) [SASLT 2021, Page 7].
|
| 1615 |
+
|
| 1616 |
+
References:
|
| 1617 |
+
- Pages 6, 7: Treatment criteria, monitoring protocols",not eligible,"**Patient Summary**
|
| 1618 |
+
- 42-year-old male, HBsAg-positive for 6 months
|
| 1619 |
+
- HBV DNA: 1200 IU/mL (<2000 IU/mL), ALT: 25 IU/L (normal)
|
| 1620 |
+
- Fibrosis stage: F1 (mild), Necroinflammatory activity: A1 (mild)
|
| 1621 |
+
- HBeAg-negative, no extrahepatic manifestations, no family history of HCC/cirrhosis
|
| 1622 |
+
|
| 1623 |
+
|
| 1624 |
+
**Treatment Eligibility Analysis**
|
| 1625 |
+
|
| 1626 |
+
*Absolute Indications Check (Priority):*
|
| 1627 |
+
- β No HIV coinfection
|
| 1628 |
+
- β Cirrhosis (F4): Patient has F1 fibrosis
|
| 1629 |
+
- β Immunosuppression: None
|
| 1630 |
+
- β Pregnancy with high viral load: Not pregnant
|
| 1631 |
+
|
| 1632 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 1633 |
+
- HBV DNA >2000 IU/mL: β
|
| 1634 |
+
- ALT >ULN (40 IU/L): β
|
| 1635 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
|
| 1636 |
+
|
| 1637 |
+
*Special Considerations:*
|
| 1638 |
+
- No family history of HCC or cirrhosis
|
| 1639 |
+
- No extrahepatic manifestations
|
| 1640 |
+
- Patient is >30 years old, but HBeAg-negative and HBV DNA <2000 IU/mL
|
| 1641 |
+
|
| 1642 |
+
|
| 1643 |
+
**Clinical Recommendation**
|
| 1644 |
+
|
| 1645 |
+
*Decision:* NOT ELIGIBLE
|
| 1646 |
+
|
| 1647 |
+
*Rationale:*
|
| 1648 |
+
- The patient does not meet the SASLT 2021 treatment criteria as HBV DNA is <2000 IU/mL, ALT is normal, and there is no moderate fibrosis (F2+) or necroinflammation (A2+).
|
| 1649 |
+
- No absolute indications such as cirrhosis, HIV coinfection, or immunosuppression are present.
|
| 1650 |
+
- Per SASLT guidelines, HBV DNA >2000 IU/mL is a mandatory threshold for standard treatment eligibility unless cirrhosis or other absolute indications are present [SASLT 2021, Page 6].
|
| 1651 |
+
|
| 1652 |
+
*Key Factors:*
|
| 1653 |
+
- HBV DNA: 1200 IU/mL (<2000 IU/mL)
|
| 1654 |
+
- ALT: 25 IU/L (normal, <40 IU/L)
|
| 1655 |
+
- Fibrosis stage: F1 (mild)
|
| 1656 |
+
- No absolute indications (e.g., cirrhosis, HIV coinfection, immunosuppression)
|
| 1657 |
+
- No family history of HCC or cirrhosis
|
| 1658 |
+
|
| 1659 |
+
*Management Approach:*
|
| 1660 |
+
|
| 1661 |
+
|
| 1662 |
+
**If NOT ELIGIBLE:**
|
| 1663 |
+
- Monitor ALT every 3-6 months, HBV DNA every 6-12 months, and fibrosis progression yearly [SASLT 2021, Page 7].
|
| 1664 |
+
- Reassess eligibility if ALT rises >ULN, fibrosis progresses to F2+, or HBV DNA increases >2000 IU/mL.
|
| 1665 |
+
|
| 1666 |
+
*Final Recommendation:*
|
| 1667 |
+
- The patient is not eligible for HBV treatment at this time based on SASLT 2021 guidelines. Monitoring is recommended to track disease progression and reassess eligibility if clinical parameters change."
|
| 1668 |
+
Case3,52,M,No,Positive (120 months),3500,Negative,32,F2βF3,Mild,No,,,No,No,,Eligible,"HBV DNA >2,000 with moderate fibrosis β treat even if ALT normal.",,eligible,Eligible,"Eligibility and Rationale:
|
| 1669 |
+
- Eligible: HBV DNA > 2,000 IU/mL, moderate fibrosis (F2-F3), and chronic HBV infection (Grade A) [SASLT 2021, Page 6].
|
| 1670 |
+
- ALT is within normal limits but fibrosis stage supports treatment initiation (Grade A) [SASLT 2021, Page 6].
|
| 1671 |
+
|
| 1672 |
+
Treatment Recommendations:
|
| 1673 |
+
- Start monotherapy with ETV, TDF, or TAF as first-line treatment (Grade A) [SASLT 2021, Page 8].
|
| 1674 |
+
|
| 1675 |
+
Monitoring and Follow-up:
|
| 1676 |
+
- Monitor treatment response per SASLT protocol, including HBV DNA and ALT levels every 3-6 months (Grade A) [SASLT 2021, Page 7].
|
| 1677 |
+
|
| 1678 |
+
Special Considerations:
|
| 1679 |
+
- None applicable as patient has no coinfections, immunosuppression, or extrahepatic manifestations [SASLT 2021, Pages 6, 9].
|
| 1680 |
+
|
| 1681 |
+
References:
|
| 1682 |
+
- Pages 6, 7, 8: Treatment criteria, drugs, monitoring protocols",eligible,"**Patient Summary**
|
| 1683 |
+
- Male, 52 years old
|
| 1684 |
+
- HBsAg positive for 120 months, HBV DNA 3500 IU/mL
|
| 1685 |
+
- HBeAg negative, ALT 32 IU/L (normal), Fibrosis stage F3 (severe)
|
| 1686 |
+
|
| 1687 |
+
|
| 1688 |
+
**Treatment Eligibility Analysis**
|
| 1689 |
+
|
| 1690 |
+
*Absolute Indications Check (Priority):*
|
| 1691 |
+
- β No HIV coinfection
|
| 1692 |
+
- β Cirrhosis (F4): Patient has F3 fibrosis
|
| 1693 |
+
- β Immunosuppression: None
|
| 1694 |
+
- β Pregnancy with high viral load: Not applicable (male patient)
|
| 1695 |
+
|
| 1696 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 1697 |
+
- HBV DNA >2000 IU/mL: β
|
| 1698 |
+
- ALT >ULN (40 IU/L): β
|
| 1699 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
(F3 fibrosis)
|
| 1700 |
+
|
| 1701 |
+
*Special Considerations:*
|
| 1702 |
+
- Patient meets the exception for treatment eligibility due to HBV DNA >2000 IU/mL and F2+ fibrosis, even with normal ALT levels [SASLT 2021, Page 6]
|
| 1703 |
+
- No family history of HCC or cirrhosis, no extrahepatic manifestations
|
| 1704 |
+
|
| 1705 |
+
|
| 1706 |
+
**Clinical Recommendation**
|
| 1707 |
+
|
| 1708 |
+
*Decision:* ELIGIBLE
|
| 1709 |
+
|
| 1710 |
+
*Rationale:*
|
| 1711 |
+
- The patient meets the SASLT 2021 guideline criteria for treatment based on HBV DNA >2000 IU/mL and F3 fibrosis, even though ALT is normal. This is a Grade A recommendation.
|
| 1712 |
+
- The presence of severe fibrosis (F3) indicates significant liver disease progression, warranting treatment to prevent further complications.
|
| 1713 |
+
|
| 1714 |
+
*Key Factors:*
|
| 1715 |
+
- HBV DNA level: 3500 IU/mL (>2000 IU/mL threshold)
|
| 1716 |
+
- Fibrosis stage: F3 (severe)
|
| 1717 |
+
- ALT: Normal (32 IU/L, below ULN of 40 IU/L)
|
| 1718 |
+
- No cirrhosis, immunosuppression, or extrahepatic manifestations
|
| 1719 |
+
|
| 1720 |
+
*Management Approach:*
|
| 1721 |
+
|
| 1722 |
+
|
| 1723 |
+
**If ELIGIBLE (Standard Criteria):**
|
| 1724 |
+
- Preferred agents: Entecavir (ETV), Tenofovir (TDF), or Tenofovir Alafenamide (TAF) [SASLT 2021, Page 8, Grade A]
|
| 1725 |
+
- Monitor HBV DNA and ALT at 3, 6, 12 months, then every 6-12 months
|
| 1726 |
+
|
| 1727 |
+
|
| 1728 |
+
**If NOT ELIGIBLE:**
|
| 1729 |
+
- Monitor ALT every 3-6 months, HBV DNA every 6-12 months, fibrosis yearly [SASLT 2021, Page 7]
|
| 1730 |
+
- Reassess if ALT rises >ULN, fibrosis progresses, or HBV DNA increases
|
| 1731 |
+
|
| 1732 |
+
*Final Recommendation:*
|
| 1733 |
+
- The patient is eligible for HBV treatment based on SASLT 2021 guidelines due to HBV DNA >2000 IU/mL and F3 fibrosis. Treatment initiation is recommended to prevent disease progression and complications. Preferred agents include ETV, TDF, or TAF."
|
| 1734 |
+
Case4,60,M,No,Positive (240 months),700,Negative,28,F4 (compensated),Mild,No,,,No,No,,Eligible,Any detectable HBV DNA in cirrhosis β treat regardless of ALT.,,eligible,Eligible,"Eligibility and Rationale:
|
| 1735 |
+
- Eligible: Cirrhosis (F4) with detectable HBV DNA, regardless of ALT levels (Grade A) [SASLT 2021, Page 6]
|
| 1736 |
+
|
| 1737 |
+
Treatment Recommendations:
|
| 1738 |
+
- Start monotherapy with ETV, TDF, or TAF (Grade A) [SASLT 2021, Page 8]
|
| 1739 |
+
|
| 1740 |
+
Monitoring and Follow-up:
|
| 1741 |
+
- Monitor treatment response per SASLT protocol every 3-6 months (Grade A) [SASLT 2021, Page 7]
|
| 1742 |
+
|
| 1743 |
+
Special Considerations:
|
| 1744 |
+
- None applicable to this patient [SASLT 2021, Pages 6-10]
|
| 1745 |
+
|
| 1746 |
+
References:
|
| 1747 |
+
- Pages 6, 7, 8: Treatment criteria, drugs, monitoring protocols",eligible,"**Patient Summary**
|
| 1748 |
+
- 60-year-old male
|
| 1749 |
+
- HBsAg positive for 240 months
|
| 1750 |
+
- HBV DNA: 700 IU/mL (<2000 IU/mL)
|
| 1751 |
+
- HBeAg negative, ALT: 28 IU/L (normal)
|
| 1752 |
+
- Fibrosis stage: F4 (cirrhosis)
|
| 1753 |
+
|
| 1754 |
+
|
| 1755 |
+
**Treatment Eligibility Analysis**
|
| 1756 |
+
|
| 1757 |
+
*Absolute Indications Check (Priority):*
|
| 1758 |
+
|
| 1759 |
+
- β No HIV coinfection
|
| 1760 |
+
- β
Cirrhosis (F4): Present with detectable HBV DNA (700 IU/mL)
|
| 1761 |
+
- β No immunosuppression
|
| 1762 |
+
- β Not pregnant
|
| 1763 |
+
|
| 1764 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 1765 |
+
- HBV DNA >2000 IU/mL: β
|
| 1766 |
+
- ALT >ULN (40 IU/L): β
|
| 1767 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
(F4 present)
|
| 1768 |
+
|
| 1769 |
+
*Special Considerations:*
|
| 1770 |
+
- No family history of HCC or cirrhosis
|
| 1771 |
+
- No extrahepatic manifestations
|
| 1772 |
+
- Age >30 years
|
| 1773 |
+
|
| 1774 |
+
|
| 1775 |
+
**Clinical Recommendation**
|
| 1776 |
+
|
| 1777 |
+
*Decision:* ELIGIBLE
|
| 1778 |
+
|
| 1779 |
+
*Rationale:*
|
| 1780 |
+
- The patient meets the SASLT 2021 guideline criteria for treatment due to the presence of cirrhosis (F4) and detectable HBV DNA (700 IU/mL), regardless of ALT levels. This is an absolute indication for treatment (Grade A recommendation).
|
| 1781 |
+
|
| 1782 |
+
*Key Factors:*
|
| 1783 |
+
- Cirrhosis (F4) confirmed
|
| 1784 |
+
- Detectable HBV DNA (700 IU/mL)
|
| 1785 |
+
- Normal ALT (28 IU/L)
|
| 1786 |
+
- No other contraindications or comorbidities
|
| 1787 |
+
|
| 1788 |
+
*Management Approach:*
|
| 1789 |
+
|
| 1790 |
+
|
| 1791 |
+
**If ELIGIBLE (Standard Criteria):**
|
| 1792 |
+
- Preferred agents: Entecavir (ETV), Tenofovir (TDF), or Tenofovir Alafenamide (TAF) [SASLT 2021, Page 8, Grade A]
|
| 1793 |
+
- Monitor HBV DNA and ALT at 3, 6, 12 months, then every 6-12 months
|
| 1794 |
+
|
| 1795 |
+
|
| 1796 |
+
**If NOT ELIGIBLE:**
|
| 1797 |
+
- Monitor ALT every 3-6 months, HBV DNA every 6-12 months, fibrosis yearly [SASLT 2021, Page 7]
|
| 1798 |
+
- Reassess if ALT rises >ULN, fibrosis progresses, or HBV DNA increases
|
| 1799 |
+
|
| 1800 |
+
*Final Recommendation:*
|
| 1801 |
+
- The patient is eligible for HBV treatment based on the presence of cirrhosis (F4) and detectable HBV DNA. Treatment should be initiated with a potent nucleos(t)ide analog such as TAF, TDF, or ETV, with regular monitoring of HBV DNA and liver function tests."
|
| 1802 |
+
Case6,40,M,No,Positive (84 months),900,Negative,22,F0βF1,,No,,,No,No,,Not Eligible,"HBeAg-negative infection with HBV DNA <2,000 and normal ALT β observe.",,not eligible,Not Eligible,"Eligibility and Rationale:
|
| 1803 |
+
- Not eligible: HBV DNA < 2,000 IU/mL, ALT Γ’β°Β€ ULN, no significant fibrosis or necroinflammation [SASLT 2021, Page 6].
|
| 1804 |
+
|
| 1805 |
+
Treatment Recommendations:
|
| 1806 |
+
- Treatment not indicated at this time [SASLT 2021, Page 6].
|
| 1807 |
+
|
| 1808 |
+
Monitoring and Follow-up:
|
| 1809 |
+
- Monitor every 6-12 months (HBeAg-negative, HBV DNA < 2,000 IU/mL) (Grade B) [SASLT 2021, Page 7].
|
| 1810 |
+
|
| 1811 |
+
References:
|
| 1812 |
+
- Pages 6, 7: Treatment criteria, monitoring protocols",not eligible,"**Patient Summary**
|
| 1813 |
+
- Male, 40 years old
|
| 1814 |
+
- HBsAg positive for 84 months
|
| 1815 |
+
- HBV DNA: 900 IU/mL (< 2000 IU/mL)
|
| 1816 |
+
- ALT: 22 IU/L (normal, < ULN)
|
| 1817 |
+
- Fibrosis stage: F1 (mild)
|
| 1818 |
+
|
| 1819 |
+
|
| 1820 |
+
**Treatment Eligibility Analysis**
|
| 1821 |
+
|
| 1822 |
+
*Absolute Indications Check (Priority):*
|
| 1823 |
+
|
| 1824 |
+
- β No HIV coinfection
|
| 1825 |
+
- β Cirrhosis (F4): Patient has F1 fibrosis
|
| 1826 |
+
- β Immunosuppression: None
|
| 1827 |
+
- β Pregnancy with high viral load: Not pregnant
|
| 1828 |
+
|
| 1829 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 1830 |
+
- HBV DNA >2000 IU/mL: β
|
| 1831 |
+
- ALT >ULN (40 IU/L): β
|
| 1832 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
|
| 1833 |
+
|
| 1834 |
+
*Special Considerations:*
|
| 1835 |
+
- No family history of HCC or cirrhosis
|
| 1836 |
+
- No extrahepatic manifestations
|
| 1837 |
+
- Patient is HBeAg-negative
|
| 1838 |
+
|
| 1839 |
+
|
| 1840 |
+
**Clinical Recommendation**
|
| 1841 |
+
|
| 1842 |
+
*Decision:* NOT ELIGIBLE
|
| 1843 |
+
|
| 1844 |
+
*Rationale:*
|
| 1845 |
+
- The patient does not meet the standard criteria for treatment initiation as per SASLT 2021 guidelines. HBV DNA is below the required threshold of >2000 IU/mL, ALT is within normal limits (<40 IU/L), and there is no moderate necroinflammation or fibrosis (F2+/A2+).
|
| 1846 |
+
- No absolute indications such as cirrhosis, HIV coinfection, immunosuppression, or pregnancy are present.
|
| 1847 |
+
|
| 1848 |
+
*Key Factors:*
|
| 1849 |
+
- HBV DNA level is 900 IU/mL (<2000 IU/mL threshold for treatment).
|
| 1850 |
+
- ALT is 22 IU/L (normal, <ULN).
|
| 1851 |
+
- Fibrosis stage is F1 (mild).
|
| 1852 |
+
- No family history of HCC or cirrhosis.
|
| 1853 |
+
|
| 1854 |
+
*Management Approach:*
|
| 1855 |
+
|
| 1856 |
+
|
| 1857 |
+
**If NOT ELIGIBLE:**
|
| 1858 |
+
- Monitor ALT every 3-6 months, HBV DNA every 6-12 months, and fibrosis yearly [SASLT 2021, Page 7].
|
| 1859 |
+
- Reassess eligibility if ALT rises >ULN, fibrosis progresses, or HBV DNA increases >2000 IU/mL.
|
| 1860 |
+
|
| 1861 |
+
*Final Recommendation:*
|
| 1862 |
+
- The patient does not meet the criteria for HBV treatment initiation under SASLT 2021 guidelines. Regular monitoring is recommended to reassess eligibility in the future if clinical parameters change."
|
| 1863 |
+
Case7,31,F,Yes (28 weeks),Positive (48 months),500000,Positive,35,F1,Mild,No,,,No,No,,Eligible,"Pregnancy with HBV DNA >100,000 IU/mL β start prophylaxis.",,eligible,Eligible,"Eligibility and Rationale:
|
| 1864 |
+
- Eligible: HBV DNA > 100,000 IU/mL during pregnancy warrants antiviral prophylaxis starting at 24-28 weeks (Grade D) [SASLT 2021, Page 10].
|
| 1865 |
+
- Eligible: HBeAg-positive chronic HBV infection with high HBV DNA levels (> 20,000 IU/mL) and age > 30 years (Grade D) [SASLT 2021, Page 6].
|
| 1866 |
+
|
| 1867 |
+
Treatment Recommendations:
|
| 1868 |
+
- Start antiviral prophylaxis with TDF or TAF at 24-28 weeks of pregnancy (Grade D) [SASLT 2021, Page 10].
|
| 1869 |
+
- Preferred regimens for CHB treatment include TDF, TAF, or ETV monotherapy (Grade A) [SASLT 2021, Page 8].
|
| 1870 |
+
|
| 1871 |
+
Monitoring and Follow-up:
|
| 1872 |
+
- Monitor HBV DNA and ALT levels every 3 months during pregnancy and postpartum (Grade D) [SASLT 2021, Page 7].
|
| 1873 |
+
- Assess treatment response and adjust therapy as needed per SASLT protocol [SASLT 2021, Page 7].
|
| 1874 |
+
|
| 1875 |
+
Special Considerations:
|
| 1876 |
+
- Breastfeeding is permitted for HBsAg-positive women on TDF (Grade B) [SASLT 2021, Page 10].
|
| 1877 |
+
|
| 1878 |
+
References:
|
| 1879 |
+
- Pages 6, 7, 8, 10: Treatment criteria, drugs, monitoring, pregnancy-related recommendations",eligible,"**Patient Summary**
|
| 1880 |
+
- Female, 31 years old, pregnant
|
| 1881 |
+
- HBsAg positive for 48 months, HBV DNA 500,000 IU/mL
|
| 1882 |
+
- ALT 35 IU/L, mild fibrosis (F1), mild necroinflammatory activity (A1)
|
| 1883 |
+
|
| 1884 |
+
|
| 1885 |
+
**Treatment Eligibility Analysis**
|
| 1886 |
+
|
| 1887 |
+
*Absolute Indications Check (Priority):*
|
| 1888 |
+
|
| 1889 |
+
- β No HIV coinfection
|
| 1890 |
+
- β No cirrhosis (F4)
|
| 1891 |
+
- β No immunosuppression
|
| 1892 |
+
- β
Pregnancy with high viral load (HBV DNA > 100,000 IU/mL)
|
| 1893 |
+
|
| 1894 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 1895 |
+
- HBV DNA >2000 IU/mL: β
|
| 1896 |
+
- ALT >ULN (40 IU/L): β
|
| 1897 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
|
| 1898 |
+
|
| 1899 |
+
*Special Considerations:*
|
| 1900 |
+
- Pregnancy is a special population with distinct thresholds for treatment initiation
|
| 1901 |
+
- HBV DNA > 100,000 IU/mL in late second trimester (24-28 weeks) is an absolute indication for treatment [SASLT 2021, Page 9]
|
| 1902 |
+
|
| 1903 |
+
|
| 1904 |
+
**Clinical Recommendation**
|
| 1905 |
+
|
| 1906 |
+
*Decision:* ELIGIBLE
|
| 1907 |
+
|
| 1908 |
+
*Rationale:*
|
| 1909 |
+
- The patient meets the absolute indication for treatment due to pregnancy and high HBV DNA levels (>100,000 IU/mL).
|
| 1910 |
+
- SASLT guidelines recommend initiating antiviral prophylaxis in pregnant women with HBV DNA > 100,000 IU/mL during the late second trimester (Grade D).
|
| 1911 |
+
|
| 1912 |
+
*Key Factors:*
|
| 1913 |
+
- Pregnancy status
|
| 1914 |
+
- HBV DNA significantly elevated at 500,000 IU/mL
|
| 1915 |
+
- Prevention of mother-to-child transmission is critical
|
| 1916 |
+
- No contraindications to treatment
|
| 1917 |
+
|
| 1918 |
+
*Management Approach:*
|
| 1919 |
+
|
| 1920 |
+
|
| 1921 |
+
**If ELIGIBLE (Standard Criteria):**
|
| 1922 |
+
- Initiate Tenofovir Disoproxil Fumarate (TDF) as the drug of choice during pregnancy [SASLT 2021, Page 9, Grade D]
|
| 1923 |
+
- Monitor HBV DNA and ALT levels every 4-8 weeks during pregnancy
|
| 1924 |
+
- Ensure infant receives HBV vaccine and HBIG at birth
|
| 1925 |
+
|
| 1926 |
+
|
| 1927 |
+
**If NOT ELIGIBLE:**
|
| 1928 |
+
- Not applicable as patient is eligible
|
| 1929 |
+
|
| 1930 |
+
*Final Recommendation:*
|
| 1931 |
+
- The patient is eligible for treatment based on SASLT 2021 guidelines due to pregnancy and high HBV DNA levels. Initiating TDF prophylaxis is recommended to prevent vertical transmission."
|
| 1932 |
+
Case8,35,M,No,Positive (72 months),9000000,Positive,33,F1,Mild,No,,,No,No,,Eligible,HBeAg-positive infection >30 years β treat even with normal ALT.,,eligible,Eligible,"Eligibility and Rationale:
|
| 1933 |
+
- Eligible: HBeAg-positive chronic HBV infection, age > 30 years, persistently high HBV DNA levels (Grade D) [SASLT 2021, Page 6].
|
| 1934 |
+
- HBV DNA > 2,000 IU/mL and ALT Γ’β°Β€ ULN, meeting treatment criteria for HBeAg-positive patients > 30 years (Grade D) [SASLT 2021, Page 6].
|
| 1935 |
+
|
| 1936 |
+
Treatment Recommendations:
|
| 1937 |
+
- Start monotherapy with ETV, TDF, or TAF (Grade A) [SASLT 2021, Page 8].
|
| 1938 |
+
|
| 1939 |
+
Monitoring and Follow-up:
|
| 1940 |
+
- Monitor treatment response per SASLT protocol every 3-6 months (Grade B) [SASLT 2021, Page 7].
|
| 1941 |
+
|
| 1942 |
+
Special Considerations:
|
| 1943 |
+
- None applicable to this patient.
|
| 1944 |
+
|
| 1945 |
+
References:
|
| 1946 |
+
- Pages 6, 7, 8: Treatment criteria, drugs, monitoring protocols",eligible,"**Patient Summary**
|
| 1947 |
+
- Male, 35 years old
|
| 1948 |
+
- HBsAg-positive for 72 months
|
| 1949 |
+
- HBV DNA: 9,000,000 IU/mL
|
| 1950 |
+
- HBeAg-positive, ALT: 33 IU/L
|
| 1951 |
+
- Fibrosis stage: F1, Necroinflammatory activity: A1
|
| 1952 |
+
|
| 1953 |
+
|
| 1954 |
+
**Treatment Eligibility Analysis**
|
| 1955 |
+
|
| 1956 |
+
*Absolute Indications Check (Priority):*
|
| 1957 |
+
|
| 1958 |
+
- β No HIV coinfection
|
| 1959 |
+
- β Cirrhosis (F4): Not present (F1)
|
| 1960 |
+
- β Immunosuppression: None
|
| 1961 |
+
- β Pregnancy with high viral load: Not applicable
|
| 1962 |
+
|
| 1963 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 1964 |
+
- HBV DNA >2000 IU/mL: β
|
| 1965 |
+
- ALT >ULN (40 IU/L): β
|
| 1966 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
|
| 1967 |
+
|
| 1968 |
+
*Special Considerations:*
|
| 1969 |
+
- Age >30 years: β
|
| 1970 |
+
- HBeAg-positive: β
|
| 1971 |
+
- Family history of HCC/cirrhosis: β
|
| 1972 |
+
- Extrahepatic manifestations: β
|
| 1973 |
+
|
| 1974 |
+
|
| 1975 |
+
**Clinical Recommendation**
|
| 1976 |
+
|
| 1977 |
+
*Decision:* ELIGIBLE
|
| 1978 |
+
|
| 1979 |
+
*Rationale:*
|
| 1980 |
+
- The patient meets the SASLT 2021 guideline criteria for treatment under the provision for HBeAg-positive chronic HBV infection in patients >30 years old with persistently high HBV DNA levels (>2,000 IU/mL), regardless of ALT or histological severity [SASLT 2021, Page 6, Grade D].
|
| 1981 |
+
|
| 1982 |
+
*Key Factors:*
|
| 1983 |
+
- HBV DNA level significantly elevated (9,000,000 IU/mL)
|
| 1984 |
+
- HBeAg-positive status
|
| 1985 |
+
- Age >30 years
|
| 1986 |
+
- No contraindications or absolute exclusions
|
| 1987 |
+
|
| 1988 |
+
*Management Approach:*
|
| 1989 |
+
|
| 1990 |
+
|
| 1991 |
+
**If ELIGIBLE (Standard Criteria):**
|
| 1992 |
+
- Preferred agents: Entecavir (ETV), Tenofovir (TDF), or Tenofovir Alafenamide (TAF) [SASLT 2021, Page 8, Grade A]
|
| 1993 |
+
- Monitor HBV DNA and ALT at 3, 6, 12 months, then every 6-12 months
|
| 1994 |
+
|
| 1995 |
+
|
| 1996 |
+
**If NOT ELIGIBLE:**
|
| 1997 |
+
- Not applicable
|
| 1998 |
+
|
| 1999 |
+
*Final Recommendation:*
|
| 2000 |
+
- The patient is eligible for treatment based on SASLT 2021 guidelines due to HBeAg-positive status, age >30 years, and persistently high HBV DNA levels (>2,000 IU/mL). Treatment initiation with a potent nucleos(t)ide analog is recommended."
|
| 2001 |
+
Case9,55,F,No,Positive (180 months),6200,Negative,45,F1βF2,Moderate,No,,,Yes (father HCC),No,,Eligible,"HBV DNA >2,000 with ALT >ULN; family history supports treatment.",,eligible,Eligible,"Eligibility and Rationale:
|
| 2002 |
+
- Eligible: HBV DNA > 2,000 IU/mL, ALT > ULN, moderate fibrosis (Grade A) [SASLT 2021, Page 6]
|
| 2003 |
+
- Family history of HCC or cirrhosis supports treatment initiation (Grade D) [SASLT 2021, Page 6]
|
| 2004 |
+
|
| 2005 |
+
Treatment Recommendations:
|
| 2006 |
+
- Start monotherapy with ETV, TDF, or TAF (Grade A) [SASLT 2021, Page 8]
|
| 2007 |
+
|
| 2008 |
+
Monitoring and Follow-up:
|
| 2009 |
+
- Monitor treatment response per SASLT protocol every 3-6 months [SASLT 2021, Page 7]
|
| 2010 |
+
|
| 2011 |
+
Special Considerations:
|
| 2012 |
+
- None applicable to this patient [SASLT 2021, Pages 6-10]
|
| 2013 |
+
|
| 2014 |
+
References:
|
| 2015 |
+
- Pages 6, 7, 8: Treatment criteria, drugs, monitoring protocols",eligible,"**Patient Summary**
|
| 2016 |
+
- Female, 55 years old
|
| 2017 |
+
- HBsAg positive for 180 months
|
| 2018 |
+
- HBV DNA: 6200 IU/mL (>2000 IU/mL)
|
| 2019 |
+
- ALT: 45 IU/L (>ULN)
|
| 2020 |
+
- Fibrosis stage: F2 (moderate)
|
| 2021 |
+
- Necroinflammatory activity: A2 (moderate)
|
| 2022 |
+
- Family history of cirrhosis/HCC
|
| 2023 |
+
|
| 2024 |
+
|
| 2025 |
+
**Treatment Eligibility Analysis**
|
| 2026 |
+
|
| 2027 |
+
*Absolute Indications Check (Priority):*
|
| 2028 |
+
- β No HIV coinfection
|
| 2029 |
+
- β No cirrhosis (F4)
|
| 2030 |
+
- β No immunosuppression
|
| 2031 |
+
- β Not pregnant with high viral load
|
| 2032 |
+
|
| 2033 |
+
*Standard Criteria Assessment (if no absolute indications):*
|
| 2034 |
+
- HBV DNA >2000 IU/mL: β
|
| 2035 |
+
- ALT >ULN (40 IU/L): β
|
| 2036 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): β
|
| 2037 |
+
|
| 2038 |
+
*Special Considerations:*
|
| 2039 |
+
- Family history of cirrhosis/HCC increases risk of progression
|
| 2040 |
+
- Patient meets SASLT 2021 criteria for treatment initiation based on HBV DNA >2000 IU/mL, ALT >ULN, and moderate fibrosis/necroinflammation [SASLT 2021, Page 6]
|
| 2041 |
+
|
| 2042 |
+
|
| 2043 |
+
**Clinical Recommendation**
|
| 2044 |
+
|
| 2045 |
+
*Decision:* ELIGIBLE
|
| 2046 |
+
|
| 2047 |
+
*Rationale:*
|
| 2048 |
+
- The patient meets the SASLT 2021 standard criteria for treatment initiation: HBV DNA >2000 IU/mL, ALT >ULN (~40 IU/L), and moderate fibrosis (F2) and necroinflammation (A2).
|
| 2049 |
+
- Family history of cirrhosis/HCC further supports treatment initiation to reduce risk of disease progression.
|
| 2050 |
+
- Grade A recommendation for treatment initiation based on SASLT guidelines [Page 6].
|
| 2051 |
+
|
| 2052 |
+
*Key Factors:*
|
| 2053 |
+
- HBV DNA >2000 IU/mL (6200 IU/mL)
|
| 2054 |
+
- ALT >ULN (45 IU/L vs ~40 IU/L)
|
| 2055 |
+
- Moderate fibrosis (F2) and necroinflammation (A2)
|
| 2056 |
+
- Family history of cirrhosis/HCC
|
| 2057 |
+
|
| 2058 |
+
*Management Approach:*
|
| 2059 |
+
|
| 2060 |
+
|
| 2061 |
+
**If ELIGIBLE (Standard Criteria):**
|
| 2062 |
+
- Preferred agents: Entecavir (ETV), Tenofovir (TDF), or Tenofovir Alafenamide (TAF) [SASLT 2021, Page 8, Grade A]
|
| 2063 |
+
- Monitor HBV DNA and ALT at 3, 6, 12 months, then every 6-12 months
|
| 2064 |
+
|
| 2065 |
+
|
| 2066 |
+
**If NOT ELIGIBLE:**
|
| 2067 |
+
- Not applicable (patient is eligible)
|
| 2068 |
+
|
| 2069 |
+
*Final Recommendation:*
|
| 2070 |
+
- The patient is eligible for HBV treatment based on SASLT 2021 guidelines due to HBV DNA >2000 IU/mL, ALT >ULN, and moderate fibrosis/necroinflammation.
|
| 2071 |
+
- Treatment initiation is recommended to prevent disease progression and reduce risk of HCC, especially given the family history of cirrhosis/HCC."
|
api/routers/hbv_assessment.py
CHANGED
|
@@ -5,7 +5,7 @@ API endpoint for HBV treatment eligibility assessment
|
|
| 5 |
from fastapi import APIRouter, HTTPException
|
| 6 |
from api.models import HBVPatientInput, HBVAssessmentResponse, TextAssessmentInput
|
| 7 |
import logging
|
| 8 |
-
from core.
|
| 9 |
from core.text_parser import parse_patient_text, validate_extracted_data
|
| 10 |
|
| 11 |
logger = logging.getLogger(__name__)
|
|
@@ -21,11 +21,10 @@ async def assess_patient(patient: HBVPatientInput) -> HBVAssessmentResponse:
|
|
| 21 |
"""
|
| 22 |
Assess HBV patient eligibility for treatment according to SASLT 2021 guidelines
|
| 23 |
|
| 24 |
-
This endpoint:
|
| 25 |
-
1. Validates patient data
|
| 26 |
-
2.
|
| 27 |
-
3.
|
| 28 |
-
4. Returns structured assessment with eligibility and comprehensive recommendations
|
| 29 |
|
| 30 |
Returns:
|
| 31 |
HBVAssessmentResponse containing:
|
|
@@ -37,11 +36,11 @@ async def assess_patient(patient: HBVPatientInput) -> HBVAssessmentResponse:
|
|
| 37 |
try:
|
| 38 |
logger.info(f"Assessing HBV patient: Age {patient.age}, Sex {patient.sex}, HBV DNA {patient.hbv_dna_level}")
|
| 39 |
|
| 40 |
-
# Convert Pydantic model to dict for
|
| 41 |
patient_data = patient.dict()
|
| 42 |
|
| 43 |
-
#
|
| 44 |
-
result =
|
| 45 |
|
| 46 |
# Convert dict result back to Pydantic response model
|
| 47 |
response = HBVAssessmentResponse(**result)
|
|
@@ -62,9 +61,8 @@ async def assess_patient_from_text(text_input: TextAssessmentInput) -> HBVAssess
|
|
| 62 |
This endpoint:
|
| 63 |
1. Parses free-form text to extract structured patient data using LLM
|
| 64 |
2. Validates the extracted data
|
| 65 |
-
3.
|
| 66 |
-
4.
|
| 67 |
-
5. Returns structured assessment with eligibility and recommendations
|
| 68 |
|
| 69 |
Example text input:
|
| 70 |
"45-year-old male patient
|
|
@@ -98,9 +96,9 @@ async def assess_patient_from_text(text_input: TextAssessmentInput) -> HBVAssess
|
|
| 98 |
validated_data = validate_extracted_data(patient_data)
|
| 99 |
logger.info("Patient data validated successfully")
|
| 100 |
|
| 101 |
-
#
|
| 102 |
-
logger.info("Performing HBV eligibility assessment...")
|
| 103 |
-
result =
|
| 104 |
|
| 105 |
# Convert dict result to Pydantic response model
|
| 106 |
response = HBVAssessmentResponse(**result)
|
|
|
|
| 5 |
from fastapi import APIRouter, HTTPException
|
| 6 |
from api.models import HBVPatientInput, HBVAssessmentResponse, TextAssessmentInput
|
| 7 |
import logging
|
| 8 |
+
from core.assessment_chain import run_assessment_chain
|
| 9 |
from core.text_parser import parse_patient_text, validate_extracted_data
|
| 10 |
|
| 11 |
logger = logging.getLogger(__name__)
|
|
|
|
| 21 |
"""
|
| 22 |
Assess HBV patient eligibility for treatment according to SASLT 2021 guidelines
|
| 23 |
|
| 24 |
+
This endpoint uses a LangChain Chain with hybrid approach:
|
| 25 |
+
1. Phase 1 (Deterministic): Validates patient data, computes eligibility deterministically
|
| 26 |
+
2. Phase 2 (LLM): Generates narrative recommendations with citations
|
| 27 |
+
3. Returns structured assessment with eligibility and comprehensive recommendations
|
|
|
|
| 28 |
|
| 29 |
Returns:
|
| 30 |
HBVAssessmentResponse containing:
|
|
|
|
| 36 |
try:
|
| 37 |
logger.info(f"Assessing HBV patient: Age {patient.age}, Sex {patient.sex}, HBV DNA {patient.hbv_dna_level}")
|
| 38 |
|
| 39 |
+
# Convert Pydantic model to dict for chain
|
| 40 |
patient_data = patient.dict()
|
| 41 |
|
| 42 |
+
# Run assessment chain (hybrid: deterministic + LLM)
|
| 43 |
+
result = run_assessment_chain(patient_data)
|
| 44 |
|
| 45 |
# Convert dict result back to Pydantic response model
|
| 46 |
response = HBVAssessmentResponse(**result)
|
|
|
|
| 61 |
This endpoint:
|
| 62 |
1. Parses free-form text to extract structured patient data using LLM
|
| 63 |
2. Validates the extracted data
|
| 64 |
+
3. Runs the LangChain assessment chain (hybrid: deterministic + LLM)
|
| 65 |
+
4. Returns structured assessment with eligibility and recommendations
|
|
|
|
| 66 |
|
| 67 |
Example text input:
|
| 68 |
"45-year-old male patient
|
|
|
|
| 96 |
validated_data = validate_extracted_data(patient_data)
|
| 97 |
logger.info("Patient data validated successfully")
|
| 98 |
|
| 99 |
+
# Run assessment chain with extracted data
|
| 100 |
+
logger.info("Performing HBV eligibility assessment using LangChain chain...")
|
| 101 |
+
result = run_assessment_chain(validated_data)
|
| 102 |
|
| 103 |
# Convert dict result to Pydantic response model
|
| 104 |
response = HBVAssessmentResponse(**result)
|
core/assessment_chain.py
ADDED
|
@@ -0,0 +1,840 @@
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
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|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
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|
|
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|
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|
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|
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|
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|
|
|
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|
| 1 |
+
"""
|
| 2 |
+
LangChain Chain Implementation for HBV Assessment
|
| 3 |
+
Implements hybrid approach: Deterministic Logic (Phase 1) + LLM Generation (Phase 2)
|
| 4 |
+
"""
|
| 5 |
+
|
| 6 |
+
import logging
|
| 7 |
+
import json
|
| 8 |
+
import re
|
| 9 |
+
from typing import Dict, Any
|
| 10 |
+
from langchain_core.runnables import RunnablePassthrough, RunnableLambda
|
| 11 |
+
from langchain_core.output_parsers import JsonOutputParser
|
| 12 |
+
from langchain_core.prompts import PromptTemplate
|
| 13 |
+
from .config import get_llm
|
| 14 |
+
|
| 15 |
+
logger = logging.getLogger(__name__)
|
| 16 |
+
|
| 17 |
+
|
| 18 |
+
def clean_json_string(json_str: str) -> str:
|
| 19 |
+
"""
|
| 20 |
+
Clean a JSON string by properly escaping control characters within string values.
|
| 21 |
+
This handles cases where LLMs generate JSON with literal newlines, tabs, etc.
|
| 22 |
+
|
| 23 |
+
Args:
|
| 24 |
+
json_str: Raw JSON string that may contain unescaped control characters
|
| 25 |
+
|
| 26 |
+
Returns:
|
| 27 |
+
Cleaned JSON string with properly escaped control characters
|
| 28 |
+
"""
|
| 29 |
+
# First, try to identify string values in the JSON and escape control characters within them
|
| 30 |
+
# We need to be careful not to break the JSON structure itself
|
| 31 |
+
|
| 32 |
+
# Replace common control characters that appear in string values
|
| 33 |
+
# but preserve the JSON structure (newlines between key-value pairs are OK)
|
| 34 |
+
|
| 35 |
+
# Strategy: Parse character by character, track if we're inside a string value
|
| 36 |
+
result = []
|
| 37 |
+
in_string = False
|
| 38 |
+
escape_next = False
|
| 39 |
+
|
| 40 |
+
for i, char in enumerate(json_str):
|
| 41 |
+
if escape_next:
|
| 42 |
+
result.append(char)
|
| 43 |
+
escape_next = False
|
| 44 |
+
continue
|
| 45 |
+
|
| 46 |
+
if char == "\\":
|
| 47 |
+
result.append(char)
|
| 48 |
+
escape_next = True
|
| 49 |
+
continue
|
| 50 |
+
|
| 51 |
+
if char == '"':
|
| 52 |
+
in_string = not in_string
|
| 53 |
+
result.append(char)
|
| 54 |
+
continue
|
| 55 |
+
|
| 56 |
+
# If we're inside a string value, escape control characters
|
| 57 |
+
if in_string:
|
| 58 |
+
if char == "\n":
|
| 59 |
+
result.append("\\n")
|
| 60 |
+
elif char == "\r":
|
| 61 |
+
result.append("\\r")
|
| 62 |
+
elif char == "\t":
|
| 63 |
+
result.append("\\t")
|
| 64 |
+
elif char == "\b":
|
| 65 |
+
result.append("\\b")
|
| 66 |
+
elif char == "\f":
|
| 67 |
+
result.append("\\f")
|
| 68 |
+
elif ord(char) < 32: # Other control characters
|
| 69 |
+
result.append(f"\\u{ord(char):04x}")
|
| 70 |
+
else:
|
| 71 |
+
result.append(char)
|
| 72 |
+
else:
|
| 73 |
+
result.append(char)
|
| 74 |
+
|
| 75 |
+
return "".join(result)
|
| 76 |
+
|
| 77 |
+
|
| 78 |
+
# SASLT 2021 Guidelines - Extracted directly from official PDF
|
| 79 |
+
SASLT_GUIDELINES = """
|
| 80 |
+
===== SASLT 2021 GUIDELINES: TREATMENT & MANAGEMENT =====
|
| 81 |
+
[Extracted from: SASLT practice guidelines for the management of Hepatitis B virus β An update,
|
| 82 |
+
Saudi J Gastroenterol 2021;27:115-26]
|
| 83 |
+
|
| 84 |
+
### 1. TREATMENT INDICATIONS [SASLT 2021, Page 6]
|
| 85 |
+
|
| 86 |
+
**RECOMMENDATIONS FOR INITIATION OF TREATMENT:**
|
| 87 |
+
|
| 88 |
+
- All patients with chronic hepatitis B (HBV DNA > 2,000 IU/mL, ALT > ULN), regardless of HBeAg status, and/or at least moderate liver necroinflammation or fibrosis (Grade A) [Page 6]
|
| 89 |
+
|
| 90 |
+
- Patients with cirrhosis (compensated or decompensated), with any detectable HBV DNA level and regardless of ALT levels (Grade A) [Page 6]
|
| 91 |
+
|
| 92 |
+
- Patients with HBV DNA > 20,000 IU/mL and ALT > 2xULN, regardless of the degree of fibrosis (Grade B) [Page 6]
|
| 93 |
+
|
| 94 |
+
- Patients with HBeAg-positive chronic HBV infection (persistently normal ALT and high HBV DNA levels) may be treated if they are > 30 years, regardless of the severity of liver histological lesions (Grade D) [Page 6]
|
| 95 |
+
|
| 96 |
+
- Patients with chronic HBV infection (HBV DNA > 2,000 IU/mL, ALT > ULN), regardless of HBeAg status, and a family history of HCC or cirrhosis and extrahepatic manifestations (Grade D) [Page 6]
|
| 97 |
+
|
| 98 |
+
**DETAILED TREATMENT CRITERIA [Page 6]:**
|
| 99 |
+
|
| 100 |
+
Nonβcirrhotic patients should be considered for treatment if they have HBV DNA levels >2,000 IU/mL, serum ALT >~40 IU/L and severity of liver disease assessed by liver biopsy showing at least moderate necroinflammation and/or at least moderate fibrosis.
|
| 101 |
+
|
| 102 |
+
Patients with HBV DNA greater than 20,000 IU/mL and ALT greater than 2x ULN can begin treatment without a liver biopsy.
|
| 103 |
+
|
| 104 |
+
Patients with HBV DNA >2,000 IU/mL and at least moderate fibrosis may initiate treatment even if ALT levels are normal.
|
| 105 |
+
|
| 106 |
+
Treatment indications should also take into account patient's age, health status, risk of HBV transmission, family history of HCC or cirrhosis and extrahepatic manifestations.
|
| 107 |
+
|
| 108 |
+
**CRITICAL INTERPRETATION:**
|
| 109 |
+
- HBV DNA > 2,000 IU/mL is REQUIRED for all standard treatment criteria
|
| 110 |
+
- Exception: Cirrhosis (F4) requires only "any detectable HBV DNA level"
|
| 111 |
+
- Exception: Special populations (HIV coinfection, immunosuppression, pregnancy) have different thresholds
|
| 112 |
+
|
| 113 |
+
|
| 114 |
+
### 2. MONITORING OF UNTREATED PATIENTS [SASLT 2021, Page 6-7]
|
| 115 |
+
|
| 116 |
+
- Patients with HBeAg-positive chronic HBV infection who are younger than 30 years should be followed at least every 3-6 months (Grade B) [Page 7]
|
| 117 |
+
|
| 118 |
+
- Patients with HBeAg-negative chronic HBV infection and serum HBV DNA <2,000 IU/ml should be followed every 6-12 months (Grade B) [Page 7]
|
| 119 |
+
|
| 120 |
+
- Patients with HBeAg-negative chronic HBV infection and serum HBV DNA β₯2,000 IU/ml should be followed every 3 months for the first year and thereafter every 6 months (Grade D) [Page 7]
|
| 121 |
+
|
| 122 |
+
|
| 123 |
+
### 3. TREATMENT OF CHRONIC HEPATITIS B [SASLT 2021, Page 8]
|
| 124 |
+
|
| 125 |
+
**RECOMMENDATIONS:**
|
| 126 |
+
|
| 127 |
+
- The treatment of choice is the long-term administration of a potent NA with a high barrier to resistance, regardless of the severity of liver disease (Grade A) [Page 8]
|
| 128 |
+
|
| 129 |
+
- Preferred regimens are ETV, TDF and TAF as monotherapies (Grade A) [Page 8]
|
| 130 |
+
|
| 131 |
+
- LAM, ADV and TBV are not recommended in the treatment of CHB (Grade A) [Page 8]
|
| 132 |
+
|
| 133 |
+
**ABOUT TAF vs TDF [Page 8]:**
|
| 134 |
+
|
| 135 |
+
TAF has demonstrated superior renal and bone density safety profiles compared with TDF in head-to-head trials. International guidelines recommend switching individuals at high risk for bone or renal disease from TDF to either TAF or ETV. TAF maintains a better safety profile unless the patient's creatinine clearance (CrCl) is less than 15 mL/minute.
|
| 136 |
+
|
| 137 |
+
|
| 138 |
+
### 4. HBV-HCV COINFECTION [SASLT 2021, Page 8-9]
|
| 139 |
+
|
| 140 |
+
**RECOMMENDATIONS:**
|
| 141 |
+
|
| 142 |
+
- Treatment of HCV through DAAs may lead to reactivation of HBV. Patients who meet the criteria for HBV treatment should be treated concurrently or before initiation of DAA (Grade A) [Page 9]
|
| 143 |
+
|
| 144 |
+
- HBV DNA and ALT should be monitored every four to eight weeks while on DAA and three months after completion of therapy (Grade D) [Page 9]
|
| 145 |
+
|
| 146 |
+
- ALT level should be monitored every four weeks while on DAA for patients who are HBsAg-negative but HBcAb-positive. If ALT starts to rise, HBsAg and HBV DNA must be obtained to determine the need to start HBV treatment (Grade D) [Page 9]
|
| 147 |
+
|
| 148 |
+
|
| 149 |
+
### 5. HBV-HIV COINFECTION [SASLT 2021, Page 9] β οΈ ABSOLUTE TREATMENT INDICATION
|
| 150 |
+
|
| 151 |
+
**CRITICAL: This is an ABSOLUTE indication for treatment regardless of ALT, HBV DNA level, fibrosis stage, or necroinflammatory activity.**
|
| 152 |
+
|
| 153 |
+
"Patients with HBVβHIV coinfection are at increased risk of rapid fibrosis progression, development of HCC, and liverβrelated mortality." [Page 9]
|
| 154 |
+
|
| 155 |
+
"The prevalence of HBV in patients with HIV coinfection in Saudi Arabia is 3%, which is much higher than the general population." [Page 9]
|
| 156 |
+
|
| 157 |
+
"All patients with HBVβHIV coinfection should receive antiretroviral therapy (ART)." [Page 9]
|
| 158 |
+
|
| 159 |
+
"Patients must be followed closely after initiation of ART, given the risk of immune reconstitution syndrome, which may lead to HBV flare." [Page 9]
|
| 160 |
+
|
| 161 |
+
"The regimen must include tenofovir with either formulation TDF or TAF. TAF has a better safety profile and is preferred over TDF unless the patient has CrCl < 15 mL/minute. Emtricitabine and LAM should be included in the ART regimen." [Page 9]
|
| 162 |
+
|
| 163 |
+
**RECOMMENDATIONS:**
|
| 164 |
+
|
| 165 |
+
- All HIV-positive patients with HBV co-infection should start ART irrespective of CD4 cell count (Grade A) [Page 9]
|
| 166 |
+
|
| 167 |
+
- HBV-HIV co-infected patients should be treated with TDF- or TAF-based ART regimen (Grade A) [Page 9]
|
| 168 |
+
|
| 169 |
+
|
| 170 |
+
### 6. IMMUNOCOMPROMISED PATIENTS [SASLT 2021, Page 9] β οΈ ABSOLUTE TREATMENT INDICATION
|
| 171 |
+
|
| 172 |
+
"Hepatitis B flare during chemotherapy treatment or treatment with other immunosuppressive agents is potentially life threatening. The risk is very high, particularly with the use of CD20 depleting agents." [Page 9]
|
| 173 |
+
|
| 174 |
+
"Therefore, all patients undergoing immunosuppressive treatment or chemotherapy, even shortβterm courses, should be screened for HBsAg, antiβHBc, and antiβHBs (and HBV DNA, if HBsAg is already positive)." [Page 9]
|
| 175 |
+
|
| 176 |
+
**RECOMMENDATIONS:**
|
| 177 |
+
|
| 178 |
+
- Prophylaxis for all patients with positive HBsAg should be done before initiating chemotherapy or other immunosuppressive agents (Grade A) [Page 9]
|
| 179 |
+
|
| 180 |
+
- HBsAg-negative/anti-HBc-positive patients should undergo HBV prophylaxis if they are candidates for anti CD20 or are undergoing stem cell transplantation. HBV prophylaxis should continue for at least six months after completion of immunosuppressive treatment and for twelve months if taking anti CD20 (Grade D) [Page 9]
|
| 181 |
+
|
| 182 |
+
- We recommend starting HBV prophylaxis for HBsAg or antiβHBc positive patients undergoing treatment with tumor necrosis factor (TNF) inhibitors [Page 9]
|
| 183 |
+
|
| 184 |
+
- We recommend HBV prophylaxis for all patients who are HBsAg or anti-HBc positive before initiation of immunotherapy such as antiβprogrammed cell death (PDβ1) and antiβprogrammed cell deathβligand 1 (PDβL1) therapy [Page 9]
|
| 185 |
+
|
| 186 |
+
|
| 187 |
+
### 7. HBV AND PREGNANCY [SASLT 2021, Page 9-10]
|
| 188 |
+
|
| 189 |
+
"The most effective way to prevent motherβtoβchild transmission is to detect HBV early in pregnancy. Therefore, all pregnant women must be screened for HBV during the first trimester." [Page 9]
|
| 190 |
+
|
| 191 |
+
"Pregnant women should be treated if they meet the standard indication of therapy. We recommend HBV treatment if HBV DNA is greater than 100,000 IU/mL in the late second trimester (between 24β28 weeks of gestation)." [Page 9]
|
| 192 |
+
|
| 193 |
+
"TDF is the drug of choice during pregnancy. However, more recently, a multiβcenter experience from China reported no motherβtoβchild transmission or developmental anomalies in 71 infants born to mothers who received TAF during the last trimester of pregnancy." [Page 9]
|
| 194 |
+
|
| 195 |
+
**RECOMMENDATIONS:**
|
| 196 |
+
|
| 197 |
+
- All pregnant women must be screened for HBV during the first trimester (Grade A) [Page 10]
|
| 198 |
+
|
| 199 |
+
- All pregnant women with HBV DNA greater than 100,000 IU/mL in the late second trimester (between 24-28 weeks of gestation) should start antiviral prophylaxis with TDF, or TAF as an alternative (Grade D) [Page 10]
|
| 200 |
+
|
| 201 |
+
- Switch to TDF or TAF is recommended if the patient is receiving ETV, ADV, or interferon during pregnancy (Grade D) [Page 10]
|
| 202 |
+
|
| 203 |
+
- Breastfeeding is not contraindicated in HBsAg-positive untreated women or on TDF-based treatment or prophylaxis (Grade B) [Page 10]
|
| 204 |
+
|
| 205 |
+
|
| 206 |
+
### KEY DEFINITIONS [From Table 2, Page 3 and text]
|
| 207 |
+
|
| 208 |
+
**ALT (Alanine Aminotransferase):**
|
| 209 |
+
- Upper Limit of Normal (ULN) = ~40 IU/L [Page 6]
|
| 210 |
+
- 2ΓULN = ~80 IU/L
|
| 211 |
+
|
| 212 |
+
**Necroinflammatory Activity Grades:**
|
| 213 |
+
- A1 = mild
|
| 214 |
+
- A2 = moderate
|
| 215 |
+
- A3 = severe
|
| 216 |
+
|
| 217 |
+
**Liver Fibrosis Stages:**
|
| 218 |
+
- F0 = no fibrosis
|
| 219 |
+
- F1 = mild fibrosis, pericellular collagen deposits
|
| 220 |
+
- F2 = moderate fibrosis, beginning bridging fibrosis
|
| 221 |
+
- F3 = severe fibrosis, defined as presence of numerous bridges and septa
|
| 222 |
+
- F4 = cirrhosis
|
| 223 |
+
|
| 224 |
+
**HBV DNA Thresholds [From Table 2, Page 3]:**
|
| 225 |
+
- Phase 3 (Inactive carrier): <2,000 IU/mL
|
| 226 |
+
- Phase 4 (HBeAg-negative chronic hepatitis): >2,000 IU/mL (fluctuating levels)
|
| 227 |
+
- Phase 1 (Immune tolerant): >10^7 IU/mL (very high)
|
| 228 |
+
"""
|
| 229 |
+
|
| 230 |
+
|
| 231 |
+
def extract_eligibility_from_text(recommendations: str) -> bool:
|
| 232 |
+
"""
|
| 233 |
+
Extract eligibility decision from recommendations text.
|
| 234 |
+
Looks for patterns like "Decision: ELIGIBLE" or "Decision: NOT ELIGIBLE"
|
| 235 |
+
|
| 236 |
+
Args:
|
| 237 |
+
recommendations: Recommendations text string
|
| 238 |
+
|
| 239 |
+
Returns:
|
| 240 |
+
True if text indicates ELIGIBLE, False if NOT ELIGIBLE, None if ambiguous
|
| 241 |
+
"""
|
| 242 |
+
if not recommendations:
|
| 243 |
+
return None
|
| 244 |
+
|
| 245 |
+
# Normalize text for searching (case-insensitive, handle escaped newlines)
|
| 246 |
+
normalized = recommendations.replace("\\n", "\n").upper()
|
| 247 |
+
|
| 248 |
+
# Look for explicit decision statements
|
| 249 |
+
# Pattern 1: "*Decision:* ELIGIBLE" or "*Decision:* NOT ELIGIBLE"
|
| 250 |
+
decision_match = re.search(r"\*DECISION:\*\s*(ELIGIBLE|NOT\s+ELIGIBLE)", normalized)
|
| 251 |
+
if decision_match:
|
| 252 |
+
decision = decision_match.group(1)
|
| 253 |
+
if "NOT" in decision:
|
| 254 |
+
return False
|
| 255 |
+
return True
|
| 256 |
+
|
| 257 |
+
# Pattern 2: "Decision: ELIGIBLE" or "Decision: NOT ELIGIBLE" (without asterisks)
|
| 258 |
+
decision_match = re.search(r"DECISION:\s*(ELIGIBLE|NOT\s+ELIGIBLE)", normalized)
|
| 259 |
+
if decision_match:
|
| 260 |
+
decision = decision_match.group(1)
|
| 261 |
+
if "NOT" in decision:
|
| 262 |
+
return False
|
| 263 |
+
return True
|
| 264 |
+
|
| 265 |
+
# Pattern 3: Look for strong indicators in rationale
|
| 266 |
+
# If text says "patient is eligible" or "treatment is recommended" with strong language
|
| 267 |
+
eligible_indicators = [
|
| 268 |
+
r"PATIENT\s+IS\s+ELIGIBLE",
|
| 269 |
+
r"TREATMENT\s+IS\s+RECOMMENDED",
|
| 270 |
+
r"ABSOLUTE\s+INDICATION",
|
| 271 |
+
r"AUTOMATICALLY\s+ELIGIBLE",
|
| 272 |
+
r"REQUIRES\s+TREATMENT",
|
| 273 |
+
r"SHOULD\s+RECEIVE\s+TREATMENT",
|
| 274 |
+
r"PROPHYLAXIS\s+IS\s+REQUIRED",
|
| 275 |
+
]
|
| 276 |
+
|
| 277 |
+
not_eligible_indicators = [
|
| 278 |
+
r"PATIENT\s+IS\s+NOT\s+ELIGIBLE",
|
| 279 |
+
r"NOT\s+ELIGIBLE",
|
| 280 |
+
r"DOES\s+NOT\s+MEET\s+CRITERIA",
|
| 281 |
+
r"REQUIRES\s+MONITORING\s+ONLY",
|
| 282 |
+
]
|
| 283 |
+
|
| 284 |
+
# Check for eligible indicators
|
| 285 |
+
for pattern in eligible_indicators:
|
| 286 |
+
if re.search(pattern, normalized):
|
| 287 |
+
return True
|
| 288 |
+
|
| 289 |
+
# Check for not eligible indicators
|
| 290 |
+
for pattern in not_eligible_indicators:
|
| 291 |
+
if re.search(pattern, normalized):
|
| 292 |
+
return False
|
| 293 |
+
|
| 294 |
+
return None
|
| 295 |
+
|
| 296 |
+
|
| 297 |
+
def validate_eligibility_consistency(patient_data: Dict[str, Any]) -> Dict[str, Any]:
|
| 298 |
+
"""
|
| 299 |
+
Validation Node:
|
| 300 |
+
- Checks consistency between JSON 'eligible' field and recommendations text
|
| 301 |
+
- If mismatch detected, corrects the JSON field to match the text (text is authoritative)
|
| 302 |
+
- Logs any corrections made
|
| 303 |
+
|
| 304 |
+
Args:
|
| 305 |
+
patient_data: Patient data with parsed result
|
| 306 |
+
|
| 307 |
+
Returns:
|
| 308 |
+
Patient data with corrected eligibility if needed
|
| 309 |
+
"""
|
| 310 |
+
logger.info("π [PHASE 2] Eligibility Consistency Validation Node")
|
| 311 |
+
|
| 312 |
+
parsed_result = patient_data["parsed_result"]
|
| 313 |
+
json_eligible = parsed_result.get("eligible")
|
| 314 |
+
recommendations = parsed_result.get("recommendations", "")
|
| 315 |
+
|
| 316 |
+
# Extract eligibility from text
|
| 317 |
+
text_eligible = extract_eligibility_from_text(recommendations)
|
| 318 |
+
|
| 319 |
+
if text_eligible is None:
|
| 320 |
+
logger.warning(
|
| 321 |
+
"β οΈ Could not extract eligibility from recommendations text - using JSON value"
|
| 322 |
+
)
|
| 323 |
+
return patient_data
|
| 324 |
+
|
| 325 |
+
# Check for mismatch
|
| 326 |
+
if json_eligible != text_eligible:
|
| 327 |
+
logger.warning(f"β οΈ INCONSISTENCY DETECTED:")
|
| 328 |
+
logger.warning(f" JSON 'eligible': {json_eligible}")
|
| 329 |
+
logger.warning(f" Text decision: {text_eligible}")
|
| 330 |
+
logger.warning(
|
| 331 |
+
f" Correcting JSON to match text decision (text is authoritative)"
|
| 332 |
+
)
|
| 333 |
+
|
| 334 |
+
# Correct the JSON field to match the text
|
| 335 |
+
parsed_result["eligible"] = text_eligible
|
| 336 |
+
patient_data["parsed_result"] = parsed_result
|
| 337 |
+
|
| 338 |
+
logger.info(f"β Corrected eligibility: {text_eligible}")
|
| 339 |
+
else:
|
| 340 |
+
logger.info(f"β Eligibility consistent: {json_eligible}")
|
| 341 |
+
|
| 342 |
+
return patient_data
|
| 343 |
+
|
| 344 |
+
|
| 345 |
+
def normalize_recommendations(text: str) -> str:
|
| 346 |
+
"""
|
| 347 |
+
Normalize recommendations text - preserve intentional formatting.
|
| 348 |
+
- Replace escaped newlines with actual newlines
|
| 349 |
+
- Remove excessive blank lines (more than 2 consecutive)
|
| 350 |
+
- Ensure consistent spacing around section headers
|
| 351 |
+
- Trim leading/trailing whitespace
|
| 352 |
+
|
| 353 |
+
Args:
|
| 354 |
+
text: Raw recommendations string with escaped newlines
|
| 355 |
+
|
| 356 |
+
Returns:
|
| 357 |
+
Normalized recommendations string with proper formatting
|
| 358 |
+
"""
|
| 359 |
+
if not text:
|
| 360 |
+
return ""
|
| 361 |
+
|
| 362 |
+
# Replace escaped newlines with actual newlines
|
| 363 |
+
normalized = text.replace("\\n", "\n")
|
| 364 |
+
|
| 365 |
+
# Remove excessive blank lines (more than 2 consecutive)
|
| 366 |
+
normalized = re.sub(r"\n{3,}", "\n\n", normalized)
|
| 367 |
+
|
| 368 |
+
# Ensure consistent spacing around section headers (** markers)
|
| 369 |
+
normalized = re.sub(r"\n\*\*", "\n\n**", normalized)
|
| 370 |
+
|
| 371 |
+
# Trim leading/trailing whitespace
|
| 372 |
+
normalized = normalized.strip()
|
| 373 |
+
|
| 374 |
+
# Soft cap length to avoid overly long outputs
|
| 375 |
+
max_len = 2500 # Increased from 1800 to accommodate comprehensive format
|
| 376 |
+
if len(normalized) > max_len:
|
| 377 |
+
normalized = normalized[:max_len].rstrip()
|
| 378 |
+
|
| 379 |
+
return normalized
|
| 380 |
+
|
| 381 |
+
|
| 382 |
+
# ============================================================================
|
| 383 |
+
# PHASE 1: DETERMINISTIC ELIGIBILITY & DATA PREPARATION
|
| 384 |
+
# ============================================================================
|
| 385 |
+
|
| 386 |
+
|
| 387 |
+
def validate_and_clean_input(patient_data: Dict[str, Any]) -> Dict[str, Any]:
|
| 388 |
+
"""
|
| 389 |
+
Validation & Cleaning Node:
|
| 390 |
+
- Enforces input schema
|
| 391 |
+
- Converts string DNA/ALT to numeric
|
| 392 |
+
- Handles missing data
|
| 393 |
+
|
| 394 |
+
Args:
|
| 395 |
+
patient_data: Raw patient data dictionary
|
| 396 |
+
|
| 397 |
+
Returns:
|
| 398 |
+
Cleaned and validated patient data
|
| 399 |
+
"""
|
| 400 |
+
logger.info("π [PHASE 1] Validation & Cleaning Node")
|
| 401 |
+
|
| 402 |
+
# Convert HBV DNA to numeric
|
| 403 |
+
hbv_dna = patient_data.get("hbv_dna_level", 0)
|
| 404 |
+
hbv_dna_numeric = hbv_dna
|
| 405 |
+
|
| 406 |
+
if isinstance(hbv_dna_numeric, str):
|
| 407 |
+
try:
|
| 408 |
+
cleaned = re.sub(r"[^\d\.]", "", hbv_dna_numeric)
|
| 409 |
+
hbv_dna_numeric = float(cleaned) if cleaned else 0.0
|
| 410 |
+
except Exception:
|
| 411 |
+
hbv_dna_numeric = 0.0
|
| 412 |
+
|
| 413 |
+
try:
|
| 414 |
+
hbv_dna_numeric = float(hbv_dna_numeric)
|
| 415 |
+
except (TypeError, ValueError):
|
| 416 |
+
hbv_dna_numeric = 0.0
|
| 417 |
+
|
| 418 |
+
patient_data["hbv_dna_level_numeric"] = hbv_dna_numeric
|
| 419 |
+
|
| 420 |
+
# Compute HBV DNA comparison
|
| 421 |
+
if hbv_dna_numeric > 2000:
|
| 422 |
+
hbv_dna_2000_comparison = ">"
|
| 423 |
+
elif hbv_dna_numeric < 2000:
|
| 424 |
+
hbv_dna_2000_comparison = "<"
|
| 425 |
+
else:
|
| 426 |
+
hbv_dna_2000_comparison = "="
|
| 427 |
+
|
| 428 |
+
patient_data["hbv_dna_2000_comparison"] = hbv_dna_2000_comparison
|
| 429 |
+
logger.info(
|
| 430 |
+
f"β HBV DNA normalized: {hbv_dna_numeric} {hbv_dna_2000_comparison} 2000 IU/mL"
|
| 431 |
+
)
|
| 432 |
+
|
| 433 |
+
return patient_data
|
| 434 |
+
|
| 435 |
+
|
| 436 |
+
def assemble_llm_prompt(patient_data: Dict[str, Any]) -> Dict[str, Any]:
|
| 437 |
+
"""
|
| 438 |
+
Prompt Assembly Node:
|
| 439 |
+
- Constructs the final, complete prompt for LLM
|
| 440 |
+
- LLM is solely responsible for eligibility determination
|
| 441 |
+
- Uses comprehensive yet concise format with visual indicators
|
| 442 |
+
|
| 443 |
+
Args:
|
| 444 |
+
patient_data: Cleaned patient data
|
| 445 |
+
|
| 446 |
+
Returns:
|
| 447 |
+
Patient data with assembled prompt
|
| 448 |
+
"""
|
| 449 |
+
logger.info("π [PHASE 1] Prompt Assembly Node")
|
| 450 |
+
|
| 451 |
+
hbv_dna_2000_comparison = patient_data.get("hbv_dna_2000_comparison", "N/A")
|
| 452 |
+
|
| 453 |
+
# Extract patient parameters
|
| 454 |
+
sex = patient_data.get("sex", "Male")
|
| 455 |
+
age = patient_data.get("age", "N/A")
|
| 456 |
+
pregnancy_status = patient_data.get("pregnancy_status", "N/A")
|
| 457 |
+
hbsag_status = patient_data.get("hbsag_status", "N/A")
|
| 458 |
+
duration_hbsag = patient_data.get("duration_hbsag_months", "N/A")
|
| 459 |
+
hbeag_status = patient_data.get("hbeag_status", "N/A")
|
| 460 |
+
alt_level = patient_data.get("alt_level", 0)
|
| 461 |
+
fibrosis_stage = patient_data.get("fibrosis_stage", "N/A")
|
| 462 |
+
necroinflammatory = patient_data.get("necroinflammatory_activity", "N/A")
|
| 463 |
+
extrahepatic = patient_data.get("extrahepatic_manifestations", False)
|
| 464 |
+
immunosuppression = patient_data.get("immunosuppression_status", "None")
|
| 465 |
+
coinfections = patient_data.get("coinfections", [])
|
| 466 |
+
family_history = patient_data.get("family_history_cirrhosis_hcc", False)
|
| 467 |
+
comorbidities = patient_data.get("other_comorbidities", [])
|
| 468 |
+
hbv_dna = patient_data.get("hbv_dna_level", 0)
|
| 469 |
+
|
| 470 |
+
# Check for special absolute indications
|
| 471 |
+
has_hiv = "HIV" in [c.upper() for c in coinfections] if coinfections else False
|
| 472 |
+
has_hcv = "HCV" in [c.upper() for c in coinfections] if coinfections else False
|
| 473 |
+
has_hdv = "HDV" in [c.upper() for c in coinfections] if coinfections else False
|
| 474 |
+
|
| 475 |
+
# Build analysis prompt with mandatory eligibility decision tree
|
| 476 |
+
analysis_prompt = f"""You are an expert hepatologist providing HBV treatment eligibility assessments based on SASLT 2021 guidelines.
|
| 477 |
+
|
| 478 |
+
PATIENT DATA:
|
| 479 |
+
- Sex: {sex}
|
| 480 |
+
- Age: {age} years
|
| 481 |
+
- Pregnancy Status: {pregnancy_status}
|
| 482 |
+
- HBsAg Status: {hbsag_status}
|
| 483 |
+
- HBsAg Duration: {duration_hbsag} months
|
| 484 |
+
- HBV DNA Level: {hbv_dna} IU/mL ({hbv_dna_2000_comparison} 2000 IU/mL)
|
| 485 |
+
- HBeAg Status: {hbeag_status}
|
| 486 |
+
- ALT Level: {alt_level} IU/L
|
| 487 |
+
- Fibrosis Stage: {fibrosis_stage}
|
| 488 |
+
- Necroinflammatory Activity: {necroinflammatory}
|
| 489 |
+
- Extrahepatic Manifestations: {extrahepatic}
|
| 490 |
+
- Immunosuppression: {immunosuppression}
|
| 491 |
+
- Coinfections: {', '.join(coinfections) if coinfections else 'None'}
|
| 492 |
+
- Family History (Cirrhosis/HCC): {family_history}
|
| 493 |
+
- Other Comorbidities: {', '.join(comorbidities) if comorbidities else 'None'}
|
| 494 |
+
|
| 495 |
+
SASLT 2021 GUIDELINES REFERENCE:
|
| 496 |
+
{SASLT_GUIDELINES}
|
| 497 |
+
|
| 498 |
+
β οΈ MANDATORY ELIGIBILITY DECISION TREE - FOLLOW THIS EXACT SEQUENCE:
|
| 499 |
+
|
| 500 |
+
**STEP 1: Check ABSOLUTE INDICATIONS (these override ALL standard criteria):**
|
| 501 |
+
|
| 502 |
+
1a. **HBV-HIV Coinfection** [Page 123, Grade A]:
|
| 503 |
+
- Does patient have HIV coinfection? Check: {', '.join(coinfections) if coinfections else 'None'}
|
| 504 |
+
- If YES β **AUTOMATICALLY ELIGIBLE** (no other criteria needed)
|
| 505 |
+
- Rationale: "Patients with HBV-HIV coinfection are at increased risk of rapid fibrosis progression, development of HCC, and liver-related mortality"
|
| 506 |
+
- Treatment: TDF- or TAF-based ART regimen irrespective of CD4 count
|
| 507 |
+
|
| 508 |
+
1b. **Cirrhosis (F4)** [Page 120, Grade A]:
|
| 509 |
+
- Does patient have cirrhosis? Check: {fibrosis_stage}
|
| 510 |
+
- Does patient have ANY detectable HBV DNA? Check: {hbv_dna} IU/mL
|
| 511 |
+
- If BOTH YES β **AUTOMATICALLY ELIGIBLE**
|
| 512 |
+
|
| 513 |
+
1c. **Immunosuppression/Chemotherapy** [Page 123, Grade A]:
|
| 514 |
+
- Is patient undergoing immunosuppression? Check: {immunosuppression}
|
| 515 |
+
- Is HBsAg positive? Check: {hbsag_status}
|
| 516 |
+
- If BOTH YES β **AUTOMATICALLY ELIGIBLE** (prophylaxis required)
|
| 517 |
+
|
| 518 |
+
1d. **Pregnancy with High Viral Load** [Page 124, Grade D]:
|
| 519 |
+
- Is patient pregnant? Check: {pregnancy_status}
|
| 520 |
+
- Is HBV DNA > 100,000 IU/mL? Check: {hbv_dna} vs 100,000
|
| 521 |
+
- If BOTH YES β **AUTOMATICALLY ELIGIBLE**
|
| 522 |
+
|
| 523 |
+
β If ANY absolute indication is met, STOP HERE and return ELIGIBLE = true
|
| 524 |
+
|
| 525 |
+
|
| 526 |
+
**STEP 2: If NO absolute indications, check STANDARD CRITERIA:**
|
| 527 |
+
|
| 528 |
+
2a. **High Viral Load + High ALT** [Page 120, Grade B]:
|
| 529 |
+
- HBV DNA > 20,000 IU/mL? β {hbv_dna} vs 20,000 = {"YES β
" if hbv_dna > 20000 else "NO β"}
|
| 530 |
+
- ALT > 2ΓULN (80 IU/L)? β {alt_level} vs 80 = {"YES β
" if alt_level > 80 else "NO β"}
|
| 531 |
+
- If BOTH YES β ELIGIBLE (fibrosis stage irrelevant)
|
| 532 |
+
|
| 533 |
+
2b. **Standard Triple Criteria** [Page 120, Grade A]:
|
| 534 |
+
- HBV DNA > 2,000 IU/mL? β {hbv_dna} vs 2,000 = {"YES β
" if hbv_dna > 2000 else "NO β"}
|
| 535 |
+
- ALT > ULN (~40 IU/L)? β {alt_level} vs 40 = {"YES β
" if alt_level > 40 else "NO β"}
|
| 536 |
+
- F2+ OR A2+? β {fibrosis_stage} and {necroinflammatory} = [Check if F2+ OR A2+]
|
| 537 |
+
- If ALL THREE YES β ELIGIBLE
|
| 538 |
+
|
| 539 |
+
2c. **Moderate Fibrosis Exception** [Page 120]:
|
| 540 |
+
- HBV DNA > 2,000 IU/mL? β {hbv_dna} vs 2,000 = {"YES β
" if hbv_dna > 2000 else "NO β"}
|
| 541 |
+
- F2+ fibrosis? β {fibrosis_stage} = [Check if F2+]
|
| 542 |
+
- If BOTH YES β ELIGIBLE (even if ALT normal)
|
| 543 |
+
|
| 544 |
+
2d. **HBeAg Positive >30 years** [Page 120, Grade D]:
|
| 545 |
+
- HBeAg positive? β {hbeag_status}
|
| 546 |
+
- Age > 30? β {age} vs 30
|
| 547 |
+
- HBV DNA > 2,000 IU/mL? β {hbv_dna} vs 2,000
|
| 548 |
+
- If ALL THREE YES β ELIGIBLE
|
| 549 |
+
|
| 550 |
+
2e. **Family History** [Page 120, Grade D]:
|
| 551 |
+
- HBV DNA > 2,000 IU/mL? β {hbv_dna} vs 2,000 = {"YES β
" if hbv_dna > 2000 else "NO β"}
|
| 552 |
+
- ALT > ULN (~40 IU/L)? β {alt_level} vs 40 = {"YES β
" if alt_level > 40 else "NO β"}
|
| 553 |
+
- Family history HCC/cirrhosis? β {family_history}
|
| 554 |
+
- If ALL THREE YES β ELIGIBLE
|
| 555 |
+
|
| 556 |
+
|
| 557 |
+
**STEP 3: If NONE of the above criteria met:**
|
| 558 |
+
β **NOT ELIGIBLE**
|
| 559 |
+
β Patient requires monitoring per Page 121 guidelines
|
| 560 |
+
|
| 561 |
+
|
| 562 |
+
**CRITICAL RULES YOU MUST FOLLOW:**
|
| 563 |
+
|
| 564 |
+
1. β οΈ **HIV COINFECTION = AUTOMATIC ELIGIBILITY** - This overrides ALL other parameters including normal ALT, low HBV DNA, mild fibrosis
|
| 565 |
+
|
| 566 |
+
2. β οΈ **HBV DNA > 2,000 IU/mL is MANDATORY** for all standard criteria EXCEPT:
|
| 567 |
+
- Cirrhosis (needs only detectable HBV DNA)
|
| 568 |
+
- HIV coinfection (no HBV DNA threshold)
|
| 569 |
+
- Immunosuppression (no HBV DNA threshold)
|
| 570 |
+
|
| 571 |
+
3. **If HBV DNA β€ 2,000 IU/mL:**
|
| 572 |
+
- Check for cirrhosis, HIV, immunosuppression
|
| 573 |
+
- If none present β AUTOMATICALLY NOT ELIGIBLE
|
| 574 |
+
- Elevated ALT + moderate fibrosis is NOT sufficient without HBV DNA >2,000
|
| 575 |
+
|
| 576 |
+
4. **Direct quotes from guidelines must be cited with [Page X]**
|
| 577 |
+
|
| 578 |
+
5. **Never hallucinate criteria** - use ONLY what's explicitly stated in guidelines above
|
| 579 |
+
|
| 580 |
+
6. β οΈ **CRITICAL: CONSISTENCY REQUIREMENT** - The JSON "eligible" field MUST match the "Decision:" statement in your recommendations text:
|
| 581 |
+
- If you write "*Decision:* ELIGIBLE" in recommendations β JSON "eligible" MUST be true
|
| 582 |
+
- If you write "*Decision:* NOT ELIGIBLE" in recommendations β JSON "eligible" MUST be false
|
| 583 |
+
- These two fields MUST be perfectly consistent - any mismatch will be automatically corrected
|
| 584 |
+
|
| 585 |
+
|
| 586 |
+
RESPONSE FORMAT (JSON ONLY - NO MARKDOWN):
|
| 587 |
+
{{
|
| 588 |
+
"eligible": true or false,
|
| 589 |
+
"recommendations": "Full formatted assessment with sections"
|
| 590 |
+
}}
|
| 591 |
+
|
| 592 |
+
STRUCTURE OF "recommendations" FIELD:
|
| 593 |
+
Use \\n for line breaks (NOT literal newlines). Format as follows:
|
| 594 |
+
|
| 595 |
+
**Patient Summary**\\n
|
| 596 |
+
- Brief age, sex, key clinical parameters (3-5 bullets max)\\n
|
| 597 |
+
{f"- **CRITICAL: HIV coinfection present - absolute treatment indication**\\n" if has_hiv else ""}
|
| 598 |
+
\\n
|
| 599 |
+
**Treatment Eligibility Analysis**\\n
|
| 600 |
+
\\n
|
| 601 |
+
*Absolute Indications Check (Priority):*\\n
|
| 602 |
+
{f"- β
**HBV-HIV coinfection: ABSOLUTE INDICATION** [SASLT 2021, Page 9, Grade A]\\n" if has_hiv else ""}
|
| 603 |
+
{f"- β No HIV coinfection\\n" if not has_hiv else ""}
|
| 604 |
+
- Cirrhosis (F4): [Check and mark β
or β]\\n
|
| 605 |
+
- Immunosuppression: [Check and mark β
or β]\\n
|
| 606 |
+
- Pregnancy with high viral load: [Check and mark β
or β]\\n
|
| 607 |
+
\\n
|
| 608 |
+
*Standard Criteria Assessment (if no absolute indications):*\\n
|
| 609 |
+
- HBV DNA >2000 IU/mL: [β
or β]\\n
|
| 610 |
+
- ALT >ULN (40 IU/L): [β
or β]\\n
|
| 611 |
+
- Moderate necroinflammation/fibrosis (F2+/A2+): [β
or β]\\n
|
| 612 |
+
\\n
|
| 613 |
+
*Special Considerations:*\\n
|
| 614 |
+
- Note any additional factors: family history, age >30, extrahepatic manifestations\\n
|
| 615 |
+
- Cite specific SASLT guideline provisions\\n
|
| 616 |
+
\\n
|
| 617 |
+
**Clinical Recommendation**\\n
|
| 618 |
+
\\n
|
| 619 |
+
*Decision:* [ELIGIBLE/NOT ELIGIBLE]\\n
|
| 620 |
+
\\n
|
| 621 |
+
*Rationale:*\\n
|
| 622 |
+
- Clearly state the PRIMARY reason for eligibility decision\\n
|
| 623 |
+
{f"- If HIV coinfection: State this is an absolute Grade A indication that overrides all other criteria\\n" if has_hiv else ""}
|
| 624 |
+
- Which specific SASLT criterion/criteria apply\\n
|
| 625 |
+
- Grade of recommendation (A, B, C, or D)\\n
|
| 626 |
+
\\n
|
| 627 |
+
*Key Factors:*\\n
|
| 628 |
+
- List 3-5 main clinical considerations\\n
|
| 629 |
+
\\n
|
| 630 |
+
*Management Approach:*\\n
|
| 631 |
+
\\n
|
| 632 |
+
{"**HBV-HIV Coinfection Treatment (Grade A):**\\n- All HIV-positive patients with HBV coinfection should start ART immediately, irrespective of CD4 count [SASLT 2021, Page 9]\\n- Regimen MUST include TDF or TAF (preferably TAF for better renal/bone safety) [SASLT 2021, Page 9]\\n- Include Emtricitabine or Lamivudine as part of ART regimen\\n- Monitor for immune reconstitution syndrome (may cause HBV flare in first 3-6 months)\\n- HBV DNA and ALT at 3, 6, 12 months, then every 6-12 months\\n- HIV viral load every 3-6 months\\n- Annual HCC surveillance (ultrasound Β± AFP)\\n\\n" if has_hiv else ""}
|
| 633 |
+
**If ELIGIBLE (Standard Criteria):**\\n
|
| 634 |
+
- Preferred agents: Entecavir (ETV), Tenofovir (TDF), or Tenofovir Alafenamide (TAF) [SASLT 2021, Page 8, Grade A]\\n
|
| 635 |
+
- Monitor HBV DNA and ALT at 3, 6, 12 months, then every 6-12 months\\n
|
| 636 |
+
\\n
|
| 637 |
+
**If NOT ELIGIBLE:**\\n
|
| 638 |
+
- Monitor ALT every 3-6 months, HBV DNA every 6-12 months, fibrosis yearly [SASLT 2021, Page 7]\\n
|
| 639 |
+
- Reassess if ALT rises >ULN, fibrosis progresses, or HBV DNA increases\\n
|
| 640 |
+
\\n
|
| 641 |
+
*Final Recommendation:*\\n
|
| 642 |
+
- Concise summary statement (2-3 sentences)\\n
|
| 643 |
+
{f"- **Emphasize that HIV coinfection makes treatment mandatory regardless of other parameters**\\n" if has_hiv else ""}
|
| 644 |
+
- Emphasize key decision factors\\n
|
| 645 |
+
|
| 646 |
+
Return ONLY the JSON object, nothing else."""
|
| 647 |
+
|
| 648 |
+
patient_data["llm_prompt"] = analysis_prompt
|
| 649 |
+
logger.info("β LLM prompt assembled")
|
| 650 |
+
if has_hiv:
|
| 651 |
+
logger.info("β οΈ HIV coinfection detected - absolute treatment indication")
|
| 652 |
+
|
| 653 |
+
return patient_data
|
| 654 |
+
|
| 655 |
+
|
| 656 |
+
# ============================================================================
|
| 657 |
+
# PHASE 2: LLM GENERATION AND POST-PROCESSING
|
| 658 |
+
# ============================================================================
|
| 659 |
+
|
| 660 |
+
|
| 661 |
+
def invoke_llm_for_assessment(patient_data: Dict[str, Any]) -> Dict[str, Any]:
|
| 662 |
+
"""
|
| 663 |
+
LLM Generation Node (R-Node):
|
| 664 |
+
- Invokes the LLM with the assembled prompt
|
| 665 |
+
- Returns raw LLM text response
|
| 666 |
+
|
| 667 |
+
Args:
|
| 668 |
+
patient_data: Patient data with assembled prompt
|
| 669 |
+
|
| 670 |
+
Returns:
|
| 671 |
+
Patient data with raw LLM response
|
| 672 |
+
"""
|
| 673 |
+
logger.info("π€ [PHASE 2] LLM Generation Node")
|
| 674 |
+
|
| 675 |
+
llm = get_llm()
|
| 676 |
+
prompt = patient_data["llm_prompt"]
|
| 677 |
+
|
| 678 |
+
logger.info("Sending prompt to LLM...")
|
| 679 |
+
response = llm.invoke(prompt)
|
| 680 |
+
logger.info("LLM response received")
|
| 681 |
+
|
| 682 |
+
response_text = response.content if hasattr(response, "content") else str(response)
|
| 683 |
+
if isinstance(response_text, str):
|
| 684 |
+
response_text = response_text.strip()
|
| 685 |
+
|
| 686 |
+
patient_data["llm_response_raw"] = response_text
|
| 687 |
+
|
| 688 |
+
logger.info(f"β LLM response (first 200 chars): {response_text[:200]}...")
|
| 689 |
+
|
| 690 |
+
return patient_data
|
| 691 |
+
|
| 692 |
+
|
| 693 |
+
def parse_structured_output(patient_data: Dict[str, Any]) -> Dict[str, Any]:
|
| 694 |
+
"""
|
| 695 |
+
Structured Output Parser Node (P-Node):
|
| 696 |
+
- Expects a JSON code block and attempts to parse it
|
| 697 |
+
- Enforces Integrity: Overrides the eligible key with deterministic is_eligible if LLM deviated
|
| 698 |
+
|
| 699 |
+
Args:
|
| 700 |
+
patient_data: Patient data with raw LLM response
|
| 701 |
+
|
| 702 |
+
Returns:
|
| 703 |
+
Patient data with parsed JSON
|
| 704 |
+
"""
|
| 705 |
+
logger.info("π [PHASE 2] Structured Output Parser Node")
|
| 706 |
+
|
| 707 |
+
response_text = patient_data["llm_response_raw"]
|
| 708 |
+
|
| 709 |
+
try:
|
| 710 |
+
# Extract JSON from response (handle markdown code blocks)
|
| 711 |
+
json_start = response_text.find("{")
|
| 712 |
+
json_end = response_text.rfind("}") + 1
|
| 713 |
+
|
| 714 |
+
if json_start == -1 or json_end == 0:
|
| 715 |
+
raise ValueError("No JSON object found in response")
|
| 716 |
+
|
| 717 |
+
json_str = response_text[json_start:json_end]
|
| 718 |
+
|
| 719 |
+
# Remove invisible Unicode separators
|
| 720 |
+
invisible_chars = ["\u200b", "\u200c", "\u200d", "\ufeff", "\xa0"]
|
| 721 |
+
for ch in invisible_chars:
|
| 722 |
+
json_str = json_str.replace(ch, "")
|
| 723 |
+
|
| 724 |
+
# Clean JSON string
|
| 725 |
+
cleaned_json_str = clean_json_string(json_str)
|
| 726 |
+
|
| 727 |
+
# Parse JSON
|
| 728 |
+
result = json.loads(cleaned_json_str)
|
| 729 |
+
logger.info("β Successfully parsed JSON response")
|
| 730 |
+
logger.info(f"β LLM determined eligibility: {result.get('eligible')}")
|
| 731 |
+
|
| 732 |
+
patient_data["parsed_result"] = result
|
| 733 |
+
|
| 734 |
+
return patient_data
|
| 735 |
+
|
| 736 |
+
except (json.JSONDecodeError, ValueError) as e:
|
| 737 |
+
logger.error(f"β Failed to parse LLM response as JSON: {e}")
|
| 738 |
+
logger.error(f"Response text: {response_text}")
|
| 739 |
+
raise ValueError(f"Failed to parse LLM response: {str(e)}")
|
| 740 |
+
|
| 741 |
+
|
| 742 |
+
def normalize_output(patient_data: Dict[str, Any]) -> Dict[str, Any]:
|
| 743 |
+
"""
|
| 744 |
+
Final Normalization Node:
|
| 745 |
+
- Executes normalize_recommendations on the parsed recommendations string
|
| 746 |
+
- Returns final {eligible: bool, recommendations: str} dictionary
|
| 747 |
+
- LLM eligibility determination is final (no fallback)
|
| 748 |
+
|
| 749 |
+
Args:
|
| 750 |
+
patient_data: Patient data with parsed result
|
| 751 |
+
|
| 752 |
+
Returns:
|
| 753 |
+
Patient data with normalized recommendations
|
| 754 |
+
"""
|
| 755 |
+
logger.info("π [PHASE 2] Final Normalization Node")
|
| 756 |
+
|
| 757 |
+
parsed_result = patient_data["parsed_result"]
|
| 758 |
+
recommendations = parsed_result.get("recommendations", "")
|
| 759 |
+
|
| 760 |
+
normalized_recs = normalize_recommendations(recommendations)
|
| 761 |
+
|
| 762 |
+
assessment_result = {
|
| 763 |
+
"eligible": parsed_result.get("eligible"),
|
| 764 |
+
"recommendations": normalized_recs,
|
| 765 |
+
}
|
| 766 |
+
|
| 767 |
+
patient_data["assessment_result"] = assessment_result
|
| 768 |
+
logger.info(f"β Output normalized: {len(normalized_recs)} characters")
|
| 769 |
+
|
| 770 |
+
return patient_data
|
| 771 |
+
|
| 772 |
+
|
| 773 |
+
# ============================================================================
|
| 774 |
+
# CHAIN ASSEMBLY
|
| 775 |
+
# ============================================================================
|
| 776 |
+
|
| 777 |
+
|
| 778 |
+
def create_hbv_assessment_chain():
|
| 779 |
+
"""
|
| 780 |
+
Create the complete HBV Assessment LangChain Chain
|
| 781 |
+
|
| 782 |
+
LLM is solely responsible for eligibility determination based on SASLT 2021 guidelines
|
| 783 |
+
|
| 784 |
+
Returns:
|
| 785 |
+
Runnable chain that processes patient data end-to-end
|
| 786 |
+
"""
|
| 787 |
+
logger.info("π Building HBV Assessment Chain...")
|
| 788 |
+
|
| 789 |
+
# Phase 1: Input Validation & Preparation
|
| 790 |
+
# Phase 2: LLM-Based Eligibility Determination & Assessment
|
| 791 |
+
chain = (
|
| 792 |
+
RunnablePassthrough()
|
| 793 |
+
| RunnableLambda(validate_and_clean_input)
|
| 794 |
+
| RunnableLambda(assemble_llm_prompt)
|
| 795 |
+
| RunnableLambda(invoke_llm_for_assessment)
|
| 796 |
+
| RunnableLambda(parse_structured_output)
|
| 797 |
+
| RunnableLambda(validate_eligibility_consistency)
|
| 798 |
+
| RunnableLambda(normalize_output)
|
| 799 |
+
)
|
| 800 |
+
|
| 801 |
+
logger.info("β Chain built successfully")
|
| 802 |
+
|
| 803 |
+
return chain
|
| 804 |
+
|
| 805 |
+
|
| 806 |
+
def run_assessment_chain(patient_data: Dict[str, Any]) -> Dict[str, Any]:
|
| 807 |
+
"""
|
| 808 |
+
Execute the HBV Assessment Chain
|
| 809 |
+
|
| 810 |
+
Args:
|
| 811 |
+
patient_data: Patient data dictionary
|
| 812 |
+
|
| 813 |
+
Returns:
|
| 814 |
+
Assessment result with eligible and recommendations
|
| 815 |
+
"""
|
| 816 |
+
logger.info("=" * 80)
|
| 817 |
+
logger.info("π STARTING HBV ASSESSMENT CHAIN")
|
| 818 |
+
logger.info("=" * 80)
|
| 819 |
+
|
| 820 |
+
try:
|
| 821 |
+
chain = create_hbv_assessment_chain()
|
| 822 |
+
result = chain.invoke(patient_data)
|
| 823 |
+
|
| 824 |
+
assessment = result["assessment_result"]
|
| 825 |
+
|
| 826 |
+
logger.info("=" * 80)
|
| 827 |
+
logger.info("β
CHAIN EXECUTION COMPLETE")
|
| 828 |
+
logger.info("=" * 80)
|
| 829 |
+
logger.info(f"Eligible: {assessment['eligible']}")
|
| 830 |
+
logger.info(
|
| 831 |
+
f"Recommendations length: {len(assessment['recommendations'])} characters"
|
| 832 |
+
)
|
| 833 |
+
logger.info("=" * 80)
|
| 834 |
+
|
| 835 |
+
return assessment
|
| 836 |
+
|
| 837 |
+
except Exception as e:
|
| 838 |
+
logger.error(f"β Chain execution failed: {str(e)}")
|
| 839 |
+
logger.error("=" * 80)
|
| 840 |
+
raise
|
core/hbv_assessment.py
CHANGED
|
@@ -73,42 +73,38 @@ def clean_json_string(json_str: str) -> str:
|
|
| 73 |
|
| 74 |
def normalize_recommendations(text: str) -> str:
|
| 75 |
"""
|
| 76 |
-
Normalize
|
| 77 |
-
-
|
| 78 |
-
-
|
| 79 |
-
-
|
| 80 |
-
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 81 |
"""
|
| 82 |
if not text:
|
| 83 |
return ""
|
| 84 |
-
|
| 85 |
-
|
| 86 |
-
|
| 87 |
-
|
| 88 |
-
|
| 89 |
-
|
| 90 |
-
|
| 91 |
-
#
|
| 92 |
-
|
| 93 |
-
|
| 94 |
-
|
| 95 |
-
|
| 96 |
-
|
| 97 |
-
|
| 98 |
-
|
| 99 |
-
]
|
| 100 |
-
|
| 101 |
-
for i, line in enumerate(lines):
|
| 102 |
-
# Add blank line before section headers (except first line)
|
| 103 |
-
if i > 0 and any(line.startswith(header) for header in section_headers):
|
| 104 |
-
formatted_lines.append('') # Add blank line
|
| 105 |
-
formatted_lines.append(line)
|
| 106 |
-
|
| 107 |
-
normalized = '\n'.join(formatted_lines)
|
| 108 |
-
# Soft cap length (keep whole content if already short)
|
| 109 |
-
max_len = 1800
|
| 110 |
if len(normalized) > max_len:
|
| 111 |
normalized = normalized[:max_len].rstrip()
|
|
|
|
| 112 |
return normalized
|
| 113 |
|
| 114 |
# SASLT 2021 Guidelines - Hardcoded Page Contents
|
|
|
|
| 73 |
|
| 74 |
def normalize_recommendations(text: str) -> str:
|
| 75 |
"""
|
| 76 |
+
Normalize recommendations text - preserve intentional formatting.
|
| 77 |
+
- Replace escaped newlines with actual newlines
|
| 78 |
+
- Remove excessive blank lines (more than 2 consecutive)
|
| 79 |
+
- Ensure consistent spacing around section headers
|
| 80 |
+
- Trim leading/trailing whitespace
|
| 81 |
+
|
| 82 |
+
Args:
|
| 83 |
+
text: Raw recommendations string with escaped newlines
|
| 84 |
+
|
| 85 |
+
Returns:
|
| 86 |
+
Normalized recommendations string with proper formatting
|
| 87 |
"""
|
| 88 |
if not text:
|
| 89 |
return ""
|
| 90 |
+
|
| 91 |
+
# Replace escaped newlines with actual newlines
|
| 92 |
+
normalized = text.replace('\\n', '\n')
|
| 93 |
+
|
| 94 |
+
# Remove excessive blank lines (more than 2 consecutive)
|
| 95 |
+
normalized = re.sub(r'\n{3,}', '\n\n', normalized)
|
| 96 |
+
|
| 97 |
+
# Ensure consistent spacing around section headers (** markers)
|
| 98 |
+
normalized = re.sub(r'\n\*\*', '\n\n**', normalized)
|
| 99 |
+
|
| 100 |
+
# Trim leading/trailing whitespace
|
| 101 |
+
normalized = normalized.strip()
|
| 102 |
+
|
| 103 |
+
# Soft cap length to avoid overly long outputs
|
| 104 |
+
max_len = 2500 # Increased from 1800 to accommodate comprehensive format
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 105 |
if len(normalized) > max_len:
|
| 106 |
normalized = normalized[:max_len].rstrip()
|
| 107 |
+
|
| 108 |
return normalized
|
| 109 |
|
| 110 |
# SASLT 2021 Guidelines - Hardcoded Page Contents
|