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Evaluate clinically for evidence of compensated or decompensated cirrhosis; features include: - Portal HTN (ascites, variceal hemorrhage, and hepatic encephalopathy)
- Coagulopathy
- Liver insufficiency (jaundice)
- Other (hepatomegaly, splenomegaly, pruritus, fatigue, arthralgia, palmar erythema, edema)
Or, use noninvasive test (NIT) to determine liver dz stage at baseline [C/L]: - APRI (AST-to-platelet ratio), score >2 consistent w/ cirrhosis:1 preferred in resource-limited settings | View online APRI Calculator
- Transient elastography (eg, FibroScan) or FibroTest:2 may be preferred if available and cost not a concern
- (FIB-4):3 not validated
Footnotes 1 APRI = (AST/ULN) x100)/platelet count (10 9/L); values >2 consistent w/ cirrhosis. | View online APRI Calculator
2 FibroTest components: GGT, haptoglobin, bilirubin, A1 apoprotein, α-2 macroglobulin; requires specialized tests at designated labs, commercial assay.
3 FIB-4 has not been validated for cirrhosis dx. Formula: (age(yrs) x AST (IU/L))/(platelet count (10 9/L x [ALT (IU/L) 1/2]). | View online FIB-4 Calculator
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Cirrhosis | clinical s/sx or APRI >2 or positive FibroScan/FibroTest
Treat adults, adolescents, children w/ cirrhosis4 regardless of ALT level, HBeAg status, or HBV DNA levels [S/M] Lifelong tx w/ nucleos(t)ide analogues5 w/ high drug resistance barrier [S/L];6 options: - Tenofovir disoproxil 300 mg PO daily7-9 [S/M]
- Entecavir:10 0.5 mg PO daily if compensated liver dz and lamivudine naïve; 1 mg PO daily if decompensated liver dz [S/M]
Monitor ALT/AST, HBsAg, HBeAg, HBV DNA levels, renal function11 and adherence annually [S/M]; exceptions: - q3mo during 1st yr of tx [C/VL]
- q6-12mo if HIV/HBV co-infxn [C/L]
- q6mo in pts w/ HCC family hx [S/L]
- q6mo if renal dysfxn
Surveillance for HCC w/ abdo US + AFP q6mo [S/L] If HIV co-infxn, tx w/ tenofovir disoproxil + lamivudine (or emtricitabine) + efavirenz as a fixed-dose combo12 [S/M] If confirmed or suspected antiviral resistance (hx of prior exposure or 1° nonresponse) to lamivudine, entecavir, adefovir or telbivudine, switch to tenofovir disoproxil [S/L] Footnotes 4 Cirrhosis defined by clinical features or noninvasive test.
Clinical features of compensated or decompensated cirrhosis include:
• Portal HTN (ascites, variceal hemorrhage, and hepatic encephalopathy)
• Coagulopathy
• Liver insufficiency (jaundice)
• Other (hepatomegaly, splenomegaly, pruritus, fatigue, arthralgia, palmar erythema, edema)
Noninvasive test options:
• APRI (AST-to-platelet ratio), score >2 consistent w/ cirrhosis: preferred in resource-limited settings | View online APRI Calculator
• Transient elastography (eg, FibroScan) or FibroTest: may be preferred if available and cost not a concern
5 Pre-tx eval: baseline renal function w/ Cr and eGFR; liver dz severity, viral replication, HIV, HCV, HDV, NAFLD, alcoholic liver dz, Fe overload, HCC. Counsel pt on tx, committing to long-term tx, follow-up, adherence, measures to ↓transmission, ↓use of tobacco/EtOH, and costs. HBV genotyping and resistance testing not required to guide tx when using NAs w/ high resistance barrier.
6 Avoid agents w/ low resistance barrier (lamivudine, adefovir, telbivudine) [S/M].
7 If eGFR <50 mL/min, ↓tenofovir disoproxil dose or use entecavir.
8 Eval baseline renal dysfxn risk: proteinuria, glycosuria, uncontrolled DM, active glomerulonephritis, solid organ transplant, concomitant nephrotoxic drugs.
9 Tenofovir disoproxil preferred in pregnancy. IFN-based tx is contraindicated in pregnancy.
10 Entecavir preferred in children 2-11 yo. Use oral solution in children <30 kg.
11 During tx, adjust dose or interrupt tx if CrCl <50 ml/min.
12 ART should be initiated in all HBV/HIV-co-infected pts w/ evidence of severe chronic liver dz, regardless of CD4 count and in pts w/ CD4 ≤500 cells/mm 3 regardless of liver dz stage [S/L].
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No cirrhosis | no clinical s/sx, APRI ≤2, negative FibroScan/FibroTest
Monitor ALT/AST, HBsAg, HBeAg, HBV DNA levels, and assess for cirrhosis annually [S/M]; exceptions: - If HIV co-infxn, monitor labs q6-12mo [C/L]
- If family hx HCC, monitor labs q6mo [S/L]
Intermittently abnormal ALT Monitor ALT/AST, HBsAg, HBeAg, HBV DNA levels, and assess for cirrhosis annually [S/M]; exceptions: - If HIV co-infxn, monitor labs q6-12mo [C/L]
- If family hx HCC, monitor labs q6mo [S/L]
Persistently abnormal ALT Treat w/ nucleos(t)ide analogues13,14 w/ high drug resistance barrier15 [S/M]; options: - Tenofovir disoproxil 300 mg PO daily16-18 [S/M]
- Entecavir:19 0.5 mg PO daily if compensated liver dz and lamivudine naïve; 1 mg PO daily if decompensated liver dz [S/M]
Monitor ALT/AST, HBsAg, HBeAg, HBV DNA levels, renal function20 and adherence annually [S/M]; exceptions: - q3mo during 1st yr of tx [C/VL]
- q6-12mo if HIV/HBV co-infxn [C/L]
- q6mo in pts w/ HCC family hx [S/L]
- q6mo if renal dysfxn
Surveillance for HCC w/ abdominal US + AFP q6mo [S/L] If HIV co-infxn, treat w/ tenofovir disoproxil + lamivudine (or emtricitabine) + efavirenz as a fixed-dose combo21 [S/M] If confirmed or suspected antiviral resistance (ie, hx of prior exposure or 1° nonresponse) to lamivudine, entecavir, adefovir or telbivudine, switch to tenofovir disoproxil [S/L] Consider discontinuing tx if all the following criteria met: - Can be followed carefully long-term by healthcare provider
- Evidence of HBeAg loss + seroconversion to anti-HBe
- Completion of ≥1 additional yr of tx
- Persistently normal ALT
- Undetectable HBV DNA
If HBV relapse, restart tx; signs of reactivation include: - HBsAg or HBeAg becomes positive
- ↑ALT
- HBV levels become detected [S/L]
Footnotes 13 HBV genotyping and resistance testing not required to guide tx when using NAs w/ high barrier to resistance.
14 Pre-tx eval: baseline renal function w/ Cr and eGFR, liver dz severity, viral replication, HIV, HCV, HDV, NAFLD, alcoholic liver dz, Fe overload, HCC. Counsel pts on tx, committing to long-term tx, follow-up, adherence, measures to ↓transmission, ↓tobacco/EtOH use, and costs.
15 Avoid agents w/ low resistance barrier (lamivudine, adefovir, telbivudine) [S/M].
16 If eGFR <50 mL/min, ↓tenofovir disoproxil dose or use entecavir.
17 Eval baseline renal dysfxn risk: proteinuria, glycosuria, uncontrolled DM, active glomerulonephritis, solid organ transplant, concomitant nephrotoxic drugs.
18 Tenofovir disoproxil preferred in pregnancy. Use of IFN-based tx contraindicated in pregnancy.
19 Entecavir preferred in children 2-11 yo. Use oral solution in children <30 kg.
20 During tx, adjust dose or interrupt tx if CrCl <50 ml/min.
21 ART should be initiated in all HBV/HIV-coinfected pts w/ evidence of severe chronic liver dz, regardless of CD4 count and in pts w/ CD4 ≤500 cells/mm3 regardless of liver dz stage [S/L].
HBV DNA 2,000-20,000 IU/mL Monitor ALT/AST, HBsAg, HBeAg, HBV DNA levels, and assess for cirrhosis q6-12mo [S/M]: - If HIV co-infxn, also monitor labs q6-12mo [C/L]
- If family hx HCC, monitor labs q6mo [S/L]
Monitor ALT/AST, HBsAg, HBeAg, and HBV DNA levels, assess for cirrhosis annually [S/M]; exceptions: - If HIV co-infxn, monitor labs q6-12mo [C/L]
- If family hx HCC, monitor labs q6mo [S/L]
Monitor ALT/AST, HBsAg, HBeAg, HBV DNA levels, and assess for cirrhosis annually [S/M]: - If HIV co-infxn, also monitor labs q6-12mo [C/L]
- If family hx HCC, monitor labs q6mo [S/L]
Intermittently abnormal ALT Monitor ALT/AST, HBsAg, HBeAg, HBV DNA levels, and assess for cirrhosis q6-12mo [S/M]: - If HIV co-infxn, also monitor labs q6-12mo [C/L]
- If family hx HCC, monitor labs q6mo [S/L]
Persistently abnormal ALT Treat w/ nucleos(t)ide analogues22,23 w/high drug resistance barrier24 [S/M]; options: - Tenofovir disoproxil 300 mg PO daily25-27 [S/M]
- Entecavir:28 0.5 mg PO daily if compensated liver dz and lamivudine naïve; 1 mg PO daily if decompensated liver dz [S/M]
Monitor ALT/AST, HBsAg, HBeAg, HBV DNA levels, renal function29 and adherence annually [S/M]; exceptions: - q3mo during 1st yr of tx [C/VL]
- q6-12mo if HIV/HBV co-infxn [C/L]
- q6mo in pts w/ HCC family hx [S/L]
- q6mo if renal dysfxn
Surveillance for HCC w/ abdominal US + AFP q6mo [S/L] If HIV co-infxn, treat w/ tenofovir disoproxil + lamivudine (or emtricitabine) + efavirenz as a fixed-dose combo30 [S/M] If confirmed or suspected antiviral resistance (ie, hx of prior exposure or 1° nonresponse) to lamivudine, entecavir, adefovir or telbivudine, switch to tenofovir disoproxil [S/L] Consider discontinuing tx if all the following criteria met: - Can be followed carefully, long-term by healthcare provider
- Evidence of HBeAg loss + seroconversion to anti-HBe
- Completion of ≥1 additional yr of tx
- Persistently normal ALT
- Undetectable HBV DNA
If HBV relapse, restart tx; signs of reactivation include: - HBsAg or HBeAg becomes positive
- ↑ALT
- HBV levels become detected [S/L]
Footnotes 22 HBV genotyping and resistance testing not required to guide tx when using NAs w/ high resistance barrier.
23 Pre-tx eval: baseline renal function with Cr and eGFR, liver dz severity, viral replication, HIV, HCV, HDV, NAFLD, alcoholic liver dz, Fe overload, HCC. Counsel pts on tx, committing to long-term tx, follow-up, adherence, measures to ↓transmission, ↓tobacco/EtOH use, and costs.
24 Avoid agents w/ low resistance barrier (lamivudine, adefovir, telbivudine) [S/M].
25 If eGFR <50 mL/min, ↓tenofovir disoproxil dose or use entecavir.
26 Eval baseline renal dysfxn risk: proteinuria, glycosuria, uncontrolled DM, active glomerulonephritis, solid organ transplant, concomitant nephrotoxic drugs.
27 Tenofovir disoproxil preferred in pregnancy. Use of IFN-based tx contraindicated in pregnancy.
28 Entecavir preferred in children 2-11 yo. Use oral solution in children <30 kg.
29 During tx, adjust dose or interrupt tx if CrCl <50 ml/min.
30 ART should be initiated in all HBV/HIV-co-infected pts w/ evidence of severe chronic liver dz, regardless of CD4 count and in pts w/ CD4 ≤500 cells/mm3 regardless of liver dz stage [S/L]
HBV DNA 2,000-20,000 IU/mL Monitor ALT/AST, HBsAg, HBeAg, HBV DNA, and assess for cirrhosis q6-12mo [S/M]: - If HIV co-infxn, also monitor labs q6-12mo [C/L]
- If family hx HCC, monitor labs q6mo [S/L]
Monitor ALT/AST, HBsAg, HBeAg, HBV DNA levels and assess for cirrhosis annually [S/M]; exceptions: - If HIV co-infxn, monitor labs q6-12mo [C/L]
- If family hx HCC, monitor labs q6mo [S/L]
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