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Recommendations for initial treatment of chronic hepatitis B in nonpregnant adults

Recommendations for initial treatment of chronic hepatitis B in nonpregnant adults
HBeAg HBV DNA
(PCR)
ALT Treatment strategy
Patients without cirrhosis*
+ >20,000 international units/mL ≤2 x ULN Treatment is not recommended, because current treatment has low efficacy in inducing HBeAg seroconversion. Treatment may be considered in older patients (>40 years) and in those with family history of HCC.
Patients should be monitoredΔ and treatment considered if ALT becomes elevated >2 x ULN, liver biopsy shows moderate/severe inflammation or fibrosis (eg, METAVIR score ≥F2), and/or noninvasive testing suggests moderate/severe fibrosis.
+ >20,000 international units/mL >2 x ULN Observe for 3 to 6 months if compensated and treat if no spontaneous HBeAg loss.
Immediate treatment if severe hepatitis flare (eg, icteric or clinical decompensation).
ETV, TAF, TDF, or PegIFN alfa are preferred for initial therapy.§¥
End-point of treatment  Seroconversion from HBeAg to anti-HBe.
Duration of therapy:
  • PegIFN alfa: 48 weeks.
  • ETV, TAF, or TDF: Continue for at least 12 months after HBeAg seroconversion.
>2000 international units/mL

>2 x ULN

OR

1 to 2 x ULN if liver biopsy shows moderate/severe necroinflammation or significant fibrosis (eg, METAVIR score ≥F2) or non-invasive testing shows significant fibrosis
ETV, TAF, TDF, or PegIFN alfa are preferred for initial therapy.§¥
End-point of treatment  HBsAg loss.
Duration of therapy:
  • PegIFN alfa: One year.
  • ETV, TAF, or TDF: Several years or indefinite.
≤2000 international units/mL ≤ULN Monitor and treat if HBV DNA and ALT increase as described above.
Patients with cirrhosis*
+/– Detectable Any ALT Compensated:
  • HBV DNA >2000 international units/mL  Treat with ETV, TAF, or TDF.§¥ Treatment should be continued indefinitely.**
  • HBV DNA <2000 international units/mL  Consider treatment particularly if ALT elevated; close monitoring if treatment is not initiated.
Decompensated:
  • Treat immediately, regardless of ALT or HBV DNA levels. ETV preferred.§¥ TDF may be used with close monitoring of renal function. Refer for liver transplant.
+/– Undetectable Any ALT Compensated: Observe, recheck HBV DNA during follow-up, evaluate for other causes of cirrhosis if HBV DNA remains undetectable.
Decompensated: Refer for liver transplant, recheck HBV DNA during follow-up, evaluate for other causes of cirrhosis.
ALT: alanine aminotransferase; anti-HBe: antibody to hepatitis B e antigen; ETV: entecavir; HBeAg: Hepatitis B e antigen; HBsAg: hepatitis B surface antigen; HBV: hepatitis B virus; HCC: hepatocellular carcinoma; PegIFN alfa: pegylated interferon alfa; TAF: tenofovir alafenamide; TDF: tenofovir disoproxil fumarate; ULN: upper limit of normal.
* Based upon findings on noninvasive testing or liver biopsy performed during the initial evaluation. Patients with advanced fibrosis determined by noninvasive methods should be evaluated using a second method, and if results are concordant, consider managing the same way as patients with cirrhosis.
¶ The American Association for the Study of Liver Diseases (AASLD) recommends using an ALT >35 U/L for men and >25 U/L for women as the upper limit of normal (ULN) rather than local laboratory values.
Δ Refer to UpToDate topic on "Hepatitis B virus: Overview of management" for a discussion of monitoring.
Refer to UpToDate topic on "Hepatitis B virus: Overview of management" for a discussion of indications for biopsy.
§ Adefovir, lamivudine, and telbivudine are not recommended due to a high rate of resistance after the first year and/or weak antiviral activity.
¥ Refer to UpToDate topic on "Hepatitis B virus: Overview of management" for a discussion of which agent to use.
‡ Up to 50% of patients who achieve HBeAg seroconversion can experience a virologic relapse after discontinuing treatment with oral agents. Thus, some providers prefer to treat until HBsAg-loss.
† For most patients, antiviral therapy should be continued indefinitely. However, treatment discontinuation may be considered in persons without cirrhosis who have demonstrated loss of HBsAg and in selected patients who have had undetectable serum HBV DNA for >3 years and agree to close monitoring after stopping treatment. Persons who stop antiviral therapy should be monitored every month for the first six months. Refer to the UpToDate topic on management of hepatitis B virus infection for a detailed discussion of the risks and benefits of stopping antiviral therapy in this setting.
** This includes HBeAg-positive adults with cirrhosis who seroconvert to anti-HBe on therapy.
References: 
  1. Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology 2018; 67:1560.
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