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Hepatology. 2016 Jan;63(1):284-306. doi: 10.1002/hep.28280. Epub 2015 Nov 13.

Antiviral therapy for chronic hepatitis B viral infection in adults: A systematic review and meta-analysis.

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Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI.
Liver Diseases and Hepatitis Program, Alaska Native Tribal Health Consortium, Anchorage, AK.
Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, NY.
Division of Clinical Decision Making, Tufts Medical Center, Boston, MA.
Evidence-Based Practice Research Program, Mayo Clinic, Rochester, MN.
Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN.
Division of Hospital Internal Medicine, Mayo Clinic, Rochester, MN.
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN.
Library Public Services, Mayo Clinic, Rochester, MN.
Division of Preventive, Occupational and Aerospace Medicine, Mayo Clinic, Rochester, MN.


Chronic hepatitis B viral (HBV) infection remains a significant global health problem. Evidence-based guidelines are needed to help providers determine when treatment should be initiated, which medication is most appropriate, and when treatment can safely be stopped. The American Association for the Study of Liver Diseases HBV guideline methodology and writing committees developed a protocol a priori for this systematic review. We searched multiple databases for randomized controlled trials and controlled observational studies that enrolled adults ≥18 years old diagnosed with chronic HBV infection who received antiviral therapy. Data extraction was done by pairs of independent reviewers. We included 73 studies, of which 59 (15 randomized controlled trials and 44 observational studies) reported clinical outcomes. Moderate-quality evidence supported the effectiveness of antiviral therapy in patients with immune active chronic HBV infection in reducing the risk of cirrhosis, decompensated liver disease, and hepatocellular carcinoma. In immune tolerant patients, moderate-quality evidence supports improved intermediate outcomes with antiviral therapy. Only very low-quality evidence informed the questions about discontinuing versus continuing antiviral therapy in hepatitis B e antigen-positive patients who seroconverted from hepatitis B e antigen to hepatitis B e antibody and about the safety of entecavir versus tenofovir. Noncomparative and indirect evidence was available for questions about stopping versus continuing antiviral therapy in hepatitis B e antigen-negative patients, monotherapy versus adding a second agent in patients with persistent viremia during treatment, and the effectiveness of antivirals in compensated cirrhosis with low-level viremia.


Most of the current literature focuses on the immune active phases of chronic HBV infection; decision-making in other commonly encountered and challenging clinical settings depends on indirect evidence.

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