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Efficacy of tenofovir disoproxil fumarate in the treatment of adults with chronic HBV infection who do not have HIV infection

Anna SF Lok, MD
Section Editor
Rafael Esteban, MD
Deputy Editor
Jennifer Mitty, MD, MPH


Tenofovir disoproxil fumarate, like adefovir dipivoxil, is a nucleotide reverse transcriptase inhibitor that has activity against the hepatitis B (HBV) and HIV viruses. It is approved for treatment of HIV infection and has also received approval for treatment of chronic HBV.

This topic review will focus on treatment in patients infected with HBV alone. Treatment in patients coinfected with HBV and HIV is presented separately. (See "Treatment of chronic hepatitis B in the HIV-infected patient".)


Tenofovir is effective for the treatment of chronic HBV in patients who are HBeAg positive. However, patients in the immune tolerant phase of infection should generally not be treated, including with tenofovir; this issue is discussed elsewhere. (See "Overview of the management of hepatitis B and case examples", section on 'Who should be treated and how'.)

The largest study in nucleoside-naïve patients included 266 patients with HBeAg positive chronic HBV who were randomly assigned to tenofovir (300 mg) or adefovir (10 mg) in a ratio of 2:1 [1-3]. Significantly more patients who received tenofovir achieved an HBV DNA level of <400 copies/mL (76 versus 13 percent), ALT normalization (68 versus 54 percent), and HBsAg loss (3 versus 0 percent). The proportion of patients achieving a ≥2 point reduction in the Knodell necroinflammatory score without worsening fibrosis was similar (74 versus 68 percent), as was the proportion of patients achieving HBeAg seroconversion (21 versus 18 percent).

A follow-up study of the one described above included data on 248 HBeAg positive patients who received open-label tenofovir [4]. Among these 248 patients, including those who dropped out or discontinued therapy, 65 percent had an HBV DNA level <400 copies/mL after five years of treatment. However, of the patients who remained on treatment during this period, 97 percent achieved an HBV DNA of <169 copies/mL and 49 percent became HBeAg negative.


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Literature review current through: Sep 2016. | This topic last updated: Jun 19, 2014.
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