Efficacy of tenofovir disoproxil fumarate in the treatment of adults with chronic HBV infection who do not have HIV infection
- Anna SF Lok, MD
Anna SF Lok, MD
- Professor of Medicine
- University of Michigan Medical School
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".)
EFFICACY IN PATIENTS WITH HBEAG POSITIVE CHRONIC HEPATITIS B
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 . 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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- van Bömmel F, Trojan J, Deterding K, et al. Evolution of adefovir-resistant HBV polymerase gene variants after switching to tenofovir disoproxil fumarate monotherapy. Antivir Ther 2012; 17:1049.
- Berg T, Marcellin P, Zoulim F, et al. Tenofovir is effective alone or with emtricitabine in adefovir-treated patients with chronic-hepatitis B virus infection. Gastroenterology 2010; 139:1207.
- Berg T, Zoulim F, Moeller B, et al. Long-term efficacy and safety of emtricitabine plus tenofovir DF vs. tenofovir DF monotherapy in adefovir-experienced chronic hepatitis B patients. J Hepatol 2014; 60:715.
- Garg H, Sarin SK, Kumar M, et al. Tenofovir improves the outcome in patients with spontaneous reactivation of hepatitis B presenting as acute-on-chronic liver failure. Hepatology 2011; 53:774.
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- EFFICACY IN PATIENTS WITH HBEAG POSITIVE CHRONIC HEPATITIS B
- EFFICACY IN PATIENTS WITH HBEAG NEGATIVE CHRONIC HEPATITIS B
- HBV RESISTANCE TO TENOFOVIR DOES NOT OCCUR
- EFFICACY IN PATIENTS WITH PREVIOUS EXPOSURE TO LAMIVUDINE OR ADEFOVIR
- Lamivudine resistance
- Adefovir resistance
- SPONTANEOUS REACTIVATION
- IN COMBINATION WITH OTHER DRUGS
- Renal insufficiency
- Bone density
- SUMMARY AND RECOMMENDATIONS