Efficacy and safety of adefovir dipivoxil plus pegylated interferon-alpha2a for the treatment of lamivudine-resistant hepatitis B virus infection in HIV-infected patients.

BACKGROUND Up to 10% of the HIV-positive population is coinfected with hepatitis B virus (HBV). Generally, combined treatment includes agents against both viruses, such as lamivudine (3TC). However, HBV resistance to 3TC is high. Adefovir dipivoxil (ADV) has shown its efficacy for treating 3TC-resistant (3TC-R) HBV in HIV-coinfected patients. ADV combined with pegylated interferon (PEG-IFN) has never been evaluated in this population. METHODS HIV-HBV-coinfected patients with positive HBV e antigen (HBeAg), documented 3TC-R HBV mutation and antiretroviral treatment including 3TC were selected and received ADV (10 mg daily) and PEG-IFN-alpha2a (180 microg weekly) for 48 weeks. RESULTS Of 18 eligible patients (n=16 [89%] male, mean +/-SD age 40.45 +/-4.82 years), 17 were treated for 48 weeks. One stopped IFN treatment because of adverse events and continued ADV only. The median (interquartile range) HBV DNA at baseline was 8.0 (5.30-8.97) log10 copies/ml and the median (95%/ confidence interval [CI]) decrease after 48 and 72 weeks was 3.6 (4.9-2.4) and 1.4 (-5.0-2.2) log,0 copies/ml, respectively. None of the patients became HBeAg-negative. Median (95%/ CI) decrease of serum alanine aminotransferase was 27.8 (-66.2-10.5) IU/ml after 48 weeks and 93.0 (-80.0-26.1) IU/ml after 72 weeks. CONCLUSIONS ADV and PEG-IFN is safe and effective for treating 3TC-R HBV in HIV patients. However, on-treatment response was not maintained off therapy and did not lead to HBV seroconversion. The combination had no effect on HIV disease progression.