Effects of lamivudine on replication of hepatitis B virus in HIV-infected men

Background: Therapy for hepatitis B virus (HBV) infection is still unsatisfactory, particularly in patients who are co-infected with the human immunodeficiency virus (HIV). Lamivudine, a retroviral inhibitor, has been shown to have activity against HBV replication in vitro, in animal models, and in studies of immunocompetent persons. Objective: To assess the efficacy of lamivudine in inhibiting HBV replication during a 12-month period in patients with both HBV and HIV infection. Design: Prospective, open study. Setting: University hospital. Patients: 40 consecutive patients (39 men and 1 woman) infected with both HIV and HBV. All had progressive HIV disease; were refractory to or unable to tolerate therapies other than lamivudine; and received lamivudine, 600 mg/d or 600 mg/d followed by 300 mg/d, as therapy for HIV disease. Measurements: Serum concentrations of HBV DNA were assessed every 2 months by using molecular hybridization. Polymerase chain reaction (PCR) for HBV DNA was done at baseline and was done at months 2, 6, and 12 only if the HBV DNA concentration was less than 5 pg/mL. Results: Two groups were retrospectively identified at baseline: patients with high HBV replication (serum HBV DNA concentrations >5 pg/mL) (n = 30) and patients with low HBV replication (serum HBV DNA concentrations <5 pg/mL) (n = 10). After 12 months of treatment, 26 of 27 patients (96.3% [95% Cl, 81% to 99.9%]) who had had high HBV replication at baseline had serum HBV DNA concentrations less than 5 pg/mL. However, PCR could still detect HBV DNA in serum in 11.5% (Cl, 2% to 30%) of these patients. Among patients who had had low HBV replication at baseline, the results of PCR for serum HBV DNA became negative in the 6 patients who had had a positive result on PCR at baseline. No serious adverse events occurred during treatment. Conclusion: Although this study was not a randomized, blinded trial, it suggests that lamivudine is active against HBV replication in men infected with both HBV and HIV.