Long-term use of tenofovir as part of antiretroviral therapy was safe and effective in reducing HBV DNA levels.
Tenofovir is an effective first-line agent for patients with hepatitis B virus (HBV) infection (JW Gastroenterol Jan 23 2009). The drug also seems to be effective for patients who are coinfected with HBV and HIV, although follow-up evaluations have been limited.
In this multicenter, prospective, cohort study, Dutch researchers followed 102 HBV/HIV patients (mean age, 42; 90% men) for a median of 55 months (interquartile range, 42–64 months). At baseline, all patients had received tenofovir as part of antiretroviral therapy for 6 months, 80% had detectable HBV DNA (mean level, 7 log10 IU/mL), 66% were positive for hepatitis B e antigen (HBeAg), 49% were treated previously with lamivudine, and 32% had evidence of lamivudine resistance. During the study period, patients received tenofovir plus concomitant lamivudine or emtricitabine. The primary endpoint was virologic response, defined as HBV DNA level <20 IU/mL. Renal toxicity was monitored with serum creatinine levels.
Among HBeAg-positive patients, 92% had virologic response after 5 years of treatment (response was similar in patients with or without lamivudine resistance), 46% achieved loss of HBeAg, and 12% achieved loss of hepatitis B surface antigen (HBsAg). Among HBeAg-negative patients, 100% achieved virologic response after 4 years, and 13% achieved loss of HBsAg. Only one patient developed resistance, and three patients discontinued tenofovir because of increased serum creatinine levels.
Comment: This long-term study of tenofovir in HBV/HIV coinfected patients demonstrates excellent safety and efficacy similar to findings in HBV monoinfected patients. These results were the same for patients with or without baseline lamivudine resistance. This study validates the practice of using tenofovir as the foundation of antiretroviral therapy in HBV/HIV coinfected patients.
Published in Journal Watch Gastroenterology February 18, 2011