Anti‐hepatitis B virus efficacy of tenofovir disoproxil fumarate in HIV‐infected patients

Tenofovir disoproxil fumarate (TDF) has shown in vitro activity against both HIV and hepatitis B virus (HBV). We retrospectively evaluated the efficacy of TDF (300 mg/d), administered as a part of anti‐retroviral therapy, in a large cohort of HIV/HBV‐coinfected patients. Sixty‐five HIV/HBV‐coinfected patients who received TDF for at least 6 months with serum HBV DNA levels above 2.3 log 10 copies/mL at TDF initiation and who had stored serum samples before and during TDF therapy were included. Serum HBV DNA was measured on stored samples. The median follow‐up period was 12 (Q1‐Q3: 8‐17) months. Serum hepatitis B e antigen (HBeAg) was positive in 54 patients (83.1%). Fifty‐two patients (80.0%) were receiving lamivudine (LAM) (150 mg twice a day), and 68.8% had documented LAM resistance at baseline. Among HBeAg‐positive patients, the median reduction from baseline (8.17; Q1‐Q3 = 7.30‐8.30 log 10 copies/mL) of serum HBV DNA was 4.56 log 10 copies/mL (Q1‐Q3 = 3.33‐5.55) ( P < .0001). In HBeAg‐negative patients, serum HBV DNA decline from baseline (4.83; Q1‐Q3 = 2.69‐6.40 log 10 copies/mL) was 2.53 log 10 copies/mL (Q1‐Q3 = 0.39‐4.10). At the end of the study, HBV DNA became undetectable in 29.6% and 81.6% of the HBeAg‐positive and HBeAg ‐negative patients, respectively. Serum HBeAg became negative in 4 patients, 2 of whom acquired serum hepatitis B e antibody. In conclusion , this retrospective analysis demonstrates the efficacy of TDF against wild‐type, presumed precore mutants and LAM‐resistant HBV when used as a part of anti‐retroviral therapy in HIV‐coinfected patients. (H EPATOLOGY 2006;43:548–555.)