Efficacy and Safety of Abacavir/Lamivudine/Zidovudine Plus Tenofovir in HBV/HIV-1 Coinfected Adults: 48-Week Data.

Abstract

In HBV/HIV-coinfected patients, the risk of end-stage liver disease and death is increased. This open-label, prospective, pilot study evaluated abacavir/lamivudine/zidovudine twice daily plus tenofovir once daily in HBV/HIV-coinfected antiretroviral-naïve subjects. Nine adults (8 males) enrolled, with baseline mean HIV-1 RNA = 4.5 log(10) copies/mL, HBV DNA = 9.0 log(10) copies/mL, and median CD4 count =158 cells/mm(3). No subject had baseline ALT >5x ULN.SIX SUBJECTS COMPLETED THE STUDY: 1 withdrew due to non-treatment-related toxoplasmosis and 2 were lost-to-follow-up. At week 48, 100% (6/6) of remaining subjects had ≥2 log(10) decrease in HBV DNA, and 100% (6/6) and 83% (5/6) had HIV-1 RNA <400 and <50 copies/mL, respectively. Median change from baseline in CD4 count was 157 cells/mm(3). One subject experienced treatment-related grade 3 leukopenia. These results demonstrate that abacavir/lamivudine/zidovudine and tenofovir were well tolerated with sustained HIV-1 and HBV antiviral activity through 48 weeks in HBV/HIV-coinfected, antiretroviral-naïve subjects.