Short-term effect of ritonavir-boosted atazanavir in hepatitis B and/or C co-infected, treatment-experienced HIV patients.

ABSTRACT

OBJECTIVE: To describe the short-term, liver safety, immunological, and virological outcome in HIV subjects according to their hepatitis co-infection status after switching to ritonavir-boosted atazanavir (ATV/r)-based therapy. METHODS: Rates of treatment discontinuation, changes in liver enzyme values, viral load, and CD4+ T-cell counts responses from patients included in the Bristol-Myers Squibb Atazanavir Early Access Program (BMS ATV EAP) were evaluated in hepatitis C and/or B co-infected patients (co-infected) and non-co-infected. RESULTS: A total of 304 subjects with known HCV and/or HBV status from 55 centers were included in the analysis: 180 co-infected and 124 HIV non-co-infected. Accumulated follow-up until study closure was 762 and 551 person-months in the co-infected and non-co-infected subjects, respectively. The proportion of discontinuations through Month 6 was 9.4% (co-infected) and 5.6% (non-co-infected). Discontinuations due to elevated liver enzymes [1.7% (co-infected) and 0% (non-co-infected)] and due to scleral icterus/jaundice [4.4% (co-infected) and 3.2% (non-co-infected)] were low and similar between groups. Only three subjects (1%) discontinued due to virological failure. Successful virological outcome (viral load <500 copies/mL or a decrease >1 log(10)) was observed in 74% of subjects in each group. CD4+ T-cell count changes were +51 (co-infected) and +53 cells/mm3 (non-co-infected). CONCLUSIONS: Short-term effectiveness and liver safety in HCV and or HBV co-infected patients changing to an ATV/r-based regimen was similar to that observed in non-co-infected patients.