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 log₁₀) 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.

Keywords:

• ARV-experienced
• boosted atazanavir
• HBV
• HCV
• HIV