Durability and Tolerability of Fosamprenavir/Ritonavir Containing Regimens in HIV-Infected Patients with or without Hepatitis B or C Co-Infection: Results from a Large French Cohort in Clinical Practice

Background: We investigated whether tolerance and durability were different according to the presence or absence of co-infection (hepatitis B and/or hepatitis C virus) among a cohort of HIV-1 patients treated with fosamprenavir/r (FPV/r) containing regimen. Methods: Data were collected from 7 large HIV reference medical centers in France. We selected adult HIV-1 infected patients who were receiving an antiretroviral combination including FPV/r between January 2004 and December 2007. Date and reason for FPV/r discontinuation were recorded. Time to treatment discontinuation was analyzed by Kaplan Meier survival method. Results: In total, 1279 patients treated with FPV/r containing regimen were analysed in the study period out of them 20% were ART (antiretroviral therapy)-naive. 460 patients were hepatitis co-infected (13% are ART naive), 74% with HCV, 17% with HBV, 6% both. 263 co-infected patients (57.2%) and 469 mono-infected patients (57.2%) discontinued the FPV/r-including regimen after a median duration of 23 months, with no difference between coinfected and non-co-infected patients, at 23.2 months (95% CI 19.3-27.7) and 23.0 months (95% CI 20.3-25.5), respectively. Tolerability issues were the main reason for early discontinuation and among them gastro-intestinal (GI) adverse effects were the most frequent. Conclusion: In summary, antiviral therapy including FPV/r provides similar durability in HIV/HCV or HBV coinfected patients as in HIV mono-infected patients, for both naive and experienced patients.