Several new oral direct active agent (DAA)-based regimens are available in France for HCV-HIV co-infected patients. We report on efficacy and safety of DAA-based regimen in real-life settings.
HIV-HCV co-infected patients enrolled in the French nationwide ANRS CO13 HEPAVIH cohort were included in this analysis if an oral DAA-based regimen without peg-interferon was initiated before March 1st 2015 (3-month regimen) or before December 1st 2014 (6-month regimen) and if the patients had sufficient follow-up data to evaluate DAA efficacy. Treatment success was defined as an undetectable HCV-RNA (<15 UI/mL) at 12 weeks or thereafter (SVR12). Patients with premature treatment stops, detectable HCV-RNA and those who died during treatment were considered as treatment failures.
We included 171 patients in 23 clinics with a median age of 53 years (IQR: 50-56), 78% men and 98% on antiretroviral therapy. HIV viral load was <50 copies/mL in 86% and median CD4 was 520 cells/mm3 (IQR: 319-730). Seventy-three percent of the patients were cirrhotic, and 70% had failed previous anti-HCV treatment. HCV genotype (Gt) distribution was as follows: Gt1, 62%; Gt2, 2%; Gt3, 14%; Gt4, 22%. Overall, we observed SVR12 in 92% of patients (95% CI: 86-97): 92% (CI: 87-97) in cirrhotic and 91% (CI: 83-99) in non-cirrhotic patients. Frequencies of DAA regimen prescribed and corresponding SVR12 are presented in table 1. In a subgroup analysis of 90 cirrhotic patients receiving a regimen without ribavirin, SVR12 for 12 or 24 weeks of treatment were 91% (CI: 71-99) and 93% (CI: 84-98), respectively. Furthermore, in cirrhotic patients receiving a DAA regimen with ribavirin for 12 and 24 weeks, SVR12 rates were 83 (CI: 36-99) and 93% (CI: 77-99), respectively. Of 14 patients with treatment failure, there were 12 relapses, one premature stop for adverse event and one death. Patients with treatment failure had a median age of 55 years (IQR: 53-58), were mainly men (86%); nine of them were Gt1, three Gt3 and two Gt 4; 71% were cirrhotic. Treatment duration was 24 weeks in 8 of these patients and 12 weeks for the remaining 6 patients.
In this real-life prospective French nationwide cohort of HIV-HCV co-infected patients, oral-DAA based regimens showed high efficacy and excellent tolerability. In cirrhotic patients neither a longer duration of treatment nor the addition of ribavirin seemed to have an impact on treatment response.