Interferon-free therapy for treating HCV in difficult-to-treat HIV-coinfected patients as implemented in routine medical practice.

BACKGROUND/AIMS: Data regarding the use of all-oral direct-acting antivirals (DAA) in HIV/HCV-coinfected patients with advanced liver fibrosis are required, because they are generally under-represented in clinical trials. This study sought to evaluate the use of these drugs in a cohort of coinfected patients, mostly with factors that have previously been recognised as predictors of treatment failure.

METHODS: COINFECOVA-2 is an observational, multicenter study conducted in Eastern Spain. Data of all HIV/HCV-coinfected patients treated with DAA under real-life conditions were retrospectively collected, and factors associated with treatment success or safety were analysed.

RESULTS: Among 515 included patients, 96% were on antiretroviral therapy and 89.5% had an HIV-RNA < 50 copies/mL. HCV genotype (G) distribution was: 47% G-1a, 20% G-4, 14.4% G-1b, and 12.8% G-3. Patients with cirrhosis were 54.2%, and 46% failed to prior HCV-therapies. Overall, 92.8% patients (95% CI: 90.2-94.9) achieved sustained virologic response (SVR12). Cirrhosis was the only factor associated with treatment failure, and SVR12 rate was significantly lower in patients with liver stiffness ≥ 21 kPa. Adverse events (AEs) were reported in 36.7%, but only two patients (0.4%) discontinued treatment because of AEs. The bivariate analysis showed an association between ribavirin use and an increased risk of AEs (OR 2.84; 95%CI: 1.95-4.1; p ≤ 0.0001).

CONCLUSIONS: This heterogeneous cohort of coinfected patients showed a high rate of SVR12. Among cirrhotic patients, those with a liver stiffness ≥ 21 kPa had a higher probability of treatment failure. Ribavirin use seem to increase the appearance of AEs.