Real-world efficacy and safety of ombitasvir, paritaprevir/r+dasabuvir+ribavirin in genotype 1b patients with hepatitis C virus cirrhosis

Abstract Background Direct antiviral agents ( DAA ) showed very good results in terms of efficacy and safety in clinical trials, but real‐life data are still needed in order to confirm this profile. Material and methods In Romania, through a nationwide government‐funded programme in 2015‐2016, approx.5800 patients with virus C cirrhosis received fully reimbursed DAA therapy with OBV / PTV /r+ DSV + RBV for 12 weeks. We analysed a national prospective cohort enrolling the first 2070 patients, all with genotype 1b. The only key inclusion criteria was advanced fibrosis (Metavir stage F4) confirmed by Fibromax testing (or liver biopsy/Fibroscan). Efficacy was assessed by the percentage of patients achieving SVR 12 weeks post‐treatment ( SVR 12). Results Forty patients stopped the treatment because of hepatic decompensation (1.9%), 21 stopped because of other adverse events and one was lost to follow‐up. This cohort was 51% females, mean age 60 years (25÷82), 67% pretreated, 70% associated NASH , 67% with severe necro‐inflammation (severity score 3‐Fibromax), 37% with comorbidities, 10.4% with Child Pugh A6, 0.5% B7. The median MELD score was 8.09 (6 ÷ 22). SVR by intention‐to‐treat was reported in 1999/2070(96.6%), 55/2070 failed to respond. Liver decompensation was statistically associated in multivariate analysis with platelets< 10 5 /mm 3 ( P = .03), increased total bilirubin ( P < .001), prolonged INR ( P = .02), and albumin<3.5 g/dL ( P = .03). Conclusions OBV / PTV /r+ DSV + RBV proved to be highly efficient in our population of cirrhotics with a 96.6% SVR . Serious adverse events related to therapy were reported in 61/2070(2.9%), most of them liver decompensation (1.9%), related to hepatic dysfunction, and lower platelet count.