Preda CM, et al. – The clinicians aimed to investigate the real world efficacy and safety of ombitasvir, Paritaprevir/r+Dasabuvir+Ribavirin (OBV/PTV/r+DSV+RBV) in genotype 1B patients with hepatitis C virus (HCV) liver cirrhosis. In this population of cirrhotics with a 96.6% SVR, OBV/PTV/r+DSV+RBV proved to be highly effective. Related to therapy, serious adverse events were reported in 61/2070(2.9%), most of them liver decompensation (1.9%), related to hepatic dysfunction, and lower platelet count.

• In 2015-2016, through a nationwide government-funded programme in Romania, approx.5800 patients with virus C liver cirrhosis received fully reimbursed DAA therapy with OBV/PTV/r+DSV+RBV for 12 weeks.
• In this study, the clinicians examined a national prospective cohort enrolling the first 2070 patients, all with genotype 1b.
• Advanced fibrosis (Metavir stage F4) confirmed by Fibromax testing (or liver biopsy/Fibroscan) was the only key inclusion criteria.
• They assessed efficacy by the percentage of patients achieving SVR 12 weeks post-treatment (SVR12).

• Due to hepatic decompensation, 40 patients stopped the treatment (1.9%), 21 patients stopped due to other adverse events and 1 was lost to follow-up.
• This cohort was 51% females, mean age 60 years (25÷82), 67% pre-treated, 70% associated NASH, 67% with severe necro-inflammation (severity score 3-Fibromax), 37% with co-morbidities, 10.4% with Child Pugh A6, 0.5% B7.
• In this study, the median MELD score was 8.09 (6 ÷ 22).
• By intention to treat, SVR was reported in 1999/2070(96.6%), 55/2070 failed to respond.
• In multivariate analysis, liver decompensation was statistically correlated with platelets< 10⁵/mm³(p=0.03), increased total bilirubin (p<0.001), prolonged INR (p=0.02), albumin<3.5g/dl (p=0.03).