Hepatitis and Liver Diseases

Biography

Biography: Ligita Jancoriene

Abstract

The aim of multicenter, international, real-life study was to evaluate efficacy and safety of Ombitasvir/Paritaprevir/Ritonavir+Dasabuvir±Ribavirin in treatment-naive and treatment-experienced GT1-infected patients, who failed previous PEG-INF/RBV±first generation protease inhibitor therapy. 114 (54 males) GT1-infected (102-GT1b) patients, aged 54.4±10.6 years, were included. 28.1% were treatment-naive, 71.9% treatment-experienced. 21 patients failed previous triple therapy with telaprevir or boceprevir. 57% were cirrhotics. Treatment was scheduled for 12 weeks in 112, 24 weeks in 2 patients. RBV was administered to 89 patients. Sustained virologic response (SVR12) was assessed by HCV-RNA undetectability 12 weeks after the end of treatment (EOT). 111 patients completed therapy and had undetectable HCV-RNA at the EOT. 73 patients with available follow-up evaluation achieved SVR12. The average reduction in alpha-fetoprotein (16.3 versus 4.9, p<0.001) and hepatic fibrosis (17.3 versus 15.5, p<0.001) was demonstrated at the end of follow-up. RBV was reduced in 18, discontinued in 11 patients. The most frequent adverse events were asthenia (25.4%), fatigue (15.8%), itching (13.2%) and dyspepsia (11.4%). Treatment was disontinued in 3 patients due to exacerbation of psoriasis (day 3), depression (week 5) and elevation of ALT, AST (week 9). 10 liver transplant patients recieved 24 weeks treatment(4 males, 50.7±8.0 years, 9-GT1b, 8-treatment-experienced). RBV was administred to 9, reduced in 3, discontinued in 2 patients. All patients completed therapy and had undetectable HCV-RNR at the EOT. 9 patients with available follow-up evaluation achieved SVR12. In conclusion, treatment with Ombitasvir/Paritaprevir/Ritonavir+Dasabuvir±Ribavirin achieved 100% SVR12. Adverse events were mostly mild and related to RBV administration.