Direct-acting antivirals ombitasvir/paritaprevir/rotonavir+dasabuvir with or without ribavirin in hepatitis C virus (HCV) genotype 1-infected treatment-naive or treatment-experienced patients with or without cirrhosis: real-life experience in Lithuania and Latvia

Background: The current international multicentre open-label, uncontrolled, real-world retrospective study aimed at evaluating the effectiveness and safety of ombitasvir / paritaprevir / ritonavir + dasabuvir ± ribavirin (3D therapy) in treatment-naive and treatment-experienced hepatitis C virus (HCV) genotype 1-infected (GT1) patients. Methods: Adult patients with chronic HCV GT1 infection, scheduled for 3D therapy according to therapeutic guidelines, were eligible. Demographic and clinical data were collected retrospectively by reviewing individuals health records. The primary effectiveness endpoint was the sustained virological response at 12 weeks following the end of treatment (SVR12). Results: The participants in the current study consisted of 134 patients with HCV GT1 infection, including 10 liver transplant recipients. SVR12 was achieved in 120 (96.8%) non-transplant and all liver transplant patients (100%). Significant improvement in liver function tests were observed. Among 4 treatment failures, 2 patients were non-responders and 2 patients relapsed. OBV/PTV/r + DSV ± RBV regimen was well tolerated in most patients with treatment discontinuation due to adverse events in 3 patients. The most frequent adverse events were asthenia (25.8%), fatigue (16.1%), skin pruritus (12.9%), and dyspepsia (11.3%). Conclusions: The current real-life study demonstrated the effectiveness and safety of OBV/PTV/r + DSV ± RBV in patients with HCV GT1, including patients with cirrhosis, a liver transplant recipient and the one who failed previous antiviral therapies.