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Real‐world experience with the all‐oral, interferon‐free regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir for the treatment of chronic hepatitis C virus infection in the German Hepatitis C Registry

2017; Wiley; Volume: 24; Issue: 10 Linguagem: Inglês

10.1111/jvh.12708

1365-2893

Tania M. Welzel, Holger Hinrichsen, Christoph Sarrazin, Peter Buggisch, Axel Baumgarten, Stefan Christensen, Thomas Berg, Stefan Mauss, G Teuber, Kerstin Stein, Katja Deterding, Florian van Bömmel, R Heyne, C John, Tim Zimmermann, Thomas A. Lutz, E. Schott, Julia Hettinger, H. O. Kleine, Bettina König, D Hüppe, Heiner Wedemeyer,

Liver Disease Diagnosis and Treatment

Summary Real‐world studies are relevant to complement clinical trials on novel antiviral therapies against chronic hepatitis C; however, clinical practice data are currently limited. This study investigated effectiveness and safety of ombitasvir/paritaprevir/ritonavir ( OBV / PTV /r)±dasabuvir ( DSV )±ribavirin ( RBV ) for treatment of HCV genotype ( GT ) 1 and GT 4 infection in a large real‐world cohort. The German Hepatitis C Registry is an observational cohort study prospectively collecting clinical practice data on direct‐acting antiviral therapies. Patients with GT 1/4 infection treated with OBV / PTV /r± DSV ± RBV were analysed. Effectiveness was assessed by sustained virologic response in 558 patients who reached post‐treatment week 12 ( SVR 12). Safety is reported in 1017 patients who initiated treatment. Of the patients, 892 (88%) had GT 1 and 125 (12%) had GT 4 infection. Prior treatment experience and cirrhosis were reported in 598 (59%) and 228 (22%) patients, respectively. Overall, SVR 12 ( mITT ) was 96% (486/505) in GT 1‐ and 100% (53/53) in GT 4 patients. SVR 12 rates were high across subgroups including patients with cirrhosis (95%, 123/129), patients with moderate to severe renal impairment (100%, 34/34), and subgroups excluded from registrational trials like patients ≥70 years (96%, 64/67) and failures to prior protease inhibitor treatment (96%, 46/48). Adverse events (AEs) and serious AEs were reported in 52% (525/1017) and 2% (21/1017) of patients, respectively, and led to treatment discontinuation in 1.5% (15/1017) of patients. OBV / PTV /r± DSV ± RBV was effective and generally well tolerated for treatment of HCV infection in clinical practice.