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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
Author(s) -
Welzel T. M.,
Hinrichsen H.,
Sarrazin C.,
Buggisch P.,
Baumgarten A.,
Christensen S.,
Berg T.,
Mauss S.,
Teuber G.,
Stein K.,
Deterding K.,
Bömmel F.,
Heyne R.,
John C.,
Zimmermann T.,
Lutz T.,
Schott E.,
Hettinger J.,
Kleine H.,
König B.,
Hüppe D.,
Wedemeyer H.
Publication year - 2017
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1111/jvh.12708
Subject(s) - ombitasvir , paritaprevir , dasabuvir , ritonavir , medicine , ribavirin , regimen , hepatitis c , gastroenterology , discontinuation , adverse effect , hepatitis c virus , virology , viral load , virus , antiretroviral therapy
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.