Viekirax (ombitasvir/paritaprevir/ritonavir) approved for genotype 1 hepatitis C in Japan- AbbVie
The Japanese Ministry of Health, Labour and Welfare approved AbbVie’s Viekirax (ombitasvir/paritaprevir/ritonavir), as a new interferon-free and ribavirin-free treatment option for adult patients in Japan with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated liver cirrhosis. Viekirax consists of two-direct-acting antiviral (2-DAA), fixed-dose tablets containing paritaprevir/ritonavir with ombitasvir. Viekirax is approved in Japan using once daily dosing for 12 weeks for GT1 HCV patients.
The approval was supported by the phase III GIFT-I study. An overall 95% (n=140/148) of treatment-naïve and 94% (n=102/109) of treatment-experienced GT1b HCV infected patients achieved SVR12 with Viekirax. The primary endpoint was achieved, demonstrating 95% (n=106/112) SVR12 in a sub-group of treatment-naïve, non-cirrhotic, adult, GT1b HCV infected Japanese patients who were eligible for therapy with interferon (IFN) and had a high viral load.
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