FDA Approves VIEKIRA PAK Without Ribavirin in Patients With Genotype 1b HCV
The FDA has approved a supplemental New Drug Application for the use of Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets; AbbVie) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child-Pugh class A).
The use of Viekira Pak without RBV for this patient population was evaluated in a 12-week, multi-center, open-label, single-arm Phase 3b study, called the TURQUOISE-III study. Participants included 60 adult patients with GT1b HCV infection and Child-Pugh class A cirrhosis who were treatment-naïve or had failed previous therapy with pegylated interferon and RBV. At 12 weeks post-treatment, 100% of participants achieved sustained virologic response (SVR) and were considered cured of HCV, as the virus was no longer detectable in the blood.
None of the study participants discontinued treatment due to adverse events. The most commonly reported adverse events were fatigue, diarrhea, arthralgia, dizziness, insomnia, and pruritus.—FRMC Editor
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