AbbVie announced positive data from its Phase 3 study of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in Japanese patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection without cirrhosis.
CERTAIN-1 is a multicenter, Phase 3 trial evaluating the efficacy, safety and pharmacokinetics (PK) of G/P in adult Japanese patients. It consists of two studies: Substudy 1, a randomized, open-label, active-controlled study in treatment-naïve [direct-acting antivirals (DAA)] GT1 chronic HCV-infected patients without cirrhosis, and Substudy 2, a non-randomized, open-label study in GT1-6 HCV patients with complications, including compensated cirrhosis (Child-Pugh A), chronic kidney disease (CKD), and DAA treatment failure. Patients received either G/P for 8 weeks or ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) for 12 weeks. The primary endpoints are safety and non-inferiority of G/P compared to OBV/PTV/r.
Results showed that the study met its primary endpoint, demonstrating that treatment with G/P for 8 weeks was non-inferior to 12 weeks of OBV/PTV/r (100% SVR12; n=52). In patients without both cirrhosis and the Y93H variant, 99% (n=105/106) achieved sustained virologic response at 12 weeks posttreatment. Patients with the Y93H variant (n=23) received G/P treatment and all achieved SVR12. In addition, the G/P regimen was shown to have a tolerable safety profile, with the most common adverse events as nasopharyngitis and pruritus. Further results of the study will be presented at an upcoming scientific congress.
G/P is an investigational, fixed-dose, once-daily, pan-genotypic regimen consisting of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, NS5A inhibitor.
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