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Glecaprevir/Pibrentasvir in Japanese Patients
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Efficacy and Safety of Glecaprevir/Pibrentasvir in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection With and Without Cirrhosis - (05/01/17)
CERTAIN-1: Efficacy and Safety of Glecaprevir/Pibrentasvir in Japanese Patients With Chronic Genotype 1 Hepatitis C Virus Infection With and Without Cirrhosis - (05/01/17)
Efficacy and Safety of Glecaprevir/Pibrentasvir in Japanese Patients with Chronic Genotype 2 Hepatitis C Virus Infection
Sept 2 2017
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ABSTRACT
Glecaprevir (NS3/4A protease inhibitor) and pibrentasvir (NS5A inhibitor) (G/P), a coformulated once-daily, all oral, ribavirin (RBV)-free, direct-acting anti-viral (DAA) regimen was evaluated for safety and efficacy in Hepatitis C Virus GT2-infected Japanese patients, including those with compensated cirrhosis. CERTAIN-2 is a phase 3, open-label, multicenter study assessing the safety and efficacy of G/P (300/120mg) once daily (QD) in treatment-naïve and interferon (IFN) ± RBV treatment-experienced non-cirrhotic Japanese patients with GT2 infection. Patients were randomized 2:1 to receive 8 weeks of G/P (Arm A) or 12 weeks of sofosbuvir (400 mg QD) + RBV (600 -1000 mg weight-based, BID) (Arm B). The primary endpoint was non-inferiority of G/P compared to SOF+RBV by assessing sustained virologic response at post-treatment week 12 (SVR12) among patients in the intent-to-treat (ITT) population. SVR12 was also assessed in treatment-naïve and IFN ± RBV treatment-experienced patients with GT2 infection and compensated cirrhosis who received G/P for 12 weeks in the phase 3, open-label, multicenter CERTAIN-1 study. A total of 136 patients were enrolled in CERTAIN-2. SVR12 was achieved by 88/90 (97.8%) patients in Arm A and 43/46 (93.5%) patients in Arm B. No patient in Arm A experienced virologic failure, while two did in Arm B. The primary endpoint was achieved. In CERTAIN-1, 100% (18/18) of GT2-infected patients with compensated cirrhosis achieved SVR12. Treatment-emergent serious adverse events were experienced by two non-cirrhotic patients in each arm and no cirrhotic patient. Results demonstrate high efficacy and favorable tolerability of G/P in GT2-infected Japanese patients.
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