Merck: The Phase 3 C-Edge Treatment-Naive (TN) Study of a 12-Week Oral Regimen of Grazoprevir (GZR, MK-5172)/Elbasvir (EBR, MK-8742) in Patients with Chronic HCV Genotype (Gt) 1, 4, or 6 Infection—S Zeuzem et al
Drug Pipeline and Conference Coverage
This was a phase 3 study of a one pill, once-a-day grazoprevir and elbasvir pill taken for 12 weeks. The study included treatment naïve (TN). The trial included a total of 421 infected HCV genotype 1, 4 or 6. Most of the trial participants were male sex, and White. Ninety-one percent were genotype 1. Approximately 22% had cirrhosis.
The overall cure rate was 95%: 92% for genotype 1a and 99% for genotype 1b; 100% (36 of 36 pts) of the genotype 4 patients were cured; 80% (5 of 6 pts) of genotype 6 patients were cured. The most common side effects were headache, fatigue, nausea and joint pain.
Comments: These are high cure rates with a low side effect profile and it will make a good addition to the treatment landscape of HCV in 2016. In people with the genotype 1a NS5A resistance-associated variants (RAVs) it shows greater than a 5-fold loss in sensitivity to elbasvir (a protease inhibitor). What this means in clinical practice in unknown at this time.