VIENNA — Patients with cirrhosis as well as genotype 1 and genotype 3 HCV responded favorably to 8 weeks of treatment with a novel grazoprevir and elbasvir-based combination regimen, according to findings presented at the 2015 International Liver Congress.
Fred Poordad, MD, of the Texas Liver Institute and University of Texas Health Science Center in San Antonio, Texas, and colleagues aimed to evaluate a fixed-dose combination of 100 mg grazoprevir and 50 mg elbasvir (MK-5172, MK-8742; Merck) plus 400 mg sofosbuvir (Sovaldi, Gilead) in treatment-naive patients with or without cirrhosis.
Patients with genotype 1 disease (n = 102) were treated for 4, 6 or 8 weeks, while patients with genotype 3 disease (n = 41) were treated for 8 or 12 weeks. Non-cirrhotic patients with genotype 1 disease were treated for 4 or 6 weeks; cirrhotic genotype 1 patients were treated for 6 or 8 weeks; non-cirrhotic genotype 3 patients were treated for 8 or 12 weeks; and cirrhotic genotype 3 patients were treated for 12 weeks. SVR12 served as the primary endpoint in this ongoing study.
Among patients with genotype 1 disease, SVR12 rates were 33% for patients without cirrhosis treated for 4 weeks, 87% for those without cirrhosis treated for 6 weeks, 80% for patients with cirrhosis treated for 6 weeks and 94% for those with cirrhosis treated for 8 weeks.
In the genotype 3 group, treatment for 8 weeks yielded a 93% SVR12 rate, while SVR12 was 100% for patients without cirrhosis treated for 12 weeks and 91% for patients with cirrhosis treated for 12 weeks.
“All patients became target-not-detected at the end of treatment,” Poordad said. He added that there were very few adverse events and no significant declines in hemoglobin.
“This novel regimen of grazoprevir and elbasvir with sofosbuvir was able to shorten treatment duration to 8 weeks or less among cirrhotic and non-cirrhotic genotype 1 patients,” Poordad. “Genotype 3 patients achieved high SVR12 rates with 8 to 12 weeks of treatment. The concept of shortening therapy even in the cirrhotic patient has been demonstrated in this study. Retreatment of the virologic failures is ongoing.” – by Rob Volansky