VIDEO: C-CREST-1 trial shows fixed-dose combo effective at 8 weeks for HCV
BOSTON — In this exclusive video from The Liver Meeting, Eric J. Lawitz, MD, vice president of scientific and research development at The Texas Liver Institute and clinical professor of medicine at the University of Texas Health Science Center, discusses results of the C-CREST-1 clinical study where treatment-naive patients with hepatitis C genotype 1, 2 and 3 infection showed high sustained virologic response rates after treatment with MK-3682, MK-8408 and grazoprevir.
“What we learned is there were high rates of sustained virologic response across genotypes 1, 2 and 3 irrespective of treatment experience, irrespective of the presence or absence of ribavirin or irrespective of cirrhosis,” Lawitz said.
In part B of two ongoing, randomized clinical trials, the researchers treated a heterogenous population of patients with HCV: 176 patients with HCV genotype 1 treatment-naive patients with or without cirrhosis; 151 treatment-naive patients with genotype 2 with or without cirrhosis; and 337 treatment-naive or experienced patients with or without cirrhosis; with 450 mg of MK-3682 (Merck), 100 mg of grazoprevir (Merck) and 60 mg of MK-8408 (Merck) with or without ribavirin for 8, 12 or 16 weeks.
Eight weeks of treatment with MK-3682B resulted in SVR12 rates of 95%, 86% and 95% in genotype 1, genotype 2 and genotype 3 patients, respectively. A 12-week treatment duration resulted in high SVR12 rates in all genotypes (GT1, 99%; GT2, 97%; GT3, 97%). Efficacy was comparable in patients with and without cirrhosis. There were no virologic failures in the patients with genotype 1 or genotype 2 infection who received 12 weeks of MK-3682B.
Lawitz said the safety profile of the regimen is similar to the safety profile seen with drugs in the past.
“They were safe, well-tolerated with low rates of serious adverse events,” Lawitz said.
Disclosure: Lawitz reports financial relationships with AbbVie, Achillion Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Enanta Pharmaceuticals, Gilead Sciences, GlaxoSmithKline, Janssen, Merck & Co., Novartis, Regulus, Roche, Salix, Santaris Pharmaceuticals, Tacere, and Theravance.
Editor's Note: This has been updated with clarifications from the presenter.