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ARTICLE | Clinical News

MK-8408: Interim Phase IIa data

October 26, 2015 7:00 AM UTC

Interim data from 240 treatment-naive, non-cirrhotic patients with chronic HCV infection in Part A of the ongoing, open-label, international Phase IIa C-CREST-1 and C-CREST-2 trials showed that once-daily 100 mg grazoprevir plus 300 or 450 mg MK-3682 and either 50 mg elbasvir or 60 mg MK-8408 for 8 weeks led to an SVR 12 weeks after the end of treatment in 98% of patients with HCV genotype 1a infection (n=46); 98% in patients with HCV genotype 1b infection (n=47); and 91% in patients with HCV genotype 3 infection (n=86). In patients with HCV genotype 2 infection, once-daily 100 mg grazoprevir plus 450 mg MK-3682 and 60 mg MK-8408 for 8 weeks led to an SVR12 rate of 94% (n=16), while regimens containing the 300 mg dose of MK-3682 led to an SVR12 rate of 64% (n=45). All regimens were generally well tolerated with no treatment-related serious adverse events reported and no cardiac or renal safety signals identified. The most common treatment-related adverse events were headache, fatigue, nausea, diarrhea, flatulence and insomnia. Next month, data will be presented at the American Association for the Study of Liver Diseases meeting in San Francisco. ...