Investigational Triple Therapy for Chronic HCV Shows Sustained Virologic Response

Merck announced interim data from the C-SWIFT study investigating the triple-therapy regimen consisting of the fixed-dose combination of grazoprevir/elbasvir (Zepatier; Merck), a NS3/4A protease inhibitor and NS5A inhibitor in combination with sofosbuvir, a nucleotide (NS5B) inhibitor for the treatment of chronic hepatitis C virus (HCV) infection.

The C-SWIFT study enrolled a 102 treatment-naïve patients with HCV genotype 1 (GT1a and GT1b) infection. Treatment-naïve, non-cirrhotic patients were randomized to receive the fixed-dose combination of grazoprevir/ elbasvir (one pill containing 100mg, 50mg respectively) plus the nucleotide inhibitor sofosbuvir (400mg) once daily for eight, six or four weeks. Treatment-naïve, cirrhotic patients were randomized to receive the investigational combination for either eight or six weeks. The primary endpoint of the study is the percentage of patients achieving sustained virologic response 12 weeks after the completion of therapy (SVR12).

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The investigational triple therapy has shown response rates at 4/8 weeks following therapy) ranging from 80% to 94.7% in cirrhotic and non-cirrhotic patients following six and eight weeks of treatment in this study. The four-week regimen resulted in sub-optimal efficacy. Preliminary findings in treatment-naïve HCV genotype 1- (GT1) infected non-cirrhotic patients, following six and four weeks of treatment, and patients with cirrhotic disease, following eight and six weeks of treatment, will be presented by Dr. Eric Lawitz, Vice President, scientific and research development, the Texas Liver Institute, San Antonio, TX and C-SWIFT lead investigator.

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