The tablet’s efficacy and safety were assessed in eight clinical studies in about 2,000 patients.
The development program intended to evaluate Zepatier across different chronic HCV patients, including those on opioid agonist therapy, with chronic kidney disease or with HCV/HIV-1 co-infection.
Overall sustained virologic response (SVR) 12 weeks after the completion of therapy was achieved in 96% of chronic HCV GT1b-infected patients treated with Zepatier for 12 weeks.
The company said in chronic HCV GT1a-infected patients, 93% and 95% achieved cure after treatment with Zepatier for 12 weeks or Zepatier and RBV for 16 weeks, respectively.
In addition, 94% and 100% of chronic HCV GT4-infected patients achieved cure following treatment with Zepatier for 12 weeks or Zepatier plus RBV for 16 weeks, respectively.
Merck Research Laboratories president Roger Perlmutter said: “The approval of Zepatier in the European Union, following approvals in the United States and Canada earlier this year, is an important step in offering a new and effective treatment for millions of people infected with hepatitis C virus genotype 1 or 4.
“Zepatier is the most recent advance from MSD in our more than 30-year effort to combat the effects of hepatitis C virus infection, and hence, to reduce the burden of this disease around the world.”
Image: The offices of Merck, located in Upper Gwynedd Township, Montgomery County, Pennsylvania. Photo: courtesy of Montgomery County Planning Commission.