Merck announced that the development programs for two hepatitis C virus (HCV) infection treatments, MK-3682B (grazoprevir/ruzasvir/uprifosbuvir) and MK-3682C (ruzasvir/uprifosbuvir), have been discontinued. The decision was made based on an evaluation of Phase 2 efficacy data. The Company also took into consideration the increasing number of treatments for HCV already available in the marketplace.
The MK-3682B trial evaluated a triple-combination therapy that included an HCV nucleotide analogue NS5B polymerase inhibitor (uprifosbuvir), an HCV NS3/4A protease inhibitor (grazoprevir) and an HCV NS5A inhibitor (ruzasvir) in treatment-experienced patients with HCV genotype 1 infection for whom treatment with approved direct-acting antiviral regimens had failed. The study showed that 100% of patients achieved SVR12 at 16 weeks (n=43) and 24 weeks (n=49).
“Remarkable progress has been made in the fight against hepatitis C infection, and Merck is enormously proud of the role we have had in that fight over the past 30 years,” said Dr. Eliav Barr, senior vice president, global clinical development, infectious diseases and vaccines, Merck Research Laboratories. “We will continue to study Zepatier to understand even more about its role in treating chronic hepatitis C infection and will continue to work with others to help bring Zepatier to appropriate patients with chronic hepatitis C genotype 1 or 4 infection, the genotypes which make up the majority of patients with chronic hepatitis C infection.”
Zepatier (elbasvir/grazoprevir) is a once-daily, fixed-dose tablet that combines elbasvir, a NS5A inhibitor, and grazoprevir for the treatment of HCV genotypes 1 or 4 with or without ribavirin. It is available as 50mg/100mg strength tablets in two 14-count dose packs, for a total of 28 tablets.
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