Merck says its Zepatier showed better efficacy and safety compared with competition in Phase III trials
pharmafile | April 14, 2016 | News story | Research and Development, Sales and Marketing | Gilead, HCV, Merck & Co, Zepatier
US pharma giant Merck (NYSE: MRK) on Thursday said late-stage trials for its Zepatier (elbasvir and grazoprevir) to treat chronic hepatitis C (HCV), in patients who have already received therapy, showed efficacy and safety compared with the competition.
Jan Sperl, lead study investigator said: “Overall in this study, the elbasvir and grazoprevir regimen showed superior SVR rates and improvement on pre-specified safety endpoints compared to the sofosbuvir plus peginterferon and ribavirin regimen in these genotype 1- or 4-infected patients. Sofosbuvir in combination with peginterferon and ribavirin continues to be a prescribed treatment regimen in many regions, and this comparative study versus combination treatment with elbasvir and grazoprevir provides interesting and important insights.”
The drug was tested against Gilead’s (Nasdaq: GILD) Sovaldi (sofosbuvir) plus peginterferon and ribavirin, the company said in a statement.
Jan Gerstoft, clinic for infectious diseases and rheumatology, Copenhagen, Denmark, said: “Treatment regimens containing peginterferon and ribavirin are associated with certain serious side effects. This study provides evidence for the clinical potential of elbasvir and grazoprevir in chronic HCV genotype 1- or 4-infection as compared with a regimen containing peginterferon and ribavirin along with sofosbuvir.”
Zepatier was approved by the US Food and Drug Administration (FDA) in January.
Anjali Shukla
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