US regulators on Thursday approved a new once-daily treatment for the liver-destroying hepatitis C virus made by Merck & Co Inc.
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CVS Health Corp, the No. 2 drug benefit manager, which now gives preferred status to Gilead’s hepatitis C drugs, said in an email that it is “employing a strategic assessment of the therapy landscape and engaging with drugmakers to evaluate options”. The FDA approval for Zepatier provides patients with genotype 1 and 4 infections another treatment option to improve prognosis for their condition. Some people with chronic HCV infection develop cirrhosis over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer.
According to the findings of the clinical trial, 94 to 97 percent of those with genotype 1 infections and 97 to 100 percent of those with genotype 4 infections achieved intended results.
Merck hasn’t disclosed the list price for the drug, which requires a 12-week course of treatment.
The safety and efficacy of Zepatier with or without ribavirin was evaluated in clinical trials of 1,373 participants with chronic HCV genotype 1 or 4 infections with and without cirrhosis. The drug not only removed the need for side-effect ridden interferon administration for 40% of patients, but also delivered cure rates north of 90% within 12-24 weeks, from a prior 24-48 week period.
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Shares of Gilead were down 5 percent at $83.00 in Friday Nasdaq trading – their lowest since June 2014. It is recommended that healthcare professionals screen genotype 1a-infected patients for certain viral genetic variations prior to starting treatment with Zepatier to determine dosage regimen and duration. Common adverse effects of the combination drug without ribavirin include fatigue, headache, and nausea, while adverse effects with ribavirin include anemia and headache. It is not for use in patients with moderate of severe liver impairment, that is, those rated as having a Child-Pugh score of B or C. It is also not for use with organic anion transporting polypedtides. Besides, the company says that the range is within the net prices of other competing drugs.
