November 11, 2014
By Ransdell Pierson
Gilead Sciences Inc on Tuesday said its new Harvoni drug for hepatitis C achieved cure rates of 96% to 97% in a study of patients who had cirrhosis and had failed to benefit from prior treatments.
The data bolsters the attractiveness of Harvoni, a combination drug that U.S. regulators approved last month and whose $95,000 cost for a course of treatment has raised complaints from insurers and politicians.
The Gilead study, presented at Annual Meeting of the American Association for the Study of Liver Diseases, involved 155 patients with cirrhosis and the most common genotype 1 form of the liver virus. They previously had failed to benefit from standard older treatments that included protease inhibitors as well as interferon and ribavirin, drugs that can cause harsh side effects and must be taken for almost a year.
All patients received Harvoni, a once-daily pill containing Gilead's Sovaldi and ledipasvir. The combination eliminates the need to take interferon and ribavirin with Sovaldi.
In one group taking Harvoni alone for 24 weeks, the cure rate was 97%. It was 96% for patients who received Harvoni plus ribavirin for 12 weeks.
Three far smaller Gilead studies evaluated Sovaldi, a nucleotide, in combination with the company's experimental NS5A inhibitor GS-5816, with and without ribavirin for eight or 12 weeks.
Of patients taking the combination for 12 weeks without ribavirin, sustained cures were seen in 100% of genotype 1 patients, with and without cirrhosis, and in 88% of those with the less common genotype 3 form of the virus, with cirrhosis.
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