November 14, 2012

Gilead’s Hep C Combo Therapy Shows 100% Cure Rate in Small Study

Gilead Sciences’ pair of investigatory hepatitis C virus (HCV) therapies led to a 100 percent cure rate among a small cohort of patients, Reuters reports. The pharmaceutical company announced interim data from its ongoing Phase II ELECTRON study at the annual meeting of the American Association of the Study of Liver Disease (AASLD) in Boston. The news joined a flurry of research data from other companies, including Abbott Laboratories, whose own investigatory interferon-free drug regimen showed sustained virological response (SVR) rates above 90 percent. The potential market is large, considering that an estimated 5 million Americans are living with hep C and could use drug regimens that are both more tolerable and more effective than those available today.

Gilead studied 25 genotype 1-infected, treatment-naive patients taking a 12-week course of the investigational nucleotide sofosbuvir (formerly known as GS-7977) along with the NS5A inhibitor GS-5885, plus ribavirin. The viral loads of all 25 participants remained undetectable four weeks after completing the treatment, which proved well tolerated. The most common side effects were headache, fatigue, upper respiratory infection and nausea.

The pharmaceutical giant has just begun a Phase III study of sofosbuvir and GS-5885, both with and without ribavirin, for 12- and 24-week courses. Twenty percent of the 800-person study group has evidence of cirrhosis, promising results both more statistically significant and more relevant to the diverse hep C population.

To read the Reuters report, click here.

To read the Gilead release, click here.

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