Gilead Leaps to First with Phase 3 Success for All-Oral Hepatitis C Drug Program

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"Gilead Sciences is sprinting ahead with initial positive results from a Phase 3 study for what could be a first all-oral combination therapy for certain patients with chronic hepatitis C virus in the U.S."

Gilead Sciences ($GILD) is sprinting ahead with initial positive results from a phase 3 study for what could be a first all-oral combination therapy for certain patients with chronic hepatitis C virus in the U.S. The company reported clinical cures for about three quarters of patients with genotypes 2 or 3 of the liver-damaging virus on a combination of its experimental "nuc" sofosbuvir or GS-7977 and standard ribavirin.

In a crowded and fast-moving contest to grab a piece of a potential $20 billion market for interferon-free treatments, Gilead has established the lead spot with all-oral cocktails built around sofosbuvir. Its latest trial results come from the first of three late-stage studies of the once-daily nucleotide analog polymerase inhibitor in patients with genotypes 2/3, and Gilead aims to file for FDA approval of the drug in mid-2013. Results from the other late-stage studies are due early next year. . .View Full Article

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