FDA approves Gilead Sciences' Sovaldi for chronic hepatitis C

Gilead Sciences announced Friday that the FDA cleared Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection in patients with genotypes 1, 2, 3 or 4, as part of a combination antiviral regimen involving ribavirin and in certain cases peg-interferon alfa. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, described the decision as "a significant shift in the treatment paradigm for some patients with chronic hepatitis C."

The approval of the nucleotide polymerase inhibitor was supported by data from six Phase III trials. In documents released ahead of an FDA advisory panel vote in October that recommended approval of the drug, Gilead said Sovaldi was associated with a cure rate of 90 percent after 12 weeks of therapy in treatment-naïve patients with genotypes 1, 4, 5 or 6, while rates of 67 percent were recorded for patients infected with less common genotypes.

For HCV subtypes 2 and 3, which together account for about 25 percent of cases in the US, Sovaldi's label recommends the drug be used with ribavirin. In these cases, the regimen would constitute the first all-oral, interferon-free treatment for the disease. Meanwhile, Sovaldi is to be used with ribavirin plus interferon in patients with genotype 1 HCV, which accounts for more than 70 percent of US cases. However, the drug can be considered for use in genotype-1 patients who are ineligible for interferon, whereas analysts had not been expecting an all-oral regimen to be endorsed for this population. Those with the much less common genotype 4 infections will also be treated with the three-drug combination.

Gilead indicated that the therapy, which was approved under the agency's priority review programme, will cost $84 000 for one 12-week course of treatment, although patients with a less common subtype may require two rounds of treatment. Analysts at BMO Capital Markets project revenue of $1.9 billion for the drug next year, while UBS analyst Matthew Roden suggested annual sales could eventually surpass the approximately $13 billion achieved by Pfizer's Lipitor (atorvastatin) in its peak year.

For related analysis, read Physician Views Poll Results – Convenient dosing and stronger than expected launch in 2014 to drive Gilead Sciences' dominance of hepatitis C market? and Physician Views Poll Results – Gilead Sciences' sofosbuvir could take significant share of warehoused HCV population prior to launch of interferon-free regimens.

Last month, the FDA also approved Johnson & Johnson's NS3/4A protease inhibitor Olysio (simeprevir) for the treatment of chronic HCV infection as part of a regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis.

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