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The Food and Drug Administration has approved sofosbuvir, a first-in-its-class antiviral, to treat chronic hepatitis C infection.
Sofosbuvir is a nucleotide analogue inhibitor of the hepatitis C virus (HCV) NS5B polymerase enzyme, which plays an important role in HCV replication. It is taken orally once a day at a 400-mg dose. It will be marketed as Sovaldi by Gilead Sciences.
The drug is approved for two chronic hepatitis C indications: In combination with pegylated interferon and ribavirin for treatment-naïve adults with genotype 1 and 4 infections, and in combination with ribavirin for adults with genotypes 2 and 3 infection.
The second indication is the first approval of an interferon-free regimen for the treatment for chronic hepatitis C.
"Today’s approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C," Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA Center for Drug Evaluation and Research, said in a statement.
This is "truly a historic moment," Dr. Demetre Daskalakis, medical director of the HIV program at Mt. Sinai School of Medicine, New York, said at an FDA advisory committee meeting on the drug held Oct. 25. "I can’t wait to get this drug into the clinic. We are all excited," he added. The Antiviral Drugs Advisory Committee voted unanimously that day to recommend approval for sofosbuvir.
Sofosbuvir was approved based on data from six clinical trials consisting of 1,947 patients – both treatment-naïve and treatment experienced – some of whom were also HIV positive.
The most common side effects reported in clinical study participants treated with sofosbuvir and ribavirin were fatigue and headache. In participants treated with sofosbuvir, ribavirin, and peginterferon-alfa, the most common side effects reported were fatigue, headache, nausea, insomnia, and anemia, according to the FDA.
According to Gilead, sofosbuvir is also on the verge of receiving marketing approval in the European Union. Sofosbuvir is the second drug approved by the FDA in the past two weeks to treat chronic HCV infection. Simeprevir was approved Nov. 22.
Elizabeth Mechcatie contributed to this report.