Gilead’s hepatitis C drug wins US approval

The US Food and Drug Administration (FDA) has approved Sovaldi (sofosbuvir), Gilead's once-daily tablet for combination with other antivirals in the treatment of chronic hepatitis C infection.

The approval comes after the regulator fast-tracked sofosbuvir by designating "priority review and breakthrough therapy".

Clinical data leading to the decision showed the combination drug reduced treatment burden and duration, according to one of Gilead's principal investigators.

"In clinical studies, Sovaldi in combination with other agents achieved very high cure rates while shortening the duration of treatment to as little as 12 weeks and reducing or completely eliminating the need for interferon injections, depending on the viral genotype."

Dr Ira Jacobson, head of gastroenterology and hepatology at Weill Cornell Medical College in New York

Dr Jacobson added the drug would improve the numbers of people cured of hepatitis C.

Genotypes 1, 2, 3 or 4 of the hepatitis C virus can be treated with the antiviral, which is the first to remove the need in many cases for injection with interferon. The tablet also cuts down on the weeks of therapy.

"The current standard of care for HCV," a Gilead statement says, "involves up to 48 weeks of therapy with a pegylated interferon (peg-IFN)/ribavirin (RBV)-containing regimen". This compares with a need for half the treatment duration or less for many patients offered the new option - between 12 and 24 weeks of treatment, depending on medical condition and viral genotype.

The US Centers for Disease Control and Prevention (CDC) received 16,000 reports of acute hepatitis C infections in 2009 in the US.

The FDA decision in favour of sofosbuvir follows the European Medicines Agency's positive opinion towards approval reached by its Committee for Medicinal Products for Human Use (CHMP) on 22nd November.