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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update
UNITED STATES: F.D.A. Approves Pill to Treat Hepatitis C
By Andrew Pollack
December 9, 2013
New York Times (12.06.2013)

The New York Times reported that on December 7 the US Food and Drug Administration (FDA) approved Gilead Sciences’ drug Sovaldi to treat hepatitis C virus (HCV) infection. Sovaldi, generic name sofosbuvir, shortens treatment, is more effective, and will allow some patients to be treated with pills instead of the weekly injections of interferon, which can have severe side effects. Sovaldi is a polymerase inhibitor, which works by inhibiting enzymes produced by HCV. This is the same approach used with HIV drugs. As with HIV, two or more drugs are used together to prevent the virus from developing resistance. Gilead priced the drug at $28,000 wholesale for four weeks, or $1,000 per daily pill. Treatment for 12 weeks would cost $84,000, and for 24 weeks for patients with the certain HCV strains would cost $168,000. The company said it would offer financial aid to some patients. Other companies are in the process of developing all-oral HCV treatments that could be ready within one to three years. Also Merck, Roche, and Idenix pharmaceutical companies are claiming that Sovaldi infringes on their patents. The cure rate for Sovaldi is higher than 80 percent, depending on the HCV strain or genotype. Sovaldi should be used with ribavirin to treat HCV genotypes 2 and 3, which infect 20 to 25 percent of US cases. Genotype 2 requires 12 weeks of treatment and genotype 3, 24 weeks. HCV genotype 1 is found in more than 70 percent of US cases and should be treated with Sovaldi plus injected interferon and ribavirin for 12 weeks. The cure rate is 90 percent for newly treated patients. Genotype 1 patients who are not eligible for interferon can be treated for 24 weeks with Sovaldi and ribavirin. Gilead plans to combine Sovaldi with another drug into one pill to be taken once daily for genotype 1.