As expected, the U.S. Food and Drug Administration approved Gilead Sciences’ hotly anticipated new hepatitis C therapy Sovaldi (sofosbuvir) in December. What came as a surprise, however, was the FDA’s approval for the highly effective drug’s use among people coinfected with hep C and HIV. No previous hep C therapy has ever been approved to treat the coinfected population.
“We in the hepatology community are very, very encouraged that coinfected patients were studied vigorously enough and included in the label,” says Andrew Aronsohn, MD, an assistant professor of medicine at the University of Chicago Medical Center. “It’s really making treatment for HIV-coinfected patients a reality, something that is going to be attainable.”
Sovaldi, which must be paired with ribavirin for 12 to 24 weeks of treatment, also offers the potential for those with genotypes 2 or 3 of hep C to receive the first-ever regimen that ditches the notorious weekly injections of interferon and its flu-like side effects. Also, for people who have genotype 1 and who are ineligible to take interferon (a category that some physicians argue includes those who simply do not want to take the drug), physicians may consider prescribing a longer course of treatment with just Sovaldi and ribavirin.