Sovaldi sofosbuvir regulatory update

The European Commission approved an MAA for Gilead's Sovaldi sofosbuvir to treat chronic HCV infection in adults, including patients co-infected with HIV. Sovaldi is approved in combination with ribavirin for 24 weeks as an all-oral therapy to treat HCV genotypes 2 and 3 infection. Sovaldi is approved in combination with ribavirin and pegylated interferon to treat HCV genotypes 1, 4, 5 and 6 infection; the all-oral regimen is indicated for these patients when they are ineligible or intolerant to peginterferon. The approval also covers use of Sovaldi in combination with ribavirin for patients with HCV who are awaiting liver transplantation.

For HCV genotype 2 infection, the recommended treatment duration of Sovaldi is 12 weeks in combination with ribavirin. For HCV genotypes 1, 3, 4, 5 and 6 infection, the recommended treatment duration for the once-daily pill is 24 weeks when used in combination with ribavirin only and 12 weeks when in combination with ribavirin and peginterferon. ...