FDA authorizes Olysio-Sovaldi Hep C combination

The FDA advises 12 weeks of Olysio-Sovaldi combination for people not suffering from cirrhosis and 24 weeks of the combination therapy for those with cirrhosis.

“It’s a very promising time for people with chronic Hepatitis as the usage of new direct-acting treatment combinations, like Olysio plus generic Sovaldi, offer all-oral Interferon- and Ribavirin-free treatment choices,” Eric Lawitz, MD, the main investigator for the COSMOS clinical study and a professor of medicine at the University of Texas Health Science Center, reported in an interview. “The multiple accesses of different treatment options is important for both doctors and patients so advanced treatment decisions can be made.”

The Olysio-Sovaldi approval was oriented on data from the Phase II COSMOS trial, an open, study that monitored 12 or 24 weeks of two drugs, with or without Ribavirin, among individuals with genotype 1 of the virus, including volunteers easily responding to treatment suffering from compensated liver disease as well as treatment-naive participants. The study comprised non-responders to therapy with no to moderate fibrosis.

Ninety-five percent (20 out of 21 partakers) of those with METAVIR fibrosis scores of F0 to F3 who used 12 weeks of Olysio-Sovaldi reached a stable virologic response 12 weeks after finishing therapy (SVR12, regarded as a cure). Eighty-six percent (6/7) of all volunteers who had cirrhosis and followed the combination therapy for 12 weeks reached an SVR12, and 100 percent (10/10) of those with cirrhosis who underwent treatment for 24 weeks were considered cured.