Stribild elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate regulatory update

Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said that Gilead's Stribild has a "smaller" benefit than comparator Atripla to treat HIV-1 infection in treatment-naïve adults or adults without mutations associated with resistance to the antiviral agents in the product. IQWiG's assessment notes that pooled data showed that Stribild was associated with more AIDS-defining events than Atripla. Comments are due Oct. 7, with a final assessment from Germany's Federal Joint Committee (G-BA) expected in early December.

The European Commission approved Stribild for the indication in May. The once-daily tablet comprising elvitegravir, cobicistat and Gilead's Truvada emtricitabine/tenofovir is also approved in the U.S., Canada, South Korea, Japan, Turkey and Australia. Gilead and Bristol-Myers Squibb Co. (NYSE:BMY, New York, N.Y.) co-market Atripla emtricitabine/tenofovir/efavirenz. ...