Corporate HighlightsIn August, Gilead together with Mylan Laboratories, Ranbaxy Laboratories Limited and Strides Arcolab, announced a collaboration agreement to promote access to high-quality, low-cost generic versions of Gilead's HIV medicine emtricitabine in developing countries - including single tablet regimens containing emtricitabine, and fixed-dose combinations of emtricitabine co-formulated with other Gilead HIV medicines. Product and Pipeline Update Antiviral Franchise In July, Gilead announced:
- The U.S. Food and Drug Administration (FDA) approved once-daily oral Truvada, in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk for acquiring HIV. Truvada is the first drug to be approved for HIV prevention in uninfected adults, a strategy called pre-exposure prophylaxis (PrEP).
- 24-week data from a Phase 3 clinical trial, SPIRIT ( Switching boosted PI to Rilpivirine In Combination with Truvada as a Single Tablet Regimen), which evaluated virologically suppressed treatment-experienced HIV patients switching from a multi-pill regimen containing a ritonavir-boosted protease inhibitor to the once-daily single tablet regimen Complera. The study met its 24-week primary endpoint, which found that switching to Complera was non-inferior to remaining on a ritonavir-boosted protease inhibitor regimen. The findings were presented in an oral session at the 19th International AIDS Conference in Washington, D.C.
- Two-year Phase 3 clinical trial results showing that the integrase inhibitor elvitegravir dosed once daily is non-inferior to raltegravir dosed twice daily among treatment-experienced HIV patients. The findings were presented in an oral session at the 19th International AIDS Conference in Washington, D.C.
- Full clinical trial results from a pivotal Phase 3 study evaluating cobicistat, a pharmacoenhancing or “boosting” agent for HIV therapy, compared to ritonavir, currently the only approved agent used to boost certain antiretroviral treatment regimens. The study found that an HIV regimen containing a cobicistat-boosted protease inhibitor was non-inferior to a regimen containing a ritonavir-boosted protease inhibitor at 48 weeks of therapy. The findings were presented in an oral session at the 19th International AIDS Conference in Washington, D.C.