Gilead Sciences, Inc. (NASDAQ: GILD) today presented additional results from the DISCOVER trial evaluating an investigational use of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) for HIV pre-exposure prophylaxis (PrEP). In a sub-analysis of the DISCOVER trial, Descovy reached intracellular drug concentration levels above the estimated protective threshold significantly more quickly than Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets; F/TDF), and additional pharmacokinetic data confirm that these drug concentration levels persist longer than Truvada. The results were presented at the 10th International AIDS Society Conference on HIV Science (IAS 2019) being held in Mexico City.
“Gilead is committed to driving advances in HIV prevention and supporting broader public health initiatives that are designed to reduce HIV infections,” said Diana Brainard, MD, Senior Vice President, HIV and Emerging Viruses, Gilead Sciences. “These results presented at IAS provide further evidence supporting the potential for Descovy for PrEP™ to offer an important new prevention option for people at risk of acquiring HIV.”
In April, Gilead submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for once-daily Descovy for PrEP. A Priority Review voucher was submitted with the filing, leading to an anticipated review time of six months. Descovy was approved in the United States in 2016 for the treatment of HIV-1 infection in combination with other antiretroviral agents, and the use of Descovy for a PrEP indication is investigational. Descovy and Truvada have a Boxed Warning in their U.S. product label regarding the risk of post-treatment acute exacerbation of hepatitis B; Truvada for PrEP also includes a Boxed Warning regarding the risk of drug resistance with use of Truvada for PrEP in undiagnosed early HIV infection.
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