Gilead Sciences announced plans to donate Truvada for PrEP (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets) to the U.S. Centers for Disease Control and Prevention (CDC) in support of national efforts to help prevent HIV and end the epidemic. This medication donation is among the largest ever in the United States. Gilead will provide up to 2.4 million bottles of Truvada annually for uninsured Americans at risk for HIV. The donation, which extends up to 2030, will transition to Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets), if it is approved for use as PrEP.
Approximately 200,000 of the estimated 1.1 million Americans who are at risk for HIV currently receive Truvada for PrEP.
Following five years of declines, the annual number of new HIV diagnoses has remained stable in the United States since 2013. During 2016 and 2017, half of new diagnoses concentrated in 48 “hotspot” counties as well as Washington, D.C., and Puerto Rico.
In the U.S., Truvada is indicated in combination with safer sex practices for HIV PrEP to reduce the risk of sexually acquired HIV in at-risk individuals who are HIV-negative and weigh at least 35 kg. Descovy is approved in combination with other antiretroviral agents for the treatment of HIV infection in patients weighing at least 25 kg and is not approved for PrEP anywhere globally.
Gilead submitted a supplemental New Drug Application (sNDA) for Descovy for PrEP to the U.S. Food and Drug Administration (FDA) on April 5, 2019. A Priority Review voucher was submitted with the filing, leading to an anticipated review time of six months.
Read the New York Times report