Descovy is indicated in combination with other antiretrovirals (ARVs) in the treatment of HIV-1 infection in patients weighing at least 35 kg. Descovy is also indicated in combination with other antiretroviral drugs, with the exception of protease inhibitors requiring a CYP3A inhibitor, in the treatment of HIV-1 infection in pediatric patients weighing at least 25 kg and less than 35 kg. In the United States, Truvada, in combination with safer sexual practices, is indicated for PREP HIV to reduce the risk of sexually acquired HIV/AIDS in people at risk of HIV who weigh ≥35 kg. Descovy is licensed in combination with other antiretroviral drugs for the treatment of HIV infection in patients weighing ≥25 kg and is not allowed anywhere in the world for PrEP. The use of Descovy for an indication of PrEP HIV has been studied and has not been found to be safe or effective. Gilead has patient assistance programs in the United States to help people who need funding to access Truvada for PrEP. For those eligible for commercial insurance, Gilead offers copay coupon support, which allows patients to pay as little as $0 per bottle for Truvada for PrEP. People without insurance can use truvada for PrEP for free through our long-standing medical assistance program or, in the near future, through the new CDC-Gilead partnership. Those interested in learning more about the support programs available to them are encouraged to visit Gilead Advancing Access®`s website at www.gileadadvancingaccess.com. About 200,000 of the 1.1 million Americans at risk of HIV are currently receiving PrEP from Truvada. The wider use of the population is hampered by significant social and structural barriers such as HIV stigma, homophobia, limited awareness of PrEP among providers and patients and, overall, lack of access to health care. Gilead`s donation will support a very accelerated effort to reach these people and will enable government and local partnerships to develop and implement protocols to ensure that people exposed to HIV without insurance have free access to PrEP.
On April 5, 2019, Gilead submitted a new application of the drug (SNDA) for Descovy for PrEP to the U.S. Food and Drug Administration (FDA). The submission was accompanied by a priority review order that resulted in a planned six-month review period. . Truvada, Truvada for PrEP, Descovy, Descovy for PrEP, COMPASS Initiative, Advancing Access, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or their related companies. “We are proud to work with the CDC to significantly expand access to drugs that can help prevent new HIV infections,” said Gregg Alton, Patient Director of Gilead Sciences. “We believe that today`s donation, combined with efforts to address the causes of the epidemic, such as racism, violence against women, stigma, homophobia and transphobia, can play an important role in ending the HIV epidemic in the United States, especially in areas with the highest disease.” This press release contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risk that the FDA and other regulators may not be able to authorize Descovy for PrEP on schedule, and all marketing authorizations , if granted, may be subject to significant restrictions on its use.