15 May 2019 - - US-based biopharmaceutical company Gilead Sciences, Inc. (NASDAQ: GILD) will donate Truvada for PrEP (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets) to the US Centers for Disease Control and Prevention in support of national efforts to help prevent HIV and end the epidemic, the company said.

This medication donation is among the largest ever in the United States and is part of Gilead's broader ongoing initiatives to help ensure that everyone who can benefit from PrEP is able to access it.

Gilead will provide to CDC up to 2.4 m bottles of Truvadaannually 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 1.1m Americans who are at risk for HIV currently receive Truvada for PrEP.

Broader usage among at-risk populations 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 healthcare.

Gilead's donation will support a greatly accelerated effort to reach these individuals, as well as create an opportunity for state and local partnerships to develop and implement protocols that are intended to ensure uninsured people at risk for HIV are given access to PrEP at no cost.

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, DC, and Puerto Rico.

In the US, 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 ≥35 kg.

Descovy is approved in combination with other antiretroviral agents for the treatment of HIV infection in patients weighing ≥25 kg and is not approved for PrEP anywhere globally. The use of Descovy for an HIV PrEP indication is investigational and has not been determined to be safe or efficacious.

Gilead submitted a supplemental New Drug Application for Descovy for PrEP to the US Food and Drug Administration on April 5, 2019. A Priority Review voucher was submitted with the filing, leading to an anticipated review time of six months.

Descovy and Truvada each have a Boxed Warning in their respective product labels regarding the risk of post-treatment acute exacerbation of hepatitis B; the Truvada label also carries a Boxed Warning for the risk of drug resistance with PrEP in undiagnosed early HIV infection.

Beyond the donation, Gilead's commitment to combating the HIV/AIDS epidemic includes the COMPASS (COMmitment to Partnership in Addressing HIV/AIDS in Southern States) Initiative. COMPASS is a 10-year, USD100 m commitment to address the HIV/AIDS epidemic in the South through capacity building, mental health and trauma-informed care, and awareness and anti-stigma education.

Gilead has longstanding patient support programs in the US to help eligible individuals with financial need to access Truvada for PrEP.

For commercially insured, eligible individuals, Gilead provides copay coupon support, through which patients may pay as little as USD 0 per bottle for Truvada for PrEP.

Those without insurance may be able to access Truvada for PrEP free of charge through our longstanding Medication Assistance Program or, in the near future, through the new CDC-Gilead partnership.