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Gilead Sciences to Provide Free Truvada for PrEP® to Support U.S. Initiative to End the HIV Epidemic

FOSTER CITY, Calif.--(BUSINESS WIRE)--May 9, 2019-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it will 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 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 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. 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.

“We are proud to partner with CDC to dramatically expand access to medication that can help prevent new HIV infections,” said Gregg Alton, Chief Patient Officer, Gilead Sciences. “We believe today’s donation, combined with efforts to address the root 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, particularly in parts of the country with the highest burden of disease.”

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 ≥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 (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.

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. See below for Important Safety Information and complete Indications.

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, $100 million 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 U.S. 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 $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. Individuals who would like to learn more about support programs that may be available to them are encouraged to visit the Gilead Advancing Access® website at www.gileadadvancingaccess.com.

In addition, many government healthcare programs receive significant discounts on Gilead medicines. For HIV, for example, state Medicaid programs receive discounts on the company’s products. Gilead established a price freeze for all of the company’s HIV medications for state AIDS Drug Assistance Programs (ADAPs) in 2008, which remains in effect through 2019. ADAPs also receive supplemental discounts.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statement

This press release includes 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 FDA and other regulatory agencies may not approve Descovy for PrEP in the currently anticipated timelines or at all, and any marketing approvals, if granted, may have significant limitations on its use. As a result, Descovy for PrEP may never be successfully commercialized. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Source: Gilead Sciences, Inc.

Posted: May 2019

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