U.S. Food and Drug Administration Approves Descovy® for HIV Pre-Exposure Prophylaxis (PrEP)

- Descovy Demonstrated Non-inferior Efficacy and an Improved Bone and Renal Safety Profile Compared with Truvada® in People at Risk for Sexually Acquired HIV Infection in a Global Phase 3 Trial -

FOSTER CITY, CA, USA I October 03, 2019 I Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved a pre-exposure prophylaxis (PrEP) indication for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF). Descovy for PrEP™ is indicated to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are HIV-negative and at-risk for sexually acquired HIV, excluding individuals at-risk from receptive vaginal sex.

“Descovy for PrEP provides a new HIV prevention option that matches Truvada’s high efficacy with statistically significant improvements in renal and bone safety, which can be an important consideration as people at risk increasingly use PrEP for longer periods of time,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “This is a reflection of Gilead’s continued commitment to addressing the evolving needs of people living with or at risk for HIV and to driving innovation across the HIV care continuum.”

The FDA approved the supplemental New Drug Application (sNDA) for Descovy under a priority review designation. Descovy has a Boxed Warning in its U.S. product label regarding the risk of post treatment acute exacerbation of hepatitis B. The Descovy label also includes a Boxed Warning regarding the risk of drug resistance with PrEP use in undiagnosed early HIV-1 infection. The effectiveness of Descovy for PrEP in individuals at risk of HIV-1 from receptive vaginal sex has not been established; please see below for Important Safety Information.

The approval of a PrEP indication for Descovy, taken once daily with or without food in patients weighing at least 35 kg, is based on data from the DISCOVER trial, a multi-year global Phase 3 registrational clinical trial that evaluated the safety and efficacy of Descovy for PrEP compared with that of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets; F/TDF) for PrEP® in reducing the risk of acquiring HIV-1 infection. Enrollment included more than 5,300 adult cisgender men who have sex with men or transgender women (TGW) who have sex with men.

The primary efficacy endpoint of DISCOVER was the incidence of documented HIV infection per 100 person-years after all participants had follow-up of at least 48 weeks and at least half had 96 weeks of follow-up. These data, which were presented in March at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI), included 5,387 individuals who were randomized 1:1 to receive either Descovy or Truvada. Among the 2,694 participants (4,370 person-years (PY)) who were at risk of HIV-1 infection and received once-daily Descovy, seven HIV-1 infections (HIV-1 incidence 0.16/100 PY) were reported. Among the 2,693 participants (4,386 PY) who were at risk of HIV-1 infection and received Truvada, 15 HIV infections (0.34/100 PY) were reported.

Results from the DISCOVER trial demonstrated that Descovy achieved non-inferiority to Truvada in study participants who were at risk of HIV acquisition. Efficacy was strongly correlated to adherence to daily dosing.

Additionally, statistically significant advantages were observed with respect to all six pre-specified secondary endpoints for both renal and bone laboratory parameters in patients receiving Descovy compared to Truvada.

“Today, because of landmark biomedical and scientific research advances, there are unprecedented opportunities to significantly reduce new HIV infections,” said Edwin DeJesus, MD, FACP, FIDSA, Medical Director, Orlando Immunology Center. “Descovy for PrEP offers healthcare providers and appropriate people at risk for HIV an additional biomedical prevention option with a demonstrated improvement in bone and renal safety parameters as compared to Truvada.”

Descovy does not prevent other sexually transmitted infections or cure HIV infection or AIDS.

Gilead Patient Assistance Program

Gilead is committed to helping ensure access to its HIV medications to all who need them. Driven by this purpose, we offer the Gilead Advancing Access® program to help address affordability challenges and to help continue to ensure that cost is not a barrier to individuals in the United States who need Gilead medication.

Gilead’s longstanding patient support offerings in the United States include the co-pay coupon program for eligible commercially insured individuals; the Medication Assistance Program (MAP), which provides free medication for those who qualify based on financial need; and the Uninsured 24/7 portal, which provides access to MAP enrollment and free medication that can be accessed from a pharmacy within hours. In addition, the Advancing Access program offers a range of options to assist patients with obtaining information about insurance coverage and investigating insurance benefits for their Gilead medication.

Information about Gilead’s support programs is available on the Gilead Advancing Access website at www.gileadadvancingaccess.com.

About PrEP

PrEP is an HIV prevention strategy in which medicine is taken daily before an HIV-negative person may be exposed to the virus through sex to help reduce the risk of infection. According to the Centers for Disease Control and Prevention (CDC), PrEP is highly effective at reducing the risk of HIV infection in at-risk populations.

Prevention methods, including PrEP, and safer sex practices are essential tools in the effort to end the HIV epidemic. PrEP use received an “A” rating from the U.S. Preventive Services Task Force (USPSTF), signifying that PrEP has a high certainty of substantial preventive benefits for reducing the risk of HIV. In addition, PrEP is recommended by the CDC, the World Health Organization and other national healthcare organizations as part of a comprehensive prevention strategy for individuals at risk for HIV.

IMPORTANT U.S. SAFETY INFORMATION AND INDICATION FOR DESCOVY FOR PREP

INDICATION

DESCOVY for HIV-1 pre-exposure prophylaxis (PrEP) is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. HIV-1-negative status must be confirmed immediately prior to initiation.

Limitation of Use: DESCOVY FOR PrEP is not indicated in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.

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.

For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it’s estimated that more than 12 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.

SOURCE: Gilead Sciences

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