– Latest HIV Clinical Research and Development Data Drive the Next Wave of Innovation in Treatment, Prevention and Reaches Towards a Cure –

– Key Initiatives Highlight Role of Catalytic Collaboration to Help End the Epidemic for Everyone, Everywhere –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced its upcoming contributions to the 24th International AIDS Conference (AIDS 2022). AIDS 2022 will be a hybrid conference, taking place in person in Montreal, Canada, as well as virtually, from July 29-August 2, 2022. As the leader in HIV innovation, the company will provide an update on its signature initiatives, key collaborations and share new scientific data from its HIV research and development programs as part of its ongoing commitment to help end the HIV epidemic for everyone, everywhere.

“Continued scientific innovation and inclusive approaches are essential in the discovery and development of person-centered options that address the evolving needs of a broad range of individuals and communities affected by HIV,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “Our scientific advancements are grounded in collaboration with community and research partners around the world. AIDS 2022 will highlight how our expertise and dedication are helping us drive the next generation of innovation in HIV treatment and prevention and reach towards cure.”

“At Gilead we recognize that scientific innovation alone will not end the epidemic, so we are committed to advancing equity, and optimizing health outcomes in partnership with the global HIV community,” said Alex Kalomparis, Senior Vice President, Public Affairs, Gilead Sciences. “The convergence of the COVID-19 pandemic and HIV epidemic has further highlighted how inequities result in adverse health outcomes. Through innovative programs like the COMPASS Initiative®, RADIAN®, and Zeroing In™, Gilead seeks to address the evolving needs of the communities most impacted by HIV. As part of our enduring commitment to helping end the HIV epidemic, we look forward to sharing the latest from these and other key programs at AIDS 2022.”

Advancing Efforts to Address Barriers to HIV Care

At AIDS 2022, Gilead will convene a diverse, global panel – “Working Together to End the Epidemic: Guided by the Voices on the Ground” – to discuss community perspectives and Gilead’s ongoing efforts to change the future of the HIV epidemic through catalytic collaboration. The panel will discuss different challenges in delivering HIV care around the world, and programs that support practical solutions with sustainable impact toward better care for people with HIV or people who could benefit from PrEP medicines. The panel will convene on Aug. 1 at 8:00-9:00 a.m. ET.

Driving Transformational Innovation in HIV Research

Gilead is driving scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead's long-standing research leadership and community engagement, built over decades of collaborative research and development, enable the company to help advance preclinical and clinical programs with the goal of achieving a functional cure for HIV. During AIDS 2022, Gilead will share new findings on HIV treatment and prevention strategies, as well as the latest updates from the company’s continued pursuit of an HIV cure. Updates will be shared on efforts to ensure HIV clinical trials are inclusive, representative and meaningful through expanding the participation of communities most affected. Presentations from Gilead’s HIV research and development programs will include:

• Five-year cumulative outcomes from two Phase 3 trials (Study 1489 and Study 1490), evaluating Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in treatment-naïve people living with HIV, reinforcing Biktarvy’s high barrier to resistance, durability, efficacy, and safety in people with HIV who initiated treatment with the single-tablet regimen.
• First data from the ALLIANCE trial, a first-of-its-kind study evaluating the efficacy of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) versus dolutegravir (50 mg, DTG) + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, F/TDF, DTG+F/TDF, in adults with HIV-1/HBV co-infection who are initiating treatment.
• Multiple studies evaluating the antiviral activity of investigational lenacapavir, Gilead’s potential first-in-class, long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection. Specifically, the studies evaluate resistance data from the CAPELLA trial in heavily treatment-experienced people with HIV, and the CALIBRATE trial in people with HIV initiating treatment for the first time, as well as the pharmacokinetics and potential dosing schedules of lenacapavir.
• Results evaluating innovative testing methods and real-world utilization of PrEP medicines, emphasizing the company’s progress in research that can help shape the future of HIV prevention options.
• Early data identifying potential biomarkers associated with time-to-HIV-rebound (TTHR) post-antiretroviral therapy (ART) interruption following treatment with Gilead’s investigational TLR-7 agonist, vesatolimod. In a pre-clinical study, researchers tested a novel vaccine combination that showed promise in eliciting a strong anti-HIV immune response, specifically in the cell types seen in HIV-infected elite controllers. This early data suggests that this treatment regimen may have the potential to become part of a combination therapeutic approach for an HIV cure.

Summary of Presentations

Accepted abstracts at the 24th International AIDS Conference include:

For more information about Gilead at AIDS 2022, including a complete list of abstracts, please visit: https://aids2022.org. To learn more about Gilead’s unique collaborations around the world and the work to help end the epidemic for everyone, everywhere, visit: https://www.gileadhivtogether.com.

Please see below for U.S. Indications and Important Safety Information, including Boxed Warnings, for Biktarvy®.

The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational, and the safety and efficacy of Biktarvy for this use have not been established.

Lenacapavir and vesatolimod are investigational compounds and are not approved anywhere globally. Their safety and efficacy have not been established.

There is currently no cure for HIV or AIDS.

U.S. Indication for Biktarvy

Biktarvy is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

U.S. Important Safety Information for Biktarvy

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

• Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY.Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted.

Contraindications

• Coadministration: Do not use BIKTARVY with dofetilide or rifampin.

Warnings and precautions

• Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions.
• Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
• New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl)