– New Clinical and Patient-Reported Outcomes in People with HIV on Biktarvy® in Observational BICSTaR Study Demonstrate Consistent Efficacy Profile in Real-World Setting –

– Long-Term Switch Data Further Establish the Robust and Durable Efficacy Profile of Biktarvy –

– Clinical Data Reinforces the Sustained Efficacy of Twice-Yearly Lenacapavir in People with Multi-Drug Resistant HIV –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the company’s upcoming new data from its HIV research and development programs to be presented at the 30th International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2022) in Glasgow, Scotland and virtually from October 23-26, 2022. Gilead will present data supporting its current and pipeline innovations in HIV treatment and the latest research from its ongoing cure development program, reflecting the company’s innovative approach to continuous scientific discovery.

“Continued scientific innovation and inclusive approaches are essential in the discovery and development of person-centred 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. “The data presented at HIV Glasgow reflect the latest progress in our research and development programs and underscore Gilead’s commitment to driving transformational innovation in HIV research. Our goal, together with the broader HIV community, is to end the HIV epidemic for everyone, everywhere. We look forward to connecting in person in Scotland at this year’s meeting and sharing these data with the scientific community as we work towards this important goal.”

Driving Transformational Innovation in HIV Research

Gilead will present new data on Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) evaluating the safety, efficacy and resistance profile of the once-daily single-tablet regimen in a broad range of people with HIV. The latest findings from the BICSTaR study, a global, observational, real-world study evaluating the effectiveness, safety, and tolerability of Biktarvy in treatment-naïve and treatment-experienced people with HIV with a high burden of co-morbidities, will be presented. As the average age of persons living with HIV increases, the evaluation and management of comorbid conditions that may occur in an individual’s life takes on a larger role in HIV clinical care. These latest findings may help inform the future of coordinated, person-centred HIV care and the role of Biktarvy in long-term treatment.

Gilead will also present long-term safety and efficacy data from two Phase 3 studies (Study 1489 and Study 1490) evaluating outcomes in adults with HIV who switched to treatment with Biktarvy following 144 weeks of initial treatment with a dolutegravir-based regimen. Following previous presentation of the primary endpoint findings at Week 48, at HIV Glasgow 2022 results of the open-label extension phase through a maximum of Week 240 will be presented. These data provide additional long-term evidence of the safety and efficacy of Biktarvy in those who switch from a DTG-containing regimen. Long-term clinical outcomes following a regimen switch are often lacking for modern antiretroviral therapy.

Additionally, Gilead will share new findings on long-acting HIV treatment strategies. Data will include a subgroup analysis from the ongoing Phase 3 CAPELLA trial evaluating lenacapavir, recently approved in the EU and UK and marketed as Sunlenca®, in people with HIV who are heavily-treatment experienced with poor outcome measures at baseline, including high HIV-1 RNA, low CD4+ T cell counts and resistance to some or all the active agents in their optimized background regimen.

Summary of Presentations

Accepted abstracts at HIV Glasgow 2022 include:

For more information about Gilead at HIV Glasgow 2022, including a complete list of abstracts, please visit: https://www.hivglasgow.org/scientific-programme-2022

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 is a first-in-class, long-acting HIV capsid inhibitor approved in the EU and UK for the treatment of HIV infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. Lenacapavir, alone or in combination, is not approved by any regulatory authority outside of the EU or the UK for any use. The European Marketing Authorization applies to all 27 member states of the European Union, as well as Norway, Iceland and Liechtenstein.

For important safety information for lenacapavir, including dosing and method of administration, special warnings, drug interactions and adverse drug reactions, please see the Summary of Product Characteristics (SmPC) for lenacapavir, available from the European Medicines Agency website at www.ema.europa.eu.

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)