– Latest HIV Treatment Research Reinforces Biktarvy Efficacy Data in a Broad Range of People with HIV and Highlights the Potential Impact of Twice-Yearly Lenacapavir on the Future of HIV Clinical Care –

– Data Reinforces Veklury’s Strong Safety Profile and Continued In Vitro Activity Against New Variants –

– Studies Evaluate Utility of Obeldesivir as a Potential Treatment for COVID-19 –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from its virology research and development programs that will be presented at IDWeek 2023, October 11-15 in Boston. These latest data demonstrate the company’s ongoing efforts to address the unmet medical needs of people and communities affected by HIV and COVID-19. Gilead will be presenting 16 abstracts, including real-world evidence, as the company continues to pursue the next wave of scientific discovery in virology.

“Gilead is committed to advancing transformational innovation in virology research and development that aims to help address unmet needs,” said Frank Duff, MD, Senior Vice President, Therapeutic Area Head Virology Clinical Development, Gilead Sciences. “At IDWeek 2023, we look forward to sharing our latest data with the broader community and discussing potential implications for the treatment of COVID-19 among some of the most vulnerable populations. In HIV we are pleased to share the latest data from long-term treatment studies, and new data that can help inform strategies to meet the needs of a range of people affected by HIV.”

HIV Research

At IDWeek 2023, the latest outcomes from Gilead’s HIV treatment and prevention programs will demonstrate how the company is working to advance transformational innovation in HIV research to meet the changing needs of people affected by HIV worldwide.

Research studies evaluating Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) for HIV treatment include long-term real-world efficacy and safety data from the ongoing observational BICSTaR study, which involves a diverse range of people with HIV. Additional results include two retrospective observational studies that investigate the efficacy and safety of Biktarvy in adults with HIV who have suboptimal adherence to daily oral antiretroviral therapy and in people living with the virus who have pre-existing drug resistance.

Gilead will also present outcomes from multiple studies evaluating lenacapavir, Gilead’s first-in-class, long-acting HIV-1 capsid inhibitor. This includes two-year results from CAPELLA, an ongoing Phase 2/3 registrational study designed to evaluate the antiviral activity and safety of twice-yearly lenacapavir administered as a subcutaneous injection in adults with multi-drug resistant HIV who are heavily treatment-experienced. Additionally, research will be presented on the evaluation of alternative subcutaneous administration sites for lenacapavir.

HIV prevention data include results from a study investigating the real-world impacts of pre-exposure prophylaxis (PrEP) access and dispensing status on likelihood of acquiring HIV, as well as a study on the increase in new HIV cases among people who could benefit from PrEP during the COVID-19 pandemic.

COVID-19 Research

At IDWeek 2023, Gilead will present data that reinforces the ongoing role Veklury® (remdesivir) plays as the antiviral standard of care for the treatment of hospitalized patients with COVID-19. One in vitro analysis will demonstrate the continued antiviral activity of Veklury against recent SARS-CoV-2 Omicron subvariants. Separate studies will examine the safety of Veklury across vulnerable populations including a study on the safety profile of Veklury and its impact on the liver across phase 3 placebo-controlled COVID-19 studies, as well as a study that included resistance analyses in patients with severely reduced kidney function who were hospitalized for COVID-19.

As part of the company’s ongoing commitment to COVID-19 and the unmet needs of patients, Gilead will present a study analyzing the potential for drug-drug interactions (DDIs) with the investigational oral antiviral obeldesivir, as well as an in vitro analysis examining obeldesivir’s antiviral activity against recent Omicron subvariants, including BF.7, BQ.1, XBB.1.5, CH.1.1, and XBF.

Summary of Presentations

Key abstracts will include:

For more information about Gilead at IDWeek 2023, including a complete list of abstracts and their corresponding oral and poster sessions, please visit https://idweek.org/program/.

The use of Biktarvy in patients with known drug resistance and obeldesivir for any use are investigational and have not been determined to be safe or efficacious and is not approved by the FDA.

Please see below for the U.S. Indication and Important Safety Information for Sunlenca® and Veklury. Please also see below for U.S. Indication and Important Safety Information, including Boxed Warning, for Biktarvy. There is currently no cure for HIV or AIDS.

About Biktarvy

Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines.

About Sunlenca

Sunlenca (300 mg tablet and 463.5 mg/1.5 mL injection) [(lenacapavir)] is a first-in-class, long-acting HIV capsid inhibitor approved in Australia, Canada, the European Union, Israel, Japan, Switzerland, the United Arab Emirates, the United Kingdom, and the United States for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV who are heavily treatment-experienced. Sunlenca is the only HIV treatment option administered twice-yearly. Sunlenca tablets are approved for oral loading during initiation of Sunlenca treatment, prior to or at the time of the first long-acting lenacapavir injection depending on initiation option. Sunlenca is a nominee from the USA for the Prix Galien Award in the “Best Pharmaceutical Product” category. The Galien Foundation is widely recognized as the leading global institution dedicated to honoring innovators in life sciences, and the Prix Galien Award is highly prestigious. The award will be selected by a distinguished panel of judges and announced during the Prix Galien USA Awards Ceremony on October 26, 2023.

The multi-stage mechanism of action of Sunlenca’s active pharmaceutical agent, lenacapavir, is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, Sunlenca is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes.

Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead's HIV prevention and treatment research program. Lenacapavir for HIV prevention is investigational, and its safety and efficacy for this use have not been established. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV.

About Gilead’s COVID-19 Development Program

Veklury (remdesivir) is a nucleotide analog prodrug invented and developed by Gilead, building on more than a decade of the company’s research on broad-spectrum antivirals for emerging viruses. Veklury is the antiviral standard of care for the treatment of hospitalized patients with COVID-19 and is also recommended for the treatment of non-hospitalized patients at high risk of disease progression. Veklury has an established safety profile and minimal known drug interactions in diverse populations. It plays an important role in enabling faster recovery and reducing disease progression across a spectrum of disease severity.

Veklury directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. Based on in vitro analyses, Veklury retains antiviral activity against recent Omicron subvariants of concern, including XBB, XBB.1.5 and CH.1.1. Veklury continues to be evaluated against emerging variants of interest and concern, including EG.5, EG.5.1 and BA.2.86.

Veklury is approved in more than 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to more than 13 million patients around the world, including more than 8 million people in middle- and low-income countries through Gilead’s voluntary licensing program.

With most people being treated for COVID-19 outside the hospital, Gilead is working to address the need for additional effective oral antiviral treatments that can be easily taken by the broadest range of patients. Obeldesivir is an investigational oral pill that is designed to stop the replication of the SARS-CoV-2 virus by inhibiting the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), a critical component that the virus uses to replicate.

Obeldesivir is a GS-441524 prodrug, which is currently being evaluated in Phase 3 trials as a single tablet, with twice daily dosing for 5 days.

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)