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Gilead to Present New Data Across HIV and Emerging Antiviral Research at IDWeek 2026

October 19, 2026 8:00 AM

– Analyses of Bixlenvo™ (bictegravir 75 mg/lenacapavir 50 mg) Examine Outcomes in People with HIV and Selected Comorbidities or Renal Impairment –

– Real-World Evidence Provides Insight into Early U.S. Adoption of Yeztugo® (lenacapavir) for HIV PrEP –

– Phase 1b Data Highlight Virologic Efficacy, Safety and Tolerability of Investigational GS-1179 for Recurrent Genital Herpes –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) will present new findings from its HIV and antiviral research and development programs at IDWeek 2026, taking place October 21-24 in Washington, D.C. The 28 presentations, including two oral presentations, will feature research in HIV treatment, HIV prevention and new insights into broader experiences of people living with HIV, as well as emerging antiviral programs.

“We remain committed to advancing options for people affected by HIV and other serious diseases, as evidenced by the breadth of our research and antiviral pipeline,” said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences. “These findings span clinical research and real-world evidence, deepening our understanding of evolving needs and informing innovations that have the potential to make a meaningful difference for the communities we serve.”

HIV Treatment Research

New analyses from the Phase 3 ARTISTRY-1 and ARTISTRY-2 Studies will provide further insights into the safety and efficacy of Bixlenvo™ (bictegravir 75 mg/lenacapavir 50 mg), the smallest once-daily, single tablet regimen (STR) for the treatment of HIV in adults who are virologically suppressed, including those on complex regimens. New ARTISTRY-1 sub-analyses will provide insights into treatment outcomes among trial participants with comorbidities like dyslipidemia, hypertension, diabetes mellitus and renal impairment, building on data from the oldest study population in a Phase3 registrational trial for HIV-1 treatment to date. Findings from ARTISTRY-2 will examine metabolic and safety outcomes among people with HIV with selected baseline comorbidities.

Additional treatment research will examine virologic effectiveness, resistance and strategies for restarting antiretroviral therapy following interruptions in care, including studies in historically under-resourced communities and analyses of treatment patterns in real-world settings.

Data from the Phase 4 ACCELERATE Implementation Study will be presented on Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide, B/F/TAF), examining rapid antiretroviral therapy (ART) restart for people with HIV returning to care.

HIV Prevention Research

Gilead will present research examining early real-world adoption of twice-yearly Yeztugo® (lenacapavir) for HIV pre-exposure prophylaxis (PrEP) in the United States during the first nine months following approval by the U.S. Food and Drug Administration (FDA). Yeztugo is the only FDA-approved twice-yearly option for people who need or want PrEP.

Additional studies will examine factors that influence PrEP access, uptake and implementation, including provider education, linkage to prevention services, cost sharing and the potential economic and public health impact of expanded HIV prevention.

Herpes Simplex Virus (HSV) Research

Gilead will also present final results from a Phase 1b Study of Investigational GS-1179, an oral, long-acting herpes simplex virus (HSV) helicase-primase inhibitor being developed for suppression of recurrent genital herpes. The presentations will highlight findings on virologic efficacy, safety and tolerability.

Overview of Scientific Presentations

HIV Treatment Research

P - 24

Poster

Safety Analysis of BIC/LEN Single Tablet Regimen in People with HIV Who Have Comorbidities of Dyslipidemia, Hypertension, and Diabetes Mellitus from Phase 3 of ARTISTRY-1

P - 1045

Poster

Efficacy and Safety Outcomes with BIC/LEN Single Tablet Regimen in People with HIV and Renal Impairment in Phase 3 of ARTISTRY-1

P - 23

Poster

Metabolic and Safety Outcomes with BIC/LEN Single Tablet Regimen in People with HIV and Comorbidities in ARTISTRY-2

P - 1019

Poster

Pharmacokinetic and Clinical Data Supporting the Lenacapavir (LEN) Reloading Strategy for Bictegravir/Lenacapavir (BIC/LEN) Single Tablet Regimen Dosing in the ARTISTRY Studies

Oral

ACCELERATE – A Multi-Site, Effectiveness-Implementation Study to Evaluate Rapid ART Restart for People with HIV Who Are Out of Care

P - 1012

Poster

Association Between Treatment Persistence and Healthcare Resource Utilization and Costs Among People with HIV Receiving Oral Antiretroviral Therapy

P - 1049

Poster

Community HERO Treatment Survey: Characterizing Treatment Journey for Older Persons with HIV

P - 1041

Poster

Examining Pitavastatin’s Effect on Pain Severity in People with HIV Within the REPRIEVE Cohort

HIV Prevention Research

Oral

Early Real-World Adoption Patterns of Long-Acting Lenacapavir for HIV PrEP in the United States (June 2025-March 2026)

P - 1114

Poster

Baseline Characteristics and Substance Use Among People Who Inject Drugs (PWID) with Evidence of Active Use in HPTN 103/PURPOSE 4: A Phase 2 Study of Twice-Yearly Subcutaneous (SC) Lenacapavir (LEN) for Pre-Exposure Prophylaxis (PrEP)

P - 975

Poster

High Incidence of Sexually Transmitted Infections and Sexual Behaviors Associated with HIV Acquisition Among Cisgender Men and Gender Diverse Individuals in PURPOSE 2

P - 955

Poster

Evaluating the National- and State-Level Economic and Public Health Effect of Introduction of a Twice-Yearly Injectable PrEP Coupled with Minimal Overall PrEP Expansion in the General US Population and MSM

P - 1071

Poster

Low Incidence of Hepatitis B (HBV) Infection Among People Receiving Lenacapavir (LEN) or Tenofovir-Based HIV Pre-Exposure Prophylaxis (PrEP) in PURPOSE 1 and PURPOSE 2

P - 782

Poster

Descriptive Evaluation of a Medical Affairs-Led Educational Resource to Support Healthcare Providers in the Implementation of Lenacapavir for HIV PrEP

P - 974

Poster & Rapid Fire

Changes in Pre-Exposure Prophylaxis (PrEP) Cost Sharing and HIV Diagnoses Following United States Preventive Services Task Force (USPSTF) and Affordable Care Act (ACA) Coverage Milestones: An Interrupted Time Series Analysis

P - 908

Poster & Rapid Fire

Routine HIV Screening to Prevention Services: Diversifying Linkage to HIV Prevention Services Across 98 Emergency Departments, Community Health Centers, and High Impact Settings

P - 950

Poster

Pre-Exposure Prophylaxis (PrEP) Uptake and Care in Locations of High Incidence for Black Cisgender Women (CGW) in the US, 2024

P - 935

Poster

Unlocking PrEP: Knowledge, Attitudes and Linkage to PrEP for Criminal-Legal Involved Individuals

HSV Research

P - 2052

Poster & Rapid Fire

Efficacy and Virologic Analyses of GS-1179, a Novel, Oral, Long-Acting HSV Helicase-Primase Inhibitor for Recurrent Genital Herpes: Results from a Phase 1b Study

P - 2059

Poster

Safety and Tolerability of ABI-1179, a Novel, Oral, Long-Acting HSV Helicase-Primase Inhibitor for Recurrent Genital Herpes: Interim Results from a Phase 1b Study

For more information about Gilead’s presence at IDWeek 2026, including a complete list of abstracts and their corresponding oral and poster sessions, please visit https://idweek.org/program/.

Bictegravir and lenacapavir in combination for HIV treatment is approved in the U.S. but is not approved by any regulatory authority outside of the U.S. Bixlenvo requires a two-day initiation dose with Sunlenca® (lenacapavir), thereafter only Bixlenvo is taken orally once a day.

Bictegravir, emtricitabine, and tenofovir alafenamide in combination for HIV treatment is approved in the U.S., the EU, Canada, Australia, Japan, China, the UK, New Zealand and India.

Lenacapavir for HIV prevention as PrEP is approved in the U.S., the EU, Canada, Brazil, South Africa, Australia, Zambia and Zimbabwe.

Please see below for U.S. Indication and Important Safety Information, including Boxed Warning for Yeztugo and Biktarvy. Please also see below for the U.S. Indication and Important Safety Information for Bixlenvo.

There is currently no cure for HIV or AIDS.

About Bixlenvo

Bixlenvo is a once-daily, single tablet regimen that combines bictegravir, a global guideline-recommended integrase strand transfer inhibitor (INSTI) with a high barrier to resistance, and lenacapavir, a first-in-class capsid inhibitor with a multi-stage mechanism of action. Together, bictegravir and lenacapavir target multiple stages of the HIV life cycle. Developed for adults with HIV who are virologically suppressed, including those on complex regimens, Bixlenvo expands treatment choice with a simple daily oral option supported by results from the Phase 3 ARTISTRY clinical program. For more information, visit www.Bixlenvo.com.

About Lenacapavir

Lenacapavir is approved in multiple countries as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents who are at risk of HIV acquisition. Lenacapavir is also approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals.

The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its life cycle 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 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. The journal Science named lenacapavir its 2024 “Breakthrough of the Year.”

About Biktarvy

Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest three-drug, integrase strand transfer inhibitor (INSTI)-based 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 F/TAF backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines. For more information, visit www.Biktarvy.com.

About GS-1179

GS-1179, formerly ABI-1179, is an investigational helicase-primase inhibitor being developed for HSV infections. It was advanced through early clinical stage development under Assembly Bio’s collaboration with Gilead. HSV helicase-primase inhibitors target an enzyme complex essential for viral replication and represent a mechanism distinct from currently available nucleoside analog therapies. GS-1179 was selected for advancement by Gilead in the HSV HPI program based on encouraging Phase 1b results and its potential to support once-weekly oral dosing.

U.S. Indication for Bixlenvo

Bixlenvo is indicated as a complete regimen for the treatment of HIV-1 infection in adults 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 known or suspected resistance to the individual components of Bixlenvo.

U.S. Important Safety Information for Bixlenvo

Contraindications

Warnings and precautions

Adverse reactions

Drug interactions

Dosage and administration

Pregnancy and lactation

U.S. Indication for Yeztugo

Yeztugo (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo.

U.S. Important Safety Information for Yeztugo

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION

Contraindications

Warnings and precautions

Adverse reactions

Drug interactions

Dosage and administration

U.S. Indication for Biktarvy

Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing ≥14 kg with no antiretroviral treatment history; or with an ARV treatment history and not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir; or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir.

U.S. Important Safety Information for Biktarvy

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Contraindications

Warnings and precautions

Adverse reactions

Drug interactions

Dosage and administration

Pregnancy and lactation

About Gilead HIV

For almost 40 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 14 HIV medications, including the first single tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV prevention medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people.

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic worldwide. Gilead has been repeatedly recognized as one of the top two leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS.

Discover more about Gilead’s unique collaborations worldwide and the work to help end the HIV epidemic at www.GileadHIV.com.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.

Forward-Looking Statements

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 Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving bictegravir, lenacapavir and GS-1179 (such as ARTISTRY-1, ARTISTRY-2 and ACCELERATE); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently under evaluation, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

IDWeek 2026™ is an annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA) and the Pediatric Infectious Diseases Society (PIDS). IDWeek features the latest science and bench-to-bedside approaches in prevention, diagnosis, treatment and epidemiology of infectious diseases, including HIV, across the lifespan. IDWeek 2026™ takes place Oct. 21-24 at the Walter E. Washington Convention Center (801 Allen Y. Lew Place NW) in Washington, D.C. For more information, visit www.idweek.org.

Bixlenvo™, Yeztugo®, Biktarvy®, Gilead, and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks are the property of their respective owner(s).

Please see U.S. full Prescribing Information for Yeztugo, including BOXED WARNING, U.S. full Prescribing Information for Bixlenvo, and U.S. full Prescribing Information for Biktarvy, including BOXED WARNING, available at www.gilead.com.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X (@Gilead_Sciences) and LinkedIn, or contact Gilead Public Affairs.

Priscilla White, Media

[email protected]

Jacquie Ross, Investors

[email protected]

Source: Gilead Sciences, Inc.

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