FOSTER CITY, Calif. / Oct 19, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) will present new findings from its antiviral research and development programs at IDWeek, taking place October 19-22 in Atlanta, GA. Data from 34 presentations across HIV, respiratory viruses, viral hepatitis, and viruses of pandemic potential including six oral presentations underscore Gilead’s leadership in advancing antiviral science and its ongoing efforts to bring forward innovative solutions for people and communities most affected by infectious diseases.
“At IDWeek 2025, we look forward to presenting new data that reflect our ongoing commitment to developing transformational medicines for hepatitis, as well as HIV prevention and treatment, and to expanding that goal to respiratory and other viruses causing serious disease,” said Jared Baeten, MD, PhD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “These studies highlight the strength and depth of our antiviral portfolio and expanding pipeline, and our focus on person-centered innovation to help address the diverse and evolving needs of people and communities affected by serious viral diseases in the U.S. and around the world.”
HIV Prevention Research
New pivotal PURPOSE 1 (NCT04994509) and PURPOSE 2 (NCT04925752) data provided further insight into the safety of twice-yearly Yeztugo® (lenacapavir – or LEN) for pre-exposure prophylaxis (PrEP). Sub-analyses among PURPOSE 1 trial participants using progestin-type long-acting (LA) hormonal contraceptives (implants or injections) and PURPOSE 2 trial participants using gender-affirming hormone therapy (GAHT) showed no clinically significant drug-drug interactions between Yeztugo and these commonly-used products.
Findings from PURPOSE 2 also assessed Yeztugo adherence and safety among individuals who reported using stimulants and opioids. These data – from the most gender-diverse HIV prevention trial to date – underscore Yeztugo’s potential as an inclusive PrEP option for populations disproportionately affected by substance use, which can influence adherence.
HIV Treatment Research
As part of Gilead’s ongoing mission to help end the HIV epidemic through innovation, partnership, and equitable access, new data presented at IDWeek underscore the company’s deep commitment to delivering person-centered solutions that meet the evolving needs of people living with HIV. These include new findings that further reinforce the strong clinical profile of Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide, B/F/TAF) as a leading standard of care for people with HIV, with data showing greater patient preference for Biktarvy over intramuscular cabotegravir + rilpivirine (IM CAB+RPV).
Other treatment data include:
Respiratory Viruses / COVID-19 Research
Gilead will present a comprehensive set of data across respiratory viruses, emphasizing the needs of populations most vulnerable to SARS-CoV-2 and respiratory syncytial virus (RSV). Key findings include:
Overview of Scientific Presentations
HIV Prevention Research | |
Presentation 392 | Favorable Adherence and Safety of Twice-Yearly Subcutaneous Lenacapavir for PrEP Among PURPOSE 2 Participants Who Used Substances |
Presentation 390 | Lenacapavir Adherence and Effectiveness Over 2 Years of Use in the OPERA Cohort |
P-299 | No Clinically Significant Drug-Drug Interactions Between Lenacapavir and Hormonal Contraceptives in PURPOSE 1 |
P-305 | No Clinically Significant Drug-Drug Interactions with Co-administration of Feminizing or Masculinizing Hormone Therapy and Twice-yearly Lenacapavir PrEP in Gender-Diverse Persons |
P-382 | PrEP Utilization Patterns and Indications in a Cohort of HIV-Negative Individuals |
P-326 | Barriers to Oral HIV Pre-Exposure Prophylaxis (PrEP) Perceived by Those Receiving an Initial Prescription: US Survey Analysis |
P-287 | Real-World Sexually Transmitted Infection (STI) Testing Patterns Among Individuals Using PrEP for HIV-1 Prevention in the United States |
HIV Treatment Research | |
P-357 | Geographic Variations of HIV Specialist Shortages: An Observational Study to Support the 90-90-90 HIV Treatment Goals in the US |
P-382 | Characteristics and Outcomes of People with HIV (PWH) with Suboptimal Adherence on B/F/TAF or Dolutegravir Single-Tablet Regimens (STRs) |
P-386 | A Phase 4 Study to Evaluate the Safety and Efficacy of Oral B/F/TAF After Discontinuing Injectable CAB + RPV |
P-387 | Evaluation of Treatment Satisfaction and Experiences Among People With HIV When Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide From Cabotegravir + Rilpivirine: Results From the Phase 4 EMPOWER Study |
P-390 | Persistence and Adherence of PWH and Mental Health Disorder Diagnosis who Restart Antiretroviral Therapy (ART) |
P-391 | Impact of Rapid Antiretroviral Therapy Initiation on Retention in Care and Viral Suppression in an urban HIV clinic in Louisville, Kentucky |
P-393 | Treatment Switch among Medicare-insured People with HIV and Gaps in Care |
P-394 | Antiretroviral Therapy Persistence Following a Change or Restart in Regimen Among People with HIV |
P-2034 | Evaluation of Implementing Text-Messaging Based Medication Reminders to Improve Adherence to Antiretrovirals in People Living with HIV |
P-2043 | Improving Access and Adherence to Antiretroviral Therapy Through Coordinated Outreach and Care Linkage Model: A Collaborative Program Evaluation |
P-2071 | Reaching the Hard-to-Reach ACCELERATE Model of HIV Care: Telehealth, Rapid Restart, Follow-up |
P-2084 | HIV Viewpoints: Survey on the Experiences of People Living with HIV in North America |
Respiratory, Hepatitis, and Pandemic Viruses | |
P-1276 | Remdesivir And Obeldesivir Retain Potent Activity Against SARS-CoV-2 Omicron Variants |
P-1625 | SARS-CoV-2 Viral Load Dynamics in Participants With Solid Organ Transplantation and Severely Reduced Kidney Function From the Remdesivir Phase 3 REDPINE Study Who Were Hospitalized for COVID-19 |
P-1632 | Effectiveness of Remdesivir in Patients With Underlying Hepatic or Renal Comorbidity Hospitalized For SARS-CoV-2 Infection |
P-661 | Treatment Patterns Observed Among Immunocompromised and Frail Hospitalized COVID-19 Patients in the US |
P-1232 | Dose Selection of Obeldesivir for Clinical Evaluation in Treatment of Adult Participants with Respiratory Syncytial Virus Infection |
P-1231 | A Phase 1 Open-label, Parallel-group, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Obeldesivir in Participants with Normal Renal Function and Renal Impairment |
P-1169 | Obeldesivir and GS-441524 Antiviral Activity against L Protein Mutants in Respiratory Syncytial Virus (RSV) Minigenome and Recombinant Infectious Virus Systems |
P-686 | Evolving Patterns Of Testing For Respiratory Syncytial Virus In The United States: Who Is Getting Tested?
|
P-1166 | Obeldesivir Clinical Dose Projection for Marburg Virus Disease Post-Exposure Prophylaxis |
P-2195 | Influence of Nucleos(t)ide Analogue Use With Bulevirtide on Treatment Outcomes in Chronic Hepatitis Delta |
For more information about Gilead’s presence at IDWeek 2025, including a complete list of abstracts and their corresponding oral and poster sessions, please visit https://idweek.org/program/.
Lenacapavir for HIV prevention is not approved by any regulatory authority outside of U.S. or EU.
Please see below for U.S. Indication and Important Safety Information, including Boxed Warning, for Biktarvy and Yeztugo. Please also see below for the U.S. Indication and Important Safety Information for Veklury.
There is currently no cure for HIV or AIDS.
The use of obeldesivir is investigational and has not been determined to be safe or efficacious and is not approved by the FDA.
Bulevirtide 2 mg remains the only approved treatment for adults with chronic HDV and compensated liver disease in the European Economic Area (EEA), the UK, Canada, Australia and is not approved in the U.S. Bulevirtide 10 mg is an investigational product and is not approved anywhere.
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 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 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 3-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.
About Veklury
Veklury (remdesivir) is a nucleotide analog prodrug invented by Gilead, building on more than a decade of the company’s antiviral research. Veklury is the antiviral standard of care for the treatment of hospitalized patients with COVID-19 and is a recommended treatment for reducing disease progression in non-hospitalized patients at high risk of disease progression. Veklury is the only antiviral studied in hospitalized COVID-19 patients in clinical trials and large real-world analyses that has demonstrated reduced time to recovery, as well as disease progression, mortality and readmission.
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 XBF, XBB.1.16, FL.22, E.G.5.1 and BA.2.86. Veklury continues to be evaluated against emerging variants of interest and concern.
Veklury is approved in more than 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to approximately 14.5 million patients around the world, including more than 8.1 million people in middle- and low-income countries through Gilead’s voluntary licensing program.
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 ( ≥ 35kg) 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
U.S. Indication for Veklury
Veklury (remdesivir 100 mg for injection) is indicated for the treatment of COVID-19 in adults and pediatric patients (weighing ≥1.5 kg) who are:
For more information, please see the U.S. full Prescribing Information available at www.gilead.com.
U.S. Important Safety Information for Veklury
Contraindication
Veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to Veklury or any of its components.
Warnings and precautions
Adverse reactions
Drug interactions
Dosage and administration
Pregnancy and lactation
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. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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 within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Biktarvy, Veklury, Yeztugo (lenacapavir), bulevirtide, obeldesivir (such as the EMPOWER, PURPOSE 1, PURPOSE 2 and REDPINE trials); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for 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 programs for indications currently under evaluation and, as a result, such programs may never be successfully commercialized for such indications; 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, 2025, 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.
Biktarvy, Yeztugo, Veklury, 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 Biktarvy, including BOXED WARNING, U.S. full Prescribing Information for Yeztugo, including BOXED WARNING, and U.S. full Prescribing Information for Veklury, available at www.gilead.com.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
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