– Additional Phase 3 PURPOSE Data Reinforce the Safety Profile of Twice-Yearly Yeztugo® as an Effective HIV Prevention Option Across Diverse Populations –
– New Data Show Higher Treatment Satisfaction After Switching from IM CAB+RPV to Biktarvy® –
– New Research Reaffirms Veklury® in High-Risk COVID-19 Populations and Obeldesivir in Emerging Pathogens –
October 19, 2025--FOSTER CITY, Calif.--(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).
In a 12-week interim analysis of the Phase 4 EMPOWER study ( NCT06104306), individuals who switched from IM CAB+RPV to once-daily Biktarvy maintained viral suppression with no treatment-related serious adverse events and reported an increase in treatment satisfaction scores, citing higher satisfaction with side effects of their treatment.
Other treatment data include:
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Complementary findings from a large, multicountry HIV treatment survey (Canada, Mexico, U.S.) highlighted that while most people on antiretroviral therapy report satisfaction with durability, safety, and tolerability, a substantial proportion delay initiating or re-engaging in treatment due to fear of side effects, needing time to accept their diagnosis, or physician guidance.
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An analysis of IQVIA data revealed persistent geographic disparities in HIV specialist availability, with the U.S. requiring an additional 1,565 providers to meet UNAIDS’ 90-90-90 targets, particularly in the South where shortages are most acute. Achieving these targets – which call for 90% of people with HIV to be diagnosed, 90% of those diagnosed to receive treatment, and 90% of those treated to achieve viral suppression – will depend on addressing these gaps. These findings highlight the need for equitable access to care alongside therapeutic innovation.
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:
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New analyses of Veklury®(remdesivir) from the Phase 3 REDPINE ( NCT04745351) study, which investigated viral load dynamics in individuals hospitalized with COVID-19 who have severely impaired renal function or have undergone solid organ transplantation – two groups at elevated risk for prolonged infection.
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Complementary real-world evidence will further illuminate treatment patterns among older adults with compromised health and immunocompromised individuals hospitalized with COVID-19 in the U.S., highlighting persistent gaps in care and areas of unmet needs.
Overview of Scientific Presentations
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.
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.