Gilead Sciences Presents New Antiviral Data at IDWeek 2025

Atlanta, GA — October 19, 2025 — Leads & Copy — Gilead Sciences, Inc. (Nasdaq: GILD) is presenting 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.

Jared Baeten, MD, PhD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences, said that at IDWeek 2025, the company looks forward to presenting new data that reflect its 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. He added that these studies highlight the strength and depth of Gilead’s antiviral portfolio and expanding pipeline, and its 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.

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.

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.

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.

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.

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). 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.

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.

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.

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.

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.

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.

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.

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.

Source: Gilead Sciences

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