FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov 2, 2026--Gilead Sciences, Inc. (Nasdaq: GILD) today announced its upcoming participation in the International Congress on Drug Therapy in HIV Infection ( HIV …
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FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov 2, 2026--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced its upcoming participation in the International Congress on Drug Therapy in HIV Infection ( HIV Glasgow 2026 ), taking place from November 8-11. As a leader in HIV innovation, Gilead will share new clinical data and real-world evidence from its HIV research and development programs and provide updates on its strategic initiatives and key collaborations. Results from more than 50 studies, including late-breaking data and two oral presentations, along with Gilead-led symposia and community forums, reflect the company’s person-centered approach to advancing scientific discovery and the importance of partnership to help end the HIV epidemic.
Key Highlights
“We look forward to presenting new research from our broad and innovative HIV portfolio and pipeline as we strive to help end the epidemic through continuous scientific discovery,” said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences. “Our contributions to HIV Glasgow 2026 demonstrate that people are at the center of all we do at Gilead. The breadth and depth of Gilead’s work underscore our commitment to driving the next wave of transformational innovation in HIV research.”
Continuous scientific discovery in HIV prevention, treatment and cure research is a pillar of Gilead’s commitment to help end the epidemic.
Gilead’s program highlights during HIV Glasgow include:
HIV Prevention Research
Researchers will present one-year persistence results from the PURPOSE 5 ( NCT06513312 ) clinical trial evaluating the use of twice-yearly injectable lenacapavir (Yeytuo) compared to daily oral Truvada ® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; [F/TDF]) among people in the United Kingdom and France who need or want PrEP but who have not previously engaged with existing HIV prevention options. The results will explore continued persistence to, and adverse events experienced, with both options, offering learnings for public health strategies to support persistence and long-term effectiveness of PrEP in Europe.
HIV Treatment Research
Study results and analyses presented will include further evaluation of Biktarvy as a long-term treatment option for a broad range of people with HIV, including those who may also have common comorbidities and other specific health needs. Additional HIV treatment research includes new analyses from the Phase 3 ARTISTRY studies evaluating the oral daily combination regimen of BIC/LEN. In August 2026, BIC/LEN gained U.S. FDA approval under the trade name Bixlenvo ™. Outcomes from pipeline research studies will provide insights into investigational treatment candidates, including the oral weekly combination regimen of ISL/LEN. Phase 3 data from the ISLEND trials, including patient-reported outcomes, will be presented.
Specifically, Biktarvy presentations will include outcomes from BICSTaR, ( NCT03580668 ) an ongoing global, observational, real-world study evaluating the effectiveness, safety, and tolerability of Biktarvy in treatment-naïve and treatment-experienced people with HIV who have a high burden of co-morbidities. As the average age of people with HIV increases, the management of comorbid conditions is an important consideration in HIV clinical care. BICSTaR helps to inform what the future of coordinated person-centered HIV care could look like.
Gilead will also present outcomes from the Phase 3 ARTISTRY-2 study ( NCT06333808 ) assessing the treatment response of people with HIV who are virologically suppressed with preexisting resistance-associated mutations switching to the once-daily single tablet regimen combination of BIC/LEN. Additional results from the ARTISTRY trial program will include pooled data characterizing viremic events experienced by participants post-treatment with BIC/LEN or their baseline antiretroviral therapy.
HIV treatment pipeline research includes outcomes from the Phase 3 ISLEND trials evaluating the investigational once-weekly oral single-tablet regimen of ISL/LEN. The combination pairs Merck's islatravir, a next-generation nucleoside analog with multiple mechanisms of action including HIV-1 reverse transcriptase translocation inhibition, with Gilead's lenacapavir, a first-in-class capsid inhibitor that disrupts HIV-1 at multiple stages of its lifecycle. Data will explore efficacy and safety findings across diverse demographic and clinical populations enrolled in the Phase 3 ISLEND-1 ( NCT06630286 ) and ISLEND-2 ( NCT06630299 ) trials. Additionally, an analysis of participants in the ISLEND-2 trial who switched to ISL/LEN will detail treatment preferences and patient-reported outcomes to better understand the acceptability of changing to a once-weekly dosing schedule.
Additional long-acting HIV treatment pipeline data presented at HIV Glasgow 2026 include a presentation of Phase 1b results from a study of GS-3242, an investigational integrase inhibitor being studied as a component of a potential twice-yearly injectable HIV treatment. GS-3242 in combination with lenacapavir is being evaluated in two phase 2 studies: PULSAR 1 ( NCT07645287 ) and PULSAR 2 ( NCT07708727 ). In October 2026, GS-3242 was granted an FDA fast-track designation, which is intended to expedite the development of new drugs with the potential to address an unmet medical need.
HIV Cure Research
Gilead will present an update from its HIV cure research program, exploring the immunogenicity and associated safety of amtabafusp alfa (GS-8588), a bispecific T-cell engager, in a Phase 1b study in people with HIV.
Gilead Symposia and Community Programing at HIV Glasgow 2026
In addition to its scientific presentations, Gilead will host two symposia during HIV Glasgow: The prevention paradox: What will it take to change trajectory? and Ageing Well with HIV: Supporting evolving needs. The sessions will bring together healthcare professionals, researchers and people affected by HIV to discuss clinical progress, the importance of effective person-centered care strategies, and the value of shared decision-making to address diverse needs throughout life.
Gilead will also host three Educational Theater sessions from the Gilead Booth:
Overview of Scientific Presentations
Key abstracts will include:
HIV Prevention Research |
Higher persistence on twice-yearly lenacapavir versus daily F/TDF for PrEP in the UK and France in the PURPOSE 5 study |
Persistence and Safety of Twice-Yearly Lenacapavir versus Daily F/TDF for PrEP at One Year in the PURPOSE 5 Study |
Phenotypic analyses of HIV clinical isolates with capsid substitutions observed in the PURPOSE 1 and PURPOSE 2 studies |
Referral from Post-Exposure Prophylaxis to Pre-Exposure Prophylaxis in the United States, 2016 – 2025: An Analysis of Real World Claims Data |
Projected Public Health Impact of Removing Financial Barriers to PrEP in High-Incidence Populations |
Return on Investment of Eliminating Insurance Barriers to PrEP in High-Incidence Populations |
HIV Treatment Research |
Bictegravir/Lenacapavir: Baseline and Week 48 Resistance in the ARTISTRY-2 Study |
Characterising viraemic events in the ARTISTRY-1 and ARTISTRY-2 trials |
Community HERO Treatment Survey: Understanding Drivers of Treatment Satisfaction and Adherence among Cis Women with HIV |
Patient-Reported Outcomes in Treatment-Naïve People With HIV Initiating B/F/TAF: A Pooled Analysis of the BICSTaR Cohort |
BICSTaR: 24-month effectiveness and tolerability of B/F/TAF by HIV diagnosis era |
Examining the healthcare burden of antiretroviral therapy resistance among people with HIV in the United States |
Identifying and characterising people with HIV who are virologically suppressed and receiving complex regimens in Spain: the CoRIS cohort |
Demographics, clinical characteristics, and treatment patterns of people with HIV who are virologically suppressed receiving complex regimens in Japan: A real-world database study using electronic medical records |
Characterising Resistance-Associated Mutations and Virological Status Among People Living with HIV Receiving Regimens Containing Bictegravir, Cabotegravir, or Dolutegravir |
Virological outcomes of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) through Week 48 in children and infants aged ≥1 month and weighing ≥3 to <25 kg |
Efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) tablet for oral suspension (TOS) in children and infants aged ≥1 month, weighing 3 to <25 kg: Week 48 (W48) outcomes |
Antiviral Activity, Pharmacokinetics, and Safety of Oral GS-3242 for HIV-1 Treatment |
Understanding Treatment Experiences with Weekly Oral Islatravir/Lenacapavir in the Phase 3 ISLEND-2 Study: Participant and Provider Interviews |
Efficacy and safety of once-weekly oral islatravir/lenacapavir (ISL/LEN) versus daily standard of care (SOC) across demographic and clinical subgroups through Week 48 in the Phase 3 ISLEND-2 trial |
Quality of life and treatment preference with weekly ISL/LEN versus standard of care: Week 48 patient-reported outcome analysis of the Phase 3 ISLEND-2 study |
Once-weekly oral islatravir/lenacapavir (ISL/LEN) versus daily bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in virologically suppressed adults with HIV-1: Week 48 subgroup analyses of the Phase 3 ISLEND-1 trial |
HIV Cure Research |
Immunogenicity and associated safety of amtabafusp alfa, a bispecific T-cell engager, in a phase 1b study in people with HIV |
Referral from Post-Exposure Prophylaxis to Pre-Exposure Prophylaxis in the United States, 2016 – 2025: An Analysis of Real World Claims Data |
For more information about the data Gilead will be presenting at HIV Glasgow 2026, including a list of abstracts and their corresponding oral and poster sessions, please visit: https://hivglasgow.org/programme-2. The full abstracts will be published in a Supplement to the Journal of the International AIDS Society (JIAS).
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.
Bixlenvo requires a two-day initiation dose with Sunlenca ® (lenacapavir), thereafter only Bixlenvo is taken orally once a day. In the EU and UK, bictegravir and lenacapavir in combination are investigational and not approved for use. Their safety and efficacy have not been established in combination by the European Medicines Agency, the Medicines and Healthcare products Regulatory Agency or any other regulatory authorities
Lenacapavir for HIV prevention as PrEP is approved in the U.S., the EU, and multiple countries worldwide.
Islatravir and lenacapavir in combination are investigational and not approved for use by any regulatory authority.
GS-3242 is an investigational compound, and alone or in combination with lenacapavir, is not approved by any regulatory authority. Its safety and efficacy are unknown.
GS-8588 is an investigational agent and has not been approved anywhere globally; its safety and efficacy has not been established.
Please see below for U.S. Indications and Important Safety Information for Biktarvy, Bixlenvo, and Yeztugo ® (lenacapavir), including Boxed Warning for Biktarvy and Yeztugo.
There is currently no cure for HIV or AIDS.
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 approved classes of antiretroviral agents. While most antiretrovirals act on one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known exhibited cross-resistance 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 treatment and prevention research program. Lenacapavir is being developed as a foundation for potential future HIV therapies to offer both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address the individual needs and preferences of people and communities affected by HIV.
EU Indication for Yeytuo
Yeytuo injection is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV-1 acquisition risk weighing at least 35kg.
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 INUNDIAGNOSED HIV-1 INFECTION
Contraindications
Warnings and precautions
Adverse reactions
Drug interactions
Dosage and administration
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 F/TAF backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines.
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 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.
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
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.
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 planned $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 Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF), bictegravir, lenacapavir, GS-3242 and GS-8588 (such as PURPOSE 1, PURPOSE 2 and PURPOSE 5, ARTISTY-1, ARTISTRY-2, BICSTaR, ISLEND-1, ISLEND-2, PULSAR-1 and PULSAR-2); 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 September 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.
U.S. full Prescribing Information for Biktarvy, Truvada, and Yeztugo, including Boxed Warning, are available atwww.gilead.com. U.S. full Prescribing Information for Bixlenvo is available at www.gilead.com.
Biktarvy, Bixlenvo, Truvada, Yeytuo, Yeztugo, Choose U, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company’s website atwww.gilead.com, follow Gilead on X(@Gilead Sciences)andLinkedIn, orcontactGilead Public Affairs.
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PUB: 11/02/2026 08:30 AM/DISC: 11/02/2026 08:31 AM
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