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Gilead to Present Late-Breaking Clinical Data and Real-World Evidence at HIV Glasgow
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November 2, 2026
FOSTER CITY, Calif.--(BUSINESS WIRE)-- 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
HIV prevention research includes Phase 2 findings from the ongoing PURPOSE 5 study exploring persistence and safety of twice-yearly lenacapavir (Yeytuo ®) in individuals in the United Kingdom and France previously not taking daily oral pre-exposure prophylaxis (PrEP)
Outcomes from the real-world BICSTaR study analyzing the treatment responses of a broad range of people with HIV taking Biktarvy ®(bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF)
Phase 3 results from the ARTISTRY studies assessing the treatment responses of people with HIV switching to the once-daily oral single-tablet regimen combination of bictegravir 75mg/lenacapavir 50 mg (BIC/LEN)
HIV treatment pipeline research includes Phase 3 results from the ISLEND trials evaluating an investigational once-weekly oral single-tablet HIV treatment regimen of islatravir 2 mg/lenacapavir 300 mg (ISL/LEN), and data on GS-3242, an investigational integrase inhibitor being studied in combination with lenacapavir as a potential twice-yearly injectable regimen
HIV cure research: Immunogenicity data from a Phase 1b first-in-human study of amtabafusp alfa, a novel bispecific T cell engager targeting the HIV reservoir
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:
Monday November 9: Choose U™: Centered on People and Powered by U=U, featuring lived experiences and personal insights from community members on how to break down stigma and build greater education around HIV treatment as prevention (TasP).
Monday November 9: HIV Prevention in Europe: Progress, Persistent Gaps, and the Path Forward, exploring how testing, care pathways, and prevention innovation can help Europe to achieve its HIV prevention goals.
Tuesday November 10: From Diagnosis to Long-Term Success: Advancing HIV Care Through Person-Centered Practice, examining how person-centered care principles can be translated into everyday clinical practice to improve engagement, testing, linkage to care and long-term outcomes for people affected by HIV.
https://www.gilead.com/news/news-details/2026/gilead-to-present-late-breaking-clinical-data-and-real-world-evidence-at-hiv-glasgow
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.
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