Gilead to Present Late-Breaking Clinical Data and Real-World Evidence at HIV Glasgow

The program spans approved daily treatments and investigational weekly oral and twice-yearly injectable HIV regimens.

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– Results Highlight the Potential of Long-Acting Regimens, Including Twice-Yearly and Once-Weekly Options, to Transform the Treatment and Prevention of HIV –

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

“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:

• 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.

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 IN UNDIAGNOSED HIV-1 INFECTION

• Individuals must be tested for HIV-1 infection prior to initiating Yeztugo, and with each subsequent injection of Yeztugo, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of Yeztugo by individuals with undiagnosed HIV-1 infection. Do not initiate Yeztugo unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving Yeztugo must transition to a complete HIV-1 treatment regimen.

Contraindications

• Yeztugo is contraindicated in individuals with unknown or positive HIV-1 status.

Warnings and precautions

• Comprehensive risk management:
  • Use Yeztugo to reduce the risk of HIV-1 acquisition as part of a comprehensive prevention strategy including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs).
  • HIV-1 acquisition risk includes behavioral, biological, or epidemiologic factors including, but not limited to, condomless sex, past or present STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network. Counsel individuals on the use of other prevention methods to help reduce their risk.
  • Use Yeztugo only in individuals confirmed to be HIV-1 negative. Evaluate for current or recent signs or symptoms consistent with HIV-1 infection. Confirm HIV-1 negative status prior to initiating, prior to each subsequent injection, and as clinically appropriate.
• Potential risk of resistance:
  • There is a potential risk of developing resistance to Yeztugo if an individual acquires HIV-1 before or when receiving Yeztugo, or following discontinuation. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection taking only Yeztugo, because Yeztugo alone is not a complete regimen for HIV-1 treatment.
  • To minimize this risk, it is essential to test before each injection and additionally as clinically appropriate. Individuals confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen.
  • Alternative forms of PrEP should be considered after discontinuation of Yeztugo for those who are at continuing risk of HIV-1 acquisition and should be initiated within 28 weeks of the last Yeztugo injection.
• Long-acting properties and potential associated risks:
  • Residual concentrations of Yeztugo may remain in systemic circulation for up to 12 months or longer after the last injection.
  • Select individuals who agree to the required injection dosing schedule because nonadherence or missed doses could lead to HIV-1 acquisition and development of resistance.
• Serious injection site reactions: Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer. Only administer Yeztugo subcutaneously.

Adverse reactions

• Most common adverse reactions (≥5%) in Yeztugo clinical trials were injection site reactions, headache, and nausea.

Drug interactions

• Strong or moderate CYP3A inducers may significantly decrease Yeztugo concentrations. Dosage modifications are recommended when initiating these inducers.
• It is not recommended to use Yeztugo with combined P-gp, UGT1A1, and strong CYP3A inhibitors.
• Coadministration of Yeztugo with sensitive substrates of CYP3A or P-gp may increase their concentrations and result in the increased risk of their adverse events. Yeztugo may increase the exposure of drugs primarily metabolized by CYP3A initiated within 9 months after the last injection of Yeztugo.

Dosage and administration

• HIV screening: Test for HIV-1 infection prior to initiating, prior to each subsequent injection, and as clinically appropriate using an approved or cleared test for the diagnosis of acute or primary HIV-1 infection.
• Dosage: Initiation dosing (injections and tablets) followed by once-every-6-months continuation injection dosing. Tablets may be taken with or without food.
  • Initiation: Day 1: 927 mg by subcutaneous injection (2 x 1.5-mL injections) and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally.
  • Continuation: 927 mg by subcutaneous injection every 6 months (26 weeks) from date of last injection ±2 weeks.
• Anticipated delayed injections: If scheduled 6-month injection is anticipated to be delayed by more than 2 weeks, Yeztugo tablets may be taken on an interim basis (for up to 6 months) until injections resume. Dosage is 300 mg orally (1 x 300-mg tablet) once every 7 days. Resume continuation injections within 7 days of the last oral dose.
• Missed injections: If more than 28 weeks have elapsed since the last injection and Yeztugo tablets have not been taken, restart with initiation dosing if clinically appropriate.
• Dosage modifications of Yeztugo are recommended when initiating with strong or moderate CYP3A inducers. Consult the full Prescribing Information for recommendations.

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

• Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF) and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted.

Contraindications

• Coadministration: Do not use BIKTARVY with dofetilide or rifampin.

Warnings and precautions

• Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions.
• Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
• New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus.
• Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse reactions

• Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).

Drug interactions

• Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
• Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1.
• Drugs affecting renal function: Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions.

Dosage and administration

• Dosage: Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes.
• Renal impairment: For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, not recommended in patients with CrCl <30 mL/min.
• Hepatic impairment: Not recommended in patients with severe hepatic impairment.
• Prior to or when initiating: Test patients for HBV infection.
• Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.

Pregnancy and lactation

• Pregnancy: BIKTARVY is recommended in pregnant individuals who are virologically suppressed on a stable ARV regimen with no known substitutions associated with resistance to any of the individual components of BIKTARVY. Lower plasma exposures of BIKTARVY were observed during pregnancy; therefore, viral load should be monitored closely during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for BIC, FTC, or TAF show no difference in the rates of birth defects compared with a US reference population.
• Lactation: Individuals infected with HIV-1 should be informed of the potential risks of breastfeeding.

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

• Coadministration: Concomitant administration of Bixlenvo is contraindicated with dofetilide and strong CYP3A inducers.

Warnings and precautions

• See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during Bixlenvo therapy and monitor for adverse reactions.

Adverse reactions

• Most common adverse reactions (incidence > 2%; all grades) reported in clinical trials were headache (4%), nausea (3%), and diarrhea (2%).

Drug interactions

• Prescribing Information: Consult the full Prescribing Information for Bixlenvo for more information on contraindications, warnings, and potentially significant drug interactions, including clinical comments.
• Enzymes/transporters: Drugs that are both a strong inducer of CYP3A and induce UGT1A1 can substantially decrease the concentration of components of Bixlenvo. Drugs that are strong or moderate inducers of CYP3A may significantly decrease the concentrations of components of Bixlenvo. Drugs that are both a strong CYP3A inhibitor and a UGT1A1 inhibitor, or combined P-gp, UGT1A1, and strong CYP3A inhibitors can significantly increase concentrations of components of Bixlenvo.

Dosage and administration

• Dosage: Two-day initiation regimen of Bixlenvo 1 tablet plus Sunlenca 2 tablets taken orally daily, followed by a maintenance regimen of Bixlenvo 1 tablet orally once daily. Tablets may be taken with or without food.
  • Day 1: Bixlenvo 1 tablet of 75 mg/50 mg orally and Sunlenca 2 tablets of 300 mg orally (600 mg dose)
  • Day 2: Bixlenvo 1 tablet of 75 mg/50 mg orally and Sunlenca 2 tablets of 300 mg orally (600 mg dose)
  • Day 3 and once daily thereafter: Bixlenvo 1 tablet of 75 mg/50 mg orally once daily
• Missed dose: If the initiation doses of Bixlenvo or Sunlenca are missed, patients should take them as soon as possible. Patients should not take both Day 1 and Day 2 doses of Sunlenca on the same day. Patients should take missed maintenance doses as soon as possible. If more than 7 days have elapsed since the last maintenance dose, restart initiation dosage regimen from Day 1, if clinically appropriate to continue treatment.

Pregnancy and lactation

• Pregnancy: Lower exposures of bictegravir were observed in clinical studies with a bictegravir-containing regimen. Therefore, viral load should be monitored closely in pregnant individuals. An Antiretroviral Pregnancy Registry (APR) has been established.
• Lactation: Individuals with HIV-1 should be informed of the potential risks of breastfeeding.

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 at www.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 at www.gilead.com, follow Gilead on X (@Gilead Sciences) and LinkedIn, or contact Gilead Public Affairs.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261102514601/en/

Priscilla White, Media
public_affairs@gilead.com

Jacquie Ross, Investors
investor_relations@gilead.com

Source: Gilead Sciences, Inc.

Key Terms

prep medical

Pre-exposure prophylaxis (PrEP) is a medical strategy where people take a medication before possible exposure to an infectious disease to greatly reduce their risk of becoming infected. For investors, PrEP matters because it defines a market for preventive drugs or products—success in clinical results, approvals, or wider adoption can drive sales, shape pricing and reimbursement, and change forecasts for companies working on those preventive treatments, much like insurance that prevents costly future claims.

integrase inhibitor medical

A drug that blocks a viral protein called integrase, which viruses use to stitch their genetic blueprint into human cells; by stopping that step, these medicines prevent the virus from replicating and spreading. Investors care because integrase inhibitors are a major class of antiviral treatments whose clinical trial outcomes, regulatory approvals, patent status, pricing and market share can drive a biotech or pharmaceutical company’s revenues and valuation—think of them as cutting the glue that lets the virus install itself.

capsid inhibitor medical

A capsid inhibitor is a type of antiviral drug that binds to or disrupts a virus's capsid — the protein shell that protects its genetic material — preventing the virus from assembling, entering cells, or releasing its contents. For investors, capsid inhibitors matter because they represent a specific pathway for treating viral infections; successful drugs can create new market opportunities, affect clinical and regulatory risk profiles, and influence a company's valuation depending on trial results and approval prospects.

bispecific t-cell engager medical

A bispecific T‑cell engager is a lab-made protein that binds both a cancer cell and a patient’s immune T cell at the same time, bringing them together so the T cell can attack and kill the cancer cell. For investors, these drugs matter because they represent a targeted immunotherapy approach with potential for strong effectiveness but also unique safety and regulatory risks—think of it as a matchmaker that can unlock powerful results if it works safely and reliably.