– Pivotal Phase 3 Findings Support the Potential of a Novel Single-Tablet Combination of Bictegravir and Lenacapavir for HIV Treatment –
– Latest Data from the PURPOSE Program Further Demonstrates the Safety and Efficacy Profile of Twice-Yearly Lenacapavir for HIV Prevention –
FOSTER CITY, Calif.–(BUSINESS WIRE)–#CROI2026–Gilead Sciences, Inc. (Nasdaq: GILD) today announced details of new clinical and real-world data from its innovative HIV treatment and prevention portfolio and research pipeline that will be presented at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) being held from February 22-25 in Denver, Colorado. Focusing on expanding therapeutic options to meet the diverse needs of communities affected by HIV, notable late-breaking abstracts include Phase 3 results from the ARTISTRY-1 and ARTISTRY-2 trials that explored the efficacy and safety of an investigational, single-tablet combination regimen of bictegravir and lenacapavir for HIV treatment.
“Striving for continuous progress in HIV means delivering transformative therapies that support people across their entire treatment journey, aiming for sustained long-term health,” said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences. “Our commitment to ending the HIV epidemic globally fuels our scientific innovation and our goal to develop novel options that are responsive to the needs and preferences of people with HIV.”
HIV Treatment Research
At CROI 2026, Gilead will present data showing how new regimens can potentially expand options and optimize HIV treatment.
Results from the Phase 3 ARTISTRY-1 and ARTISTRY-2 trials will highlight the efficacy and safety of an investigational, single-tablet combination regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) in people living with HIV who are virologically suppressed and switched from their prior antiretroviral therapy to the novel combination. Both studies were selected to be in the late-breaking abstract program. The findings provide further detail on the positive topline results from ARTISTRY-1 and ARTISTRY-2 announced in November and December 2025.
Additional research will expand scientific understanding of Gilead’s exploratory HIV treatment combinations, including:
- 96-week viral suppression results from a Phase 2 study evaluating islatravir plus lenacapavir, which has the potential to be the first weekly oral HIV treatment regimen.
- Patient-reported outcomes from lenacapavir in combination with the broadly neutralizing antibodies (bNAbs) teropavimab (GS-5423, TAB) and zinlirvimab (GS-2872, ZAB), which has the potential to be the first twice-yearly HIV treatment regimen.
- Results on the safety, pharmacokinetics and antiviral activity of GS-3242, an investigational long-acting integrase inhibitor being evaluated for potential twice-yearly dosing for HIV treatment, in a combination regimen that would include lenacapavir.
HIV Prevention Research
Gilead will present new research focused on broadening HIV prevention options to help meet the needs of diverse populations worldwide who need or want pre-exposure prophylaxis (PrEP), expanding understanding of how less frequent dosing strategies could help to support uptake and persistence:
- Further data from the PURPOSE program spotlighting the efficacy and safety profile of twice-yearly subcutaneous lenacapavir for PrEP among broad and geographically diverse populations, including cisgender men and women, and gender-diverse individuals.
- Updates on the resistance profile of lenacapavir as a long‑acting PrEP option.
- Real-world data on concomitant medication use in people taking PrEP in the United States, including insights into coadministration with lenacapavir.
- The design of the Phase 3 trial for investigational once-yearly intramuscular lenacapavir for PrEP, plus a model-informed drug development approach to support dose selection.
HIV Cure Research
Gilead continues to advance efforts to identify an efficacious, scalable cure for HIV. At CROI 2026, Gilead will present new data from the first HIV cure clinical program conducted in South Africa, including genetic characterization and viral control data from cisgender women participating in the FRESH (Females Rising through Education, Support, and Health) cohort.
For more information about the research Gilead will present at CROI 2026, including abstracts and their corresponding oral and poster sessions, please visit: https://www.croiconference.org.
Bictegravir and lenacapavir in combination are investigational and not approved anywhere globally. The safety and efficacy of this combination use has not been established by the U.S. FDA.
The combination of islatravir and lenacapavir is investigational. The safety and efficacy of this combination use has not been established by the U.S. FDA.
Teropavimab and zinlirvimab are investigational compounds. The use of these compounds alone or in combination with lenacapavir are investigational, are not approved by any regulatory authority, and their safety and efficacy has not been established.
Lenacapavir is being studied in multiple ongoing early and late-stage development programs and has the potential to offer a diverse set of person-centric options for treatment that could uniquely fit into the lives of people with HIV.
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.
There is currently no cure for HIV or AIDS.
About Bictegravir
Bictegravir is a global guideline-recommended integrase strand transfer inhibitor (INSTI) with a high barrier to resistance. INSTIs are a class of antiretroviral agents that target the viral integrase. Bictegravir is used only in combination with other antiretroviral agents in the treatment of HIV.
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 antiretroviral agents. While most antiretrovirals 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. Lenacapavir was chosen as one of TIME’s Best Inventions, recognized on Fortune’s Change the World list, named the 2024 Breakthrough of the Year by the journal Science, and selected as the 2025 Prix Galien USA Award for Best Pharmaceutical Product.
U.S. Indication for Yeztugo®
Yeztugo® (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for preexposure 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 Gilead HIV
For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 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 treatment 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 bictegravir, lenacapavir, teropavimab, zinlirvimab, GS-3242 and any combinations thereof (such as ARTISTRY-1 and ARTISTRY-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, 2025, 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 Yeztugo, including Boxed Warning, are available at www.gilead.com.
Yeztugo, 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.
Contacts
Priscilla White, Media
public_affairs@gilead.com
Jacquie Ross, Investors
investor_relations@gilead.com