FOSTER CITY, Calif. / Jul 16, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced its program for the upcoming 25th International AIDS Conference (AIDS 2024), taking place in Munich, Germany, and virtually, from July 22-26. As the leading innovator in HIV, Gilead will share new data from its research and development programs and Gilead-supported collaborations that unite leading scientific innovation and partnership aimed at ending the HIV epidemic.
"The AIDS 2024 conference convenes the global HIV community – scientists, advocates, and partners from the public and private sectors," said Jared Baeten, MD, PhD, Senior Vice President, Virology Clinical Development, Gilead Sciences. "Our contributions to this year's meeting demonstrate Gilead's leadership in person-centered innovations across HIV prevention, treatment, and cure. Our scientific advancements are grounded in collaboration with community and research partners around the world. I look to a future where every person has options to help obtain their own HIV prevention or treatment success and where we've come together to end the HIV epidemic."
Gilead’s AIDS 2024 program highlights include:
Late-breaking: Full data from pivotal PURPOSE 1 trial: Data evaluating lenacapavir, an investigational, twice-yearly medicine for HIV prevention, will be presented at the Co-Chairs’ Choice session on July 24, 10:30 a.m.-noon, CEST. Developed in partnership with communities affected by HIV around the world, the PURPOSE clinical trials comprise the most comprehensive and diverse HIV prevention trial program ever conducted. PURPOSE 1 is the first HIV prevention trial to intentionally include pregnant and lactating women. In June, the topline results from an interim analysis of the Phase 1 trial were announced, demonstrating 100% efficacy for the investigational use of HIV prevention in cisgender women.
Oral presentation: Week 48 outcomes from ARTISTRY-1: The latest data from an ongoing Phase 2/3 study (NCT05502341) designed to evaluate an investigational once-daily single-tablet regimen of bictegravir and lenacapavir in virologically suppressed people with HIV who are on a complex regimen.
Two-year outcomes from BICSTaR: The latest findings from an ongoing global, observational study evaluating the effectiveness, safety and tolerability of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in treatment-naïve and treatment-experienced people with HIV who have a high burden of co-morbidities.
Additional research studies evaluating Biktarvy include five-year outcomes from the pivotal trials evaluating Biktarvy as a long-term treatment option in older adults with a high burden of comorbidities and the Hispanic/Latine community, respectively.
HIV treatment research pipeline findings will also include new data on GS-1720 and GS-4182. Both investigational agents are being clinically evaluated as part of potential future once-weekly oral HIV treatment options. Additionally, resistance analyses from a study evaluating the investigational combination of lenacapavir + teropavimab (GS-5423, TAB) + zinlirvimab (GS-2872, ZAB) will be presented to support previously presented data demonstrating the potential of this combination as a novel, long-acting, twice-yearly treatment option.
Symposia focused on addressing barriers to HIV care and prevention: Two symposia to discuss the latest progress in policies and practical solutions from around the world to help achieve more equitable access to HIV care and services.
Gilead-supported initiatives highlighting collaboration to advance health equity: To help end the HIV epidemic, it is essential to extend beyond science. Gilead will highlight two initiatives that aim to bridge gaps in HIV awareness and improve linkage to and retention in care:
Overview of Scientific Presentations
HIV TREATMENT RESEARCH (B/F/TAF) |
Efficacy and Safety of B/F/TAF in Hispanic/Latine Adults With HIV-1 Initiating First-Line Therapy: 5-Year Follow-Up From Two Phase 3 Studies |
Switching To B/F/TAF in A Real-World Cohort of Older People With HIV And High Burden of Non AIDS-Related Comorbidities (BICSTaR) |
LONG-ACTING HIV TREATMENT & PREVENTION RESEARCH (LENACAPAVIR) |
Centring Community Leadership With Purpose: Inclusion Of Adolescents, Ciswomen, and Pregnant And Lactating Individuals in a Phase 3 Clinical Trial Evaluating Lenacapavir and F/TAF For PrEP |
Twice-Yearly Lenacapavir or Daily Emtricitabine/Tenofovir Alafenamide for HIV Prevention in Cisgender Women: Interim Analysis Results from the PURPOSE 1 Study |
Experiences and Quality of Life with Long-Acting Lenacapavir from People With Multidrug-Resistant HIV-1 Enrolled in the Phase 2/3 CAPELLA Study |
Injection Site Reactions with Subcutaneous Lenacapavir Administration at Alternate Injection Sites |
Resistance Analyses During Treatment of Lenacapavir With Broadly Neutralizing Antibodies in PWH |
HIV PIPELINE RESEARCH |
Efficacy and Safety of Bictegravir Plus Lenacapavir: 48-Week Outcomes in Virologically Suppressed People With HIV-1 on Complex ART Regimens at Baseline (Artistry-1) |
Phase 1a PK and Safety of Single Ascending Doses of GS-1720 in Healthy Participants Supports Oral Weekly Administration and Phase 1b Dose Selection |
Nonclinical Pharmacology Profile of GS-1720, a Novel, Highly Potent Once-Weekly Oral HIV-1 INSTI Inhibitor in Clinical Development |
Safety and PK Profile of Single and Multiple Ascending Doses of GS-4182, an Oral Prodrug of Lenacapavir, in Participants Without HIV-1 |
Nonclinical Profile of GS-4182, a Once-Weekly Oral Prodrug of the HIV-1 Capsid Inhibitor Lenacapavir in Clinical Development |
ADDITIONAL HIV PREVENTION RESEARCH |
Real-World Adherence of HIV-1 Oral PrEP Regimens in the United States: A Group-Based Trajectory Modeling Approach |
HIV CURE RESEARCH |
GS-8588, a Novel Envelope-Targeting Bispecific T-Cell Engager for HIV Cure |
For more information, including a complete list of abstracts and their corresponding oral and poster session titles, please visit: https://programme.aids2024.org/
Bictegravir and lenacapavir in combination are investigational and not approved anywhere globally. Their safety and efficacy have not been established.
GS-5423, GS-2872, GS-1720, GS-4182 and GS-8588 are investigational compounds, and alone or in combination with lenacapavir, are not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use. Their safety and efficacy are unknown.
Lenacapavir, marketed as Sunlenca®, 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 and prevention that could uniquely fit into the lives of people with HIV and individuals who need or want pre-exposure prophylaxis (PrEP).
The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established. 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.
Please see below for U.S. Indication and Important Safety Information, including Boxed Warning, for Biktarvy. Please also see below for the U.S. Indication and Important Safety Information for Sunlenca.
There is currently no cure for HIV or AIDS.
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 Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines.
About Sunlenca
Sunlenca (300 mg tablet and 463.5 mg/1.5 mL injection) [(lenacapavir)] is a first-in-class, long-acting HIV capsid inhibitor approved in Australia, Canada, the European Union, Israel, Japan, Switzerland, the United Arab Emirates, the United Kingdom, and the United States for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV who are heavily treatment-experienced. Sunlenca is the only HIV treatment option administered twice-yearly. Sunlenca tablets are approved for oral loading during initiation of Sunlenca treatment, prior to or at the time of the first long-acting lenacapavir injection depending on initiation option.
The multi-stage mechanism of action of Sunlenca’s active pharmaceutical agent, lenacapavir, is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, Sunlenca 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 for HIV prevention is investigational, and its safety and efficacy for this use have not been established. 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.
U.S. Indication for Biktarvy
Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral (ARV) treatment history 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
U.S. Indication for Sunlenca
Sunlenca, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
U.S. Important Safety Information for Sunlenca
Contraindications
Warnings and precautions
Adverse reactions
Drug interactions
Dosage and administration
Pregnancy and lactation
About Gilead Sciences in HIV
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, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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 12 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 is recognized as one of the leading funders of HIV-related programs in a report released by Funders Concerned About AIDS.
Learn more about Gilead’s unique collaborations worldwide and the work to help end the global HIV epidemic.
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, lenacapavir, teropavimab, zinlirvimab, GS-1720, GS-4182 and GS-8588; uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for indications currently under evaluation; 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 March 31, 2024, 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. Prescribing Information for Biktarvy, including BOXED WARNING, and U.S. full Prescribing Information for Sunlenca are available at www.gilead.com
Biktarvy, Descovy, Sunlenca, RADIAN, Gilead and the Gilead logo are registered 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 at This email address is being protected from spambots. You need JavaScript enabled to view it., 1-800-GILEAD-5 or 1-650-574-3000.
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