Gilead Demonstrates the Impact of Global Collaboration in Advancing HIV Research and Health Equity at EACS 2023

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced its upcoming participation in the 19th European AIDS Conference (EACS) to be held in Warsaw, Poland from October 18-21, 2023. As a leader in HIV innovation, Gilead will provide an update on its signature initiatives, key collaborations and share new scientific data from its HIV research and development programs. The research that will be presented at EACS 2023, along with symposia led by Gilead, reflects the company’s person-centered approach to advancing scientific innovation and underscores its focus on community partnership to help end the HIV epidemic.

“At Gilead, our person-centered approach to science involves engaging community voices in the research process from the initial planning stages of new compounds to the real-world and patient-reported outcomes of approved medicines,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “Our commitment to transformative innovation goes beyond the laboratory. Innovative approaches to collaborating at the global, national, and local levels have the potential to address the diverse needs of people and communities affected by HIV and improve linkage to and retention in care.”

Scientific Progress in HIV Research

At EACS 2023, Gilead will present new findings on long-acting HIV treatment strategies, including outcomes from multiple studies evaluating twice-yearly lenacapavir, Gilead’s first-in-class, long-acting HIV-1 capsid inhibitor. These findings will include insights, experience and perspectives from healthcare professionals and study coordinators from CAPELLA, an ongoing Phase 2/3 registrational study designed to evaluate the antiviral activity and safety of twice-yearly lenacapavir administered as a subcutaneous injection in adults with multi-drug resistant HIV who are heavily treatment experienced. Additional lenacapavir data presented at EACS 2023 will provide insight into the therapy’s resistance profile. Lenacapavir has exhibited no overlapping resistance in vitro with any currently approved antiretroviral therapy.

As part of ongoing efforts to advance treatment research in communities with diverse health needs, Gilead will present three-year outcomes from BICSTaR, an ongoing global, observational, real-world 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. As the average age of persons with HIV increases, the management of comorbid conditions is an important consideration in HIV clinical care. BICSTaR helps to inform the future of coordinated person-centred HIV care. The mental health outcomes reported by participants in BICSTaR over a two-year period will also be presented at EACS 2023. Rates of mental health conditions are higher among people with HIV compared to the general population. Mental health impairments can further increase the risk of negative health outcomes at every stage of the HIV care continuum. Additional research studies evaluating Biktarvy include a pooled analysis of viral re-suppression rates in participants from nine studies who had experienced virologic rebound following starting or switching to treatment with the single-tablet regimen.

Additionally, Gilead will also convene two symposia to examine the barriers and challenges in helping people with HIV reach and sustain long-term success.

Treatment Selection for Long-term Success: A Question of Empowerment (October 19, 6:30 – 8:00 p.m. CEST), will feature a distinguished faculty of experts and community representatives exploring how a person-centred approach to treatment selection could contribute to long-term success. Focusing on the individual requires a holistic approach to care that enables people with HIV to be equal partners in the healthcare decisions that impact and determine their future wellbeing. Ultimately long-term success in HIV requires a truly equitable healthcare system that is culturally sensitive, relevant, and responsive to all people with HIV.

ART Resistance – A Question of Innovation (October 20, 12:15 – 1:45 p.m. CEST) will showcase insights from a diverse and esteemed panel of international experts, emphasizing how innovation can help address ART resistance and maximize long-term success. Long-term HIV treatment and drug resistance remain significant challenges that necessitate various drug development strategies. These strategies include working to enhance safety and resistance profiles within existing antiretroviral classes, discovering drugs with novel mechanisms of action, and regimen simplification.

Gilead also highlights the importance of new perspectives across HIV research. Gilead’s Research Scholars Program (RSP) recognizes and supports junior researchers and works to reduce barriers to entry for underrepresented researchers. The RSP also continues to facilitate connections between scholars globally to encourage collaborative research approaches in the effort to help end the HIV epidemic. In Warsaw, prior to the start of EACS, Gilead will celebrate the 2023 award recipients for their efforts to advance scientific knowledge in areas of unmet medical need for people affected by HIV.

Collaborations to Advance Global Health Equity

Tremendous progress has been made toward ending the HIV epidemic, including biomedical advancements in prevention and treatment that have helped people and communities affected by the virus. However, scientific innovation alone will not end the epidemic. Through our many global and local collaborations, we aim to reduce disparities across HIV care and prevention worldwide, advance education among healthcare professionals and support the local communities in which they operate.

Although new HIV acquisitions have greatly declined globally over the last ten years, many underserved communities, including in the Eastern Europe and Central Asia (EECA) region, remain disproportionately affected.

To make a lasting impact in areas like EECA, Gilead has forged partnerships that support local action to drive change on a global scale. One of these is RADIAN^® – a ground-breaking partnership between Gilead and the Elton John AIDS Foundation (EJAF) to help ensure communities in EECA have resources to meaningfully address new HIV acquisitions and deaths from AIDS-related illnesses. Launched in 2019, the RADIAN initiative drives focused action to improve the quality of care for those impacted by HIV in the region.

RADIAN is hosting the forum In Crisis: The Urgent Need for Action on HIV in Eastern Europe and Central Asia (October 18, 7:00 – 9:30 p.m. CEST). The session will feature a diverse panel discussing challenges in the region and sharing replicable and scalable models to end the HIV epidemic in EECA.

Gilead believes that everyone should have equitable access to healthcare, regardless of their background. We provide resources to support underserved communities that have faced greater social or economic barriers to health. At EACS, we will make a philanthropic donation to Res Humanae, a Polish Foundation for Humanitarian Aid. This organization has been working for several decades to promote education and awareness about stigmatized and socially excluded individuals, with a particular focus on people with HIV. The donation will help raise funds for international foundations that support marginalized and migrant communities.

Summary of Presentations

Key abstracts will include:

For more information about Gilead at EACS 2023, including a complete list of abstracts and their corresponding oral and poster sessions, please visit: https://eacs-conference2023.com/

The use of Biktarvy in patients with a history of treatment failure is investigational and the safety and efficacy of this use has not been determined.

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 is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or 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 history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

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: There is insufficient human data on the use of BIKTARVY during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using BIKTARVY during pregnancy and conception. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for FTC shows no difference in the rates of birth defects compared with a US reference population.
• Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.

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

• Coadministration: Concomitant administration of Sunlenca is contraindicated with strong CYP3A inducers.

Warnings and precautions

• Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported in patients treated with combination antiretroviral (ARV) therapy.
• Long-acting properties and potential associated risks with Sunlenca: Residual concentrations of Sunlenca may remain in the systemic circulation of patients for up to 12 months or longer. Sunlenca may increase exposure, and potential risk of adverse reactions, to drugs primarily metabolized by CYP3A initiated within 9 months after last injection. Counsel patients regarding the dosing schedule because nonadherence could lead to loss of virologic response and development of resistance. If virologic failure occurs, switch to an alternative regimen if possible. If discontinuing Sunlenca, begin alternate suppressive ARV regimen within 28 weeks from last injection.
• Injection site reactions may occur, and nodules and indurations may be persistent.

Adverse reactions

• Most common adverse reactions (incidence ≥3%, all grades) are injection site reactions (65%) and nausea (4%).

Drug interactions

• Prescribing information: Consult the full prescribing information for Sunlenca for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
• Enzymes/transporters: Drugs that are strong or moderate inducers of CYP3A may significantly decrease the concentration of Sunlenca. Drugs that strongly inhibit CYP3A, P-gp, and UGT1A1 together may significantly increase the concentration of Sunlenca. Sunlenca may increase the exposure of drugs primarily metabolized by CYP3A, when initiated within 9 months after the last injection of Sunlenca, which may increase the potential risk of adverse reactions.

Dosage and administration

• Dosage: Initiation with 1 of 2 options, followed by maintenance dosing once every 6 months. Tablets may be taken with or without food.
  • Initiation Option 1: Day 1: 927 mg by subcutaneous injection and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally (2 x 300-mg tablets).
  • Initiation Option 2: Day 1: 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally (2 x 300-mg tablets). Day 8: 300 mg orally (1 x 300-mg tablet). Day 15: 927 mg by subcutaneous injection.
  • Maintenance: 927 mg by subcutaneous injection every 26 weeks +/- 2 weeks from date of last injection.
• Missed Dose: During the maintenance period, if more than 28 weeks have elapsed since the last injection and if clinically appropriate to continue Sunlenca treatment, restart the initiation dosage regimen from Day 1, Option 1 or Option 2.

Pregnancy and lactation

• Pregnancy: There is insufficient human data on the use of Sunlenca during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established.
• Lactation: Individuals infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.

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, 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 reduce the risk of acquiring HIV infection, 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 and collaborations, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as the number one philanthropic funder 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 HIV epidemic for everyone, everywhere.

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 and lenacapavir; 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 June 30, 2023, 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 Informationfor Biktarvy, including BOXED WARNING, U.S. full Prescribing Informationfor Sunlenca are available at www.gilead.com.

Biktarvy, 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 Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.