New Data Presented at EACS 2023 Further Demonstrate Strong Clinical Profile of Twice-Yearly Sunlenca® for Adults With Multi-Drug Resistant HIV

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) presented new data today supporting Sunlenca^® (lenacapavir) as an important treatment option for adults with multi-drug resistant (MDR) HIV who have extensive treatment history. These findings highlight the significance of lenacapavir, the first long-acting injectable HIV treatment medication administered twice-yearly, as a person-centric therapy option and its potential to help transform the future of coordinated HIV clinical care. The data were presented at the 19^th European AIDS Conference (EACS 2023) in Warsaw, Poland, from October 18-21.

The latest results include two-year data from the Phase 2/3 CAPELLA trial, which demonstrate that resistance to Sunlenca occurred in a minority of participants and only among those with inadequate adherence to their optimized background regimen (OBR) or without fully active antiretrovirals as part of their OBR. Furthermore, a survey of healthcare professionals and coordinators conducting the CAPELLA trial reveal positive perceptions of Sunlenca, suggesting its potential to help improve clinical outcomes and health-related quality of life for adults who are heavily treatment experienced.

“The bar is rightly now set high for the efficacy and safety of HIV treatment across a diverse range of people living with the virus. The next wave of innovation in HIV includes long-acting options that are aiming to help address the differentiated needs and preferences of the diverse range of individuals and communities affected by the epidemic,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “These unmet needs fueled our research teams at Gilead to develop Sunlenca, an innovative treatment option that helps respond to the unmet needs of adults with limited therapy choices. The new findings presented at EACS 2023 demonstrate that Sunlenca has the potential to improve clinical outcomes for adults with HIV who are heavily treatment experienced and also positively impact their health-related quality of life.”

CAPELLA Two-Year Resistance Data

CAPELLA is an ongoing Phase 2/3 study evaluating the safety and effectiveness of Sunlenca in combination with other antiretrovirals as an optimized background regimen (OBR) for people with multi-drug resistant HIV who are heavily treatment experienced. CAPELLA investigators enrolled 72 participants with advanced HIV disease. Of the 27 participants who met the resistance analysis criteria, 13 did not develop resistance to Sunlenca. Fourteen participants developed Sunlenca resistance-associated mutations; importantly, all 14 either had inadequate adherence to their OBR (n=10) or an OBR lacking fully active antiretrovirals (n=4), 7 of the 14 participants with Sunlenca resistance resuppressed (HIV-1 <50 copies/mL) upon re-adherence to their OBR or with OBR change. These findings emphasize the importance of including more than one fully active agent whenever possible when creating a treatment regimen for people with multi-drug resistant HIV who have limited therapy options.

Insights and Experiences from Healthcare Professionals and Study Coordinators in CAPELLA

In an additional survey conducted amongst 25 CAPELLA healthcare professionals and study coordinators, the majority of respondents believed Sunlenca would be easy to integrate into real-world clinical practice. Respondents reported that Sunlenca has strong potential to improve clinical outcomes and health-related quality of life for heavily treatment-experienced adults. All respondents perceived that injection site reactions did not affect participants’ willingness to continue Sunlenca treatment.

Lenacapavir is being developed as a foundation for future HIV therapies. The goal is to offer both long-acting oral and injectable options with various dosing frequencies in combination with other antiretroviral agents for treatment or as a single agent for prevention. This approach aims to help address the individual needs and preferences of people with HIV and people who would benefit from 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.

Sunlenca (lenacapavir) is approved in Australia, Canada, the European Union, Israel, Japan, Switzerland, the United Arab Emirates, the United Kingdom or the United States for the treatment of people with multi-drug resistant HIV in combination with other antiretroviral(s).

Please see below for the U.S. Indication and Important Safety Information for Sunlenca.

There is no cure for HIV or AIDS.

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 indicated for the treatment of HIV 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.

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 multi-drug 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 and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving lenacapavir; uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for indications currently under evaluation; Gilead’s ability to receive regulatory approvals in a timely manner or at all, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir and, as a result, lenacapavir may never be successfully commercialized for the indications currently under evaluation; the risk that physicians may not see the benefits of prescribing Sunlenca; 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. full Prescribing Informationfor Sunlenca is available at www.gilead.com

Sunlenca, 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.