Gilead Sciences Announces New Clinical Trial in Europe to Assess Lenacapavir for HIV Prevention as Part of Landmark Purpose Program

– PURPOSE 5 trial will evaluate lenacapavir as twice-yearly prevention option in people who could benefit from HIV pre-exposure prophylaxis (PrEP) in France and the United Kingdom –

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced PURPOSE 5, the first Phase 2 clinical trial to evaluate an investigational long-acting HIV prevention option in Europe. The study will assess the persistence—defined as consistent and continuous use—of lenacapavir compared with emtricitabine/tenofovir disoproxil fumarate (F/TDF) in people who may benefit from pre-exposure prophylaxis (PrEP) and who are not currently taking PrEP. The study has an intentional focus on recruiting participants from groups across France and the United Kingdom that are disproportionally affected by HIV and often underrepresented in clinical trials.

HIV continues to be a public health threat across Europe, where in 2022 more than 100,000 people were newly diagnosed with HIV. HIV prevention is critical and has the potential to change the trajectory of the epidemic, but stigma and other barriers to uptake limit the impact that PrEP medications can have on reducing HIV infections in Europe. At this time, it is estimated that less than 15% of people in Europe who could benefit from PrEP are accessing PrEP options. Current PrEP options may not meet the diverse needs of everyone who could benefit from PrEP, hindering the potential impact those medicines could have on reducing new infections.

Lenacapavir is a first-in-class HIV capsid inhibitor that can be administered as a twice-yearly subcutaneous injection. It is currently approved, in combination with other antiretrovirals, for HIV treatment in persons with multidrug-resistant HIV-1 infection. It is also under investigation for HIV prevention. If approved, lenacapavir with its twice-yearly dosing could offer a potential long-acting option to help address the differing needs and preferences of individuals who could benefit from PrEP. The safety and efficacy of lenacapavir for HIV prevention has not been established.

“I am encouraged by Gilead’s long-acting prevention research program, and I am excited to partner on the PURPOSE 5 trial to expand our understanding of how lenacapavir may impact PrEP utilization among communities that could benefit from PrEP across France and the United Kingdom,” said Jean-Michel Molina, MD, PhD, Université Paris Cité, Professor of Infectious Diseases and Head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals. “While existing PrEP options have certainly helped transform the way HIV is prevented, offering a variety of person-centered options will be an important step towards making PrEP accessible among a greater range of people.”

PURPOSE 5 is the latest example of Gilead’s ongoing commitment and work to assess the potential of lenacapavir to help a diverse range of people around the world who could benefit from PrEP. PURPOSE 1 (NCT04994509) is evaluating lenacapavir for PrEP and emtricitabine/tenofovir alafenamide (F/TAF) for PrEP in cisgender adolescent girls and young women ages 16-25 in South Africa and Uganda; this pivotal registrational trial completed full enrolment in September 2023 with more than 5,300 participants enrolled.

PURPOSE 2 (NCT04925752) is assessing lenacapavir for PrEP among cisgender men who have sex with men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States. PURPOSE 3 will study lenacapavir for PrEP among cisgender women in the United States who are disproportionately affected by HIV, with a focus on Black women and other women of color, and PURPOSE 4 will study lenacapavir for PrEP among people who inject drugs in the United States. PURPOSE 1-5 is the most comprehensive and diverse program for an investigational HIV PrEP program ever conducted. More information about the PURPOSE program can be found at www.purposestudies.com.

“Since Gilead launched the PURPOSE clinical trials in 2019, we have actively engaged a diverse group of global stakeholders who informed not only what we were studying in our innovative HIV prevention research program, but how we conduct that work and continually evolve it,” said Jared Baeten MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “There is a critical need to bring forward new PrEP options that are informed by and designed for the communities that could benefit from PrEP in Europe. We are excited to engage with communities and broader stakeholders to inform PURPOSE 5 and partner with them in our goal to develop person-centered innovations that can help end the HIV epidemic in Europe.”

Gilead is conducting its PURPOSE program with a commitment to partnering with communities that are disproportionately affected by HIV in their respective countries and regions. Community input on the PURPOSE clinical trials has so far provided critical guidance on issues ranging from program design and community engagement to participant recruitment strategies and important cultural considerations. These kinds of collaborations will continue to help Gilead implement trials with rigor, innovation and intentional inclusion of communities that have traditionally been underrepresented in HIV prevention research.

The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established.

Lenacapavir, marketed as Sunlenca^®, is approved in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals. Please see below for the U.S. Indication and Important Safety Information for Sunlenca.

There is currently 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 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 HIV

For 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.

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; 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; 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.

Sunlenca, 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 or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

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