Arrivals of the twice-yearly PrEP option in Eswatini and Zambia mark an important milestone in the goal of ending the HIV epidemic in sub-Saharan Africa

Company Website: https://www.gilead.com/
FOSTER CITY, Calif. & MBABANE, Eswatini -- (Business Wire)

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the delivery of first shipments of lenacapavir – Gilead’s twice-yearly injectable HIV-1 capsid inhibitor – for the prevention of HIV as pre-exposure prophylaxis (PrEP) to Eswatini and Zambia. The deliveries advance ongoing efforts to accelerate equitable access to long-acting HIV prevention options across sub-Saharan Africa, which is home to approximately two-thirds of all people living with HIV globally.

“The arrivals of the first doses of lenacapavir in Eswatini and Zambia mark an important milestone in HIV prevention and reflect our commitment to supporting communities with the greatest need. For the first time, a new HIV medicine is reaching communities in sub-Saharan Africa in the same year as its U.S. approval,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. “Our work with the Global Fund, PEPFAR, governments, and many others, accelerates access and moves us closer to finally ending the HIV epidemic.”

“Seeing the first boxes arrive at Central Medical Stores, and then meeting the health workers being trained to administer lenacapavir, reinforced just how transformational this moment is,”said Peter Sands, Executive Director of the Global Fund. “The Global Fund is proud to see countries gaining firsthand experience with a product that represents a new era in HIV prevention. The real impact will come from rapidly reaching the most at-risk populations at scale. If communities are at the center, innovation becomes impact, and progress becomes sustainable.”

“Through our America First Global Health Strategy, the Trump Administration is making targeted and high-impact investments in breakthrough health innovations like lenacapavir that will bend the curve of the HIV epidemic and help countries globally to break away from reliance on external health assistance,” said Jeremy Lewin, Senior Official for Foreign Assistance, Humanitarian Affairs and Religious Freedom. “The United States is proud to champion this American biomedical achievement and, along with the Global Fund, to provide a catalytic investment to facilitate broad adoption globally.”

The deliveries to Eswatini and Zambia demonstrate Gilead’s swift progress toward enabling sustainable, long-term availability of lenacapavir for PrEP in low- and lower-middle-income countries, if approved. Speed has been one of Gilead’s guiding principles, driving the company to introduce lenacapavir to the first sub-Saharan Africa countries just five months after U.S. FDA approval. Gilead anticipates product arrival in additional sub-Saharan Africa countries, including South Africa, in early 2026.

By the end of 2025, Gilead intends to complete regulatory submissions for lenacapavir for PrEP in 18 countries that represent approximately 70% of the HIV burden in the region covered by the company’s voluntary licensing agreements. In sub-Saharan Africa, lenacapavir for HIV prevention has been approved in South Africa and Zambia. Gilead has filed regulatory submissions so far in Botswana, Kenya, Malawi, Namibia, Rwanda, Tanzania, Uganda and Zimbabwe.

Gilead has secured royalty-free agreements with six generic manufacturers to cover 120 high-incidence, resource-limited countries that account for a large share of the global HIV burden. These agreements allow these manufacturers to seek regulatory approvals for their own generic versions of lenacapavir for PrEP and provide access in sufficient volumes to meet demand and generate competition to drive down costs. Gilead will supply lenacapavir at no profit for up to two million people until generic manufacturers are able to fully support demand in countries supported by the Global Fund and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) with the ability to produce additional supply to fulfill the needs of countries and global procurers.

Gilead remains deeply committed to delivering innovative, cost-effective solutions that strengthen global health security through initiatives to accelerate access to transformative HIV prevention tools like lenacapavir. By partnering with governments, advocacy groups and multilateral organizations to pursue the fastest paths to access, Gilead is working to ensure that lifesaving medicines reach those who need them most while fostering resilient health systems.

In middle-income countries with a high HIV burden that are not covered by Gilead’s voluntary licensing program and the agreements with the Global Fund and PEPFAR, Gilead is working with governments, regional bodies and partners to define and pursue the fastest paths to access.

Gilead will continue to provide updates on regulatory filings and other steps aimed at expanding access to lenacapavir for PrEP. We remain deeply engaged with stakeholders around the world, including community-based organizations, governments and multilateral organizations, to ensure that our access efforts help address the needs and preferences of the people and communities that could benefit from PrEP.

Lenacapavir for HIV prevention is not approved by any regulatory authority outside of U.S., EU, South Africa or Zambia. In Eswatini, lenacapavir was imported under an authorization issued by the Ministry of Health. This authorization was granted based on prior approval by a Stringent Regulatory Authority (SRA)—for example, the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) — and World Health Organization (WHO) Prequalification.

There is currently no cure for HIV or AIDS.

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 antiviral agents. While most antivirals 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. The journal Science named lenacapavir its 2024 “Breakthrough of the Year.”

U.S. Indication for Yeztugo^®

Yeztugo^® (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre‑exposure 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 for everyone, everywhere. Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS.

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 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 regulatory applications for lenacapavir for PrEP, 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; Gilead’s ability to effectively manage the access strategy relating to lenacapavir, subject to necessary regulatory approvals; 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, is available at www.gilead.com.

Yeztugo, Yeytuo, 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/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).

View source version on businesswire.com: https://www.businesswire.com/news/home/20251118297734/en/

Contacts:

Ashleigh Koss, Media
public_affairs@gilead.com

Jacquie Ross, Investors
investor_relations@gilead.com

Source: Gilead Sciences, Inc.