LATEST UPDATES
- Positive EU-M4all opinion: In July, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive EU-Medicines for all (EU-M4all) opinion, which enables a streamlined assessment for World Health Organization (WHO) prequalification and will facilitate national regulatory evaluations in low- and lower-middle-income countries.
- Global Fund agreement: In July, Gilead finalized an agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) to supply lenacapavir for PrEP for up to two million people in primarily low- and lower-middle-income countries.
Despite decades of progress, the world is still far from stopping the spread of HIV. We’re committed to doing our part to help end the epidemic – especially in areas with the greatest need.
We understand that long-acting HIV pre-exposure prophylaxis (PrEP) options are critical for people around the world who need additional choices to reduce their chances of acquiring HIV. We've developed an access plan to help address this need.
We're supporting access to lenacapavir for PrEP in low- and lower-middle-income countries (LLMICs) through a two-part strategy:
Progress to Date
We’re moving intentionally and with urgency to implement this access strategy on multiple fronts:
- Completed voluntary licensing agreements to generic companies: In October 2024, Gilead announced it signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical companies to manufacture and supply high-quality, low-cost versions of lenacapavir for 120 primarily LLMICs. These agreements were finalized well before any regulatory filing or decision, to enable these countries to quickly introduce generic versions of lenacapavir for PrEP, if approved.
- Completed technology transfer: In December 2024, tech transfers to the six generic manufacturers were completed within three months of the signing of the licensing agreements, so that manufacturers are able to ramp up production as quickly as possible.
- Pursuing accelerated global regulatory pathways: We’re working to secure approvals in key high-incidence, resource-limited countries as quickly as possible in relation to the recent U.S. approval and EU positive opinions. We’re following a strategic, phased approach formulated to facilitate the fastest possible registration for all priority countries:
- EU-M4all: In July 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive EU-Medicines for all (EU-M4all) opinion, which enables a streamlined assessment for World Health Organization (WHO) prequalification and will facilitate national regulatory evaluations in LMICs.
- WHO Prequalification: We plan to submit lenacapavir for PrEP for WHO prequalification in Q3 2025. WHO has announced that it expects to conclude the prequalification process by the end of 2025.
- WHO Stringent Regulatory Authority Collaborative Registration Procedure (WHO SRA CRP): We’ll leverage the WHO SRA CRP, which uses the regulatory expertise of stringent regulatory authorities to simplify the product evaluation and approval processes for other, national regulatory authorities, accelerating access to lenacapavir for PrEP.
- Prioritizing timely national regulatory submissions: In March 2025, Gilead submitted a new medicine application for lenacapavir for PrEP in South Africa and a registration application in Brazil. The applications will be reviewed under each country's regulatory framework for medicines registration. Additionally, now that lenacapavir for PrEP has received FDA approval and a potential EU approval, regulatory submissions are planned in Argentina, Mexico and Peru. Also, as Gilead has received a positive EU-M4all opinion for lenacapavir for PrEP, Gilead can pursue swift submissions to the National Regulatory Authorities in LMICs, utilizing the EU-M4all opinion to facilitate an accelerated review timeline.
- Ensuring supply for low- and lower-middle-income countries: We will continue to work with local stakeholders to help facilitate rapid rollout of lenacapavir for PrEP. We are taking concrete actions to meet our commitment to provide Gilead-supplied product to countries covered by the voluntary licenses at no profit to Gilead, until our voluntary licensing partners are able to fully support demand. We’re actively consulting with the Global Fund to understand product demand and collaborate on distribution and we’ve contracted at-risk manufacturing capacity to produce vials of lenacapavir for PrEP and corresponding oral initiation doses. Together, these steps will ensure supply of lenacapavir for PrEP to up to two million people in the countries covered by the voluntary licensing agreements until generics fully meet demand, with the ability to produce additional supply to fulfill the needs of countries and global procurers.
Extending Access Across More Countries
In middle-income countries with a high burden of HIV that are not covered by the Global Fund agreement and voluntary licensing program, we’re pursuing multiple strategies to support access to lenacapavir for PrEP, including tiered pricing and potential public-private partnerships, and we’re working with payors to establish fast, efficient pathways to help reach those who need or want PrEP. We’re also exploring options with partners, including the Pan American Health Organization (PAHO), to support countries outside the voluntary license scope.
We’ll 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 help ensure that our access efforts address the needs and preferences of the people and communities that could benefit from PrEP.
Our strategy reflects input from more than 100 global health stakeholders. Through these discussions, four essential priorities have consistently emerged: delivering lenacapavir for PrEP with speed, at sufficient volume to meet demand, at prices that enable widespread availability and in coordination with partners on the ground. These priorities are guiding every step of our strategy. We continue to work closely with stakeholders around the world — including community organizations, governments and multilateral organizations — to ensure our efforts help address the needs and preferences of the people and communities that could benefit from PrEP.
Our History of Supporting Global Access to Medicines
We’re proud of our two decades of innovation and leadership in global access to medicines. Our partnerships with generic drug manufacturers have helped enable millions of people to benefit from high-quality, low-cost therapies for HIV, viral hepatitis and COVID-19.
8.3 Million
Treatments for COVID-19 have been made available in 65 countries to date
2.7 Million
Treatments for HCV have been made available in 64 countries to date
14.8 Million
Treatments for HIV and HBV were made available in 93 LLMICs in 2024
In total, more than 25 million treatments for HIV, HBV, HCV and COVID-19 have been made available in LLMICs as a result of partnerships with generic licensees, governments and NGOs.
About Lenacapavir
Lenacapavir is approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals. Lenacapavir is also approved in the United States to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg who are at risk of HIV acquisition.
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.