Gilead Sciences expands global access to lenacapavir for HIV prevention, targeting 3 million people by 2028 with support from PEPFAR and The Global Fund.
Written By: Vennela Reddy, BPharm
Reviewed By: Pharmacally Editorial Team
Gilead Sciences announced that the U.S. Department of State, President’s Emergency Plan for AIDS Relief (PEPFAR), and The Global Fund will further invest in its twice-yearly injectable HIV prevention therapy, Lenacapavir. The expanded commitment aims to reach up to 3 million people in high-incidence, resource-limited countries by 2028, including an additional 1 million individuals under the latest agreement.
Delivery Infrastructure Targets High-Need Regions
The collaboration combines financing with on-the-ground delivery expertise. PEPFAR and The Global Fund bring established distribution networks and country-level implementation capabilities, enabling rapid deployment to populations at greatest risk. Lenacapavir has already reached communities in sub-Saharan Africa, with initial shipments delivered in late 2025, the same year it received approval in the United States.
Company Strategy Balances Access and Scale-Up
According to CEO Daniel O’Day, Lenacapavir represents a major advancement in HIV prevention, with the company prioritizing rapid and broad access. He stated that Gilead is supplying the drug at no profit to PEPFAR and The Global Fund in high-need countries while preparing for wider affordability through generics. Large-scale generic rollout is expected to begin in 2027, supported by voluntary licensing agreements with six manufacturers.
Generic Manufacturing Preparation Underway
Gilead has accelerated steps required for generic production, and several countries and program implementers have already initiated engagement with licensed manufacturers. This approach is intended to ensure a smoother transition to large-scale access once generics become available.
Addressing a Persistent Global Burden
With approximately 1.3 million new HIV infections reported globally each year, expanding access to long-acting prevention options remains a critical public health priority. Increasing availability of effective PrEP therapies like Lenacapavir could help reduce transmission rates and long-term healthcare burden. There is currently no cure for HIV or AIDS.
Lenacapavir: A Multi-Stage Antiviral Approach
Lenacapavir is approved in multiple countries for both HIV prevention (PrEP) and treatment of multidrug-resistant HIV, in combination with other antiretrovirals. Unlike traditional antivirals that act on a single stage of viral replication, Lenacapavir targets multiple stages of the HIV lifecycle and has shown no known cross-resistance in vitro with existing drug classes.
The therapy is being further evaluated in ongoing clinical studies as part of Gilead’s broader HIV research program. Development efforts aim to support a range of long-acting options, including injectable and oral formulations with varying dosing schedules.
Regulatory Status in the United States
In the U.S., Lenacapavir is marketed as Yeztugo injection (463.5 mg/1.5 mL) for pre-exposure prophylaxis. It is indicated to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg, with a confirmed negative HIV test required prior to initiation.
Recognition of Scientific Impact
The journal Science named lenacapavir its 2024 “Breakthrough of the Year,” underscoring its scientific significance in HIV prevention. This recognition was further reinforced by the Prix Galien USA Award 2025, which honors outstanding advancements in life sciences, and its inclusion in TIME Best Medical Inventions 2025. Together, these distinctions reflect broad acknowledgment across the scientific and medical communities of Lenacapavir potential to transform HIV prevention strategies at a global scale.
Reference
About the Writer
Vennela Reddy, B.Pharm is a pharmacy graduate with a keen interest in clinical research, pharmacovigilance, and medical writing, with a growing focus on publishable and scientific content development. In her words, she is passionate about translating complex medical data into clear, evidence-based communication.