Five months after U.S. regulators approved lenacapavir, a long-acting HIV prevention injection, the U.S. State Department announced on Nov. 18, 2025 that Eswatini and Zambia have each received 500 doses. The drug, produced by Gilead Sciences and described in scientific coverage as a major innovation, can protect against HIV with just two injections per year. The delivered shipments are an initial step toward a Global Fund–backed target of supplying at least 2 million doses to the highest-burden countries by 2028. Officials and advocates say the arrival is welcome but that significant delivery and systems challenges remain.
Key Takeaways
- Eswatini and Zambia each received 500 doses of lenacapavir, announced by the U.S. State Department on Nov. 18, 2025.
- Gilead Sciences has pledged to provide doses at cost and cover up to 2 million doses before generic manufacturers scale up.
- The Global Fund, Gilead and the U.S. government aim to make at least 2 million doses available to high-burden countries by 2028, with procurement plans that could accelerate delivery into 2027.
- Lenacapavir received U.S. FDA approval in June 2025 and subsequent endorsements from WHO and the European Medicines Agency in July 2025.
- Regulatory approvals in sub-Saharan Africa so far include Zambia and South Africa; Eswatini issued an import authorization serving as its approval pathway.
- Gilead has filed for approvals in multiple African countries, including Botswana, Kenya, Malawi, Namibia, Rwanda, Tanzania, Uganda and Zimbabwe.
- Delivery challenges persist: injectable PrEP requires clinic capacity, trained staff and community outreach—systems some countries lost capacity in recent years.
Background
Lenacapavir is a long-acting injectable formulated to prevent HIV infection with two subcutaneous injections a year, a departure from daily oral PrEP regimens. Researchers and advocates have framed the drug as a potential game-changer for populations who struggle with daily pill adherence. Major regulators cleared the product in mid-2025: the U.S. Food and Drug Administration in June and the World Health Organization and European Medicines Agency in July. Those endorsements opened the path for rapid applications and emergency import authorizations across countries with the highest HIV burdens.
Global donors and manufacturers have signaled commitments to expand access. The U.S. State Department announced an initiative to procure doses, Gilead has pledged at-cost supply before generics are available, and the Global Fund has been named a partner in the effort to reach priority countries. Still, most low- and middle-income countries rely on intertwined delivery networks: ministries of health, international donors, community organizations and nongovernmental partners—many of which face funding shortfalls or were weakened by past budget cuts.
Main Event
On Nov. 18, 2025, the State Department said Eswatini and Zambia had each been shipped 500 doses of lenacapavir supplied by Gilead at cost. A senior State Department official, Jeremy Lewin, told reporters the U.S. expects to procure more than half a million doses collectively in the coming year and projected that the 2 million-dose goal could be reached in mid- to early-2027 if supply and approvals proceed. Gilead CEO Daniel O’Day confirmed the company is providing early doses without profit and intends to supply up to 2 million doses prior to licensed generic production.
Regulatory status is mixed: Zambia and South Africa have granted approvals, Eswatini issued an import authorization, and filings are underway in a string of other high-burden countries across southern and eastern Africa. Access will depend on each country’s regulatory timetable and on national decisions about financing and distribution. The U.S. said it will prioritize supporting national self-reliance, with ministries of health responsible for national rollouts and community partners often asked to execute on-the-ground delivery.
Advocates caution that supply alone is not enough. Mitchell Warren of the AIDS Vaccine Advocacy Coalition (AVAC) described the shipments as a ‘‘down payment’’ and stressed that past cuts to foreign aid and program funding have weakened systems that would identify people at risk, offer counseling, and provide injections in community settings. AVAC and other implementers had been building capacity specifically for injectable HIV prevention, and some of those initiatives experienced interruptions earlier in the year.
Analysis & Implications
The lenacapavir rollout highlights a recurring pattern in global health: technological breakthroughs can arrive faster than the systems that deliver them. Two annual injections simplify adherence compared with daily pills, but they require clinic visits, cold-chain and supply management, trained personnel, and data systems to track follow-up doses. Countries with constrained health workforces or reduced NGO support may struggle to convert early doses into population-level protection.
Strategically, prioritizing 18 high-burden countries that represent roughly 70% of the epidemic concentrates limited early supplies where they could have the biggest impact. If procurement and regulatory timelines proceed, reaching 2 million doses could significantly expand prevention options for key populations, including people who struggle with daily pill adherence, sex workers, people who inject drugs, and others at elevated risk. Yet impact depends on reaching those groups through tailored service delivery models.
There are political and financial risks. Advocates point to funding shortfalls and past U.S. foreign aid reductions as factors that reduced implementation capacity. If national governments and donors do not fill those gaps, early stocks risk underuse. Conversely, coordinated investment in community-led delivery, workforce training and monitoring could make lenacapavir a pivotal tool in reversing epidemic trends in hard-hit countries.
Comparison & Data
| Item | Timing/Amount |
|---|---|
| U.S. FDA approval | June 2025 |
| WHO & EMA positive assessments | July 2025 |
| Initial shipments | 500 doses each to Eswatini & Zambia (Nov. 18, 2025) |
| Early supply pledge | Gilead: up to 2 million doses pre-generic |
| Global target | 2 million doses to high-burden countries by 2028 |
The table summarizes the regulatory timeline and early supply commitments through late 2025. While approvals in major regulators accelerated interest, the volume of doses available for immediate distribution remains limited relative to need; achieving broader coverage will require scale-up by manufacturers and steady procurement by donors and governments.
Reactions & Quotes
This is somewhat unprecedented, to see an innovation in global health move this fast to low- and middle-income countries. These initial doses are a down payment, but we need many more and stronger delivery programs.
Mitchell Warren, Executive Director, AVAC (advocacy NGO)
We expect to procure more than half a million doses next year and believe we can hit the two‑million target in mid‑ to early‑2027 if approvals and supply continue to progress.
Jeremy Lewin, Senior Official for Foreign Assistance, U.S. State Department (official briefing)
We are supplying doses at cost and plan to provide up to 2 million doses before generic manufacturers are licensed.
Daniel O’Day, CEO, Gilead Sciences (company statement)
Unconfirmed
- Exact Gilead on-hand inventory: public statements confirm pledges but do not specify the full current stock available for rapid distribution.
- Precise national rollout schedules beyond the initial Eswatini and Zambia consignments remain subject to each country’s regulatory processes and procurement decisions.
- The degree to which recently reduced external funding will limit community-based delivery programs in specific countries has not been fully quantified.
Bottom Line
The shipment of lenacapavir doses to Eswatini and Zambia marks an important early move toward expanding long-acting HIV prevention in high-burden African settings. Regulatory clearances in mid-2025 and early company and donor pledges create a credible pathway toward broader access, but current supplies are limited and unevenly distributed.
Converting doses into public-health gains will require renewed investment in delivery systems, active engagement with community organizations, and clear national strategies for prioritizing populations at highest risk. If procurement, regulatory approvals and delivery systems align, lenacapavir could materially broaden prevention options and contribute to epidemic control.