Eswatini, Zambia, and Zimbabwe Launch Lenacapavir for HIV Prevention; African Vaccine Trial Resumes
Eswatini, Zambia, and Zimbabwe have commenced the rollout of lenacapavir, a novel semi-annual injectable drug for HIV prevention manufactured by Gilead Sciences. This marks the initial availability of the drug in certain low- and middle-income countries. Concurrently, an African-led HIV vaccine trial, previously halted due to a U.S. foreign aid freeze, has resumed in South Africa with new, albeit reduced, funding. This dual development highlights both significant advancements in prevention and the ongoing complexities of global health funding.
Lenacapavir Rollout: A New Era in HIV Prevention
The U.S. State Department announced the initial distribution of 500 doses of lenacapavir to Eswatini and Zambia. This drug, which secured U.S. FDA approval in June, followed by endorsements from the World Health Organization and the European Medicines Agency in July, is designed for two injections per year, offering near-complete protection against HIV infection. Zimbabwe has also begun its rollout, positioning itself as one of the first African nations to implement the program.
Initial Distribution and Global Strategy
In Zimbabwe, the introduction of lenacapavir is centered in Harare. It targets identified high-risk populations, including young women, sex workers, adolescent girls, gay men, and pregnant and breastfeeding women. Projections indicate that approximately 46,000 individuals across 24 sites are expected to benefit during this initial phase in Zimbabwe.
The rollout is supported by the United States President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund, who are also partners with Gilead Sciences and the U.S. State Department in a broader initiative.
This wider objective aims to supply at least 2 million doses to countries with high HIV burdens, primarily in Africa, by 2028. The U.S. State Department committed to this investment in September, anticipating the procurement of over half a million doses next year.
Gilead Sciences has confirmed the initial 500 doses are supplied at cost and plans to provide up to 2 million doses before licensed generic manufacturers become operational.
Regulatory Landscape and Future Plans
Regulatory approvals for lenacapavir have been secured in Zambia and South Africa, while Eswatini's Ministry of Health issued a distinct import authorization. Gilead has submitted applications for approval in Botswana, Kenya, Malawi, Namibia, Rwanda, Tanzania, Uganda, and Zimbabwe, with further applications planned. The company prioritizes 18 countries identified as having high HIV burdens, collectively representing 70% of the HIV epidemic.
Health ministries are primarily responsible for drug distribution, often engaging community and non-governmental organizations for support. Notably, the U.S. does not plan to fund lenacapavir doses for South Africa, encouraging the country to fund its own supply.
African-Led HIV Vaccine Trial Resumes Amid Funding Challenges
Separately, the BRILLIANT Consortium, an African-led initiative focused on developing an HIV vaccine, faced significant funding disruption. In 2023, the consortium had secured a $45 million grant from the U.S. Agency for International Development (USAID) to address HIV's impact in sub-Saharan Africa. Plans for vaccine trials were progressing, with a meeting in Zanzibar in early 2025 set to finalize preparations for an imminent launch.
The BRILLIANT Consortium's Initial Setback
However, an executive order signed on January 20, 2025, by President Trump froze all foreign aid pending a review, leading to reductions within USAID programs. This resulted in stop-work orders for the BRILLIANT Consortium, suspending the trials just before participant enrollment was scheduled to begin.
Researchers, including Penny Moore, a virologist at the University of the Witwatersrand in South Africa, described the extensive preparation required for clinical trials, emphasizing the scientific basis for the vaccine and the urgency of its need.
The vaccine strategy aims to induce broadly neutralizing antibodies, building on two decades of U.S.-supported research.
Resumption and Scaled-Down Approach
Following the USAID grant cancellation, South African researchers developed an alternative plan, scaling back the initiative to focus solely on South Africa. The project subsequently secured support from the South African Medical Research Council and the Gates Foundation. The new funding amounted to approximately one-twentieth of the original USAID grant, with no U.S. government funding for the revised project.
After nearly a year of delays, participant screening for the scaled-down trials has commenced in Philippi Village, an impoverished township in Cape Town heavily affected by HIV. Community liaison officers stress the importance of local participation, regarding communities and participants as equal partners. The first vaccine injections for new trial participants are scheduled to occur in the following week.
Global Health Initiatives: Persistent Challenges and Future Outlook
The rollout of lenacapavir and the experience of the BRILLIANT vaccine trial underscore ongoing challenges in global health. Mitchell Warren, Executive Director of the AIDS Vaccine Advocacy Coalition (AVAC), noted that the drug rollout coincides with existing political and economic challenges within the global AIDS response, including foreign aid reductions.
He stated that disrupted care could potentially contribute to an increased HIV burden and emphasized that effective utilization of drug doses depends on operational delivery programs.
Zimbabwe's Context and Broader Implications
In Zimbabwe, despite lenacapavir's potential to improve adherence compared to daily oral pre-exposure prophylaxis (PrEP), Dr. Ernest Chikwati, program director at Aids Healthcare Foundation, advised that it is not a singular solution for HIV prevention, stressing the continued importance of existing methods like condoms and daily oral PrEP. Challenges in the country include funding constraints, infrastructure gaps, and the ongoing need to keep patients engaged in prevention strategies.
Cesar Nunez, director of the UNAIDS New York Office, stated that HIV prevalence among adolescent girls and young women in sub-Saharan Africa is consistently triple that of their male counterparts, driven by factors such as gender inequality, poverty, and uneven access to health services. Nunez also indicated that a lack of funding for community responses, largely dependent on foreign assistance, is affecting progress and could contribute to an estimated 1.4 million annual new infections by 2030.
Zimbabwe, alongside Eswatini and Zambia, has achieved World Health Organization targets for testing, treatment, and viral suppression, although new infections persist as a concern. The Zimbabwean government hopes to increase beneficiaries as more donor-funded doses arrive and aims to acquire its own doses for a mass rollout, acknowledging financial limitations.