By Dr. Karin Hatzold, Global Infectious Diseases Lead, PSI
World AIDS Day 2025 marks a landmark moment for HIV prevention in Eswatini and for the global HIV response.
Today, Eswatini commemorated World AIDS Day with a historic milestone: the first doses of lenacapavir (LEN)—a twice-yearly injectable pre-exposure prophylaxis (PrEP) medication—were offered to clients across five clinics in all four regions of the country. With this early introduction, Eswatini becomes one of the first two countries in Africa, alongside Zambia, to adopt lenacapavir for HIV prevention.
The first doses on the African continent were administered today at Hhukwini Clinic in the Hhohho region near Mbabane as part of the World AIDS Day and lenacapavir launch event. Twenty-three clients attended the clinic to receive their initial injection, with the very first dose of lenacapavir given to a young woman from the same area.
Lenacapavir marks a major advancement in HIV prevention. Unlike daily oral PrEP—which can be challenging to adhere to—lenacapavir is administered only once every six months, making it the longest-acting PrEP option currently available. The only other injectable PrEP product, cabotegravir, requires dosing every two months and more frequent clinic visits.
Population Services International (PSI), together with the Clinton Health Access Initiative (CHAI), WitsRHI, and other national partners, is supporting Ministries of Health across nine early-adopter African countries in preparing for and introducing lenacapavir. This work is funded by Unitaid, the Children’s Investment Fund Foundation (CIFF), and the Global Fund. Support includes regulatory and policy processes, development of training tools, training and implementation planning, monitoring and evaluation tools and demand creation strategies.
In 2024, the PURPOSE 1 and PURPOSE 2 trials demonstrated strong efficacy of lenacapavir for HIV prevention: 100% efficacy among 5,300 cisgender women in Uganda and South Africa, and a 96% reduction in HIV incidence among cisgender men, transgender people, and non-binary individuals across multiple countries.
Regulatory progress has been rapid. The U.S. Food and Drug Administration (FDA) approved injectable lenacapavir for PrEP in June 2025, followed by the European Medicines Agency (EMA) in August 2025, and by the European Union-Medicines for all (EU-M4all) – a regulatory pathway by EMA and WHO to issue scientific opinions on medicines and vaccines for use outside the EU. WHO prequalification was granted in October 2025. Zambia, South Africa, and Zimbabwe have already approved and registered the drug, and Eswatini has issued an import authorization, making this one of the fastest pathways for a health product to reach low- and middle-income countries.
The first 500 doses of lenacapavir arrived in Zambia and Eswatini in mid-November. Beginning on World AIDS Day, five clinics—Hhukwini, Horo, Siteki Nazarene, AIDS Healthcare Foundation (AHF), and Gege in Eswatini—are now offering lenacapavir as an additional PrEP option for people who consider themselves at increased risk of HIV acquisition. While lenacapavir will be offered primarily through public health facilities, private-sector and NGO facilities are also included to broaden access. Additional shipments for Eswatini are expected in late December 2025, with deliveries to other countries following in early January. Driven by the rapid expansion of lenacapavir, this groundbreaking HIV prevention method is planned to be available nationwide by 2027, reaching over 200 facilities.
As the world renews its commitment to ending AIDS by 2030, equitable access to HIV prevention tools remains essential — reaching vulnerable populations, those most at risk, and the last mile to ensure no one is left behind. The introduction of lenacapavir in Eswatini, Zambia, and soon many other African countries is a concrete step toward that goal—strengthening and expanding HIV prevention options while supporting health systems to deliver efficient services that meet people’s needs.
