Lenacapavir – the highly effective HIV prevention medication that only requires two shots a year – is currently rolling out across African countries with a high burden of HIV. Initial data from countries such as Eswatini, Malawi, Mozambique and Kenya were shared at the 26th International AIDS Conference (AIDS 2026) in Rio de Janeiro, Brazil. Demand is already outpacing supply in some instances, with ambitious targets set for 2026 and beyond.
Countries are mostly obtaining lenacapavir through a programme set up between the US State Department, the Global Fund and Gilead Sciences. Gilead sells the drug at no profit, but at an undisclosed cost.
The programme aims to reach at least three million people with lenacapavir (LEN) by the end of 2028. This massive drive is in partnership with national governments, with high-, middle- and low-income countries simultaneously launching lenacapavir PrEP – a rare occurrence.
“Our goal is not just to launch LEN. It’s to get countries to use it strategically,” Professor Ingrid Katz, Director of the Yale Institute of Global Health and Chief of Evidence and Programme Innovation at the US Department of State, told the audience.
Across nine of the first wave of countries to offer lenacapavir, 191,620 doses have been delivered. This is around 14% of the planned total to be given in these countries in 2026 – over a million in total, with South Africa projected to give the most shots, at 345,000. Nearly 66,000 people have newly started on lenacapavir across 900 sites, while over 10,000 healthcare providers have been trained on lenacapavir administration in these nine countries: Eswatini, Kenya, Lesotho, Mozambique, Nigeria, South Africa, Uganda, Zambia and Zimbabwe.
Eswatini
Eswatini was the first country to provide lenacapavir shots in December 2025. Despite a very high adult HIV prevalence of 25%, the country has made great progress towards epidemic control: 98% of people with HIV are aware of their status, 99% are on treatment and 98% of those are virally suppressed.
However, Sindy Matse, Director of the Eswatini National AIDS Program, said that these population-level successes can mask what’s happening with subgroups who may have specific challenges, such as youth. For instance, all treatment cascade indicators are below 85% among youth aged 15 to 24. Thus, Eswatini prioritised groups such as adolescent girls and young women and pregnant and lactating women during their initial lenacapavir rollout. They also ensured that it was integrated and made available at primary healthcare, sexual and reproductive and antenatal care sites. One of the key aspects driving public awareness was King Mswati III’s public endorsement of PrEP. This helped to normalise PrEP, strengthen political commitment and accelerate implementation.
There are currently 32 sites offering lenacapavir in Eswatini. However, the implementation plan has already stalled due to supply chain limitations. While initiations were high for some months of this year, it’s been inconsistent due to limited medication availability. To ensure that returning clients can access their next injections, 10,000 doses have been kept aside and are not available for new clients.
Nearly a thousand – a third of all initiations among women – are adolescent girls and young women. As lenacapavir is safe and effective to use with pregnant and breastfeeding women too, just under 700 pregnant and breastfeeding women have also been started on lenacapavir PrEP.
Matse stated that a strong national foundation is in place and that early implementation has shown feasibility but it’s crucial to expand access, strengthen integration and continue to analyse the implementation data to improve demand creation. Eswatini will soon be launching key population friendly clinics and community outreach mobile clinics to ensure expanded access.
Malawi
In Malawi, HIV infections have gone down by 76% since 2010. However, there were an estimated 14,200 new cases in 2025, with communities such as female sex workers, people who inject drugs, adolescent girls and young women and gay and bisexual men mostly affected. Feliya Nyirenda from the Malawian Ministry of Health shared that since beginning their rollout in May, 303 clients had started lenacapavir by mid-July. Around 60% of them were taking PrEP for the first time, and over half are women, including three pregnant and ten breastfeeding women.
While a small number (under 5%) switched from oral PrEP, just over a third switched from long-acting cabotegravir to lenacapavir PrEP. According to Nyirenda, clients found the subcutaneous lenacapavir injections less painful than the intramuscular cabotegravir ones. However, some clients were afraid of abdominal site injections. Overall, lenacapavir has blended well into the existing landscape of HIV prevention options, with high acceptability from healthcare providers and clients alike. Its introduction and uptake are driving demand for increased HIV testing services and highlighting the need to better forecast how much lenacapavir will be required.
Mozambique
Mozambique has nearly 2.5 million people living with HIV, with 77,000 new infections in 2025 – young people between the ages of 15 and 24 are particularly affected.
“Lenacapavir complements – not replaces – existing HIV prevention options,” Aleny Cuoto, Director of the STI, HIV and AIDS Control Programme, Mozambican Ministry of Health, said. Despite only being launched in April, there have been nearly 10,000 lenacapavir initiations at 55 health facilities across three provinces. Lenacapavir has been integrated into their current prevention framework, provided by the existing healthcare workforce. After receiving a negative rapid test result, a dried blood spot sample is sent away for PCR testing; eligible clients can start lenacapavir once the negative result is confirmed. A decline in uptake in recent weeks has been due to limited drug availability and dried blood spot supplies, despite demand staying consistently high.
Cuoto shared that provider training and integration of lenacapavir into existing prevention structures is essential. Additionally, demand creation drives awareness of the new drug’s ease and convenience. However, it’s also essential that supply of the medication can keep up with this demand once it’s been created.
Kenya
Kenya has taken a strong key population-based approach. Dr Barbara Mambo, Head of HIV Prevention at the National AIDS and STI Control Programme, presented data on how challenges were managed with some takeaways for other countries in the early adoption phase.
Kenya is using a mixed delivery model, integrating multiple channels, such as facilities specifically for people who use drugs. Thus, they’re leaning on already trusted services that key populations are familiar with, including drop-in centres staffed and used by female sex workers, gay and bisexual men, and people who inject drugs. As a result, they’ve had over 4000 lenacapavir initiations from members of key populations. Additionally, peer navigators have visited bars, brothels and truck stops, reaching 21 sites. To assist lay providers, a PrEP choice toolkit was used which include scripts and visual aids for people with low literacy levels.
Mambo described barriers such as stigma and confidentiality concerns, as well as logistical barriers, such as clinic hours not matching key population members’ work schedules. To counter these, lenacapavir delivery remained within existing key population networks and service provision. Additionally, materials were co-designed with communities to avoid generic messaging. Drawing on established trust, along with the use of peer educators, helps lenacapavir to be viewed favourably and has assisted with debunking misinformation. To assist with logistical challenges, after-hours services and mobile outreach teams were used – Mambo emphasised that it’s about meeting community members where they’re at.
Key lessons from early implementation in these countries show that while demand creation is essential, it’s equally important to be able to keep up with that demand once communities indicate interest. In all instances, existing services and staff were used to ensure seamless integration. Lenacapavir has been introduced as another PrEP option that complements existing options. However, it’s clear that for many people, its high effectiveness with less frequent dosing, positions it as the superior option.
From product to impact: National strategies to scale Lenacapavir and accelerate HIV epidemic control. 26th International AIDS Conference, Rio de Janeiro, satellite session 55, 2026.
View the details of this session on the conference website.
Expanding prevention choice: Early lessons from twice-yearly Lenacapavir introduction. 26th International AIDS Conference, Rio de Janeiro, satellite session 39, 2026.
View the details of this session on the conference website.
Image credit: Photo © Dominic Chavez/The Global Financing Facility. Available on Flickr under a Creative Commons licence CC BY-NC-ND 2.0.