The first consignment of lenacapavir, a six-monthly HIV prevention injection for high-risk HIV-negative people, will reach less than a quarter of South Africa’s target population. Delivery of the injection, which is almost 100% effective, is taking place from now until April. Rollout will then begin immediately and end two years later.
The introduction of lenacapavir will not fully ease South Africa’s Aids crisis following the US funding withdrawal, but it offers significant potential for HIV prevention amid setbacks.
Called an HIV game-changer, the injection needs demand and compliance to work. It will be a strong contributor to ending the Aids epidemic, but doing this will require better HIV testing, even more effective antiretroviral (ARV) treatment rollout (2-million HIV-positive South Africans are not on ARVs), other prevention tools and compliance with prevention and treatment regimes. This needs targeted advocacy for young people and other high-risk groups, which is where lenacapavir comes into its own.
Mathematical models of lenacapavir’s impact show that 2-million to 4-million HIV-negative people need it each year for eight years. At that scale, new infections could drop below 0.1% by 2039, ending Aids as a public health threat sooner. A $29m Global Fund grant buys doses for 500,000 at-risk South Africans.
This needs a major scale-up from oral pre-exposure prophylaxis (PrEP), which requires a daily pill. Oral PrEP now reaches 2.1-million people, with 98% of public clinics offering it. That rollout took 10 years, from early 2016 to November 2025. Lenacapavir works if high-risk people get it consistently; it needs only two shots a year.
Hasina Subedar, chief technical adviser at the department of health, says 10% of primary health clinics (360) will offer it first, over two years. “We chose clinics that do well with oral PrEP, with enough HIV-negative people and high HIV rates, to cut incidence,” she says.
Prof Linda-Gail Bekker, an HIV researcher and CEO of the Desmond Tutu Health Foundation, adds: “We want to go to communities where the virus is circulating and probably tailor lenacapavir to young people who are sexually active in those communities. Obviously, it’s a choice thing, but I think if we take that strategy we’ll get the best value for our money. Making sure we get it to antenatal care and postnatal care is also a very intelligent way to use lenacapavir because that way we’ll be saving women’s lives but also eliminating vertical transmission.”
The question is just how many South Africans need to go onto lenacapavir for us to change the trajectory of the epidemic
— Linda-Gail Bekker
Subedar agrees, saying pregnant women take up PrEP well. They can get the first dose at three months pregnant and the second at birth, staying HIV-free for six months of breastfeeding, she says.
Subedar adds: “By February, we’ll be ready. The moment it hits our shores, we’ll be ready to roll.”
Bekker, who has been involved in HIV work for decades, says changing the course of the Aids epidemic requires multilevel interventions. One of these was regulatory approval for lenacapavir from the South African Health Products Regulatory Authority, which came in October. The others include a study, conducted by the Joint UN Programme on HIV/Aids, that started at Wits in December; and her Gates Foundation-funded study in 23 high-burden districts across 300 clinics.
Training has started, and Bekker says she hopes for delivery in March. “You must realise that half a million South Africans is just a drop in the ocean, so we’re hoping we’ll be scaling up when the generics come. The question is just how many South Africans need to go onto lenacapavir for us to change the trajectory of the epidemic.”
Between 7-million and 8-million South Africans are living with HIV, while new infections are estimated at 180,000 a year.
Research by the Health Economics & Epidemiology Research Office at Wits University shows that lenacapavir ends Aids seven to 10 years sooner than oral PrEP scale-up. South Africa needs 1-million to 2-million starters a year, at an extra cost of R650m-R1.5bn. The drug could also reduce HIV infections by an average of 32,200 a year with 1.4-million injections a year by 2030. With 2.1-million, it could reduce infections by 51,700 a year.
Bekker cites recent research done in Africa by Prof Nora Rosenberg: among 118-million girls and women aged 15-19 in 15 countries, 7.9-million (6.7%) using lenacapavir averted 130,000 infections. If 25.1-million (21.3%) were perfectly adherent, it would avert 260,000 infections. “Scale and adherence matter,” she says.
Rosenberg’s model highlights two risks: unsuppressed virus in communities and household members working away from home (unstable partners). South Africa’s migrant workers add challenges. “Real-world barriers will change outcomes,” Bekker says.
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