South Africa is preparing to roll out one of the most significant HIV prevention advances in years: lenacapavir, a long-acting injectable that offers six months of continuous protection from just one dose, twice a year.
The first batch of 37 920 doses arrived in the country in early April, and the Department of Health is now laying the groundwork for a carefully targeted national rollout, with Health Minister Dr Aaron Motsoaledi expected to announce the official launch date.
Why Two Injections a Year Change Everything
Lenacapavir is a new long-acting antiretroviral – an HIV-1 capsid inhibitor used for pre-exposure prophylaxis (PrEP). Its six-monthly dosing schedule promises to overcome many of the barriers that have limited daily oral PrEP, offering greater discretion, convenience and better adherence for people who struggle with taking a pill every day or making frequent clinic visits.
The evidence behind the medicine is remarkable. In the PURPOSE clinical trials, lenacapavir showed 100% efficacy among women within the study period, and around 96% efficacy in a second trial among men who have sex with men and transgender women. On the strength of those results, the World Health Organisation this year issued new guidelines recommending lenacapavir as an additional HIV prevention choice – noting, too, that it need not be discontinued during pregnancy and breastfeeding for HIV-negative women at high risk of exposure.
The South African Health Products Regulatory Authority (SAHPRA) registered the injectable in October 2025 for adults and adolescents weighing at least 35 kg who are HIV negative and at risk of infection, to be used alongside safer sex practices such as condoms.
A Data-Driven Rollout Where It Matters Most
The Department of Health plans to introduce lenacapavir initially in about 23 high-incidence districts across six provinces, targeting around 360 high-performing public clinics in the first phase. The rollout will prioritise the groups carrying the greatest burden of the epidemic, including pregnant and breastfeeding women, adolescent girls and young women, female sex workers, and men who have sex with men.
“To reach our goal of ending AIDS as a public health threat and achieve the UNAIDS target of 95% of people at risk having access to prevention options, we must continually improve and expand our prevention toolkit,” Motsoaledi said.
The department has stressed that lenacapavir is a preventive medicine, not a vaccine, and describes it as one of the most significant HIV prevention advances in years. It arrives as part of integrated, people-centred HIV prevention services designed to offer real choices to those who face barriers to existing methods.
New Hope in a Long Fight
For a country that has carried one of the world’s heaviest HIV burdens – and led some of its most determined responses – the arrival of a twice-yearly injection is a genuine turning point. With doses in the country, regulatory approval secured and a clinic network identified, South Africa is poised to put one of the world’s most powerful new prevention tools directly into the hands of the people who need it most.
The rollout plans were reported by SAnews.
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