While Health Minister, Dr Aaron Motsoaledi, is still to announce the date for the launch of the game changing HIV prevention medication Lenacapavir, the injectable will help the country in its fight against HIV, while also benefiting South Africans.
Lenacapavir is administered via injection twice a year, offering six months of continuous protection per dose and offers a welcomed relief from daily pills or the bi-monthly injections.
The first batch of the HIV prevention medicine, which is a new, long-acting antiretroviral drug – specifically an HIV-1 capsid inhibitor that is used for HIV prevention (as PrEP) – arrived in the country in early April.
The medicine’s six-monthly dosing schedule has the potential to overcome many of the barriers South Africa has experienced with daily oral PrEP. This as it offers greater discretion, convenience, and likely better adherence for users, especially for people who struggle with taking a pill every day or making frequent clinic visits.
The delivery of the medication is part of integrated, differentiated and people-centred HIV prevention services, offering new hope for people who face barriers to existing HIV prevention methods.
The six-monthly HIV injectable is expected to expand HIV prevention choices, improve adherence, especially amongst the most vulnerable priority groups, including adolescent girls and young women, sex workers, and men having sex with men, among others.
South Africa received the first batch of 37 920 doses of the medicine that the Department of Health has described as a preventive medicine, not a vaccine.
The department said Lenacapavir is a preventive medicine, not a vaccine, considered one of the most significant HIV prevention advances in years.
According to the World Health Organisation (WHO) Guidelines on Lenacapavir for HIV prevention, the organisation recommends offering the injectable as an additional HIV prevention choice.
Among the benefits of the drug is that it need not be discontinued during pregnancy and breastfeeding for HIV-negative women with a high likelihood of exposure to HIV, said the WHO.
In tabling the Department of Health’s Budget Vote in July last year, Motsoaledi said government plans to offer the drug to young women, and everyone at risk to stay HIV-free. This as women and girls have carried the greatest burden of the HIV epidemic.
“To reach our goal of ending AIDS as a public health threat and achieve the UNAIDS [Joint United Nations Programme on HIV/AIDS] target of 95% of people at risk having access to prevention options, we must continually improve and expand our prevention toolkit,” the Minister said at a roundtable session last October.
The department said that condoms were not being used as widely as it would like and that when coming to the taking of oral PrEP, many users find it difficult to take a pill every single day due to stigma, pill fatigue, or life circumstances.
Making HIV prevention easier
Announcing the registration of the injectable in October 2025, the South African Health Products Regulatory Authority (SAHPRA) said the antiviral medicine was developed to prevent new HIV infections with its initiation dose of a subcutaneous injection (administered just under the skin) with tablets (taken on days 1 and 2).
“It is used to reduce the risk of HIV in adults and adolescents who weigh at least 35 kg; are HIV negative, and are at risk of getting HIV. Lenacapavir for PrEP should always be used in combination with safer sex practices, such as using condoms, to reduce the risk of getting other sexually transmitted infections,” said SAHPRA.
SAHPRA is an entity of the National Department of Health.
In the Guidelines of the WHO, evidence on the safety and efficacy for HIV prevention of the medicine “was collected in a systematic review of peer-reviewed scientific reports”, whereby 12 eligible reports were included, containing data from two studies.
“The two included studies, namely PURPOSE 1 (5) and PURPOSE 2 (6), were multi-centred, double-blind, randomized, activecontrolled trials,” said the WHO.
The Department of Health said the clinical trials of PURPOSE showed outstanding efficacy.
“In one trial among women, it showed 100% efficacy within the study period – and in another trial amongst men who have sex with men and transgender women, efficacy was around 96%. On the strength of this evidence, the WHO this year issued new guidelines recommending Lenacapavir as an additional HIV prevention choice,” said the department.
South Africa’s rollout of the medicine will prioritise pregnant and breastfeeding women, adolescent girls and young key populations, female sex workers, and men who have sex with men to “yield the highest impact”.
The department’s approach of the rollout of the injectable is data driven.
The department plans to rollout Lenacapavir initially to about 23 high-incidence districts across six provinces, targeting around 360 high-performing public clinics within areas for Phase 1 implementation.
While the launch date of the game changer injectable is still to be announced, this seems to be a much-needed cog in the country’s toolkit against HIV.
Credit: SAnews.gov.za
