Government will begin rolling out the long-acting HIV prevention injection lenacapavir from March/April 2026, targeting communities with the highest infection rates, Cabinet said after its meeting on 15 October 2025.

According to the update, the first phase will focus on 23 high-incidence districts across six provinces, with about 360 high-performing public clinics earmarked to deliver the service. Lenacapavir is a twice-yearly pre-exposure prophylaxis (PrEP) option that offers protection for six months per dose, designed for people at substantial risk of HIV who struggle to use daily oral PrEP consistently.

Cabinet said the introduction forms part of South Africa’s push to reduce new HIV infections to below 0.1% by 2032, and will add to the existing prevention package of condoms, oral PrEP, treatment-as-prevention, and voluntary medical male circumcision.

What is lenacapavir and why now?

Developed by Gilead Sciences, lenacapavir is the first six-monthly PrEP injection. The medicine received rapid regulatory approvals from major agencies in 2024–2025, followed by a World Health Organization recommendation this year. It requires a short oral “lead-in” (two tablets on the day of the first injection and two the next day) to quickly reach protective levels, after which clients return every six months for injections.

Global health partners say long-acting PrEP could be transformational for prevention, especially for young women and other groups for whom taking a pill every day is difficult. UNAIDS estimates 1.3 million people acquired HIV in 2024, underscoring the need for new tools alongside proven methods.

Affordability pathway from 2027

In a separate development that strengthens South Africa’s longer-term access plans, Wits RHI, Unitaid and the Clinton Health Access Initiative (CHAI) announced a landmark agreement on 24–25 September 2025 with Dr. Reddy’s Laboratories to supply quality-assured generic lenacapavir to 120 low- and middle-income countries at US$40 per person per year from 2027. The one-time oral initiation course will cost no more than US$17.

The generics deal, coupled with a parallel agreement involving another licensed manufacturer (Hetero) supported by the Gates Foundation, is intended to create a competitive, sustainable market and keep prices on par with oral PrEP. In the interim, PEPFAR and the Global Fund have committed to procure the branded product for up to 2 million people in LMICs, helping countries bridge access before generics arrive.

What happens next in SA?

Health authorities will finalise delivery sites, clinical guidance, and client-education materials for the 2026 pilot. As with other PrEP options, lenacapavir will be offered voluntarily to people at substantial risk, alongside HIV testing, condoms, STI services and contraceptive care. The Department of Health is expected to clarify eligibility criteria, consent processes for adolescents, and how the programme will integrate with current oral PrEP services.

Officials have not yet released province-by-province clinic lists or the precise number of people to be initiated in the first year. Pricing for South Africa’s 2026 rollout has also not been disclosed; the US$40 generic price applies from 2027 under the global agreement.

Why it matters

South Africa has the world’s largest HIV treatment programme but still faces stubbornly high incidence in some districts—especially among adolescent girls and young women. A twice-yearly option could improve adherence, expand choice, and reduce new infections when combined with comprehensive prevention and social support.

Key points at a glance

• Start date: March/April 2026

• Where: 23 high-incidence districts in six provinces, ~360 public clinics

• Product: Lenacapavir (PrEP), 2 injections per year, with short oral lead-in

• Goal: Drive new infections below 0.1% by 2032

• Affordability: Global deal targets US$40/year generics from 2027 in 120 LMICs; interim procurement support pledged by PEPFAR/Global Fund.

Further operational details—districts, sites, and client volumes—are expected from the Department of Health as implementation plans are finalised.

-The VIP Team 

-GCIS

-DoH