Breakthrough HIV prevention jab gets the nod in South Africa

The South African Health Products Regulatory Authority (SAHPRA) has announced the registration of Lenacapavir (LEN), a ground-breaking HIV prevention jab that provides six months of protection at a time.

Named the “breakthrough of the year” for 2024 by the respected journal Science, this injectable antiviral offers up to six months of protection per shot, providing a significant advancement over daily oral pre-exposure prophylaxis (PrEP).

LEN should always be used with safer sex practices, such as condom use, to further reduce the risk of sexually transmitted infections, following an initiation phase that includes tablets taken on days 1 and 2.

The official Science article highlights LEN’s potential to overcome adherence challenges faced by daily oral PrEP and bimonthly injections, particularly for populations facing stigma and access challenges.

Clinical trials have demonstrated its high efficacy, achieving 100% protection in African adolescent girls and women, and 99.9% in gender-diverse groups across continents.

The drug’s novel mechanism targets HIV’s capsid protein, blocking key stages of viral replication.

Initially developed as a rescue therapy for patients resistant to other drugs, LEN’s long-lasting injectable form now positions it as a game-changer in HIV prevention.

“The registration of Lenacapavir is a game-changer, given the high prevalence rate of HIV in South Africa. This product is the most effective HIV prevention measure thus far,” said Dr Boitumelo Semete-Makokotlela, CEO of SAHPRA.

As noted by Bhekisisa health editor Mia Malan, South Africa is the first African country to register the revolutionary twice-a-year anti-HIV jab.

SAHPRA said Gilead submitted an application in March 2025, reviewed through the European Medicines for All Procedure, allowing regulators to provide scientific opinions on high-priority medicines like Lenacapavir for markets outside the EU.

Rollout plan and South Africa’s HIV history

The approval helps to clear the way for a limited public sector rollout of the “game-changing” shot set to start in early 2026.

Health Minister, Dr Aaron Motsaoledi, said in a prepared speech at the round table that the initial rollout will focus on those populations at highest risk of HIV.

“In particular, prioritising pregnant and breastfeeding women (PBFW), adolescent girls and young key populations (AGYW), female sex workers (FSW), and men who have sex with men (MSM), would yield the highest impact,” he said.

The plan is to expand the programme to more clinics in the years that follow.  

HIV prevalence in South Africa remains among the highest globally, with an estimated 16.7% of adults aged 15-49 years living with HIV as of mid-2024, according to StatsSA.

The HIV epidemic surged in the 1990s due to multiple factors, such as limited early prevention. By the early 2000s, it had skyrocketed, creating widespread orphanhood and straining healthcare and the economy.

Government AIDS denialism under President Thabo Mbeki delayed ARV rollout. This inaction is estimated to have led to between 330,000 and 365,000 preventable deaths.

Policy shifts under President Jacob Zuma from 2009 expanded free ARV access, cutting annual AIDS deaths from over 250,000 in the mid-2000s to around 50,000 two decades later.