South Africa Pushes for Local Manufacturing of Lenacapavir

Beyond local manufacturing plans, government is also working with international partners to accelerate access to lower-cost generic versions of the drug.

South Africa is moving closer to manufacturing a local generic version of Lenacapavir, a groundbreaking HIV prevention drug that has been hailed as a major advance in the global fight against HIV and AIDS.

Health Minister Dr Aaron Motsoaledi announced that discussions with pharmaceutical company Gilead have opened a pathway for a South African manufacturer to obtain a voluntary licence to produce the medicine locally. The development could significantly expand access to the drug while reducing costs for one of the countries most affected by HIV.

Speaking at the launch of Lenacapavir in Secunda, Motsoaledi addressed concerns that current supplies may not be sufficient to meet demand. While donor-funded allocations are expected to reach hundreds of thousands of people, civil society groups have expressed concern that larger numbers will be required if the country hopes to make a significant impact on HIV transmission.

The Minister said South Africa had argued its case as one of the world's largest consumers of antiretroviral medicines and had received assurances that local manufacturers would be considered for licensing opportunities.

Cheaper Generic Versions Could Arrive Next Year

Beyond local manufacturing plans, government is also working with international partners to accelerate access to lower-cost generic versions of the drug.

Motsoaledi revealed that discussions involving the Clinton Health Access Initiative, UNITAID and Indian pharmaceutical company Dr Reddy's are focused on producing a generic version that could cost dramatically less than the current originator product.

A separate initiative backed by the Gates Foundation is supporting another manufacturer, Hetero, to develop an affordable generic alternative.

The Minister said he recently visited Hetero's facilities in Hyderabad, India, where company representatives indicated that production could begin this year once regulatory approvals are granted. South Africa's medicines regulator, SAHPRA, is currently reviewing the required documentation.

Motsoaledi expressed confidence that generic Lenacapavir could become available in South Africa early next year, making the medicine far more accessible to people who need it.

Rollout Begins as HIV Prevention Enters a New Era

Lenacapavir is being described as one of the most significant developments in HIV prevention in decades. Unlike traditional pre-exposure prophylaxis (PrEP) treatments that require daily medication, Lenacapavir is administered through just two injections per year.

Clinical trials have delivered remarkable results. Studies among women recorded 100 percent effectiveness during the trial period, while research involving men who have sex with men and transgender women showed efficacy levels of approximately 96 percent.

The World Health Organization has already recommended the drug as an additional HIV prevention option for people at risk of infection.

South Africa has begun rolling out the medicine across public healthcare facilities. Gauteng, one of the provinces carrying a substantial HIV burden, is among the first regions implementing the programme.

The Gauteng Department of Health has identified 133 facilities across Johannesburg, Tshwane, Ekurhuleni, Sedibeng and the West Rand to participate in the initial phase. The programme will prioritise adolescent girls and young women, adolescent boys and young men, sex workers, men who have sex with men, transgender people, people who inject drugs, and pregnant or breastfeeding women at high risk of HIV infection.

The province has already received enough stock to initiate more than 56,000 eligible individuals by March 2027, with additional supplies expected through quarterly deliveries.

Health authorities emphasise that Lenacapavir forms part of a broader HIV prevention strategy and does not replace HIV testing, condom use, treatment of sexually transmitted infections, voluntary medical male circumcision or treatment services for people living with HIV.

For a country with an estimated 8.15 million people living with HIV, the arrival of Lenacapavir and plans for local production could mark a major turning point in efforts to reduce new infections and ultimately end the HIV epidemic.