South Africa Pursues Local Production of Lenacapavir HIV Prevention Drug

South Africa is exploring the local manufacture of the long-acting HIV prevention drug lenacapavir, a breakthrough injectable antiretroviral administered twice a year. Clinical trials have shown the drug to be almost 100% effective at preventing HIV infection when administered every six months as prescribed, making it one of the most promising new tools in global HIV prevention.

The South African government is working with global health partners, including Unitaid and the United States Pharmacopoeia, to identify a suitable local pharmaceutical manufacturer capable of producing the medication to international quality standards. The initiative forms part of a broader effort to expand access to long-acting HIV prevention tools in regions hardest hit by the epidemic.

The government has issued a call for expressions of interest to identify South African companies capable of producing the drug locally. If approved, the selected manufacturer could receive a voluntary licence from Gilead Sciences, potentially becoming one of a limited number of manufacturers authorised to produce the medicine for low- and middle-income countries.

In 2024, Gilead granted licences to manufacturers in countries including India, Pakistan and Egypt to supply generic versions of the drug to more than 120 countries. However, no South African companies were included at the time, prompting calls for greater regional production capacity.

Unlike traditional oral pre-exposure prophylaxis (PrEP), which requires daily pills, lenacapavir provides protection for six months with a single injection, helping overcome adherence challenges that have limited the effectiveness of daily medication for some people.

In the PURPOSE 1 study, conducted in South Africa and Uganda and involving about 8,000 women, the drug was found to be 100 per cent effective against HIV. Researchers also found that cases of HIV infection reduced during the study period. The PURPOSE 2 trial recorded 96 per cent efficacy against HIV infection.

Named 'Breakthrough of the Year' by Science magazine in 2024, lenacapavir is a first-in-class capsid assembly modulator. The drug works by targeting the capsid protein that forms a shell around the virus's genetic material. Any tiny change in the parts of this protein disrupts its ability to infect cells.

The discovery of lenacapavir began more than two decades ago when a biochemist at the University of Utah wanted to know how the HIV virus forms a cone-like shape. His team published their findings in the scientific journal Science on January 1, 1999. Gilead took up the challenge to manufacture lenacapavir in 2006, after having already manufactured a number of HIV drugs including Truvada.

Before human clinical trials, the team tested the potency of their discovery using rat skin. They improved the drug and started clinical trials in human beings in 2018, involving both healthy people and those living with HIV.

In June 2025, the United States Food and Drug Administration approved lenacapavir for use. A month later, the World Health Organisation endorsed its approval by releasing guidelines for its use at the 13th International Aids Society Conference held in Kigali, Rwanda.

In January this year, Kenya's Pharmacy and Poisons Board recommended the registration of Lenacapavir 300mg tablets and Lenacapavir 464mg solution for injection, following a detailed scientific assessment in line with Kenyan laws and international regulatory standards. Kenya has received 21,000 doses of Lenacapavir with about 15 counties selected to be the first to receive it.

The WHO guidelines noted that the PURPOSE 1 and 2 trials found little to no differences in rates of adverse events, except for injection site reactions, mostly in the arm. These reactions were common but typically mild and decreased in frequency over time without leading to high discontinuation rates. The studies found no impact on pregnant and breastfeeding mothers who took the drug, and noted that no dose adjustment is likely to be required during pregnancy.

Lenacapavir is not the first long-acting HIV prevention option, but it is the first given twice yearly. In 2015, the WHO recommended a daily oral PrEP called Truvada. In 2021, the dapivirine vaginal ring was recommended for women at substantial risk of HIV. In 2022, the long-acting injectable cabotegravir, administered every two months, was introduced.