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South Africa Licenses Aspen Pharmacare to Produce Monthly HIV Prevention Pill

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South Africa Licenses Aspen Pharmacare to Produce Monthly HIV Prevention Pill
HIV PreventionSouth AfricaAspen Pharmacare

South Africa has announced a licence for Aspen Pharmacare to make a promising monthly HIV prevention pill, along with other developments that could shape the future of HIV prevention in the country.

SA has announced a licence for Aspen Pharmacare to make a promising monthly HIV prevention pill. Here’s what this and other developments could mean for the future of HIV preventionDeputy health minister Joseph Phaahla at the 26th International Aids Conference, Rio de Janeiro.

South Africa returned from Rio with three big HIV announcements: a new dashboard tracking LEN, progress towards making the jab locally, and a licence to make a promising monthly HIV prevention pill. South Africa returned from the 26th International Aids Conference in Rio de Janeiro last week with three big HIV announcements: a new dashboard that tracks the roll-out of HIV prevention medicine, a licence for Aspen Pharmacare to make a promising monthly HIV prevention pill, and progress towards manufacturing a six-monthly HIV prevention injection, lenacapavir , in South Africa.

By August 3, close to 36,000 HIV-negative people had taken LEN, according to health department figures — a quarter of them pregnant and breastfeeding women, a group that has a high risk of contracting HIV. Our team was on the ground and breaks down what the announcements could mean for the country’s HIV prevention programmes.

Almost everyone who starts HIV prevention medicine at government clinics where people can choose between a daily pill and a six-monthly injection opts for the injection. South Africa unveiled a dashboard at its country booth to track the rollout of HIV prevention medicine. HIV-negative people use the medicine, known as pre-exposure prophylaxis , to stop themselves from getting HIV.

The dashboard tracks PrEP use at the 360 clinics where HIV-negative people can choose between the daily pill and the twice-yearly injection, LEN. The dashboard also breaks down PrEP users by age, gender, province and health district.

Moreover, it shows whether the programme is reaching people who have a higher chance of getting HIV — including sex workers, pregnant and breastfeeding women, gay and bisexual men, transgender people and people who inject drugs. The dashboard also tracks LEN stock, showing the health department how many doses are left at each clinic.

For now, South Africa isSo far, the data shows that a quarter of LEN users are pregnant or breastfeeding women, and most people who choose the injection are between 25 and 34 years old. By August 3, a total of 35,778 people had received a LEN injection, compared with just 579 who chose the daily pill.

The dashboard, however, has limited data on LEN uptake in the Western Cape because the province uses its own electronic medical record system to track patients. As a result, it cannot show users by age, gender or groups with a higher chance of getting HIV. Mia Malan spoke to the national health department’s deputy director-general for HIV, Fikile Ndlovu, at the conference about how the dashboard works. Watch the short video below.

alimatravir ,“We don’t yet know if the medicine will work, so Merck is taking a risk. But, in my opinion, it’s a wise strategic risk,” Mitchell Warren, executive director of the international HIV advocacy organisation Avac, toldAspen won’t make MK-8527 from start to finish.

Instead, it will import the pill’s active ingredient and then manufacture the finished medicine in South Africa, says the company’s group senior executive for strategic trade, Stavros Nicolaou. If studies show alimatravir works and regulators approve it, Aspen will be able to sell and export the pill to 129 low- and middle-income countries, including all 54 countries in Africa.that the more birth control options people have, the more likely they are to use one.

Scientists believe the same could be true for HIV prevention: the more choices people have, the better the chance that one will suit their lifestyle and preferences.the health department’s dashboard figures to see whether offering people a choice between a daily pill and a six-monthly injection was linked to more people starting HIV prevention medicine. Although the comparison isn’t perfect — the figures come from different numbers of clinics — it suggests that giving people more options may encourage more people to start PrEP.

In 2025, before LEN became available, an average of Since LEN was introduced, an average of about 4,200 people a week have started PrEP at 360 clinics in six provinces, where people can choose between the daily pill and the injection. Watch this short video from Rio, where Mia Malan explains why having more HIV prevention options could encourage more people to start PrEP.

, the CEO of the South African National Aids Council , Thembi Xulu, announced that the country had completed an assessment of local drug makers that could potentially make LEN in South Africa. The list has been submitted to LEN’s developer, Gilead Sciences, to consider them for generic licences.

“We’ve handed the list to Gilead, which will now conduct its own assessment. That includes site visits to determine whether the companies have the technical capacity to make the medicine,” Xulu said.

“The process will take three to six months. After that, we’ll know which companies can help make lenacapavir more accessible, affordable and sustainable for South Africa and the Southern African Development Community . ”because Gilead only considered manufacturers that could also make the medicine’s active pharmaceutical ingredient — the ingredient that makes the drug work.

To identify potential local manufacturers, Sanac set up two committees — an evaluation committee and an adjudication committee — made up of South African and international experts who are independent of government. The evaluation committee invited applications from companies that could manufacture the injectable form of LEN using imported API, make only the tablets taken with the injection during the first two days after starting LEN, or eventually produce the entire treatment.

The evaluation committee drew up a shortlist, which the adjudication committee used to make the final decision. Gilead will now decide which companies qualify for generic licences after completing its own assessment, including site visits. Watch our interview with Xulu, in which she explains what happens next in South Africa’s bid to manufacture LEN locally.

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