For the first time, a pharmaceutical company has given generic manufacturers permission to make copies of an HIV medicine before the studies proving it works have finished — with three of the seven licences awarded to African drug makers.

This could bring the medicine — a once-a-month HIV prevention pill known as MK-8527, or alimatravir, made by Merck (known as MSD in South Africa) — to people much faster than previous drugs. That's because the licences allow generic manufacturers to prepare their factories and production processes while the final studies are under way, so they can begin making the pill as soon as regulators approve it.

South Africa's largest drug maker, Aspen Pharmacare, received one of the licences. The other six went to manufacturers in Uganda, Kenya and India. Producing alimatravir in Africa could help make the medicine more widely available once it is approved and also help lower South Africa's roughly 140 000 new HIV infections a year.

“We don’t yet know if the medicine will work, so it’s a risk that Merck is taking but it’s, in my opinion, a wise and strategically-taken risk,” Mitchell Warren, who heads the international HIV advocacy organisation, Avac, told Bhekisisa at the 26th International Aids Conference in Rio de Janeiro. 

Aspen won’t be making MK-8527 from start to finish, it will import the key ingredient of the pill and then put the medicine together in South Africa, group senior executive for trade Stavros Nicolaou says.

If studies show alimatravir works and regulators approve it, Aspen would be able to sell and export the pill to 129 low- and middle-income countries, including all 54 countries in Africa. “This is a significant boost for Africa’s pharmaceutical industrialisation and regional manufacturing ambitions,” Nicolaou says.

A recent study estimates that generic alimatravir could be made for as little as $4.50 (about R76) a person a year. That's about a fifth of what researchers estimate it could cost to produce a generic version of the six-monthly HIV prevention injection, lenacapavir (LEN), at large scale. South Africa started rolling out LEN in June.

But “for this, we need volumes [tens of millions of doses], which we don’t yet have in the HIV prevention medication market,” Warren cautions.

What do we know about MK-8527?

New medicines are usually tested in three phases of clinical trials before regulators decide whether to approve them. If alimatravir is shown to be safe and effective in two phase 3 studies involving participants in 17 countries, the trials could finish in the second half of 2027.

Phase 2 studies in a small number of participants have shown that the pill appears to be safe and reaches target drug levels within an hour of being taken — concentrations that scientists believe should be high enough to prevent HIV infection. Large phase 3 studies are testing whether that is indeed the case.

By comparison, a daily HIV prevention pill that is available in South Africa, takes up to seven days to fully work for protection for vaginal sex. The six-monthly anti-HIV jab takes three days to reach maximum protection levels when it’s started with four pills taken over the first two days. 

Alimatravir belongs to a new class of HIV medicines, called nucleoside reverse transcriptase translocation inhibitors (NRTTIs), that block the virus in a different way from the HIV prevention pills in use. 

**Why a monthly pill if there’s a daily one and a jab? **

Family planning has shown that the more contraceptive choices people have, the more likely they are to use at least one method. Scientists believe the same could be true for HIV prevention: the more options people have, the greater the chance that one will fit their lifestyle and preferences.

Early data from South Africa's lenacapavir roll-out seem to support that idea. Until 5 June, when the health department started offering LEN at 360 clinics — about one in 10 public health facilities — across six provinces, the only HIV prevention medicine available at public clinics was a daily pill.

By 19 July — six weeks after the LEN roll-out started — 26 122 doses of HIV prevention medicine (a combination of the daily pill and LEN) had been given to people, according to health department data.

Bhekisisa analysed the department's figures to see whether offering people a choice between a daily pill and a six-monthly injection led more people to start using HIV prevention medicine.

In 2025, before LEN became available, an average of about 2 670 people a week started taking the daily HIV prevention pill at just over 4 500 public health facilities.

Since LEN was introduced, an average of about 4 200 people a week have started using the injection at 360 clinics across six provinces.

The comparison is not like for like — the 360 clinics were selected because they were ready to introduce LEN and may not reflect all public health facilities. But the early figures suggest that offering people another HIV prevention option could substantially increase demand.

And “adding a monthly pill to the choice of options, could increase demand even more”, says Warren.

About our calculations

We calculated oral PrEP uptake in 2025 by subtracting the cumulative number of people who had started oral PrEP by the end of 2025 from the cumulative total reported by the end of 2026. The difference was 138 705 initiations.

Dividing this by 52 weeks gave an average of about 2 667 new oral PrEP users a week in 2025. To calculate average weekly LEN uptake, we added the weekly numbers reported since the roll-out began on 5 June and divided the total by the number of weeks covered. This gave an average of 4 188 LEN initiations a week.

Although almost everyone (98.5%) who came for HIV prevention medicine at South Africa's pilot sites chose LEN, the overall increase in the number of people using HIV prevention medicine suggests that giving people a choice matters, says Saiqa Mullick of Wits RHI.

She leads LEN4PrEP, an implementation study that began in November and is being conducted in Tshwane.

At the Tshwane sites participating in the study, the overall uptake of HIV prevention medicine increased after LEN was introduced. More than half (57.4%) of people who chose LEN had never used HIV prevention medicine before.

"What is especially encouraging is that LEN appears to be drawing new people into PrEP [HIV prevention medicine]," Mullick said during a conference presentation.

"The conversation is not that one product is better than another. It is: here are the available options; let's support each person to choose what fits their preferences and circumstances."

**Why is it important that African companies are included as licence holders? **

For decades, countries such as South Africa have hosted clinical trials that helped bring new medicines to market. But when the medicines were approved, they almost always became available in wealthy countries first. By the time they reached Africa, they were often priced beyond the reach of countries such as South Africa.

Alimatravir could mark a break from that pattern. Three African countries hosting phase 3 trial sites — South Africa, Uganda and Kenya — are also home to three of the seven generic manufacturers that MSD has licensed to produce the monthly HIV prevention pill for 129 low- and lower-middle-income countries.

But activists at the conference say the licensing deal leaves big gaps. They have criticised __MSD for excluding several middle-income Latin American countries — including Brazil, Argentina and Peru — from the territories where the licensed generic manufacturers will be allowed to sell alimatravir, __even though Brazil, Argentina, Mexico and Peru are also hosting phase 3 alimatravir trial sites.

**SA’s LEN local production plans **

South Africa's National Aids Council (Sanac) and the health department are leading negotiations with Gilead Sciences, the company that makes LEN, for a generic licensing agreement that takes a "developmental approach". The aim is to recognise that no South African drug maker can yet manufacture LEN from start to finish, Sanac's Getrude Mngola told Bhekisisa.

When Gilead awarded six generic licences in 2024, __no South African company was included __because the company considered only manufacturers that could also produce the medicine's active pharmaceutical ingredient (API) — the key ingredient that makes the drug work.

To identify potential South African manufacturers, Sanac set up two committees — an evaluation committee and an adjudication committee — that include local and international experts from outside government.

The evaluation committee invited applications from companies that could manufacture the injectable LEN product using imported API, make only the tablets taken with the injection during the first two days of treatment or eventually produce all the components.

The evaluation committee presented a shortlist to the adjudication committee on Friday, Mngola said.

"The adjudication committee's decision on which companies will be nominated to Gilead for consideration for generic licences will be made public this week."

Sanac created two committees — an evaluation and adjudication committee that includes partners outside government, both locally and internationally. The evaluation committee invited applications from South Africa pharmaceutical companies who could make LEN in South Africa make the product by importing the key ingredient, who could only make LEN pills that have to be taken along with the jab on the first two days or who could make both.

The evaluation committee selected a shortlist, which was presented to the adjudication committee on Friday, says Mngola. “That adjudication committee’s decision as to which companies are the final candidates who will be submitted to Gilead to review for generic licences, will be made public this week.”