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. Producing alimatravir in Africa could help make the medicine more widely available once approved, and also help to 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, head of 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 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 African countries. “This is a significant boost for Africa’s pharmaceutical industrialisation and regional manufacturing ambitions,” Nicolaou says.
One recent study estimates that generic alimatravir could be made for as little as $4.50 (R76) per person per year. That’s about one-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, Warren cautions, “for this, we need volumes [tens of millions of doses], ”which we don’t yet have in the HIV prevention medication market.”
What do we know about MK-8527?
New medicines are usually tested in three clinical trial phases 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 scientists believe should be high enough to prevent HIV infection. Large phase 3 studies are now testing whether that is the case.
By comparison, a daily HIV prevention pill already available in South Africa takes up to seven days to fully work for protection for vaginal sex, while the six-monthly jab takes three days to reach maximum protection levels when it’s started with four pills taken over the first two days.
Why a monthly pill if there’s already 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 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 administered, 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 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.
Although almost everyone (98.5%) who came for HIV prevention medicine at pilot sites chose LEN, the overall increase in 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 in Tshwane.
At the Tshwane sites participating in the study, 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.” (See graphic)
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 those 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 still leaves big gaps. They have criticised MSD for excluding several middle-income Latin American countries — including Brazil, Argentina and Peru — from the territories where licenced generic manufacturers will be allowed to sell alimatravir, even though Brazil, Argentina, Mexico and Peru are also hosting phase 3 alimatravir trial sites.
- Merck has, for the first time, licensed generic manufacturers—including three African companies like South Africa’s Aspen Pharmacare—to produce the HIV prevention pill alimatravir (MK-8527) before final study results are completed, expediting potential access.
- Aspen will assemble alimatravir locally using imported ingredients, enabling distribution to 129 low- and middle-income countries, supporting Africa’s pharmaceutical industrialization and HIV prevention efforts against 140,000 new yearly infections in South Africa.
- Phase 3 studies ongoing across 17 countries aim to confirm the pill’s safety and efficacy by 2027; earlier data shows it reaches protective drug levels within one hour, faster than existing daily pills or six-monthly injections currently used.
- Offering multiple HIV prevention options (daily pill, six-monthly injection, and potentially alimatravir monthly pill) increases uptake, as seen in South Africa where introduction of lenacapavir injection boosted overall PrEP use and attracted new users.
- The inclusive licensing marks progress against unequal access patterns, but activists criticize Merck for excluding some middle-income Latin American countries hosting trials, limiting their access to affordable generic alimatravir.
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.
“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, head of 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 and then put the medicine together in
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 African countries. “
One recent study estimates that generic alimatravir could be made for as little as $4.50 (R76) per person per year.
But, Warren cautions, “for this, we need volumes [tens of millions of doses], ”which we don’t yet have in the HIV prevention medication market.”
What do we know about MK-8527?
New medicines are usually tested in three clinical trial phases 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 scientists believe should be high enough to prevent HIV infection. Large phase 3 studies are now testing whether that is the case.
By comparison, a daily HIV prevention pill already available in
Why a monthly pill if there’s already 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
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 administered, 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.
At the
“What is especially encouraging is that LEN appears to be drawing new people into PrEP [HIV prevention medicine],” Mullick said during a conference presentation.
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At the
“What is especially encouraging is that LEN appears to be drawing new people into PrEP [HIV prevention medicine],” Mullick said during a conference presentation.
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Why is it important that African companies are included as licence holders?
For decades, countries such as
Alimatravir could mark a break from that pattern.
But activists at the conference say the licensing deal still leaves big gaps.
