HIV PREVENTION27 JUL 2026#Aids2026: Daily pill. Monthly pill. Six-monthly jab. Why choice mattersFor the first time, Merck has granted generic manufacturers, including three African companies, permission to…Mia MalanLinda PretoriusKaren Harkema9 min read

A new once-a-month HIV prevention pill is moving into the final stage of testing. But early South African uptake data of the six-monthly anti-HIV jab suggest the biggest breakthrough may not be a new medicine — it may be giving people more ways to protect themselves For the first time, a pharmaceutical companyhas given generic manufacturers permissionto make copies of an HIV medicine before the studies proving it works have finished — withthree of the seven licences awardedto African drug makers. This could bring the medicine — a once-a-month HIV prevention pillknown 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 roughly140 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, toldBhekisisaat 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.

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If studies show alimatravir works and regulators approve it, Aspen would be able to sell and export the pill to129 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. Arecent study estimatesthat generic alimatravir could be made for as little as $4.50 (about R76) a person a year.

That’s about a fifth of whatresearchers estimateit 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. New medicines areusually tested in three phasesof clinical trials before regulators decide whether to approve them.

If alimatravir is shown to besafe and effectiveintwo phase 3 studiesinvolving participants in 17 countries, the trials could finish in the second half of 2027. Phase 2 studies in a small number of participants have shownthat 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. The six-monthly anti-HIV jabtakes three days to reach maximum protection levelswhen it’s started with four pills taken over the first two days.

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