User access denied after system block

South Africa may receive a new HIV prevention pill months or even years ahead of other countries. An unusual licensing agreement allows generic drugmakers to begin production before final trial results are available.

A once-a-month pill enters final testing

The drug, called alimatravir (MK-8527), is being developed by Merck, known locally as MSD. It has reached phase 3 clinical trials, the final stage before regulatory approval. Trials could conclude by the second half of 2027.

Early research indicates the pill reaches protective levels within an hour—much faster than existing options. A daily HIV prevention pill, for instance, takes up to seven days to fully guard against vaginal transmission. The six-month injectable lenacapavir, introduced in South Africa in June, requires three days to reach maximum protection.

Alimatravir operates through a new mechanism. It belongs to a class called nucleoside reverse transcriptase translocation inhibitors, which block the virus differently than older medications.

Licensing deal speeds up access for low-income countries

Merck has already permitted seven generic manufacturers, including three in Africa, to produce alimatravir before official approval. Normally, companies wait until trials finish before licensing generics, delaying access by years.

“We don’t yet know if the medicine will work, so Merck is taking a risk,” said Mitchell Warren, executive director of the HIV advocacy group Avac. “The move is both wise and strategic.”

Aspen Pharmacare, South Africa’s largest drugmaker, is among the licensees. If alimatravir is approved, Aspen will import the active ingredient and assemble the pill locally. The company could then sell and export it to 129 low- and middle-income countries, covering all 54 African nations.

Stavros Nicolaou, Aspen’s group senior executive for trade, described the agreement as “a major advance for Africa’s pharmaceutical industrialisation and regional manufacturing goals.”

Generic versions of alimatravir may cost as little as $4.50 per person annually—about one-fifth the estimated price of producing generic lenacapavir at scale. Warren noted that affordability hinges on demand. “We need tens of millions of doses, which the HIV prevention market doesn’t yet support,” he said.

For those who find daily pills difficult or injections impractical, a monthly alternative could improve adherence. More than half of people choosing the six-monthly HIV prevention jab in a Wits implementation study had never used HIV prevention medicine before, showing that one size doesn’t fit all.

The trend reflects patterns seen in family planning, where more options lead to higher overall use. Experts believe the same applies to HIV prevention.

Gaps remain in global access

While the licensing deal marks progress, activists argue it falls short. Merck’s agreement excludes several middle-income Latin American countries, including Brazil, Argentina, and Peru, which are hosting phase 3 trials. These nations won’t be able to purchase generic versions from licensed manufacturers, despite their role in testing the drug.

The exclusion shows a persistent issue: African and other low-income countries often host trials but gain access to new medicines last. Alimatravir may partly break this cycle by including African manufacturers in the licensing deal from the outset.

South Africa is also negotiating better terms for lenacapavir. The National Aids Council (Sanac) and the health department are discussing a “developmental” licensing agreement with Gilead Sciences. The goal is to allow local manufacturers to produce the drug without needing to synthesize the active ingredient. Gilead’s initial 2024 licensing round excluded South African firms because none could produce the key component.

Sanac has formed two committees—one to evaluate applications and another to review them. The evaluation committee has already submitted a shortlist, and the adjudication committee’s decision is expected soon.

If successful, the agreement could help South Africa reduce its annual 140,000 new HIV infections. For now, attention remains on alimatravir and whether the monthly pill will deliver on its potential.

Countries with high infant mortality rates often face similar challenges in securing affordable medications. Expanding access to prevention tools could ease broader health burdens.