#Aids2026: Daily pill. Monthly pill. Six-monthly jab. Why choice matters

Merck, known as MSD in South Africa, has granted generic manufacturers the right to produce copies of its experimental HIV prevention drug, MK-8527—also known as alimatravir, before the completion of final clinical trials. This unprecedented move marks a shift in how new medical treatments are developed and distributed globally. Three of the seven licenses issued were given to African-based manufacturers, including South Africa’s largest drugmaker, Aspen Pharmacare, and companies based in Uganda, Kenya, and India. The decision aims to accelerate access to the drug, potentially reducing the time it takes to get the medication to patients compared to traditional methods. The licensing allows generic producers to prepare their manufacturing infrastructure ahead of regulatory approval. This means that once the drug is cleared for use, these manufacturers can immediately begin producing it, significantly cutting down on delays caused by the usual lengthy process of setting up production lines after a drug is approved. Alimatravir is described as a once-a-month oral HIV prevention pill, which could offer a more convenient alternative to existing options such as daily pills or a six-monthly injectable treatment currently being rolled out in South Africa. Aspen Pharmacare, which received one of the licenses, plans to import the active ingredient of the drug and assemble the final product in South Africa. According to Stavros Nicolaou, a senior executive at Aspen, the company would be able to distribute the drug to 129 low- and middle-income countries, including all 54 nations in Africa, once it receives regulatory approval. This development aligns with broader goals to strengthen local pharmaceutical industries in the region. Mitchell Warren, head of the global HIV advocacy organization AVAC, emphasized that Merck is taking a calculated risk by allowing early manufacturing. He noted that while the efficacy of alimatravir is still uncertain, the potential benefits justify the gamble. The drug is currently undergoing Phase 3 clinical trials in 17 countries, with results expected by mid-2027. Earlier Phase 2 trials showed that the drug reached therapeutic levels quickly, within an hour of ingestion, which is significantly faster than current prevention options. If approved, alimatravir could be produced for as little as $4.50 per person annually, according to preliminary estimates. This price point is notably lower than the projected cost of a generic version of the six-monthly injectable HIV prevention drug, lenacapavir (LEN), which is already being introduced in South Africa. However, experts caution that achieving this cost requires mass production capabilities that are not yet established in the HIV prevention sector. Current HIV prevention methods include both daily oral medications and long-acting injectables. For example, the daily pill used in South Africa takes up to seven days to become fully effective against vaginal transmission of HIV. In contrast, the six-monthly jab requires four initial pills over two days to reach peak effectiveness. Alimatravir, belonging to a novel class of antiretroviral drugs called nucleoside reverse transcriptase translocation inhibitors (NRTTIs), operates through a distinct mechanism compared to existing prevention therapies. The availability of multiple prevention options is believed to increase the likelihood that individuals will adopt some form of protection. This concept, drawn from family planning strategies, suggests that providing diverse choices increases adherence rates. Early data from South Africa’s rollout of lenacapavir appear to support this hypothesis, indicating higher uptake among users since the drug became available in selected clinics earlier this year. Merck’s approach represents a departure from conventional practices in pharmaceutical development, where companies typically wait until a drug is fully approved before granting manufacturing rights. By allowing early preparation, the company hopes to streamline the path from research to real-world application. This strategy could set a precedent for future drug development, particularly in regions where rapid access to life-saving treatments is critical. The success of alimatravir hinges on the outcomes of ongoing clinical trials. If the drug proves effective, it could significantly alter the landscape of HIV prevention, especially in sub-Saharan Africa, where the disease continues to pose a major public health challenge. The potential for widespread availability, combined with a relatively low production cost, makes the drug an attractive option for governments and health organizations seeking affordable solutions to curb the spread of HIV.