Merck stages expanded access to monthly HIV PrEP pill ahead of approval

Pharma Merck stages expanded access to monthly HIV PrEP pill ahead of approval By Angus Liu Jul 24, 2026 10:40am Merck & Co. HIV Licensing deals PrEP Following in the footsteps of Gilead Sciences, Merck & Co. has signed voluntary licensing agreements to enable access to its investigational HIV PrEP pill alimatravir. The New Jersey pharma is accelerating that playbook even further, launching the global access strategy well before the phase 3 trial evaluating alimatravir for HIV prevention has completed enrollment or produced data. As Merck noted in a July 24 announcement, this early move represents a first in the field of HIV prevention. Merck has signed nonexclusive voluntary licensing agreements with seven generic manufactures, including Aspen Pharmacare, Quality Chemical Industries and UCL Kenya in sub-Saharan Africa; and Aurobindo, Cipla, Emcure and Viatris in India. As Merck pointed out, this is the first time that producers in sub-Saharan Africa, where HIV burden is among the highest, have been included in an initial voluntary license for the disease. “People across Africa need more options to prevent HIV. A once-monthly pill could provide a different choice for people in how to protect themselves, subject to successful trials and regulatory approval,” Jean Kaseya, director general of the Africa Centres for Disease Control and Prevention, said in a statement. “We welcome this decision to engage African manufacturers early.” The patent accords will enable supplies of generic alimatravir in 129 low- and middle-income countries (LMICs) with “targeted, regional” manufacturing in Africa and Latin America, according to Merck. Related Gilead widens global Yeztugo access agreement, but MSF says supply is 'not nearly enough' Back in 2024, Gilead made similar not-for-profit deals with six manufacturers covering its since-approved HIV PrEP med, Yeztugo (lenacapavir), after its two phase 3 trials, Purpose-1 and 2, had read out positive data. Yeztugo is administered as twice-yearly injections after an oral loading dose. Despite its ongoing effort to widen access to Yeztugo, Gilead has continuously faced criticism over the number of doses available through the programs. That supply limitation can be partly attributed to the preparation needed for large-scale production. By devising plans early, “Merck aims to make alimatravir available in LMICs as broadly and as quickly as possible, if approved,” the company said in a July 24 statement, timed to coincide with the 26th International ADIS Conference set to take place in Rio de Janeiro, Brazil. Alimatravir, also known as MK-8527, is a nucleoside reverse transcriptase translocation inhibitor (NRTTI), which aims to stop HIV from copying itself by binding to the viral reverse transcriptase enzyme. Merck originally tried to make another NRTTI, islatravir, into a PrEP option but abandoned the plan after encountering a safety signal, as trial participants taking high doses of the asset experienced decreases in total lymphocyte and CD4+ T-cell counts. Related Gilead, Merck’s phase 3 data back first weekly HIV pill From a logistics perspective, Merck’s oral alimatravir holds an advantage over injectable Yeztugo. But in HIV management, adherence is key, and Yeztugo’s twice-yearly dosing frequency is more favorable than alimatravir’s once-monthly routine. Thanks in part to strong adherence, Yeztugo has shown nearly complete protection from HIV infection in two phase 3 trials. Merck and Gilead are also collaborating, combining islatravir and lenacapavir in a new once-weekly pill for the treatment of HIV. Data from two phase 3 trials unveiled at AIDS 2026 showed the combo works as well as daily drugs like Gilead’s Biktarvy at maintaining HIV suppression. Merck & Co. HIV Licensing deals PrEP HIV prevention Antiretroviral Drugs Manufacturing Pharma