New WHO guidelines endorse long-acting injectable lenacapavir for HIV prevention, Medicines Patent Pool expands licence for long-acting injectable cabotegravir for treatment, and Merck’s once-monthly oral pill MK-8527 advances to Phase 3 trials in Africa
14 July 2025 (Kigali, Rwanda) – IAS 2025, the 13th IAS Conference on HIV Science, opened today with a call to accelerate access to long-acting HIV prevention and treatment innovations amid growing global funding challenges. Four thousand participants are attending IAS 2025 in Kigali, Rwanda, and virtually. The IAS Conference on HIV Science is the world’s most influential meeting on HIV research and its applications.
Dr Sabin Nsanzimana, Minister of Health of Rwanda, delivered welcoming remarks at a press conference, entitled “Breakthroughs amid crisis: The future of HIV innovation”, directly preceding the opening session.
“Rwanda’s experience in the HIV response over the past few decades – alongside our recent pandemic response – demonstrates what is possible when countries prioritize people-centred approaches and invest in strategic partnerships,” Dr Sabin Nsanzimana , the Minister of Health of Rwanda, said. “Together, we met the UNAIDS 95-95-95 targets ahead of schedule and continue to harness cutting-edge science – including long-acting medications – to deliver more targeted, integrated interventions. As we look ahead, our shared responsibility is to ensure that these innovations are not only developed, but also equitably accessible to all who need them.”
“Today marks a significant moment in the journey to expand choices and improve outcomes for people living with and vulnerable to HIV,” Dr Beatriz Grinsztejn , IAS President, said. “New WHO guidelines, groundbreaking licensing agreements and promising research signal that long-acting HIV prevention and treatment are moving closer to becoming part of everyday care. This is a testament to what is possible when researchers, industry, global health institutions and communities work together. Our next challenge is clear: leaders must commit the funding and resources needed to integrate these scientific advances into health systems quickly and equitably so that people everywhere can benefit from these life-changing options.”
Among the key announcements during the opening session were new World Health Organization (WHO) guidelines recommending long-acting injectable lenacapavir for HIV prevention, underscoring WHO’s commitment to equitable access to these innovations. “We have the tools and the knowledge to end AIDS as a public health problem,” Dr Meg Doherty , Director of WHO’s Department of Global HIV, Hepatitis and STI Programmes and incoming Director of Science, Research, Evidence and Quality for Health, said. “What we need now is bold implementation of these recommendations, grounded in equity and powered by communities.”
A statement from Dr Tedros Adhanom Ghebreyesus , WHO Director-General, was also issued in support of the new guidance.
“While an HIV vaccine remains elusive, lenacapavir is the next best thing: a long-acting antiretroviral shown in trials to prevent almost all HIV infections among those at risk,” Dr Tedros Adhanom Ghebreyesus , WHO Director-General, said. “The launch of WHO’s new guidelines, alongside the FDA’s recent approval, marks a critical step forward in expanding access to this powerful tool. WHO is committed to working with countries and partners to ensure this innovation reaches communities as quickly and safely as possible.”
A new licensing agreement between the Medicines Patent Pool and ViiV Healthcare was announced to expand access to long-acting injectable cabotegravir for HIV treatment. “Expanding our licence with ViiV Healthcare to include long-acting cabotegravir for HIV treatment marks a significant step forward for equitable access,” Esteban Burrone , Director of Strategy, Policy and Market Access at the Medicines Patent Pool, said.
“As the first full long-acting HIV treatment regimen, now recommended by WHO, it answers a long-standing call from communities for an option that would maintain viral suppression without the need for daily medication. This expansion shows that innovation and access not only should – but also can – go hand in hand. We now look forward to working closely with our generic licensees to accelerate the development of an affordable, quality-assured version that will serve as an important tool in the HIV treatment toolbox.”
Promising new research from MSD on MK-8527, an investigational once-monthly oral pill for HIV prevention, was also presented. The candidate is advancing to Phase 3 trials in Africa. Study co-author Dr Rebeca Plank, distinguished scientist, Global Clinical Development at MSD Research Laboratories, shared new data.
“The results of the Phase 2 study of MK-8527 shared at IAS 2025 demonstrate a favourable safety and tolerability profile with pharmacokinetic data supporting once-monthly oral dosing in our Phase 3 studies,” Rebeca Plank , MD, study co-author, Distinguished Scientist, Global Clinical Development, MSD Research Laboratories, said. “The two upcoming Phase 3 EXPrESSIVE studies are designed to evaluate the preventive efficacy and safety profile of MK-8527 across populations who could most benefit from PrEP. We are proud to partner with the Gates Foundation and the International Clinical Research Center to help advance HIV prevention research.”
Advocates urged global leaders to ensure equitable access to new HIV prevention and treatment options. “Long-acting HIV prevention and treatment can transform lives only if people can actually get them,” Yvette Raphael , Executive Director of Advocates for the Prevention of HIV and AIDS, said. “We cannot repeat the mistakes of the past, where new medicines existed but stayed out of reach for the people who needed them most. We need clear plans and real funding to make sure these drugs are affordable, available in our clinics and trusted by our communities. Science has given us powerful tools. Now we must do the work to put them in people’s hands.”
Data presented by the UNAIDS Director for Data Impact, Mary Mahy, highlighted continued gaps in prevention and treatment access for key populations and regions most heavily affected by HIV.
“By the end of 2024, 73% of all people living with HIV had achieved viral suppression. This impressive progress ensures that people living with HIV are healthy and reduces onward HIV transmission. However, the funding crisis is jeopardizing this hard-won progress in the response to HIV,” Mahy said.
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UNAIDS Executive Director Winnie Byanyima issued a global update, highlighting persistent gaps in HIV prevention and treatment access, particularly for key populations and hardest-hit regions. “We are seeing a massive interruption in international HIV financing which has created a systemic shock to the global HIV response, triggering huge disruptions to HIV treatment and prevention programmes around the world,” said Winnie Byanyima. “However, our AIDS response was created in crisis–it is in our DNA to face crisis and to fight our way out of crisis. Countries are resilient, we do not give up and we continue to stand with governments and communities as they commit to finish the fight to end AIDS.”
IAS 2025 will continue until 17 July, featuring hundreds of sessions and presentations focused on translating scientific breakthroughs into real-world impact, with a particular emphasis on solutions for regions and populations most affected by HIV.
In addition to today’s announcements, the Journal of the International AIDS Society (JIAS) has released several important thematic supplements ahead of IAS 2025. These are: “PEP in Africa: prospects, opportunities and challenges”, guest edited by Euphemia Sibanda, Julie Fox and Peter Godfrey-Faussett; “Expanding access to a choice-based HIV prevention market”, guest edited by Virginia A. Fonner, Nicolette P. Naidoo and James Ayieko; and “Differentiated service delivery – beyond HIV treatment for integration and other health needs”, guest edited by Anna Grimsrud, Charles B. Holmes and Linda Sande. Each collection looks at key challenges and opportunities for the future of the HIV response.
