September 29, 2025
Evolving the global HIV/AIDS response: Emerging tools and new opportunities
Read time:
PATH/Will Boase
It’s been a difficult year for people worldwide who live with, are at risk of, or research HIV. Funding reductions and shifting priorities among key donors have disrupted or halted critical research and health services.
Around the world, major international donors have reduced their funding for global HIV programming, leading to stoppages and cutbacks of lifesaving care. In the United States, new policies and grant terminations at the Department of Health and Human Services have significantly disrupted HIV research. The integration of the US Agency for International Development into the Department of State and resulting award terminations also interrupted HIV research and service delivery globally.
These reductions risk undermining hard-won global progress and could lead to a resurgence in cases. Already, we’re seeing declines in HIV testing and treatment initiation this year. This is especially disheartening given exciting progress in recent years: at the end of 2024, new HIV infections were down 40 percent and AIDS-related deaths down 50 percent since 2010. The last few years have also brought exciting research advances, building momentum toward breakthroughs that could change the course of the global pandemic.
With science yielding fruit and new donor countries and private funders stepping up, there is still hope that through renewed partnership and investment, we can regain momentum toward ending HIV/AIDS as a global public health threat. Here are some of the year’s most exciting advances in HIV research and innovation this year that inspire optimism amid significant challenges.
A breakthrough in HIV prevention and access
In June 2025, the US Food and Drug Administration approved lenacapavir as the first twice-yearly injectable drug for HIV prevention, marking a major milestone in the fight against the virus, While the drug, developed by Gilead using evidence from NIH-funded research, was previously approved for treating multidrug-resistant HIV, the new indication offers a discrete, twice-annual alternative to daily pills or bi-monthly injections, making prevention more accessible and easier to maintain. The approval followed highly successful clinical trials, which were notable not only for how effective the drug was across key populations, but also for their inclusion of historically underserved populations.
Following the FDA’s decision, Gilead and the Global Fund to Fight AIDS, Tuberculosis and Malaria announced an access agreement that will see Gilead supply doses, at no profit, for up to two million people over three years. The Gates Foundation and Indian manufacturer Hetero Labs are also partnering to manufacture generic lenacapavir at an affordable price. The World Health Organization swiftly recommended the drug’s use, and South Africa’s regulatory authority approved it at record speed, the first such approval in Africa. It’s exciting to see partners work together to help ensure this breakthrough can be accessible in the communities where it is most needed quickly and affordably, a sharp divergence from past HIV product rollouts that saw years-long delays before people in low- and middle-income countries received access to new tools. Earlier this year, Gilead also published data suggesting a once-yearly version of the drug may be possible, with Phase 3 trials to begin later this year.
Lenacapavir is not the only exciting advance in long-acting HIV prevention we saw in 2025. Merck’s investigational once-monthly oral prevention pill was found to be well tolerated in adults in a Phase 2 trial and is now undergoing Phase 3 trials in sub-Saharan Africa. Meanwhile, a single gene therapy injection given at birth showed promise in protecting primates from infection for at least three years in preclinical research. If this solution advances, it could be a gamechanger for preventing mother-to-child HIV transmission.
Broadly neutralizing antibodies for long-term HIV control and cure
Broadly neutralizing antibodies (bnAbs), which are made naturally by some individuals and target parts of the HIV virus that are less prone to mutation, are also showing promise in HIV treatment, prevention, and cure strategies. Studies have shown that bnAbs can effectively neutralize a broad range of HIV strains and bnAb combinations can maintain viral suppression in the absence of antiretroviral therapy, but challenges remain around their cost, global scalability, and the potential for viral resistance.
Researchers are testing combination approaches with other drugs to potentially enhance the efficacy of bnAbs in controlling HIV. Study results presented earlier this year found that more than half of study participants living with HIV who received a pair of bnAbs plus the drug N-803 experienced delayed viral rebound or maintained a low or suppressed viral load during interruption from antiretroviral treatment. N-803, which is approved as a treatment for bladder cancer, appears to help reactivate and eliminate dormant HIV virus.
Gilead also shared promising results from a Phase 2 trial earlier this year combining lenacapavir with two bnAbs as treatment for HIV. This regimen is the most advanced bnAbs-based treatment to date, with Phase 3 trials expected to start soon.
Beyond treatment, many leading HIV scientists believe that a vaccine that elicits the production of bnAbs could be key to targeting the tricky, mutating virus. IAVI and partners developed immunogens, a type of antigen that can trigger an immune response, for use in a vaccine strategy to induce bnAb production, which demonstrated success in several Phase 1 clinical trials. A new study looking at data from two of the trials shows that this targeted vaccine strategy can successfully activate early immune responses relevant to HIV, an important step toward an HIV vaccine. The candidates use an mRNA vaccine platform, enabling faster production and clinical testing.
While bnAbs have the potential to transform HIV prevention and treatment, further research is needed to overcome cost and delivery barriers to ensure that future innovations can be rapidly scaled up and distributed to the communities who can benefit most from them.
While global HIV efforts have faced setbacks this year, we’ve also seen the extraordinary progress that’s possible when partners unite around innovation. New tools and approaches are emerging that could change the course of the global HIV/AIDS pandemic, preventing millions of new infections and deaths every year. But their impact depends on what happens next. To realize their full potential, countries, donors, and partners must come together and recommit to fund research, prioritize equitable access, and accelerate the scale-up of new tools. The future of the HIV/AIDS response hinges on how we meet this moment.
Tags: