Breakthroughs Blog: HIV/AIDS

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 accessIn 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 cureBroadly 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.

An international research team led by the University of Liverpool has discovered an exciting new class of antibiotics with the potential to target some of the world’s most dangerous multidrug-resistant bacteria, including MRSA and Enterococcus faecium, as experts continue to warn of the growing global threat of antimicrobial resistance. The new class, Novltex, targets a key component of bacterial cell walls that does not mutate, meaning that, unlike traditional antibiotics, it could offer long-lasting protection against antibiotic-resistant strains of bacteria. Novltex is a synthetically designed platform, making it cheaper to produce and easier to scale up for global use than common antibiotics that utilize complex, expensive natural molecules. In studies so far, researchers found Novltex to be potent and fast-acting, even at low doses, and safe. A research team led by investigators at Weill Cornell Medicine has been awarded a five-year, $20.8 million grant from the National Institute of Allergy and Infectious Diseases at the US National Institutes of Health to further the preclinical development of a promising experimental HIV vaccine for pediatric populations. Experts agree that a preventive vaccine for HIV could help turn the tide of the pandemic. Previous studies of the experimental vaccine found that it was safe and may be effective in infants, although it seems to only work in young immune systems, not in adults. The new funding will support optimization of the vaccine in preparation for clinical trials in infants in parts of the world with a high burden of HIV. Researchers at Tulane University have designed an optimized CRISPR-based tuberculosis (TB) test that uses a simple tongue swab, which, if it continues to demonstrate promise, could be a breakthrough for TB testing. Current TB tests often rely on sputum, which can be difficult to collect and which not everyone can produce, and require sophisticated laboratory equipment and skilled health care workers, leading to gaps in diagnosis, particularly in low-resource settings. The researchers built on a previous CRISPR-based TB test, developing an assay that they found to be highly effective using tongue swabs and also highly sensitive in detecting TB in respiratory, pediatric stool, and spinal fluid samples. This painless and low-resource method could improve access to TB testing, particularly at the point of care in remote and low-resource communities. 

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. A new study from a team at the Liverpool School of Tropical Medicine found that the drug nitisinone works as a potent contact insecticide for killing the mosquito species that spread malaria, dengue, Zika, and other emerging mosquito-borne viral threats, offering hope of a new approach to combating insecticide resistance. Nitisinone, which is currently used to treat a rare genetic condition in humans, kills mosquitoes by blocking an enzyme that is necessary for them to process human blood, which is not a pathway targeted by any currently used insecticides. The research suggests that the drug could be formulated for use in indoor residual spraying or insecticide-treated bed nets, helping eliminate mosquitoes even in settings where rising insecticide resistance has undermined the effectiveness of current vector control methods.Early last week, the Gates Foundation announced a $2.5 billion commitment through 2030 to accelerate research and development on women’s health. Specifically, the funding will help advance more than 40 innovations in five critical areas: obstetric care and maternal immunization, maternal health and nutrition, gynecological and menstrual health, contraceptive innovation, and sexually transmitted infections. These areas were selected based on extensive data about where innovation can save and improve the most lives and where there are persistently high rates of misdiagnosis, as well as direct insights from women in low- and middle-income countries about their needs, preferences, and challenges.Last week, IAVI; the Mutala Trust; ReiThera; and the Ragon Institute of Mass General Brigham, the Massachusetts Institute of Technology, and Harvard University announced that the first doses of an investigational HIV vaccine candidate were administered in their Phase 1, first-in-human clinical trial. The clinical trial is taking place at three sites in Zimbabwe and South Africa among 120 healthy adults, including people living with HIV. Carrying out the trial in sub-Saharan Africa, which faces the highest disease burden, will help ensure the vaccine is effective and relevant in the communities where it is most needed. The vaccine candidate is designed to stimulate the immune system, particularly CD8+ T cells, to recognize and target critical structural regions of the virus. Scientists believe CD8+ T cells could potentially target HIV-infected cells, so the trial will also assess whether the vaccine candidate could be part of future therapeutic or cure technologies.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Scientists have launched the first-ever library of adjuvants, which are substances that boost the ability of vaccines to create stronger, longer-lasting immunity. The repository, which will be housed at the United Kingdom’s Medicines and Healthcare products Regulatory Agency and funded and led by the Coalition for Epidemic Preparedness Innovations, will include 25 adjuvants available for use in developing new vaccines against epidemic and pandemic threats. The library will act as a matchmaking service, helping developers select the best suited adjuvants to increase the effectiveness and potency of their vaccines. The project is intended to support the 100 Days Mission, an ambitious global effort to develop vaccines against newly emerging threats in as few as 100 days.A new study has found that delivering a single gene therapy injection at birth could offer years-long protection against HIV. In the study, non-human primates who received the therapy within their first month of life saw protection for at least three years without the need for a booster—a potential signal that protection could last into adolescence in humans—, while those treated at 8-12 weeks saw a less effective immune response. The immune system is naturally more tolerant within a person’s first weeks of life, so it marks an optimal window for gene treatment that could be rejected at an older age. While questions remain as to whether these findings will translate to human infants and children, if successful, this treatment could offer a “one-and-done” multiyear solution to protect again mother-to-child HIV transmission that could be more cost-effective and feasible to implement in low-resource settings worldwide.The antiparasitic drug ivermectin was found to reduce the incidence of malaria by 26 percent in a trial conducted in Kenya, a finding that demonstrates its potential use for mass drug administration alongside other malaria control interventions. Invermectin is a drug commonly used to treat parasitic diseases like onchocerciasis and lymphatic filariasis, but scientists have been exploring its potential in malaria prevention, given the rise in insecticide resistance, which has rendered other prevention tools like insecticide-treated bednets and indoor residual spraying less effective. The trial, which involved more than 20,000 participants, compared the drug, administered in a single monthly dose for three months during the rainy season, with the antiparasitic albendazole—both alongside use of existing bed nets. It is the largest study of ivermectin for malaria conducted to date.