Breakthroughs Blog: HIV/AIDS

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. The US Food and Drug Administration granted Fast Track authorization to LimmaTech Biologics' vaccine candidate targeting the Staphylococcus aureus bacterium, which is a major source of sickness and death around the world, causing infections that are becoming harder to treat as the pathogen develops resistance to traditional antibiotic treatments. There is currently no vaccine to prevent infections caused by S. aureus. The authorization will expedite the review process for the product, which will undergo Phase 1 clinical trial testing later this year.  In two Phase 3 trials, a new combination treatment for patients with virologically suppressed HIV-1 demonstrated promising results, underlining the potential of islatravir in combination with other antiretrovirals to address the treatment needs of people living with HIV. The once-daily, oral, two-drug, single-tablet regimen consists of the investigational drug islatravir and doravirine, which was approved in 2018 as a single-agent treatment and in combination with other drugs. Islatravir is also being studied in other early- and late-stage HIV combination treatment trials.  A recently published study found that an mRNA vaccine designed by the US Centers for Disease Control and Prevention and Moderna successfully protected ferrets from the avian influenza virus, which continues its worrying spread across the United States. Blood serum taken from immunized ferrets was also able to neutralize a sample of the virus taken from a patient who contracted bird flu after coming into contact with dairy cows, which have been at the center of the outbreak. While there are three avian influenza vaccines approved in the United States, they were designed for past variants of the virus rather than the clade behind the current outbreak, and they are not mRNA vaccines, which, as demonstrated during the COVID-19 pandemic, can be rapidly produced and scaled up in the face of an emergency.

In many ways, 2024 has been a year marked by change—the first new year since the official end of the COVID-19 pandemic and a record number of elections ushering in political transitions around the world. With the global spotlight shifting to antimicrobial resistance (AMR) and tuberculosis (TB) reclaiming the designation as the top infectious disease killer from COVID-19, it may seem, at first glance, that the world has moved on from the pandemic that dominated every aspect of life for the better part of four years. However, with a deeper look, it’s clear that the global community is still reacting to and learning from the pandemic—for better or worse.As the year comes to an end, GHTC is reflecting on the global health innovation news and policies that shaped 2024.1. New disease outbreaks arise around the world, spurring need for and progress in R&D.In 2024, disease outbreaks continued to dominate the headlines—from the first reports of avian flu in the United States in March to the rapid global spread of the clade 1b mpox strain over the summer to the outbreak of the deadly Marburg virus in Rwanda beginning in September. Each of these incidents exposed devastating gaps in our prevention and response toolkit and spurred important steps forward on research and development (R&D) and access.For example, in response to the worrisome spread of avian flu, both the World Health Organization (WHO) and the US government launched efforts to accelerate the development of mRNA vaccines that could be deployed in case of human-to-human transmission of the currently spreading strain of avian flu or redirected to target another form of pandemic influenza if needed. Additionally, following declarations from the Africa Centres for Disease Control and Prevention and WHO designating mpox a public health emergency this past August, WHO prequalified the first vaccine against mpox and approved the first mpox test for emergency use, with the goal of accelerating global access to these critically needed tools. The outbreak also provoked new research to develop improved vaccines against mpox and the broader range of orthopox viruses, with early studies of mRNA mpox vaccines in macaques and mice demonstrating promising results.This fall, as cases of Marburg were on the rise in Rwanda, and with no currently approved vaccines or treatments available, researchers fast-tracked efforts to evaluate tools to stem the current outbreak and curb future ones. Rwandan health authorities initiated an open label vaccine trial in health workers and others at heightened risk, and there has since been a randomized clinical trial arm launched, which will offer critical efficacy data. Additionally, scientists launched the first-ever clinical trial for a Marburg treatment this year.Beyond accelerating innovation against these outbreaks, 2024 also brought exciting research advancements targeting other pathogens scientists believe are most likely to cause the next pandemic, including trials that could lead to the first-ever approved vaccines for Sudan ebolavirus and Lassa fever, as well as further efforts to improve coronavirus vaccines and simplify and speed up vaccine development and manufacturing.2. Pandemic preparedness policy reforms march forward while post-COVID political backlash in United States grows.Multilateral efforts to strengthen the world’s pandemic preparedness and response architecture moved incrementally forward this year. At the World Health Assembly (WHA) in May, member states adopted several amendments to the International Health Regulations—an existing framework codifying international responsibilities during a pandemic—, including new commitments to solidarity and equity on financing and ensuring access to medical products. The World Bank-hosted Pandemic Fund, a financing mechanism launched in 2022 to help low- and middle-income countries strengthen their preparedness and response capacities, also raised $982 million in new contributions and an additional $1.8 billion in co-financing this year, as well as awarded $500 million in grants to countries to strengthen surveillance, laboratory, and workforce capacities and fast-tracked an additional $129 million for the mpox response. Under the Brazilian presidency, G20 nations established a voluntary coalition to strengthen local and regional production of health products, which, while focused foremost on neglected diseases, could also strengthen capacities critical for pandemic preparedness and response. Unfortunately, despite some progress on negotiations toward a new pandemic accord, countries failed to reach sufficient consensus before the end of this year, and negotiators are now pushing to wrap up by the next WHA in May of 2025.At the same time as some progress was achieved on the international front, in the United States, post-COVID political backlash has deepened and become more entrenched through congressional scrutiny and reform agendas targeting the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). Though the fiscal year 2025 budget is not expected to be finalized until next year, the health-related spending bill introduced by the House proposes spending cuts to CDC and a reorganization of NIH, which mirrors that put forward by House Republicans over the summer and could have serious implications for the agency’s core global health R&D capacities. Beyond appropriations, we also continued to see a plethora of congressional hearings targeting NIH and CDC on the origins of COVID-19, gain-of-function research, China’s influence, and the perception that these agencies are overstepping their mandates. The scrutiny and reform efforts we saw this year are expected to intensify in 2025, as Republicans gain control of both chambers of Congress and the White House.3. AMR captures the world’s attention as the global threat continues to grow.2024 was informally dubbed “the year of AMR,” with AMR elevated on the global agenda at several key moments. In May, a WHA resolution was adopted to accelerate national and global responses to AMR by advancing R&D, strengthening surveillance systems, and forging international partnerships. Later in September, a landmark report found that without further policy interventions, the death toll from AMR is expected to reach 39 million between 2025 and 2050—the equivalent of three deaths per minute.This shocking report set the scene for the United Nations High-Level Meeting on AMR in September, which led to the adoption of a political declaration that set the goal to reduce AMR deaths by 10 percent by 2030 and committed countries to promote the R&D of and equitable access to antimicrobials, vaccines, diagnostics, and other products. Global leaders also adopted an action plan in November, built off of the declaration, to provide actionable objectives and additional check-ins to monitor progress.This political momentum on AMR was also matched by exciting research breakthroughs that made the news this year. Researchers discovered a new compound that could potentially treat a resistant bacterial pathogen that can cause lethal hospital infections. Additionally, Phase 3 trials yielded promising results for both a therapeutic option for patients with serious bacterial infections and limited treatment options, as well as a new antibiotic that could cure uncomplicated gonorrhea infections, which could be approved sometime next year.4. TB reclaims title of deadliest infectious disease, but promising trials offer hope. This past year, TB surpassed COVID-19 to reclaim the spot as the world’s leading infectious disease killer, according to WHO’s Global Tuberculosis Report 2024. While this sobering news underscored major gaps in the tools needed to prevent, diagnose, and treat TB, especially drug-resistant TB, 2024 also brought exciting news on the research front that will hopefully help fill them.In March, a Phase 3 trial launched in South Africa, which is testing a TB vaccine candidate that could eventually become the first vaccine to prevent pulmonary TB in adolescents and adults. The only approved TB vaccine on the market, which was developed more than 100 years ago, is effective at preventing some types of TB in infants, but it offers inconsistent protection in adults against pulmonary TB. Additionally in November, the endTB consortium announced the completion of the first Phase 3 randomized controlled trial to exclusively enroll people with pre-extensively drug-resistant TB, a very hard-to-treat form of TB. Preliminary results demonstrated that a shorter, less toxic treatment strategy achieved high cure rates. Earlier in the year, WHO also recommended three new regimens for multidrug- or rifampicin-resistant TB, offering a much-needed variety of therapeutic alternatives for those with multidrug-resistant TB. 5. A major HIV breakthrough, but work remains on access. In what has been hailed as a breakthrough in HIV prevention, in 2024, exciting results were reported from a series of clinical trials for Gilead’s long-acting HIV prevention drug, lenacapavir, which found that the drug was 100 percent effective in preventing HIV in cisgender women and adolescent girls and 96 percent effective among cisgender men, transgender men and women, and gender nonbinary individuals who have sex with men. Both trials were so successful that they were unblinded early to offer the drug to all participants. Lenacapavir, which is administered via a twice-yearly injection, is currently approved as a treatment for multidrug-resistant HIV, but, if approved as a preventative regimen, the drug could be a game-changer for the HIV pandemic.Advocates applauded Gilead for its historic commitment to inclusion in these trials, while also urging that lenacapavir be made accessible and affordable as soon as possible to those that most need it. In October, Gilead announced a plan to allow generic versions of the drug to be sold in 120 countries, including all those with the highest HIV rates. However, the plan faced criticism for excluding most middle- and high-income countries that account for around 20 percent of new HIV infections. In these countries, the originator drug will only be available at higher prices, making it potentially inaccessible to at-risk populations.In other welcome HIV prevention news, in October, Population Council announced the results of a Phase 1 trial, which suggest that a three-month dapivirine vaginal ring for HIV prevention will be as effective as the currently approved one-month ring. The ring, which is self-inserted into the vagina and slowly releases an antiretroviral drug to prevent infection over three months, was found to deliver the drug at higher levels than the one-month ring. If the longer-acting ring continues to demonstrate success, it could offer a more cost-effective and convenient option for at-risk women. 6. Trump presidency and Republican trifecta portend changes to US leadership in global health.In the November election in the United States, former President Donald Trump won the presidency and Republicans gained control of both the US House of Representatives and the Senate. It was an across-the-board victory that will portend changes to US leadership on global health and medical research. If past is prologue, we’re likely to see President-elect Trump once again propose significant funding cuts to US global health programs and public health agencies like NIH and CDC, as well as withdraw the United States from WHO and other multilateral initiatives, the latter of which could derail efforts to finalize a pandemic accord. Given that the United States is the largest funder of global health programs and global health R&D efforts, these political changes could have a reverberating impact on health around the world.Since winning the presidency, President-elect Trump has also nominated several controversial picks to lead America’s public health agencies. These include Robert F. Kennedy Jr, a noted vaccine skeptic who has expressed a desire to cut the NIH workforce and refocus the agency on chronic diseases over infectious diseases, to lead the Department of Health and Human Services; Dr. Jay Bhattacharya, a health economist who criticized public health measures during the COVID-19 response and a vocal critic of NIH, to lead NIH; and Dr. Dave Weldon, a former Congressman who has questioned vaccine safety, to lead CDC.On the congressional front, with Republicans now in control of both chambers of the US Congress, as discussed, we’ll likely see continued scrutiny and reform efforts targeting NIH and CDC, as well as potential spending cuts to health and foreign assistance programs.7. New policies and innovative research approaches help reach underserved populations.Every person, everywhere, deserves to benefit from the fruits of science, and in this otherwise tumultuous year, there were several successful efforts to advance more inclusive clinical studies. In September, WHO released new guidance on clinical trial best practices outlining practical considerations for trials to include children and pregnant and lactating individuals, populations currently underrepresented in trials, leading to a lack of approved technologies for these groups. This guidance aligned with WHO’s living toolkit to facilitate the inclusion of pregnant and breastfeeding populations in clinical trials that was published earlier in the year. 2024 also brought the launch of two historic trials that aim to diversify research and thereby ensure that future technologies will serve the needs of underserved populations. This summer, a global consortium launched the first-ever Phase 3 clinical trial testing the efficacy and safety of antimalarials in women in their first trimester of pregnancy, which will hopefully not only lead to an urgently needed new treatment option for these women but also set a precedent for the inclusion of pregnant women in future clinical trials. Earlier this year, the US Administration for Strategic Preparedness and Response also announced funding to Walgreens to support a decentralized clinical trial testing COVID-19 vaccines. This unique approach will allow for a more diverse pool of study participants by bringing the study closer to where they live, ultimately ensuring that the resulting data reflects real-world use among a broader swath of the population. In the end, 2024 proved to be a complicated year, marked by both scientific and political steps forward and back. As new innovations and policies emerge in 2025 and beyond, GHTC will continue to work to ensure support for global health R&D remains a political priority and that the gains we have already made on neglected and emerging health challenges are not only sustained but also strengthened to combat an evolving health landscape.For other fascinating global health news delivered to your inbox weekly and to stay abreast of developments in 2025 and beyond, sign up now to receive GHTC’s R&D News Roundup newsletter.

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. Last Wednesday, The New England Journal of Medicine published the full results of the PURPOSE 2 trial testing Gilead Science’s twice-yearly lenacapavir shot for HIV prevention, finding that it was extremely effective in a broad and geographically diverse range of cisgender men and gender-diverse people. These results follow those of the first PURPOSE trial published earlier this year, which found that the drug was 100 percent effective as a prevention option in a study of women and adolescent girls. Lenacapavir is already approved and available in several countries, including the United States, as an HIV treatment option. With additional approvals as an HIV prevention option, the shot could be a game-changer for many marginalized communities that face the highest risk of HIV infection.A recent study found that the investigational drug quabodepistat in combination with delamanid and bedaquiline demonstrated safety and efficacy as a treatment for pulmonary tuberculosis (TB). TB treatment has historically been months long and difficult to tolerate, leading to discontinued treatment courses that raise the risk of the emergence of drug resistance. This combination treatment could potentially help fill the gap for safer, shorter regimens that cause fewer side effects. Further large-scale and long-term trials will be needed to validate these findings before this treatment combination can be available to the communities that face the highest burden of TB.Last week, the US Department of Health and Human Services announced nearly $27 million to support the rapid development and scale-up of manufacturing capacity for diagnostic tests to address future biologic threats through the Biomedical Advanced Research and Development Authority consortium. The COVID-19 pandemic exposed the gap in the United States' capacity to quickly develop, validate, produce, and roll out diagnostic tests to curb the spread of an infectious disease outbreak. While the funding will specifically support the development of tests to detect Burkholderia pseudomallei, the bacterium that causes melioidosis, and Marburg virus, the aim is to advance diagnostics platforms that can be leveraged to quickly produce tests for other threats as they emerge.

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. Recently published results from a Phase 3 clinical trial support Pfizer and Abbvie’s aztreonam-avibactam as a potential treatment for patients with serious gram-negative bacterial infections and limited treatment options. Aztreonam-avibactam is a combination of two antibiotic drugs that work together to effectively fight off tricky bacteria resistant to nearly all currently available antibiotics. The treatment was approved in April by the European Medicines Agency based on the results of two previous Phase 3 clinical trials that investigated the treatment's efficacy in treating several types of multidrug-resistant infections.Last week, TB Alliance announced the award of a $7.35 million four-year grant from the US Department of Defense’s Congressionally Directed Medical Research Programs for the research and development of host-directed approaches for treating tuberculosis (TB). Host-directed approaches, which target the immune response of the host (the infected person) rather than directly targeting the bacteria, could reduce the likelihood of the emergence of drug resistance and, in combination with new TB drugs, could offer shorter and less long and burdensome treatment regimens for those with drug-resistance and drug-sensitive TB. Specifically, the project will work toward preclinical proof-of-concept for at least one novel adjunct TB host-directed therapy and one therapeutic vaccine.At the HIV Research for Prevention Conference last week, the Population Council announced the results of a Phase 1 trial conducted in South Africa, which suggest that the three-month dapivirine vaginal ring for HIV prevention will be as effective as the one-month ring. The three-month dapivirine vaginal ring, a flexible silicon ring self-inserted into the vagina that slowly releases an antiretroviral drug to prevent HIV infection, was found to deliver the drug at higher levels than the one-month ring. If the longer-acting ring continues to demonstrate success in future trials, it could offer a more cost-effective and convenient option for women—it is expected to reduce the cost per user by 60 percent.