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.Last week, a US Food and Drug Administration (FDA) advisory panel recommended approval of two vaccines for respiratory syncytial virus (RSV) for adults 60 and older, one by Pfizer and one by GlaxoSmithKline. The agency could grant formal approval to the vaccines in the coming months, making them the first shots available against RSV, a disease responsible for significant deaths and hospitalizations among older adults and young children. Other vaccines, as well as monoclonal antibody treatments, also in the pipeline could additionally address the yearly burden of RSV.The US Centers for Disease Control and Prevention (CDC) has issued a warning about a rise in extensively drug-resistant cases of Shigella, especially in gay and bisexual men, in the United States and other countries. Shigella is a highly infectious bacterial infection that causes an inflammatory diarrheal condition and is spread when infected fecal matter enters the mouth or nose. The European Centre for Disease Prevention and Control also released an alert about possible cases among recent travelers. Doctors have faced major challenges in identifying viable alternative antibiotics to treat these cases, underlining the need for greater focus on the research and development of new antibiotics.This year’s Conference on Retroviruses and Opportunistic Infections saw a myriad of presentations on how best to expand global access to the cabotegravir, or CAB-LA, which is a long acting, injectable form of preexposure prophylaxis (PrEP) used to prevent HIV infection. CAB-LA joins oral PrEP and the recently approved dapivirine vaginal ring as a third safe and effective biomedical HIV prevention option, for the first time allowing people an authentic choice among products. However, to ensure access and availability of these products, there remains a need for additional research on the use of CAB-LA in certain patient populations, including among people who inject drugs, and further research on effective delivery methods to expand uptake of oral PrEP.

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 University of Minnesota’s Center for Infectious Disease Research and Policy last week announced the launch of a roadmap outlining a detailed strategy for the development of broadly protective and widely suitable vaccines to address future COVID-19 variants and other coronaviruses. The roadmap lays out the need for five broad and intersectional streams of work from virology to financing that will be necessary to break down the siloes of current vaccine development to achieve better coordination, accountability, and access. The initiative comes as a response to the COVID-19 pandemic, which is the third time in two decades that a coronavirus has become a public health crisis.A man in Germany has become at least the third person living with HIV formally declared HIV-free after undergoing a procedure in 2013 to replace his cancerous bone marrow cells with donor stem cells that contained a mutation making them effectively HIV-resistant. There remain questions about the full effects of the transplant and the factors behind the successful elimination of HIV in the body, even after follow-up studies. Experts say it is unlikely this procedure would ever be rolled out widely in people without leukemia due to high risk of a person rejecting donor marrow, but other ongoing and planned studies are looking at the potential of genetically modifying a patient’s own stem cells to include the HIV-resistant mutation.The United States is seeing a concerning rise in cases of syphilis, which has seen various cycles of rises and declines over the past century. There are few researchers that study syphilis, and the development of new diagnostics, treatments, and preventive tools has proved challenging because of past inability to grow the fragile Treponema pallidum bacterium that causes the disease in a lab and because of the virus’s ability to evolve resistance to antibiotics. A new technique that allows for lab-grown bacteria along with recent, promising studies of treatments and diagnostics for the disease provide hope. However, there is wide agreement that a vaccine is needed to eliminate the disease and the potential of resistance, and researchers are far from introducing a potential candidate.

The US Agency for International Development (USAID) released a new report on its global health research and development (R&D) programs for fiscal year 2022 that includes unprecedented insight into the product development programs the agency supported—and highlights the need for additional, dedicated resources for global health research.Why it matters: The report gives insight into an agency that is a key sponsor of global health product development.Due to a lack of commercial incentive for industry investment, most global health research is supported by public funders, most notably the US government.Several US agencies support global health research, but USAID is the only agency with a mandate to improve global health and development. The agency excels at pushing products through the end of the research pipeline and advancing tools to suit the needs of people in low-resource settings.What’s new: This report includes an unprecedented 13-page appendix detailing USAID’s individual product-level investments. By our count, USAID supported at least 59 products in 2021 covering multiple health areas and product types.By the numbers: In 2021, USAID spent US$165 million in baseline funding and $50 million in COVID-19 supplemental funding on health product development and research to assess the best way to implement new products and practices.Research spending from baseline funds increased slightly over the prior year (+$4 million) — but continued to decline as a proportion of total global health spending. In 2021, proportionate spending on research dropped slightly to 5.1 percent, continuing a years-long pattern. If the trend continues, GHTC estimates that proportionate spending on R&D will drop to 4.2 percent by 2026 unless Congress passes a policy like the Supporting Innovative Global Health Technologies (SIGHT) Fund to direct more dedicated funding to R&D.Our take: GHTC applauds the release of the report and the additional detail provided by USAID. We call policymakers’ attention to the continued need for additional, dedicated resources for global health research at USAID that this report exposes.

2022 G-FINDER report highlights the inadequacy of global health R&D funding: GHTC offers key takeaways for the global health communityThe release of the 2022 G-FINDER report sheds light on current funding trends in global health research and development (R&D). Despite hard-won advocacy victories by GHTC and the global health advocacy community, neglected diseases are living up to their moniker from a funding standpoint, as global investment in HIV/AIDS, tuberculosis (TB), malaria, and neglected tropical diseases (NTDs) remains far below levels required to overcome these persistent and devastating health threats. The new report highlights several new and ongoing funding trends. GHTC has identified three findings of particular importance to the global health research community.Funding for NTDs dropped precipitously; funding shortfalls for HIV/AIDS, malaria, and TB persist.Funding for NTDs included within the G-FINDER scope decreased by 10 percent in 2021, falling to their lowest total since 2009. NTDs impact more than a billion people each year, disproportionately afflicting women and children. The reduction in funding is particularly alarming given that many of the targets set in the WHO roadmap on NTDs (2012-2020) have not been met. Outside of NTDs, funding for malaria saw a substantial 5.7 percent dip, HIV/AIDS investment experienced a modest uptick of 2.7 percent, and TB funding remained virtually flat, dipping less than a tenth of a percent. While these three diseases receive more resources than NTDs, their funding levels are significantly below that which is needed to overcome these health crises and reach global health and development targets, like the Sustainable Development Goals.Funding for Product Development Partnerships (PDPs) declined for the fourth consecutive year.PDPs are the leading engines of medical innovation for diseases that lack sufficient commercial market incentives. Thus, it is distressing to see that neglected disease R&D funding for PDPs fell by 18 percent in 2021, continuing a multiyear backslide. Current PDP funding sits 40 percent below its peak, which was 13 G-FINDER cycles ago. The most recent dip was driven by reduced investment from large donors like the Bill & Melinda Gates Foundation, the UK Foreign, Commonwealth & Development Office, and the US Agency for International Development (USAID). These findings also highlight the need to further diversify funding sources for PDPs, as well as global health R&D more broadly. Specifically on the US government funding front, PDP funding was not the only area in which USAID funding declined. Neglected disease R&D funding from the agency reached a record low, further highlighting the need for additional mechanisms within USAID to facilitate supporting medical innovations for unmet needs. During the virtual launch event for the report, keynote speaker Dr. Peter Hotez noted the vital role that US agencies like USAID and the US National Institutes for Health play in the global health R&D ecosystem.Funding for platform technologies and non-disease-specific investment is on the rise. For the seventh consecutive year, funding for non-disease specific (NDS) R&D increased, rising by 5.6 percent. Specifically, investment in platform technologies grew for the fourth consecutive year and now accounts for 22 percent of NDS funding. Much of the past year’s growth was buoyed by an increase in drug-related platform technologies, which historically received the smallest share of funding. This trend dovetails with a larger shift of investments toward drugs, as overall drug R&D funding eclipsed vaccine R&D funding for the first time in 2021.Overall, the global health advocacy community has made incredible strides in protecting and growing funding for global health innovation. This past year in the United States, GHTC helped support the passage of a global health research-friendly fiscal year 2023 omnibus package, which included significant funding increases across nearly every line relevant to global health R&D, as well as complimentary directives that will support global health R&D across several agencies. However, the challenges of competing global interests and tough funding environments are formidable, as shown by the G-FINDER report. This coming year presents a number of strong opportunities to elevate attention and support for resources for global health innovation, including United Nations High-Level Meetings on TB and universal health coverage. We urge leaders around the world to step up and invest in lifesaving global health R&D, and our advocacy community partners to continue to hold the world accountable for ensuring health and health equity for all.