Breakthroughs Blog: Tuberculosis

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 study published last week and presented at the American Society of Tropical Medicine & Hygiene’s (ASTMH’s) annual meeting found that the malaria parasite is acquiring partial resistance to artemisinin, a key drug used to treat children with severe malaria, meaning that infection takes longer to clear and is not always being completely cleared by the drug. The researchers found partial resistance to the drug in 11 of the 100 children treated in the study, with 10 patients “cured” of severe malaria having a resurgence of the same strain within a month of the original infection, implying that the first treatment did not fully eliminate the parasite. More studies are needed to determine how widespread artemisinin resistance is in Africa. Still, the findings underscore the need for novel or alternative drugs to be used in the treatment of severe malariaThe US Centers for Disease Control and Prevention (CDC) has awarded Alveo Technologies a contract to develop a molecular assay to detect and differentiate the H5 subtype of avian influenza A from seasonable influenza A and B viruses in humans, as the ongoing spread of H5N1 in animals across the United States raises concerns about a new pandemic as regular flu season looms. Currently, only CDC and US state and jurisdictional public health labs have access to CDC’s molecular test to detect the H5 strain of influenza A, which could lead to delays in diagnosis or treatment if we start to see transmission between humans. Decentralized testing capabilities at the point of care will be needed to ensure any spread between humans is detected and controlled quickly to avoid another pandemic, as well as to reduce the burden on centralized laboratories.  Last week, the endTB consortium announced the completion of the endTB-Q trial, the first Phase 3 randomized controlled trial to exclusively enroll people with pre-extensively drug-resistant tuberculosis (pre-XDR-TB), with preliminary results demonstrating that a shorter, less toxic treatment strategy of four drugs achieved high cure rates overall, especially in those with non-severe cases of TB disease. Pre-XDR-TB has historically been treated with toxic regimens that last up to two years, are hard to tolerate, and are not very effective. This study tested a personalized medicine strategy, with disease severity and early treatment response used to decide between a six- or nine-month treatment regimen. The study included participants from India, Kazakhstan, Lesotho, Pakistan, Peru, and Vietnam.

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.  

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. On Thursday, the World Health Organization (WHO) asked manufacturers to submit mpox diagnostic tests for emergency review in an effort to speed up and broaden access to effective testing amid the mpox emergency on the African continent. WHO has also updated its mpox testing guidance and is working with countries to roll out testing, with 30,000 tests expected to arrive in African countries in the coming weeks. Manufacturers Labcorp and Roche have also said that they are working to increase their mpox testing capacity.The Coalition for Epidemic Preparedness Innovations (CEPI) will provide $2.05 million to South African biotech company Afrigen Biologics for a proof-of-concept project to investigate whether synthetic DNA could serve as an alternative to the traditional plasmid DNA used for mRNA vaccine development, cutting timelines and costs. The partnership supports the 100 Days Mission of reducing vaccine development timelines to just 100 days after identifying a disease outbreak with pandemic potential. The project could help further optimize mRNA vaccine development—which is already much faster and more flexible than traditional vaccines—in the face of an outbreak, as well as enable local manufacturing of vaccines in Africa, which could help facilitate more equitable access to vaccines.Last week, IAVI announced that the first participants at trial sites in Ghana, Liberia, and Nigeria had been vaccinated in a clinical trial of IAVI’s Lassa fever candidate. Lassa fever, for which there is limited treatment and no available vaccine, causes an estimated 300,000 cases across West Africa annually, and the threat is expected to grow due to climate change and population growth. The trial, funded by CEPI and designed in consultation with in-country partners, will evaluate the candidate’s safety, tolerability, and immunogenicity at two different dosage levels in adults, including people living with HIV, as well as in adolescents and children two years and older. The trial results are expected in 2025.

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 (FDA) on Thursday approved updated COVID-19 vaccines from Pfizer and Moderna that target the KP.2 virus strain, which emerged from the highly contagious JN.1 variant that began circulating widely in the United States last winter. The new shots are expected to be available within days amid spiking case rates and hospitalizations for COVID-19. Experts also hope the vaccines will provide cross-protection against closely related subtypes of the virus, including KP.3.1.1 and KP.3, which are now spreading rapidly and account for 36 and 17 percent of all new cases, respectively. The FDA has not yet approved a third vaccine from drugmaker Novavax.The World Health Organization (WHO) this week recommended three new oral regimens for multidrug-resistant or rifampicin-resistant tuberculosis (TB) that can cure patients more quickly and successfully than the current painful injectable regimens. These regimens—which include the use of new and repurposed medicines like bedaquiline, pretomanid, linezolid, and delamanid—can be offered to nearly all patients and can improve treatment success by shortening treatment time to six to nine months, rather than the usual 18 months, while reducing treatment toxicity and the spread of drug-resistant forms of TB. WHO’s recommendations are based on results from the BEAT-TB clinical trial conducted in South Africa and the endTB trial conducted in seven countries between 2017 and 2023 by Médecins Sans Frontières, Partners In Health, and Interactive Research and Development and funded by Unitaid.  A new study found that giving azithromycin to all children up to five years old can greatly reduce childhood mortality in sub-Saharan Africa, more so than by limiting the distribution of the antibiotic to younger children, as recommended by WHO. The study, published Wednesday in the New England Journal of Medicine, found that twice-yearly distribution of azithromycin to children ages 1 to 59 months in rural communities in Niger reduced childhood mortality by 14 percent when compared with children who received a placebo. Further, the study found that targeting only children ages 1 to 11 months (recommended by WHO in 2020) did not lead to a significant reduction in childhood mortality. However, concerns remain about the effect of routinely distributing the antibiotic to all children under five on antimicrobial resistance.