Several studies showcased at the recently-concluded Union Lung Health conference in Paris focused on addressing multi-drug resistant tuberculosis (MDR-TB), ranging from child-friendly medicines to more concise regimens for adults. The Unitaid-funded BENEFIT Kids project presented four key studies aimed at bridging gaps in MDR-TB prevention and treatment for children.
These studies, led by the Desmond Tutu TB Centre at Stellenbosch University in South Africa, aim to overcome barriers such as determining the optimal dosages of TB medicines for children. The objective is to develop more child-friendly and palatable medicines and formulations, ultimately enhancing accessibility, acceptability, and outcomes among children. The motivation for these efforts stems from the significant disparity between recent advancements in adult MDR-TB treatment and the comparatively underdeveloped treatment approaches for MDR-TB in children.
Child-friendly TB treatment
Treatment suitable for children Collaborating teams from Stellenbosch University and the University of California (San Francisco) combined data from five previously published studies involving over 240 children undergoing levofloxacin treatment. This novel methodology has successfully determined the most effective doses of levofloxacin, providing valuable insights for the development of pediatric treatment guidelines, as highlighted in the statement.
These studies complement the PERFORM trial within the project, where researchers compared a new dispersible tablet formulation of levofloxacin designed for children with the current practice of using crushed adult tablets. The evaluation focused on gauging the acceptability of these two medication forms among children.
The CATALYST trial investigated various aspects, including tolerability, of recently developed child-friendly formulations of clofazimine and moxifloxacin. This global, multi-country study took place in India in collaboration with BJ Medical College and Johns Hopkins University, the Philippines with De La Salle Medical and Health Sciences Institute, and South Africa, according to the statement.
In the ChilPref study, researchers from Stellenbosch University and the TB Alliance assessed the taste preferences of children for moxifloxacin and linezolid formulations. This research involved soliciting input from children on their preferences regarding the taste of medicines. For instance, the existing moxifloxacin formulation was mostly rejected by children, as indicated.
Multidrug-resistant tuberculosis (MDR-TB) does not respond to the standard first-line treatment using isoniazid and rifampicin. Approximately 30,000 children contract MDR-TB annually, but less than 20 percent receive diagnosis and treatment, leading to morbidity and mortality. The note underscores that over 183,000 children succumb to the disease each year, with more than 95 percent of them being under five years old and not having received treatment.
Three Novel Treatment Approaches
Earlier in the conference, the end TB consortium, led by Médecins Sans Frontières (MSF), Partners In Health (PIH), and Interactive Research and Development (IRD) with support from Unitaid, presented four enhanced regimens for treating multidrug-resistant (MDR) and rifampicin-resistant (RR) tuberculosis (TB).
According to MSF, the trial identified three new drug regimens that exhibit comparable effectiveness and safety to traditional treatments while significantly reducing the duration of treatment by up to two-thirds.
The endTB trial involved the enrollment of 754 patients from seven countries (Georgia, India, Kazakhstan, Lesotho, Pakistan, Peru, and South Africa). It intentionally included historically marginalized groups such as adolescents and individuals with comorbidities like substance-use disorders. Additionally, the trial retained participants who became pregnant during the study, as indicated in the statement. MSF emphasized that around half a million people are diagnosed with MDR/RR-TB annually, and a significant number succumb to the disease.
The trial assessed five experimental regimens for MDR/RR-TB in comparison to the standard of care, employing two distinct analysis populations. The findings revealed evidence supporting the efficacy of multiple innovative, all-oral, and abbreviated regimens, enabling patient-centered and personalized treatment of MDR-TB, as highlighted by Lorenzo Guglielmetti, MSF Director for the end TB project and Co-Principal Investigator of the study.