Paris, France – A groundbreaking clinical trial has introduced four innovative regimens for treating multi-drug resistant tuberculosis (MDR/RR-TB), a significant advancement in combating this challenging global health threat. Lorenzo Guglielmetti, Director for the endTB project at Médecins Sans Frontières and Co-Principal Investigator of the study, announced these findings at the Union World Conference on Lung Health in Paris. The trial results mark a pivotal moment in treating MDR-TB, which has long posed a formidable challenge due to limited and poorly tolerated treatment options.
According to Kenya News Agency, these all-oral, shortened regimens offer patient-centered, individualized treatment options for MDR-TB, a disease that disproportionately affects vulnerable populations. The Phase III randomized controlled trial’s diversity and generalizability make the results particularly significant. The trial discovered three new drug regimens that could match conventional treatments in efficacy and safety while reducing treatment duration by up to two-thirds.
Additionally, the new endTB regimens provide vital alternatives for MDR-TB treatment and complement the use of another effective, shorter MDR-TB regimen, BPaLM, which is not suitable for certain populations. These regimens can be administered regardless of patient age, pregnancy status, or comorbidities commonly seen in people with MDR-TB, aligning with World Health Organization recommendations.
The trial also supports a fourth regimen for those intolerant to bedaquiline or linezolid, essential drugs in current WHO-recommended regimens for MDR-TB. In a related study released in September 2023, Kenya was among eight countries that achieved a 35% reduction in TB cases from 2015, a notable public health accomplishment. Despite this progress, TB remains a significant concern in Kenya, with about 120,000 new cases annually.
MDR/RR-TB is caused by TB bacteria resistant to rifampicin, a key first-line antibiotic, and often to isoniazid. Current MDR-TB treatments, which can last up to 24 months, are plagued by low efficacy and severe side effects. The endTB clinical trial, which began in 2017 and involved 754 patients from seven countries, evaluated five nine-month treatment regimens, with promising results.
Prof. Carole Mitnick, Director of Research for the endTB project and Co-Principal Investigator, emphasized the trial’s significance in offering hope and the need for continued research and innovation. However, the high cost of some drugs, like delamanid, remains a barrier to treatment.
The trial results could transform TB treatment by offering effective, more accessible options for drug-resistant forms of the disease. Dr. Philippe Duneton, Executive Director of Unitaid, stressed the importance of these findings in providing new hope for effective treatment against the most dangerous and difficult-to-treat forms of tuberculosis globally.