FRANCE – Clinical trial findings unveiled at the Union World Conference on Lung Health in Paris have showcased a significant leap forward in the fight against multi-drug resistant tuberculosis (MDR-TB) or rifampicin-resistant tuberculosis (RR-TB).
The endTB clinical trial, initiated by the endTB consortium comprising Médecins Sans Frontières (MSF), Partners in Health (PIH), and Interactive Research and Development (IRD), presented compelling evidence supporting the efficacy and safety of four innovative regimens.
These regimens not only match the effectiveness of conventional treatments but also slash treatment times by up to two-thirds.
This Phase III randomized controlled trial, commenced in 2017, included a diverse cohort of 754 patients across seven countries—Georgia, India, Kazakhstan, Lesotho, Pakistan, Peru, and South Africa.
Participants encompassed teenagers and individuals with comorbidities such as substance-use disorders.
The trial evaluated five nine-month treatment regimens against the standard of care, revealing three regimens yielding favorable outcomes in 85-90% of participants.
Professor Carole Mitnick, co-principal investigator of the study, hailed the trial’s potential breakthrough, stating, “We stand on the cusp of a significant breakthrough in the battle against MDR, a disease that disproportionately affects impoverished populations around the globe.”
Despite the progress, Mitnick emphasized the lingering challenge of high drug costs, citing delamanid as an example, priced significantly above its estimated production cost.
MDR/RR-TB arises from a tuberculosis bacterium resistant to rifampicin and, in some cases, isoniazid.
Approximately half a million people annually suffer from MDR/RR-TB, leading to substantial mortality rates.
Drug-resistant TB poses a global threat to antimicrobial resistance, complicating and prolonging treatment with poorer outcomes for patients.
Lack of access to quality care and the economic burden on patients persist, with only one in three individuals with drug-resistant TB obtaining adequate care.
The emergence of extensively drug-resistant tuberculosis (XDR-TB) further compounds the challenge, characterized by additional resistance to fluoroquinolones and injectables.
While multiple MDR-TB regimens are now in use globally, many patients endure conventional treatments extending up to 24 months, offering only a 59% treatment success rate in 2018. Such treatments often trigger severe side effects, including acute psychosis and permanent deafness.
Dr. Lorenzo Guglielmetti, co-principal investigator from MSF, celebrated the trial’s unveiling of innovative all-oral, shortened regimens. He expressed hope for patient-centered, individualized MDR-TB treatment, emphasizing the trial’s diversity and the generalizability of its results.
The trial’s funding from Unitaid was lauded by Dr. Philippe Duneton, Unitaid’s executive director, recognizing the potential for rapid implementation of improved treatment options.
The results signify a pivotal moment in the battle against drug-resistant tuberculosis, offering renewed hope and a path towards more accessible and effective treatments for this global health challenge.