By: Bunmi Yekini
The World Health Organization (WHO) has recommended three new treatment regimens following the results of the endTB clinical trial in a significant development in the fight against multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB).
The endTB clinical trial was conducted by a consortium of organizations led by Médecins Sans Frontières (MSF), Partners In Health (PIH), and Interactive Research and Development (IRD), and funded by Unitaid, the trial marks a breakthrough in global efforts to combat MDR-TB.
Studied across seven countries between 2017 and 2023, the WHO-endorsed regimens offer a shorter, more effective treatment for MDR-TB patients. The new regimens allow for a cure within nine months using all-oral treatments, a significant improvement over the previous 18-month regimen that often included painful daily injections.
“This is a major step forward for the health of millions of patients affected by this difficult-to-treat form of tuberculosis,” said Dr. Lorenzo Guglielmetti, Director for the endTB project at MSF and Co-Principal Investigator of the clinical trial. “It’s crucial to remember that around half a million people fall ill with MDR/RR-TB every year, and many die from it.”
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WHO also recommended a 6-month treatment strategy tested in the BEAT-Tuberculosis clinical trial in South Africa, this is in addition to the endTB regimens. These recommendations, alongside the 6-month regimen known as ‘BPaLM’ endorsed by WHO in 2022, provide a range of therapeutic alternatives to the long and toxic treatments previously available.
Dr. Guglielmetti emphasized the role of NGOs in advancing these treatments: “Despite significant public financing, the pharmaceutical industry has not adequately informed the use of new drugs in regimens. It has been left to NGOs, with philanthropic and public funding, to conduct controlled trials and innovate with these novel products.”
The endTB results are the first for which WHO has declared evidence supporting the programmatic use of novel, shortened regimens for diverse population groups, including children, adolescents, pregnant, and breastfeeding women. “Clinicians can now offer these advances to nearly all patients, increasing the chances of cure while reducing treatment toxicity and the spread of drug-resistant TB in the community,” said Dr. Carole Mitnick, Director of Research for the endTB project at PIH and Professor of Global Health and Social Medicine at Harvard Medical School.
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However, challenges remain. Two of the newly recommended regimens depend on delamanid, a drug whose access is limited by its high cost. Japanese corporation Otsuka, through its exclusive licensee Viatris, charges around $1,200 for a 6-month treatment course in low- and middle-income countries, with prices in India set at $840. In contrast, generic manufacturers could offer the drug for as low as $100.
MSF has called on Otsuka and Viatris to lower their prices and allow generic manufacturers to produce more affordable versions of delamanid. “We urge Otsuka and Viatris to stop blocking price-lowering generics and to share delamanid with companies interested in making affordable, quality-assured versions of this lifesaving TB drug,” said Christophe Perrin, TB Advocacy Pharmacist at MSF’s Access Campaign.
The new WHO recommendations offer hope for the many patients worldwide who suffer from drug-resistant TB, but ensuring access to affordable treatments remains a critical challenge.