Mathatisi Sebusi
THERE is finally hope for multi-drug resistant tuberculosis (TB) and rifampicin-resistant tuberculosis (MDR/RR-TB) patients as newly discovered treatments promise to be more effective, shorter, and have more manageable side effects.
Compared to the current 24 months treatment, which?has?proved to be ineffective in some cases, this new?endTB programme is expected to reduce the treatment period to nine months.
The?new treatment includes endTB1 [BLMZ], endTB2 [BLLCZ], endTB3 [BDLLZ], endTB4 [DLLCZ] and alternatively enTB5 [DMCZ] for MDR/RR-TB patients “who cannot take bedaquiline and/or linezolid” which constitute part of the new regimen.
The endTB treatments are yet to be recommended by the World Health Organisation (WHO) for them to be rolled out?in?health facilities.
A team led by Médecins Sans Frontières (MSF), Partners In Health (PIH), and Interactive Research and Development (IRD) formed the endTB consortium and began a Phase III randomized controlled trial in 2017.
With financial assistance from Unitaid, they evaluated the efficiency and safety of five new oral, shortened regimens for MDR-TB.
Unitaid is a global health initiative that works with partners to bring about innovations to prevent, diagnose and treat major diseases in low- and middle-income countries, with an emphasis on tuberculosis, malaria, and HIV/AIDS and its deadly co-infections. It was founded in 2006, jointly by France, United Kingdom, Brazil, Norway and Chile.
This development was announced during a press conference by the MDR-TB Senior Medical Officer and Lesotho Site Principal Investigator for the endTB trial, Kunda Kwabisha Mikanda, this past week. He explained that the current regimens, which they sought to replace, required patients to take around 14,000 pills over 24 months.
Dr Mikanda said, if recommended by WHO, these new patient-centred treatment regimens would allow clinicians to offer shortened MDR-TB treatment regardless of age, pregnancy, and common comorbidities among MDR-TB patients.
He highlighted that current MDR-TB regimens, which require up to 24 months of treatment, were only 59 percent effective and often caused severe side effects.
“The regimens which are now in use often cause terrible side including acute psychosis and permanent deafness. While the newly found regimens provides for nine months treatment with manageable side effects,” Dr Mikanda said.
The endTB trials involved 754 patients from seven countries: Lesotho, South Africa, Georgia, India, Kazakhstan, Pakistan, and Peru.
“We stand on the cusp of a significant breakthrough in the battle against MDR-TB, a disease that disproportionately affects impoverished populations worldwide. Our results offer hope to those in dire need and underscore the urgency of continued research and innovation.
“For far too long, MDR-TB has been a formidable threat with limited, poorly tolerated treatment options. Today, we unveil evidence for multiple innovative all-oral, shortened regimens that will allow patient-centred, individualized treatment of MDR-TB. This marks a pivotal moment in the fight against a disease that has plagued vulnerable populations worldwide. The new regimens would provide nine months of treatment with manageable side effects.”
Dr Mikanda said the new regimens were expected to compliment the other treatment, BPaLM which was recommended by WHO in 2022. He also noted that trial results could address major barriers to care and that the endTB consortium will continue to advocate for improved access and affordability of quality TB care.
According to WHO, an estimated 410,000 people globally developed multidrug- or rifampicin-resistant tuberculosis (MDR/RR-TB) in 2022. While the treatment success rate for people diagnosed with MDR/RR-TB has steadily improved, it remains alarmingly low. In 2020, the global treatment success rate was 63 percent, up from 60 percent in 2019 and 50 percent in 2012. WHO identified mismanagement of TB treatment and person-to-person transmission as key reasons for the emergence and spread of MDR/RR-TB. Most people with TB were cured by a 6-month treatment regimen (BPaLM) provided with adequate support.
WHO further stated that inappropriate or incorrect use of TB drugs, ineffective drug formulations, poor quality medicines, bad storage conditions, and premature treatment interruption could cause drug resistance, which could then be transmitted, especially in crowded settings such as prisons and hospitals. Based on current WHO policy, several regimens could be used for patients with MDR/RR-TB. Key factors defining treatment regimen choice include the patient’s drug-resistance profile, prior exposure to TB medicines, patient history, the drug-resistance profile of close contacts, the patient’s age, the extent of pulmonary TB disease, and the localisation of extrapulmonary TB lesions.