The search for drugs and therapies to treat drug-resistant tuberculosis (TB) came in for some good news, as enrolment of people for atrial studying a new regimen was stopped after an independent board indicated it was “superior” to the current standard of care.
TB-PRACTECAL, a phase II/III clinical trial sponsored by Médecins Sans Frontières (MSF-Doctors without Borders), tested a six-month regimen of bedaquiline, pretomanid, linezolid and moxifloxacin, against the locally accepted standard of care. At the interim analysis, 242 patients had been enrolled in seven trial sites across Belarus, South Africa and Uzbekistan, MSF said.
Earlier this month, the trial’s independent data safety and monitoring board recommended that randomisation of patients into TB-PRACTECAL be stopped, as more data was doubtful to change the trial results. As a result, enrolment was closed to new patients last week, the note said.
“MSF believes these findings will have the potential to change clinical practice,.”the international humanitarian organisation said, adding that it was set to share the data with the World Health Organization (WHO).
The development comes even as the WHO, marking World TB Day on Wednesday, pointed to a 21 per cent reduction in the number of people who received TB in 2020, compared to the previous year. “An estimated 1.4 million fewer people received care for tuberculosis (TB) in 2020 than in 2019, according to preliminary data compiled by the WHO from over 80 countries,” it said. And countries reporting the biggest gaps included Indonesia (42 per cent), South Africa (41 per cent), Philippines (37 per cent) and India (25 per cent).
“This will be the first-ever multi-country, randomised, controlled clinical trial to report on the safety and efficacy of a six-month, all-oral regimen for drug-resistant TB,” said Professor David Moore, London School of Hygiene and Tropical Medicine, and a member of the Trial Steering Committee.
About 465,000 people developed rifampicin-resistant TB in 2019 and 182,000 died. Treatment is long, only cures three out of every five patients, and despite changes in WHO guidance, it often includes painful injections and drugs that cause toxic side effects including deafness, the note said.
Since the first patient was enrolled on the TB-PRACTECAL trial in 2017, new treatments for MDR-TB have become available. But lengthy regimens that patients struggle to complete are still the reality in many of the countries in which MSF works, it noted. The WHO’s current guidelines recommend treatment lasting nine to 20 months for MDR-TB (multi drug resistant TB).
Professor Nargiza Parpieva, Country Coordinating Principal Investigator in Uzbekistan hoped, the regimen would be reviewed and cleared by the WHO, paving the way for countries to adopt it.
Partners in trial
MSF is the trial sponsor. But other partners on trial included the London School of Hygiene; Global Alliance for TB Drug Development; University College London; Drugs for Neglected Diseases initiative; Swiss Tropical & Public Health Institute; eResearch Technology Inc; Uzbekistan health ministry; Belarus health ministry; TB & HIV Investigative Network (THINK); University of Liverpool ; Clinical HIV Research Unit, Wits Health Consortium; Hackensack Meridian Health; University of California, San Francisco; University of Sussex. The Dutch Postcode Lottery also contributed to the trial funding, the note said.