Cape Town - Doctors Without Borders (MSF) trial published in the New England Journal of Medicine on Wednesday has shown a new all-oral, six-month treatment regimen was safer and more effective at treating multi-drug-resistant tuberculosis (MDR-TB), curing almost 90% of patients.
This breakthrough has been welcomed by the health community, as calls intensify to make the life-saving regimen available to everyone who needs it.
According to MSF, the findings result from MSF’s TB-PRACTECAL, the first ever multi-country, randomised, controlled clinical trial to report on the efficacy and safety of the treatment regimen, which was also recommended in the updated World Health Organization’s (WHO) global TB treatment guidelines last week.
“We’re delighted that the trial results have been published in the New England Journal of Medicine after a stringent peer review process,” said MSF medical director and chief investigator of the trial, Bern-Thomas Nyang’wa.
“This publication will provide deeper evidence to policymakers and treatment providers deciding to use the TB-PRACTECAL regimen, in addition to the WHO recommendations.
Until relatively recently, there were no new treatments for TB introduced for over 50 years. Why? Because the disease doesn’t affect the people who have the resources to deal with it. This trial was an attempt by MSF to try to fill that gap. Now it is essential that the new treatment is made available to everyone who needs it.”
The trial ended enrollment in March 2021, with 552 patients overall and took place at seven sites across Belarus, South Africa, and Uzbekistan. Now, five MSF-supported countries have begun implementing the shorter regimens with almost 400 patients starting the treatment and eight more countries set to implement it in 2023.
Launched in 2017, TB-PRACTECAL tested three combinations of new treatments against the locally accepted standard of care. All were shown to be favourable against the standard of care.
A six-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM) proved most effective and safe.
The trial also studied a bedaquiline, pretomanid, and linezolid (BPaL) regimen; and a bedaquiline, pretomanid, linezolid, and clofazimine (BPaLC) regimen.
“Patients were telling us that the previous regimens were lengthy, ineffective, and gruelling and that the side effects were worse than the disease itself.
They also weren’t very effective; just one in two people were cured. The new regimen, BPaLM, has an 89 percent cure rate, is safer, shorter, and more tolerable with many fewer pills,” Nyang’wa said.
However, the drugs in this regimen cost around $600 (around R 10 371,33), still above the $500 (around R 8642,77) ceiling price called for by MSF.
TB HIV Care spokesperson, Alison Best said they were delighted and encouraged with the results of the study because they offer safer, more effective treatment for the around 21 000 South Africans who face drug-resistant TB every year.
“We look forward to more investment in TB research so that even shorter, more effective regimens can be developed. Taking a tablet every day for months is challenging for anyone.
“When this scenario is combined with stigma, difficult socio-economic circumstances and limited psychosocial support, it is easy to understand why so many people interrupt their TB treatment. In addition, health system challenges, like a lack of real-time data and insufficient resources allocated to contact tracing and the recall of patients who have interrupted treatment, also contribute to the difficulties surrounding TB treatment.
This news means that the road to recovery from drug-resistant TB, which is not easy, is now a bit smoother in that the treatment is likely to result in fewer side effects. It also gives people with drug-resistant TB even more hope for a successful outcome and cure.”
The Western Cape Department of Health welcomed the study findings saying they showed superior efficacy and safety of a shorter regimen for drug-resistant TB.
“This is good news for patients, as they often struggle to complete their courses of treatment due to the intolerable side effects of drugs and high costs associated with having to attend follow-up appointments at clinics for many months.”
The department’s spokesperson Byron La Hoe said the national department was currently finalising the clinical guidelines based on bedaquiline, pretomanid8 and linezolid (BPaL) and BPaLM regimens.
“The province will implement these guidelines as soon as we are able to procure the new drug that is required, which is pretomanid,” La Hoe said.
TB Alliance, a non-profit organisation dedicated to developing and delivering faster, better TB cures also contributed to the TB-PRACTECAL study both in the original design of the trial and as a member of the steering committee.
TB Alliance, MD, President and CEO, Mel Spigelman said: “Before the Nix-TB Phase 3 clinical trial showed the promise of a BPaL treatment regimen, patients with highly drug-resistant TB had to endure a burdensome treatment – many were required to take more than 14,000 pills over 18 months or longer, without a high chance of successfully curing their TB. In the years before BPaL, historic treatment for these forms of highly drug-resistant TB ranged from about 34-59% effective.”
The organisation said the Covid-19 pandemic had also been a challenge in the fight against TB, with more than a decade of progress against TB lost in 2020, and 2021 seeing an increase in both incidence and mortality from TB.
Spigelman added: “However, we are again seeing more progress with the availability of these shorter, more effective treatments for DR-TB. With BPaL/BPaLM, the shorter treatment time means patients spend significantly less time in healthcare facilities and fewer tests and procedures are needed to monitor their health and progress. A new study published in PLOS Global Public Health found that the BPaL/BPaLM treatment regimen could save governments up to US$740 million annually, which is enough to fund almost another year’s worth of DR-TB treatments for more than 400,000 people.
“Additionally, a new volume guarantee agreement between Viatris, a global healthcare company, MedAccess, and TB Alliance will reduce the price of pretomanid by 34%, or to $240 for a six-month treatment course in high-TB burden countries, including South Africa. We are proud of this major step forward on affordability and hope to achieve further reductions in price as more patients are reached.”
Cape Times