*The New England Journal of Medicine today released results from the TB-PRACTECAL study, showing that shorter, less toxic treatment for multidrug-resistant tuberculosis (TB) cures nearly 90 percent of patients. These findings have already led to updated WHO recommendations on the treatment of multidrug-resistant tuberculosis. *
A new six-month oral treatment is less toxic and more effective against multidrug-resistant tuberculosis (MDR-TB) than current treatments, according to the results of a Médecins Sans Frontières (MSF) study published today in the New England Journal of Medicine.
These findings come from MSF’s TB-PRACTECAL study, the first multinational, randomised, controlled clinical trial to report on the efficacy and safety of a six-month oral treatment, which the World Health Organization (WHO) recommends in its new guidelines on the treatment of tuberculosis, published last week. This is the first time that TB-PRACTECAL results have been published in a specialized medical journal.
“We are delighted to have the clinical trial results published in the New England Journal of Medicine after rigorous peer review” said Bern-Thomas Nyang’wa, MSF medical director and principal investigator of the clinical trial. “This publication will provide policy makers and clinicians using the TB-PRACTECAL regimen with additional evidence of its efficacy, in addition to the WHO recommendations. For 50 years, and until recently, no new treatment for tuberculosis had been developed. Why ? Because this disease doesn’t affect those who have the means to fight it. With this clinical trial, MSF wanted to remedy this situation. It is now essential that this treatment is made available to all who need it. »
Enrollment of study participants concluded in March 2021, with 552 patients at seven sites in Belarus, South Africa and Uzbekistan. Since then, five countries have started implementing shorter regimens with MSF support, with nearly 400 patients starting treatment. Eight more countries are set to implement it in 2023.
Launched in 2017, TB-PRACTECAL tested three combinations of new treatments against treatments provided in each country. All have demonstrated superior efficacy. Treatment with bedaquiline, pretomanid, linezolid and monxifloxacin (BPaLM) for six months was found to be the most effective and least toxic. The study also looked at bedaquiline-pretomanid-linezolid (BPaL) and bedaquiline-petromanid-linezolid-clofazimine (BPaLC) combination therapy.
“Nine years ago we started the TB-PRACTECAL clinical trial because we absolutely had to act” explains Dr. Nyang’wa. “Patients have told us that the old treatments were long, grueling and that the side effects were worse than the disease itself. Furthermore, they were ineffective and only one in two people were cured. The new regimen, BPaLM, has a 90% cure rate, is less toxic, shorter and more bearable because it requires far fewer pills.* »*
MSF’s Phase II/III clinical study shows that treatment with BPaLM is highly effective against rifampin-resistant TB and less toxic than currently available treatments. Eighty-nine percent of patients in the BPaLM group were cured, compared with 52% in the group receiving standard therapy, with fewer side effects reported in the BPaLM group. PBaLC and BPaL were also found to be more effective than existing treatments.
“When I learned I had tuberculosis, I couldn’t accept it” recalls Abdirakhman, a 24-year-old math student in Uzbekistan who had to drop out of school after his diagnosis. “I applied to be included in the TB-PRACTECAL clinical trial and was randomly selected to receive the six month treatment instead of the standard treatment which lasts two years or longer. There were difficult moments, but it was still better than a two year treatment. Now that I’ve finished my treatment, I’m back to university. »
While this new scheme gives hope to the 500,000 people affected by multidrug-resistant tuberculosis each year, the lowest price available to the Global Drug Facility (GDF) for a six-month course of BPaLM is $600 (565 euros), higher at most price of 500 dollars they require MSF. One of the new TB drugs, bedaquiline, developed by Johnson & Johnson with public support and large donations, costs as little as $270 for six months of treatment. This is despite the researchers estimating that bedaquiline could be made and sold for less than $102 for six months. Indeed, the three diets studied by TB-PRACTECAL they will likely reduce the cost of treatment compared to current standards of care.
“The launch of the BPaLM treatment could transform the lives of people suffering from tuberculosis, but for that to happen, the medicines that make it up need to be affordable” explains Christophe Perrin, tuberculosis advocacy pharmacist for MSF’s Access to Medicines campaign. “We are calling on Johnson & Johnson to lower the price of bedaquiline so that a full course of treatment for multidrug-resistant tuberculosis costs no more than $500 per patient. »
MSF is one of the largest non-governmental providers of TB care in the world. In 2021, 17,221 people started anti-tuberculosis treatment in projects led or supported by MSF, including 2,309 with multidrug-resistant tuberculosis. MSF is working closely with national TB programmes, ministries of health and other stakeholders to ensure this new treatment is available as soon as possible for patients with multidrug-resistant tuberculosis.
MSF is also conducting two other therapeutic trials for MDR-TB, endTB and endTB-Q, using other recently developed new drugs against this disease.
