TB-PRACTECAL: A Groundbreaking Medical Trial by the MSF in Treating People with Drug-resistant Tuberculosis

TEMPO.CO, London - According to a study conducted by the Médecins Sans Frontières / Doctors Without Borders (MSF), a new six-month oral medication regimen is safer and more effective for treating multidrug-resistant tuberculosis (MDR-TB) than current options for people with drug-resistant TB (DR-TB). The result of the study was published in the New England Journal of Medicine on Wednesday, December 21, 2022.

In their press release sent to Tempo, MSF stated that this discovery is the result of MSF's TB-PRACTECAL, which is the first multi-country, randomized, controlled clinical trial to report the efficacy and safety of the six-month, all-oral, treatment regimen recommended in the updated and released global TB treatment guidelines by WHO last week.

MSF also said that this publication also marks the first time that TB-PRACTECAL results have been published in a peer-reviewed medical journal.

"We are pleased that the trial results have been published in the New England Journal of Medicine after a rigorous peer-review process," said Bern-Thomas Nyang'wa, medical director of MSF and chief investigator of the trial.

Nyang'wa explained that this publication will provide in-depth evidence for policymakers and treatment providers that decide to use a TB-PRACTECAL regimen, in addition to WHO recommendations.

"Until recently, no further treatments for TB had been introduced for over 50 years. Why? Because the disease doesn't affect the people who have the resources to confront it. This trial is MSF's attempt to fill that gap. It's important now that new treatments are available to everyone who needs it."

The trial ended registration in March 2021, with a total of 552 patients and took place at seven sites in Belarus, South Africa and Uzbekistan. Currently, five MSF-supported countries have started implementing shorter regimens with nearly 400 patients starting treatment and eight more countries are due to implement it by 2023.

Three New Treatment Combinations

The TB-PRACTECAL, which was launched in 2017, tested three new treatment combinations to locally accepted standards of care.

The MSF said that they were all proved to be favourable. The six-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM) is shown to be the most effective and safe.

The test also studied the bedaquiline, pretomanid, and linezolid (BPaL) regimen; and the bedaquiline, pretomanid, linezolid, and clofazimine (BPaLC) regimen.

"When I found out that I had TB, I couldn't believe it was true," said Abdirakhman, a 24-year-old math student in Uzbekistan who had to stop his studies when he was diagnosed.

"It is devastating. I chose to enter the TB-PRACTECAL clinical trial and was randomly selected to receive a short six-month treatment course as opposed to the standard two years or more. There are some tough times, but it's still better than two years of medication. I have now finished my treatment and am returning to university," he explained.

While this new regimen provides hope for the 500,000 people who fall ill each year with DR-TB, issues persist regarding the fee of the treatment course. A six-month BPaLM treatment course can cost around US$600 (around Rp9 million), still above the highest price of US$500 (around Rp7,700,000) requested by the MSF.

One of the other new medicines for TB, bedaquiline—developed by Johnson & Johnson with substantial government and philanthropic support—is priced at US$270 (about Rp4.2 million) for six months as the lowest global price, given by the Global Drug Facility (GDF). Even though the researchers estimated that bedaquiline could be produced and sold for less than US$102 (around Rp1.5 million) profit over six months.

“Launching a shorter, safer and more effective BPaLM treatment regimen being tested in TB-PRACTECAL could change the lives of people with TB, but only if the drugs in these regimens are affordable,” said Christophe Perrin, TB advocacy pharmacist at MSF's Access Campaign.

Perrin then continued that because significant public funds are helping to pay for the development of bedaquiline, the MSF asked Johnson & Johnson to lower the price of this drug so that a full course of DR-TB treatment is no more than US$500 per person.

"Too many lives have been lost due to this deadly disease. People with TB deserve urgent access to shorter, safer, more affordable care,” he added.

MSF is one of the world's largest non-government providers of TB treatment. By 2021, at least 17,221 people under MSF's care started TB treatment, including 2,309 people with DR-TB.

The MSF is working closely with the national TB program, the ministry of health and other key stakeholders to ensure that these new regimens are available for people with DR-TB as soon as possible.

TEMPO.CO | IMAJI LASAHIDO (INTERN)

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