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TB-PRACTECAL Trial—Evidence for a shorter, safer, more effective treatment for drug-resistant tuberculosis | Collections | MSF Science Portal
TB-PRACTECAL Trial—Evidence for a shorter, safer, more effective treatment for drug-resistant tuberculosis

TB-PRACTECAL Trial—Evidence for a shorter, safer, more effective treatment for drug-resistant tuberculosis

Drug-resistant tuberculosis (DR-TB) remains an especially deadly form of the ancient scourge of TB, while current treatments are long, toxic, and ineffective for half of all patients. Aiming to change this unacceptable status quo, in the mid-2010’s MSF and partners launched three clinical trials to test novel regimens containing the first new TB drugs in decades.

On 22 December 2022 the New England Journal of Medicine published findings from TB-PRACTECAL, a three-country randomized controlled trial, showing that a shorter regimen is safer and cured 89% of DR-TB patients, compared with 52% on the standard of care. These findings have already been incorporated into the World Health Organization’s new TB treatment guidelines. A separate study shows that the new regimen is also more cost-effective.

Alongside these results the content collection linked below highlights other aspects of the trial, from community engagement strategies that helped shape TB-PRACTECAL to setbacks arising from the Covid-19 pandemic. It also examines urgent challenges in scaling up access to these life-saving drugs, including affordability and patent barriers.

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MSF Science Portal

MSF Science Portal

While Médecins Sans Frontières (MSF) is known mostly for providing direct medical aid to people affected by conflict, epidemics, disasters, or exclusion from health services, we also conduct research aimed at improving patient care and advocating for evidence-based policy and practices. To this end we conduct hundreds of research studies each year, publish extensively in peer-reviewed journals, and present our findings at scientific conferences around the world, including several annual MSF-organized events.


With the MSF Science Portal we introduce a new platform that aims to be a « one-stop shop » for content related to this work, so that users anywhere can easily find, browse, access, share and use the knowledge our research generates. Alongside frequent updates of new publications, conference materials, reports and featured content, we will continue to develop this site and to expand its range of content. To learn more about the Portal and what it offers, check out the short videos and slide presentation in this collection.

New tools and approaches to drug-resistant TB

New tools and approaches to drug-resistant TB
World NTD Day

World NTD Day
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The World Health Organization estimates that 410,000 people developed a drug-resistant tuberculosis infection (DR-TB) in 2022, only 40% of whom were diagnosed and started on treatment—and only 63% then cured. Given all these points of failure, innovation in preventing, diagnosing and treating DR-TB cannot come fast enough. To mark World TB Day (24 March 2024) the content collection linked below highlights recent work by MSF and collaborators to help change this grim picture. The TB-PRACTECAL and endTB studies delivered robust evidence for shorter, safer, more effective drug regimens that are already saving lives worldwide. Other studies explore new approaches to preventive treatment and simpler, quicker, accurate detection of TB and drug resistance—especially among difficult-to-diagnose populations such as children and people living with HIV. But to impact DR-TB globally these innovations must become widely accessible. This requires changes on many fronts, as described in an accompanying Collection (Expanding Access to Lifesaving New TB Tools).

Neglected tropical diseases (NTDs) impact nearly 1.7 billion people each year, causing serious illness or lifelong disability among many—often leading to stigma and exclusion—and killing an estimated 200,000. The vast majority of sufferers live in the world’s poorest countries.


The World Health Organization’s NTD roadmap 2021-2030 aims to address 20 tropical diseases through prevention, control, elimination, and/or eradication. But despite some progress, reaching all its targets will take better, far more accessible diagnostics and treatments along with more robust strategies, political commitment and resources.


To mark World NTD Day, this collection spotlights work by MSF and collaborators on improving approaches to snakebite envenoming, kala azar and noma. One study presents an innovative artificial intelligence-based snakebite diagnostic tool, while others evaluate shorter, less toxic drug regimens or different models of care. Several commentaries advocate for national/regional strategies adapted to contexts ranging from remote villages to active conflict zones. Another crucial factor is the climate crisis, which is intensifying the transmission and geographic spread of many NTDs.

Journal Article
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Research

Short oral regimens for pulmonary rifampicin-resistant tuberculosis (TB-PRACTECAL): an open-label, randomised, controlled, phase 2B-3, multi-arm, multicentre, non-inferiority trial

Nyang'wa BT, Berry C, Kazounis E, Motta I, Parpieva N,  et al.
2024-02-01 • Lancet Respiratory Medicine
2024-02-01 • Lancet Respiratory Medicine
BACKGROUND
Around 500,000 people worldwide develop rifampicin-resistant tuberculosis each year. The proportion of successful treatment outcomes remains low and new treatments are nee...
Journal Article
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Research

A 24-week, all-oral regimen for rifampin-resistant tuberculosis

Nyang'wa BT, Berry C, Kazounis E, Motta I, Parpieva N,  et al.
2022-12-22 • New England Journal of Medicine
2022-12-22 • New England Journal of Medicine
BACKGROUND
In patients with rifampin-resistant tuberculosis, all-oral treatment regimens that are more effective, shorter, and have a more acceptable side-effect profile than current...
Journal Article
|
Research

Cost-effectiveness of short, oral treatment regimens for rifampicin resistant tuberculosis

Sweeney S, Berry C, Kazounis E, Motta I, Vassall A,  et al.
2022-12-07 • PLOS Global Public Health
2022-12-07 • PLOS Global Public Health
Current options for treating tuberculosis (TB) that is resistant to rifampicin (RR-TB) are few, and regimens are often long and poorly tolerated. Following recent evidence from the TB-PR...
Technical Report
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Policy Brief

DR-TB drugs under the microscope 2022

MSF Access Campaign
2022-11-08
2022-11-08
TB was the leading cause of death from a single infectious agent until the COVID pandemic. The number of people newly diagnosed with TB in 2020 fell by 18% from the previous year due to ...
Journal Blog
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Perspective

New, shorter treatments for drug resistant TB are a lifeline for people living through conflict

Jain L
2022-06-29 • BMJ Opinion (blog)
2022-06-29 • BMJ Opinion (blog)
Journal Article
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Research

TB-PRACTECAL: study protocol for a randomised, controlled, open-label, phase II–III trial to evaluate the safety and efficacy of regimens containing bedaquiline and pretomanid for the treatment of adult patients with pulmonary multidrug-resistant tuberculosis

Berry C, du Cros PAK, Fielding K, Gajewski S, Kazounis E,  et al.
2022-06-13 • Trials
2022-06-13 • Trials
BACKGROUND
Globally rifampicin-resistant tuberculosis disease affects around 460,000 people each year. Currently recommended regimens are 9-24 months duration, have poor efficacy and...
Conference Material
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Video

24-week regimens for treatment of rifampicin-resistant tuberculosis: four-arm randomised trial

Berry C, Motta I, Kazounis E, Fielding K, Dodd M,  et al.
2022-06-07 • MSF Scientific Days International 2022
2022-06-07 • MSF Scientific Days International 2022
No abstract available.
Journal Blog
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Perspective

6 months TB treatment for (almost) all

Berry C
2022-05-10 • PLoS Blogs
2022-05-10 • PLoS Blogs
Journal Article
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Research

Optimising recruitment to a late-phase tuberculosis clinical trial: a qualitative study exploring patient and practitioner experiences in Uzbekistan

Wharton-Smith A, Horter SCB, Douch E, Gray NSB, James N,  et al.
2021-12-04 • Trials
2021-12-04 • Trials
BACKGROUND
Addressing the global burden of multidrug-resistant tuberculosis (MDR-TB) requires identification of shorter, less toxic treatment regimens. Médecins Sans Frontières (MSF)...
Journal Article
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Letter

TB research requires strong protections, innovation, and increased funding in response to COVID-19

Nyang'wa BT, LaHood AN, Mitnick CD, Guglielmetti L
2021-05-29 • Trials
2021-05-29 • Trials
When 2020 opened, approximately 11 million new tuberculosis (TB) cases and nearly 1.5 million TB-related deaths were predicted during the year. And, the gap between required and availabl...
Journal Blog
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Perspective

Engaging communities in tuberculosis research: The experience of the TB-PRACTECAL trial

Douch E
2018-11-09 • BMJ Opinion (blog)
2018-11-09 • BMJ Opinion (blog)