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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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Adapting essential care programs to Covid-19 pandemic times

Adapting essential care programs to Covid-19 pandemic times
As the ongoing Covid-19 pandemic grips the world, one of its most devastating indirect effects is the disruption to medical services for preventing and treating other life-threatening diseases—especially in countries with already-fragile health systems. For MSF and other global health actors this means not only responding to Covid-19 directly but also assessing its impact on other essential care and then adapting programs so they can keep serving patients despite the enormous obstacles. In this Collection you will find a selection of published articles and conference content from this year’s MSF Scientific Days 2021 conference content, encompassing a range of approaches, settings and medical challenges—from malaria, TB and HIV/AIDS prevention and care to digital health promotion and sexual and reproductive health.
New tools and approaches to drug-resistant TB

New tools and approaches to drug-resistant TB
Snake envenoming: a neglected crisis

Snake envenoming: a neglected crisis
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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).

Every year 2 million or more people fall victim to snakebite envenoming, mostly in poor, rural communities of Africa, Asia and Latin America. Between 83,000—138,000 of them die, while hundreds of thousands more suffer debilitating long-term complications or disabilities.


Although some antivenom medicines are highly effective when used promptly and appropriately, many snakebite victims get no treatment at all. Those who do may receive antivenoms which don’t work against the type of snake that bit them, or were not rigorously tested for safety and effectiveness.


To mark World Snakebite Awareness Day on September 19th, the Collection linked below brings together recent MSF work on this highly neglected disease. Several articles and conference presentations help fill evidence gaps on the burden of disease and its impacts or on treatment outcomes with specific antivenoms in specific regions. Others examine how to tackle the formidable challenges of availability and affordability, the absence of regulatory oversight for making, testing and registering antivenoms, and the anemic R&D pipeline for new products—all of which impede access for patients to safe, effective treatment tailored to local snake species.

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)