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

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.

Collection Content

Journal Article
|
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
|
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
|
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
|
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
|
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
|
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
|
Perspective

6 months TB treatment for (almost) all

Berry C
2022-05-10 • PLoS Blogs
2022-05-10 • PLoS Blogs
Journal Article
|
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
|
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
|
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)

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Expanding access to lifesaving new TB tools
Expanding access to lifesaving new TB tools
Many settings with a high burden of drug-resistant tuberculosis (DR-TB) lack access to advanced diagnostics and to groundbreaking new treatments. The Collection linked below spotlights work by MSF and collaborators to analyze barriers, identify gaps, and accelerate the roll-out of these tools to people whose lives hang in the balance. Several reports examine price, regulatory, and patent obstacles that persist despite considerable public investment into developing many of these tools. Other authors examine critical remaining weaknesses in care pathways—especially in screening and diagnosis, and particularly in children. Several studies describe new strategies that could be part of the solution, from a pilot program in Tajikisttan that trains family caregivers to treat children with DR-TB at home, to a person-centered care model adapted to a conflict zone in Afghanistan. Lastly, initial findings demonstrate that pregnant women—another vulnerable population—can be effectively treated for DR- and multidrug-resistant TB, improving maternal outcomes without harming neonates.
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Antibiotic resistance, conflict and the Middle East
No description available
Diabetes care in humanitarian settings
Diabetes care in humanitarian settings
Diabetes affect hundreds of millions of people worldwide, a large majority of them living in low- and middle-income countries. Yet finding effective strategies, tools and policies for effectively managing this chronic illness—especially amid war, displacement or exclusion from care—is a neglected area of humanitarian medicine. Here we present a cross-section of work on this front by MSF and collaborators. Several studies assess the shift towards community-based, nurse-led models of care in rural settings. Others explore obstacles to diabetes care for war refugees living in camps in Jordan or Lebanon, highlighting how health programs can adapt to their needs. The demonstration that insulin retains potency for 30 days if cooled without refrigeration is opening doors to more patient self-management, as a case study in remote South Sudan shows. At the same time, MSF and others call for regulatory and financing policies that make diabetes medications and supplies cheaper, better adapted to humanitarian settings, and far more available to patients whose lives depend on them.
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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