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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)

See more collections

Climate change and health

Climate change and health
The climate crisis is also a health and humanitarian crisis, disproportionately impacting people in the world’s most climate-sensitive regions—mainly low- and low-middle income countries with the least capacity to respond. MSF and other humanitarian organizations witness the consequences daily. More frequent, intense weather events and a warming planet contribute to food and water scarcity, more severe and widespread disease outbreaks, and more injuries and preventable deaths. They also drive massive population displacement, with over 32 million people fleeing their homes in 2022 alone due to floods, drought, storms and fire—nearly triple the number displaced by violence and conflict. As global leaders convene in Dubai for the UN climate conference (COP28, 30 Nov-12 Dec 2023) we present this cross-section of work by MSF and collaborators, drawing from first-hand experience at our medical projects. Emphasizing the urgency of adapting humanitarian operations to the climate crisis, the collection also explores loss and damage through a health lens, proposes policies and practices for creating climate-resilient health organizations, and advocates for embedding fair, just ethics perspectives into humanitarian action and research on climate.
World Hepatitis Day 2022

World Hepatitis Day 2022
Each year hundreds of millions of people suffer from chronic or acute liver disease caused by hepatitis viruses, and over one million die. To mark World Hepatitis Day (July 28th) we bring you a selection of MSF research exploring how to better prevent, identify and treat hepatitis infection in lower-income countries and emergency contexts where the burden is heaviest. For example, in a South Sudanese camp for displaced people—a type of setting where poor sanitation and water quality regularly lead to hepatitis E outbreaks—MSF and the Ministry of Health (MoH) are conducting the world’s first reactive vaccination campaign against this disease, and evaluating the process and outcomes. In Cambodia, MSF and MoH collaborators found that a simplified community-based model of care for hepatitis C was safe and highly effective in diagnosing patients and in curing them with new antiviral drugs. It was also cost-effective, according to studies in several countries and patient populations. And these new drugs were safe and effective even in patients also being treated for drug-resistant tuberculosis.
Humanitarian action & health systems (MSF Scientific Days International 2022)

Humanitarian action & health systems (MSF Scientific Days International 2022)
No description available
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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