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The endTB project | Collections | MSF Science Portal

The endTB project aims to find shorter, less toxic and more effective treatments for ‘multidrug-resistant TB’ (MDR-TB) through:

  • access to new drugs
  • two clinical trials
  • advocacy at national and global levels

Covering 18 countries, the project is a partnership between Partners In Health, Médecins Sans Frontières, Interactive Research & Development and financial partners Unitaid and the Transformational Investment Capacity (TIC) of MSF. This collection contains the final and intermediate results of the studies, advocacy reports, and study presentations. For more information about the endTB project, visit https://endtb.org/.

Collection Content

Journal Article
|
Research

Oral regimens for rifampin-resistant, fluoroquinolone-susceptible tuberculosis

Guglielmetti L, Khan U, Velásquez GE, Gouillou M, Abubakirov A,  et al.
2025-01-29 • New England Journal of Medicine
2025-01-29 • New England Journal of Medicine

BACKGROUND

For decades, poor treatment options and low-quality evidence plagued care for patients with rifampin-resistant tuberculosis. The advent of new drugs ...

Journal Article
|
Research

Nine-month, all-oral regimens for rifampin-resistant tuberculosis

Guglielmetti L, Khan U, Velasquez GE, Gouillou M, Abubakirov A,  et al.
2024-01-29 • medRxiv
2024-01-29 • medRxiv

BACKGROUND

Aft...

Journal Article
|
Short Report

Pregnancy and birth outcomes in patients with multidrug-resistant tuberculosis treated with regimens that include new and repurposed drugs

Lotia Farrukh I, Lachenal N, Adenov MM, Ahmed SM, Algozhin Y,  et al.
2024-01-25 • Clinical Infectious Diseases
2024-01-25 • Clinical Infectious Diseases
Among 43 pregnant women receiving multidrug-resistant/rifampicin-resistant tuberculosis (MDR/RR-TB) treatment with bedaquiline and/or delamanid, 98% had favorable treatment outcomes. Of ...
Journal Article
|
Research

Estimating post-treatment recurrence after multidrug-resistant tuberculosis treatment among patients with and without HIV: the impact of assumptions about death and missing follow-up

Sauer SM, Mitnick CD, Khan UT, Hewison CCH, Bastard M,  et al.
2024-01-25 • Clinical Infectious Diseases
2024-01-25 • Clinical Infectious Diseases
BACKGROUND
Quantification of recurrence risk following successful treatment is crucial to evaluating regimens for multidrug- or rifampicin-resistant (MDR/RR) tuberculosis (TB). Howev...
Journal Article
|
Research

Effectiveness of a bedaquiline, linezolid, clofazimine “core” for multidrug-resistant tuberculosis

Zeng C, Hernán MA, Trevisi L, Sauer S, Mitnick CD,  et al.
2024-01-20 • medRxiv
2024-01-20 • medRxiv

RATIONALE

Treatment outcomes may be compromised among patients with multidrug- or rifampicin-resistant tuberculosis with additional fluoroquinolone resis...

Journal Article
|
Protocol

Evaluating newly approved drugs in combination regimens for multidrug-resistant tuberculosis with fluoroquinolone resistance (endTB-Q): study protocol for a multi-country randomized controlled trial

Patil SB, Tamirat M, Khazhidinov K, Ardizzoni E, Atger M,  et al.
2023-11-30 • Trials
2023-11-30 • Trials
BACKGROUND
Treatment for fluoroquinolone-resistant multidrug-resistant/rifampicin-resistant tuberculosis (pre-XDR TB) often lasts longer than treatment for less resistant strains, yi...
Conference Material
|
Slide Presentation

endTB Clinical Trial: Design, efficacy, safety & linezolid dose-reduction randomization results

endTB Study Group
2023-11-15 • The Union World Conference on Lung Health 2023
2023-11-15 • The Union World Conference on Lung Health 2023
Technical Report
|
Study report

endTB clinical trial results

endTB Study Group
2023-11-15
2023-11-15
Conference Material
|
Video

endTB trial results presentation

endTB Study Group
2023-10-06 • The Union World Conference on Lung Health 2023
2023-10-06 • The Union World Conference on Lung Health 2023
Journal Article
|
Research

Outcomes of WHO-conforming, longer, all-oral multidrug-resistant TB regimens and analysis implications

Rich ML, Khan UT, Zeng C, LaHood AN, Franke MF,  et al.
2023-06-01 • International Journal of Tuberculosis and Lung Disease
2023-06-01 • International Journal of Tuberculosis and Lung Disease
BACKGROUND
Evidence of the effectiveness of the WHO-recommended design of longer individualized regimens for multidrug- or rifampicin-resistant TB (MDR/RR-TB) is limited.

OB...
Journal Article
|
Research

Effectiveness of bedaquiline use beyond six months in patients with multidrug-resistant tuberculosis

Trevisi L, Hernán MA, Mitnick CD, Khan UT, Seung KJ,  et al.
2023-06-01 • American Journal of Respiratory and Critical Care Medicine
2023-06-01 • American Journal of Respiratory and Critical Care Medicine
RATIONALE
Current recommendations for the treatment of rifampin- and multidrug-resistant tuberculosis include bedaquiline used for six months or longer. Evidence is needed to inform ...
Journal Article
|
Research

Comparative effectiveness of adding delamanid to a multidrug-resistant tuberculosis regimen comprised of three drugs likely to be effective

Rodriguez CA, Lodi S, Horsburgh CR, Mitnick CD, Bastard M,  et al.
2023-04-28 • PLOS Global Public Health
2023-04-28 • PLOS Global Public Health
Clarity about the role of delamanid in longer regimens for multidrug-resistant TB is needed after discordant Phase IIb and Phase III randomized controlled trial results. The Phase IIb tr...
Research & Publication Guidance
|
Guidelines/How-Tos

Technical basis of the endTB observational study

endTB Study Group
2023-03-06
2023-03-06

endTB Observational Study had sites in 17 countries. In each country, sites enrolled patients on treatment with bedaquiline and delamanid according to National TB Program guidelines, ...

Journal Article
|
Research

Concordance of three approaches for operationalizing outcome definitions for multidrug-resistant TB

Zeng C, Mitnick CD, Hewison CCH, Bastard M, Khan PY,  et al.
2023-01-01 • International Journal of Tuberculosis and Lung Disease
2023-01-01 • International Journal of Tuberculosis and Lung Disease
BACKGROUND
The WHO provides standardized outcome definitions for rifampicin-resistant (RR) and multidrug-resistant (MDR) TB. However, operationalizing these definitions can be challe...
Journal Article
|
Research

Selection bias in multidrug-resistant tuberculosis cohort studies assessing sputum culture conversion

Rodriguez CA, Lodi S, Horsburgh CR, Bastard M, Hewison C,  et al.
2022-11-10 • PLOS One
2022-11-10 • PLOS One

BACKGROUND

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 Article
|
Research

Safety and effectiveness outcomes from a 14-country cohort of patients with multi-drug resistant tuberculosis treated concomitantly with bedaquiline, delamanid and other second-line drugs

Huerga H, Khan UT, Bastard M, Mitnick CD, Lachenal N,  et al.
2022-10-15 • Clinical Infectious Diseases
2022-10-15 • Clinical Infectious Diseases
BACKGROUND
Concomitant use of bedaquiline (Bdq) and delamanid (Dlm) for multi-drug/rifampicin resistant tuberculosis (MDR/RR-TB) has raised concerns about a potentially poor risk-ben...
Journal Article
|
Research

Safety of treatment regimens containing bedaquiline and delamanid in the endTB cohort

Hewison CCH, Khan UT, Bastard M, Lachenal N, Coutisson S,  et al.
2022-09-15 • Clinical Infectious Diseases
2022-09-15 • Clinical Infectious Diseases
RATIONALE
Safety of treatment for multidrug-resistant tuberculosis (MDR/RR-TB) can be an obstacle to treatment completion.

OBJECTIVES
Evaluate safety of longer MDR/RR-TB...
Conference Material
|
Abstract

Pregnancy outcomes in patients undergoing drug-resistant tuberculosis treatment in two closely monitored cohorts

Lachenal N, Hewison CCH, Berry C, Mitnick CD, Ahmed SM,  et al.
2022-05-11 • MSF Scientific Days International 2022
2022-05-11 • MSF Scientific Days International 2022
INTRODUCTION
Drug-resistant tuberculosis (DR-TB) carries significant morbidity and mortality risk. Care of DR-TB in pregnancy is even more challenging. A recent meta-analysis examini...
Journal Article
|
Commentary

Recently developed drugs for the treatment of drug-resistant tuberculosis: a research and development case study

Perrin C, Athersuch K, Elder G, Martin M, Alsalhani A
2022-04-19 • BMJ Global Health
2022-04-19 • BMJ Global Health
Two drugs with novel mechanisms of action, the diarylquinoline bedaquiline and the nitroimidazole delamanid—as well as pretomanid from the same class of drugs as delamanid—have recently ...
Journal Article
|
Protocol

Evaluating newly approved drugs for multidrug-resistant tuberculosis (endTB): study protocol for an adaptive, multi-country randomized controlled trial

Guglielmetti L, Ardizzoni E, Atger M, Baudin E, Berikova E,  et al.
2021-09-25 • Trials
2021-09-25 • Trials
BACKGROUND
Treatment of multidrug- and rifampin-resistant tuberculosis (MDR/RR-TB) is expensive, labour-intensive, and associated with substantial adverse events and poor outcomes. W...
Technical Report
|
Study report

endTB-Q Description Video

Guglielmetti L, endTB Study Group
2021-09-21
2021-09-21
Technical Report
|
Study report

Report of fatal and life-threatening adverse events during endTB post-marketing safety surveillance of new and repurposed TB drugs

endTB Study Group
2021-09-01
2021-09-01
Journal Article
|
Research

All-oral longer regimens are effective for the management of multidrug resistant tuberculosis in high burden settings

Khan PY, Franke MF, Hewison CCH, Seung KJ, Huerga H,  et al.
2021-06-17 • European Respiratory Journal
2021-06-17 • European Respiratory Journal
BACKGROUND
Recent World Health Organisation guidance on drug-resistant tuberculosis treatment de-prioritised injectable agents, in use for decades, and endorsed all-oral longer regim...
Journal Article
|
Commentary

Cardiac safety of multidrug-resistant tuberculosis treatment: moving towards individualised monitoring

Hewison CCH, Guglielmetti L
2021-02-12 • Lancet Infectious Diseases
2021-02-12 • Lancet Infectious Diseases
We are not alone in welcoming the study by Kelly E Dooley and colleagues 1 that sheds light on the QT prolonging effects of the combination of bedaquiline and delamanid, two key drugs fo...
Journal Article
|
Research

Culture conversion in patients treated with bedaquiline and/or delamanid. A prospective multicountry study

Franke MF, Khan P, Hewison C, Khan U, Huerga H,  et al.
2021-01-01 • American Journal of Respiratory and Critical Care Medicine
2021-01-01 • American Journal of Respiratory and Critical Care Medicine
RATIONALE
Bedaquiline and delamanid offer the possibility of more effective and less toxic treatment for multidrug-resistant (MDR) tuberculosis (TB). With this treatment, however, so...
Protocol
|
Research Protocol

The endTB COVID-19 response: Interim guidance for the endTB trial sites

endTB Study Group
2020-11-24
2020-11-24

This document is designed to give guidance to the endTB Project sites on the response to the COVID-19 outbreak. It is intended to be a resource for physicians and other health care pr...

Journal Article
|
Commentary

Clinical perspectives on treatment of rifampicin-resistant/multidrug-resistant TB

Cox V, McKenna L, Acquah R, Reuter A, Wasserman S,  et al.
2020-11-01 • International Journal of Tuberculosis and Lung Disease
2020-11-01 • International Journal of Tuberculosis and Lung Disease
Rapid diagnostics, newer drugs, repurposed medications, and shorter regimens have radically altered the landscape for treating rifampicin-resistant TB (RR-TB) and multidrug-resistant TB ...
Technical Report
|
Policy Brief

DR-TB drugs under the microscope 2020

MSF Access Campaign
2020-10-27
2020-10-27

Tuberculosis (TB) is the world’s deadliest infectious disease, and drug-resistant (DR) TB is a global health emergency. The World Health Organization (WHO) has estimated that only 1 i...

Journal Article
|
Commentary

Introducing new and repurposed TB drugs: the endTB experience

Seung KJ, Khan UT, Varaine FFV, Ahmed SM, Bastard M,  et al.
2020-10-01 • International Journal of Tuberculosis and Lung Disease
2020-10-01 • International Journal of Tuberculosis and Lung Disease
In 2015, the initiative Expand New Drug Markets for TB (endTB) began, with the objective of reducing barriers to access to the new and repurposed TB drugs. Here we describe the major imp...
Journal Article
|
Research

Setting up pharmacovigilance based on available endTB project data for bedaquiline

Lachenal N, Hewison CCH, Mitnick CD, Lomtadze N, Coutisson S,  et al.
2020-10-01 • International Journal of Tuberculosis and Lung Disease
2020-10-01 • International Journal of Tuberculosis and Lung Disease
SETTING
Active pharmacovigilance (PV) is recommended for TB programmes, notably for multidrug-resistant TB (MDR-TB) patients treated with new drugs. Launched with the support of UNIT...
Journal Article
|
Research

Culture conversion in patients treated with bedaquiline and/or delamanid: A prospective multi-country study

Franke MF, Khan PY, Hewison CCH, Khan UT, Huerga H,  et al.
2020-07-24 • American Journal of Respiratory and Critical Care Medicine
2020-07-24 • American Journal of Respiratory and Critical Care Medicine
BACKGROUND
Bedaquiline and delamanid offer the possibility of more effective and less toxic multidrug-resistant tuberculosis (MDR-TB) treatment. With this treatment, however, some pa...
Journal Article
|
Research

Culture conversion at 6 months in patients receiving delamanid-containing regimens for the treatment of multidrug-resistant tuberculosis

Seung KJ, Khan P, Franke MF, Ahmed S, Aiylchiev S,  et al.
2020-07-11 • Clinical Infectious Diseases
2020-07-11 • Clinical Infectious Diseases

Delamanid should be effective against highly resistant strains of Mycobacteriumtuberculosis, but uptake has been slow globally. In the endTB (expand new drug markets for TB) Observati...

Journal Article
|
Letter

High prevalence of hepatitis C infection among multidrug-resistant tuberculosis patients

Seung KJ, Franke MF, Hewison CCH, Huerga H, Khan UT,  et al.
2020-05-01 • Journal of Hepatology
2020-05-01 • Journal of Hepatology
Technical Report
|
Policy Brief

DR-TB drugs under the microscope 2019

MSF Access Campaign
2019-11-19
2019-11-19

Drug resistance is a major public health crisis thwarting the effective treatment and care of people living with tuberculosis (TB) – the world’s leading infectious disease killer. Dec...

Protocol
|
Research Protocol

The endTB observational study protocol: treatment of MDR-TB with bedaquiline or delamanid containing regimens

Khan UT, Huerga H, Khan AS, Mitnick CD, Hewison CCH,  et al.
2019-08-20 • BMC Infectious Diseases
2019-08-20 • BMC Infectious Diseases
BACKGROUND
At a time when programs were struggling to design effective regimens for the treatment of multidrug-resistant tuberculosis (MDR-TB), the marketing authorization of bedaqui...
Conference Material
|
Video

Safety of new multidrug-resistant TB drugs: results from the endTB observational study

Hewison CCH
2019-06-13 • Epicentre Scientific Day 2019
2019-06-13 • Epicentre Scientific Day 2019
Technical Report
|
Study report

WHO global consultation on transition towards new and better treatments for MDR-TB: endTB presentation

endTB Study Group
2019-04-16
2019-04-16

Researchers from endTB participated in the WHO Global Consortium to share updated results and the study’s implementation practices, in addition to evidence to support the transition, ...

Toolkit
|
Clinical

Pharmacovigilance - endTB study

endTB Study Group
2018-11-23
2018-11-23

Pharmacovigilance forms and other resources for staff on endTB sites.

Technical Report
|
Policy Brief

DR-TB drugs under the microscope 2018

MSF Access Campaign
2018-10-01
2018-10-01

Although tuberculosis (TB) is the number-one infectious disease killer and one of the top ten causes of mortality worldwide, the global response to TB remains off track. 2 The interim...

Technical Report
|
Study report

endTB interim analysis report - Bedaquiline- and delaminid- containing regimens achieve excellent interim treatment response without safety concerns

Atwood S, Avagyan N, Bastard M, Cain M, Collin S,  et al.
2018-07-01
2018-07-01
Technical Report
|
Study report

Out of Step: TB policies in 29 countries

MSF Access Campaign
2017-07-05
2017-07-05

Out of Step 2017 includes the results of a 29-country survey on national TB policies and practices. The report was created to identify gaps in implementation and monitor progress towa...

Technical Report
|
Study report

Terms of reference: endTB medical committee

endTB Study Group
2017-05-13
2017-05-13

The endTB Medical Committee formulates recommendations for off-label and compassionate use of the new anti-TB drugs for M(X)DR-TB.

It provides advice to any MSF, PIH and IRD pro...

Research & Publication Guidance
|
Guidelines/How-Tos

endTB clinical and programmatic guide for patient management with new TB drugs

endTB Study Group
2016-11-25
2016-11-25

This guide is designed to give guidance to the endTB Project site on the use of new TB drugs bedaquiline and delamanid. It is intended to be a resource for physicians and other health...

Journal Article
|
Research

A Bayesian response-adaptive trial in tuberculosis: the endTB trial

Cellamare M, Ventz S, Baudin E, Mitnick CD, Trippa L
2016-08-23 • Clinical Trials
2016-08-23 • Clinical Trials
PURPOSE
To evaluate the use of Bayesian adaptive randomization for clinical trials of new treatments for multidrug-resistant tuberculosis.

METHODS
We built a response-ad...
Technical Report
|
Study report

endTB: Project presentation

endTB Study Group
2016-06-28
2016-06-28

This 20-page guide is designed to provide all endTB stakeholders with a detailed presentation of the project's four goals.

Technical Report
|
Policy Brief

DR-TB drugs under the microscope 2016

MSF Access Campaign
2016-03-01
2016-03-01

This report – now in its fourth edition – analyses the barriers and factors affecting access to treatment regimens for drug-resistant tuberculosis (DR-TB), including new and repurpose...

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