Comparative effectiveness of adding delamanid to a multidrug-resistant tuberculosis regimen comprised of three drugs likely to be effective
Topics
- endTB Observational Study
ABSTRACT
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
Topics
- endTB Observational Study
Abstract
Background
Quantification of recurrence risk following successful treatment is crucial to evaluating regimens for multidrug- or rifampicin-resistant (MDR/RR) tuberculosis (TB). However, such analyses are complicated when some patients die or become lost during post-treatment follow-up.
Cardiac safety of multidrug-resistant tuberculosis treatment: moving towards individualized monitoring
Topics
- endTB Observational Study
ABSTRACT
Pregnancy and Birth Outcomes in Patients With Multidrug-Resistant Tuberculosis Treated With Regimens That Include New and Repurposed Drugs
Topics
- endTB Observational Study
ABSTRACT
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 31 continued pregnancies, 81% had live births with no reported malformations, and 68% of neonates had normal birth weights. Effective MDR/RR-TB treatment during pregnancy can improve maternal outcomes without harming neonates.
Outcomes of WHO-conforming, longer, all-oral multidrug-resistant TB regimens and analysis implications
Topics
- endTB Observational Study
ABSTRACT
Effectiveness of Bedaquiline Use beyond Six Months in Patients with Multidrug-Resistant Tuberculosis
Topics
- endTB Observational Study
ABSTRACT
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 the optimal duration of bedaquiline.
OBJECTIVES: We emulated a target trial to estimate the effect of three bedaquiline duration treatment strategies (6 months, 7-11 months, ≥ 12 months) on the probability of successful treatment among patients receiving a longer individualized regimen for multidrug-resistant tuberculosis.
Selection bias in multidrug-resistant tuberculosis cohort studies assessing sputum culture conversion
Concordance of three approaches for operationalizing outcome definitions for multidrug-resistant TB
Topics
- endTB Observational Study
ABSTRACT
Letter to the editor: High prevalence of hepatitis C infection among multidrug-resistant tuberculosis patients
Topics
- endTB Observational Study
In “Integrating HCV testing with HIV programs improves hepatitis C outcomes in people who inject drugs: A cluster-randomized trial”, the authors studied an intervention that integrated HCV testing and education into HIV services across India. In our opinion, many national tuberculosis (TB) programs should also consider integrating HCV testing. TB or the highly resistant variant of the disease, multidrug-resistant (MDR) TB, is generally not considered a risk factor for HBV or HCV infection, except in those who are co-infected with HIV or who are intravenous drug users. Routine, systematic testing for HCV is rare in patients with MDR-TB and is not currently recommended in World Health Organization guidelines for MDR-TB treatment.
Publication: Culture Conversion at 6 Months in Patients Receiving Delamanid-containing Regimens for the Treatment of Multidrug-resistant Tuberculosis
Topics
- endTB Observational Study
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) Observational Study, which enrolled a large, heterogeneous cohorts of patients receiving delamanid as part of a multidrug regimen, 80% of participants experienced sputum culture conversion within 6 months.
Publication: The endTB observational study protocol: treatment of MDR-TB with bedaquiline or delamanid containing regimens
Topics
- endTB Observational Study
At a time when programs were struggling to design effective regimens for the treatment of multidrug-resistant tuberculosis (MDR-TB), the marketing authorization of bedaquiline and delamanid was a critical development in the MDR-TB treatment landscape. However, despite their availability for routine programmatic use, the uptake of these drugs has remained slow; concerns included a lack of evidence on safety and efficacy and the need to protect the new drugs from the development of acquired resistance. As part of the endTB Project, we aimed to address these barriers by generating evidence on safety and efficacy of bedaquiline or delamanid based MDR-TB regimens.
endTB fatal and life-threatening SAE report
Topics
- endTB Observational Study
Report of fatal and life-threatening adverse events during endTB post-marketing safety surveillance of new and repurposed TB drugs
As part of the endTB project and observational study (2015-2019), rigorous post-marketing safety surveillance for all patients (referred to as "endTB patients") who began MDR/RR-TB regimens containing bedaquiline or delamanid was performed. This safety surveillance conformed to the "advanced" active TB Drug Safety Monitoring and Management (aDSM) package as defined by WHO (WHO/HTM/TB/2015.28).
endTB Study Group Members
Topics
- endTB Observational Study
The endTB Study Group is the group that is responsible for the endTB Observational Study (NCT02754765), which includes more than 2700 patients started on bedaquiline and delamanid containing regimens in 17 countries. Organized by country, this is a list of doctors, nurses, data managers, pharmacists, social workers, administrators and others who have spent many hours collecting and cleaning data, working closely with patients, and ensuring that the endTB Observational Study works smoothly in every aspect of its complex existence.
Technical Basis of the endTB Observational Study (EN/RU/ES/FR)
Topics
- endTB Observational Study
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, while collecting clinical and bacteriological data on efficacy and safety. Because many of the endTB Observational Study tools were found to be useful for clinicians and programs that were starting to use the new TB drugs and regimens, we made them freely available at the endTB website.
endTB Interim Analysis Report (EN / ES / RUS)
Topics
- endTB Observational Study
Bedaquiline- and delamanid- containing regimens achieve excellent interim treatment response without safety concerns:
This report presents the results of three different analyses (a safety analysis, a delamanid analysis, and an injectables analysis) to improve the evidence base for using bedaquiline and delamanid in drug-resistant TB regimens.
Available in English, Spanish, and Russian.
