Resources

Publication: Setting up pharmacovigilance based on available endTB Project data for bedaquiline

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 UNITAID in April 2015, endTB (Expand New Drug markets for TB) facilitated treatment with bedaquiline (BDQ) and/or delamanid of >2600 patients in 17 countries, and contributed to the creation of a central PV unit (PVU).

Publication: Time for a Change: Considering Regimen Changes in Analyses of Observational MDR/RR-TB Treatment Cohort Data

Randomized clinical trials represent the gold standard in therapeutic research. Nevertheless, observational cohorts of patients treated for multidrug-resistant (MDR) or rifampin-resistant (RR) tuberculosis (TB) also play an important role in generating evidence to guide MDR/RR TB care.
  • Other

Publication: Culture Conversion in Patients Treated with Bedaquiline and/or Delamanid. A Prospective Multicountry Study

Bedaquiline and delamanid offer the possibility of more effective and less toxic treatment for multidrug-resistant (MDR) tuberculosis (TB). With this treatment, however, some patients remain at high risk for an unfavorable treatment outcome. The endTB Observational Study is the largest multicountry cohort of patients with rifampin-resistant TB or MDR-TB treated in routine care with delamanid- and/or bedaquiline-containing regimens according to World Health Organization guidance.

Publication: Culture Conversion at 6 Months in Patients Receiving Delamanid-containing Regimens for the Treatment of Multidrug-resistant Tuberculosis

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.
  • endTB Observational Study

endTB Interim Analysis Report (EN / ES / RUS)

Front cover, endTB Interim Analysis Report
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.
  • endTB Observational Study

endTB Study Group Members

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.

  • endTB Observational Study

DR-TB Drugs Under the Microscope: 6th edition

This MSF Access Campaign report – now in its sixth edition – analyses the barriers and factors affecting access to treatment regimens for drug-resistant tuberculosis (DR-TB), including new and repurposed drugs in the framework of the new 2019 WHO DR-TB guidelines.

We provide detailed pricing profiles of key DR-TB drugs available on the Global TB Drug Facility website and estimated prices of DR-TB regimens recommended by WHO in programmatic or operational research frameworks.

This report was produced using among others endTB observational cohort data.

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

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 Observational Study

DR-TB Drugs Under the Microscope: 5th edition

This MSF Access Campaign report – now in its fifth edition – analyses the barriers and factors affecting access to treatment regimens for drug-resistant tuberculosis (DR-TB), including new and repurposed drugs.

We provide detailed pricing profiles of key DR-TB drugs, using manufacturer responses to standardised questionnaires and the Global TB Drug Facility website.

This report was produced with endTB's support.

  • Other
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