Resources

endTB Clinical and Programmatic Guide for Patient Management with New TB Drugs

 

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 care professionals involved in the endTB project. Every effort possible has been made to ensure that the material presented here is accurate, reliable, and in accord with current standards. However, as new research and experience expand our knowledge, recommendations for care and treatment change.

  • endTB Clinical Trial

Publication: 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

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-benefit ratio. Yet this combination is an important alternative for patients infected with strains of TB with complex drug resistance profiles or who cannot tolerate other therapies. We assessed safety and treatment outcomes of MDR/RR-TB patients receiving concomitant Bdq and Dlm, along with other second-line anti-TB drugs.

Letter to the editor: High prevalence of hepatitis C infection among multidrug-resistant tuberculosis patients

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.
  • endTB Observational Study

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

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 (MDR-TB). There are multiple ongoing clinical trials aiming to build a robust evidence base to guide RR/MDR-TB treatment, and both observational studies and programmatic data have contributed to advancing the treatment field.
  • Other

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

You may read the full article here: Recently developed drugs for the treatment of drug-resistant tuberculosis: a research and development case study - published in April 2022 

Authors: Perrin C, Athersuch K, Elder G, et al - BMJ Global Health 2022;7:e007490.

  • Other

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

Recent World Health Organization guidance on drug-resistant tuberculosis treatment de-prioritised injectable agents, in use for decades, and endorsed all-oral longer regimens. However, questions remain about the role of the injectable agent, particularly in the context of regimens using new and repurposed drugs. We compared the effectiveness of an injectable-containing regimen to that of an all-oral regimen among patients with drug-resistant tuberculosis who received bedaquiline and/or delamanid as part of their multidrug regimen.

endTB fatal and life-threatening SAE report

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 Observational Study
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