Letter to the editor: High prevalence of hepatitis C infection among multidrug-resistant tuberculosis patients
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- endTB Observational Study
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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.
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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).
Background: Treatment of multidrug- and rifampin-resistant tuberculosis (MDR/RR-TB) is expensive, labour-intensive, and associated with substantial adverse events and poor outcomes. While most MDR/RR-TB patients do not receive treatment, many who do are treated for 18 months or more. A shorter all-oral regimen is currently recommended for only a sub-set of MDR/RR-TB. Its use is only conditionally recommended because of very low-quality evidence underpinning the recommendation.
A comprehensive summary of the study protocol of the endTB clinical trial has been published in the peer-reviewed journal Trials. Below you will find the link to the open-access article.
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