Culture Conversion in Patients Treated with Bedaquiline and/or Delamanid: A Prospective Multi-country Study.
endTB observational study team
MetadataShow full item record
AbstractBackground Bedaquiline and delamanid offer the possibility of more effective and less toxic multidrug-resistant tuberculosis (MDR-TB) treatment. 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/MDR-TB treated in routine care, according to WHO guidance, with delamanid- and/or bedaquiline-containing regimens. We report frequency of sputum culture conversion within six-months of treatment initiation and risk factors for non-conversion. Methods We included patients with a positive baseline culture who initiated a first endTB regimen prior to April 2018. Two consecutive negative cultures collected > 15 days apart constituted culture conversion. We used generalized mixed models to derive marginal predictions for the probability of culture conversion in key subgroups. Findings 1,109 patients initiated a multidrug treatment containing bedaquiline (63%), delamanid (27%) or both (10%). Of these, 939 (85%) experienced culture conversion within six months. In adjusted analyses, patients with HIV had a lower probability of conversion (0·73 [95% CI: 0·62, 0·84]) than patients without HIV (0·84 [95% CI: 0·79, 0·90]; p=0·03). Patients with both cavitary disease and highly positive sputum smear had a lower probability of conversion (0·68 [95% CI: 0·57, 0·79]) relative to patients without either (0·89; 95% CI: 0·84, 0·95; p=0·0004). Hepatitis C infection, diabetes mellitus/glucose intolerance, and baseline resistance were not associated with conversion. Interpretation Frequent sputum conversion in patients with rifampin-resistant/MDR-TB who were treated with bedaquiline and/or delamanid underscores the need for urgent expanded access to these drugs. There is a need to optimize treatment for patients with HIV and extensive disease.
DescriptionWe regret that this article is behind a paywall.
- The endTB observational study protocol: treatment of MDR-TB with bedaquiline or delamanid containing regimens.
- Authors: Khan U, Huerga H, Khan AJ, Mitnick CD, Hewison C, Varaine F, Bastard M, Rich M, Franke MF, Atwood S, Khan PY, Seung KJ
- Issue date: 2019 Aug 20
- Combined Use of Delamanid and Bedaquiline to Treat Multidrug-Resistant and Extensively Drug-Resistant Tuberculosis: A Systematic Review.
- Authors: Migliori GB, Pontali E, Sotgiu G, Centis R, D'Ambrosio L, Tiberi S, Tadolini M, Esposito S
- Issue date: 2017 Feb 7
- Cost-effectiveness of adding novel or group 5 interventions to a background regimen for the treatment of multidrug-resistant tuberculosis in Germany.
- Authors: Wirth D, Dass R, Hettle R
- Issue date: 2017 Mar 8
- Early safety and efficacy of the combination of bedaquiline and delamanid for the treatment of patients with drug-resistant tuberculosis in Armenia, India, and South Africa: a retrospective cohort study.
- Authors: Ferlazzo G, Mohr E, Laxmeshwar C, Hewison C, Hughes J, Jonckheere S, Khachatryan N, De Avezedo V, Egazaryan L, Shroufi A, Kalon S, Cox H, Furin J, Isaakidis P
- Issue date: 2018 May
- Identification of patients who could benefit from bedaquiline or delamanid: a multisite MDR-TB cohort study.
- Authors: Bonnet M, Bastard M, du Cros P, Khamraev A, Kimenye K, Khurkhumal S, Hayrapetyan A, Themba D, Telnov A, Sanchez-Padilla E, Hewison C, Varaine F
- Issue date: 2016 Feb