Title
Bedaquiline in the treatment of multidrug- and extensively drugresistant tuberculosis
Date Issued
01 February 2016
Access level
open access
Resource Type
journal article
Author(s)
Pym A.S.
Diacon A.H.
Tang S.J.
Conradie F.
Danilovits M.
Chuchottaworn C.
Vasilyeva I.
Andries K.
Bakare N.
De Marez T.
Haxaire-Theeuwes M.
Lounis N.
Meyvisch P.
Van Baelen B.
Van Heeswijk R.P.G.
Dannemann B.
Chen X.
Chu N.
Diaz D.
Erokhin V.
Flores V.
Hwang S.C.
Iberico C.
Kazennyi B.
Kim Y.S.
Kurve A.
Kuzhko M.
Jung Kwon O.
Leimane V.
Lyepshina S.
Maryandyshev A.
Melnyk V.
Narasimooloo R.
Qiu L.
Ortaköylü G.
Ozkara S.
Reano R.
Shim T.S.
Chavez E.T.
Wiwatworapan T.
Zhang X.
Publisher(s)
European Respiratory Society
Abstract
Bedaquiline, a diarylquinoline, improved cure rates when added to a multidrug-resistant tuberculosis (MDR-TB) treatment regimen in a previous placebo-controlled, phase 2 trial (TMC207-C208; NCT00449644). The current phase 2, multicenter, open-label, single-arm trial (TMC207-C209; NCT00910871) reported here was conducted to confirm the safety and efficacy of bedaquiline. Newly diagnosed or previously treated patients with MDR-TB (including pre-extensively drug-resistant (pre-XDR)-TB or extensively drug-resistant (XDR)-TB) received bedaquiline for 24 weeks with a background regimen of anti-TB drugs continued according to National TB Programme treatment guidelines. Patients were assessed during and up to 120 weeks after starting bedaquiline. Of 233 enrolled patients, 63.5% had MDR-TB, 18.9% had pre-XDR-TB and 16.3% had XDR-TB, with 87.1% having taken second-line drugs prior to enrolment. 16 patients (6.9%) died. 20 patients (8.6%) discontinued before week 24, most commonly due to adverse events or MDR-TB-related events. Adverse events were generally those commonly associated with MDR-TB treatment. In the efficacy population (n=205), culture conversion (missing outcome classified as failure) was 72.2% at 120 weeks, and 73.1%, 70.5% and 62.2% in MDR-TB, pre-XDR-TB and XDR-TB patients, respectively. Addition of bedaquiline to a background regimen was well tolerated and led to good outcomes in this clinically relevant patient cohort with MDR-TB.
Start page
564
End page
574
Volume
47
Issue
2
Language
English
OCDE Knowledge area
Enfermedades infecciosas Sistema respiratorio
Scopus EID
2-s2.0-84958073475
PubMed ID
Source
European Respiratory Journal
ISSN of the container
09031936
Sources of information: Directorio de Producción Científica Scopus