RT Journal Article
SR Electronic
T1 Delamanid for Rifampicin–Resistant Tuberculosis: A Retrospective Study from South Africa
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 1800017
DO 10.1183/13993003.00017-2018
A1 Erika Mohr
A1 Jennifer Hughes
A1 Anja Reuter
A1 Laura Trivino Duran
A1 Gabriella Ferlazzo
A1 Johnny Daniels
A1 Virginia De Avezedo
A1 Yulene Kock
A1 Sarah Jane Steele
A1 Amir Shroufi
A1 Serge Ade
A1 Natavan Alikhanova
A1 Guido Benedetti
A1 Jeffrey Edwards
A1 Helen Cox
A1 Jennifer Furin
A1 Petros Isaakidis
YR 2018
UL http://erj.ersjournals.com/content/early/2018/04/26/13993003.00017-2018.abstract
AB Background Experience with delamanid (Dlm) is limited, particularly among HIV-positive individuals. We describe early efficacy and safety from a programmatic setting in South Africa.Methods This was a retrospective cohort study of patients receiving Dlm-containing treatment regimens between November 2015 and August 2017. Twelve-month interim outcomes, sputum culture conversion (SCC) by months-2 and 6, serious adverse events (SAEs), and QTcF data were reported.Results Overall, 103 patients initiated Dlm; 79(77%) were HIV-positive. The main indication for Dlm was intolerance to second-line anti-TB drugs (n=58, 56%). Forty-six patients had 12-months of follow-up; 28(61%) had a favorable outcome (cure, treatment completion, or culture negativity). Fifty-seven patients had positive cultures at Dlm initiation; 16/31(52%) and 25/31(81%) had SCC within 2 and 6-months, respectively. There were 67 SAEs reported in 29(28%) patients. There were four instances of QTcF prolongation >500 ms in 2(2%) patients, leading to permanent discontinuation in one case, however no cardiac arrhythmias occurred.Conclusions This large cohort of difficult-to-treat patients receiving Dlm for rifampicin-resistant tuberculosis treatment in a programmatic setting with high HIV prevalence had favorable early treatment response and tolerated treatment well. Dlm should remain available, particularly for those that cannot be treated with conventional regimens and/or with limited treatment options.Rifampicin-resistant TB patients treated with delamanid had good treatment response and cardiotoxicity was rareFootnotesThis manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.Conflict of interest: Ms. Mohr has nothing to disclose.Conflict of interest: Dr. Hughes has nothing to disclose.Conflict of interest: Dr. Reuter has nothing to disclose.Conflict of interest: Dr. Trivino Duran has nothing to disclose.Conflict of interest: Dr. Ferlazzo has nothing to disclose.Conflict of interest: Mr. Daniels has nothing to disclose.Conflict of interest: Dr. Kock has nothing to disclose.Conflict of interest: Dr. Shroufi has nothing to disclose.Conflict of interest: Dr. ADE has nothing to disclose.Conflict of interest: Dr. Benedetti has nothing to disclose.Conflict of interest: Dr. Edwards has nothing to disclose.Conflict of interest: Dr. Cox has nothing to disclose.Conflict of interest: Dr. Furin has nothing to disclose.Conflict of interest: Dr. Isaakidis has nothing to disclose.Conflict of interest: Dr. Steele has nothing to disclose.Conflict of interest: Dr. De Azevedo has nothing to disclose.