Abstract
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.
Abstract
Rifampicin-resistant TB patients treated with delamanid had good treatment response and cardiotoxicity was rare
Footnotes
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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.
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