Delamanid for Rifampicin–Resistant Tuberculosis: A Retrospective Study from South Africa
- Erika Mohr1,
- Jennifer Hughes1,
- Anja Reuter1,
- Laura Trivino Duran1,
- Gabriella Ferlazzo2,
- Johnny Daniels1,
- Virginia De Avezedo3,
- Yulene Kock4,
- Sarah Jane Steele5,
- Amir Shroufi5,
- Serge Ade6,
- Natavan Alikhanova7,
- Guido Benedetti8,
- Jeffrey Edwards8,9,
- Helen Cox10,
- Jennifer Furin11 and
- Petros Isaakidis2
- 1Médecins Sans Frontières, Operational Centre Brussels (OCB), Khayelitsha Project, Cape Town, South Africa
- 2Médecins Sans Frontières, South African Medical Unit (SAMU), Cape Town, South Africa
- 3City of Cape Town Health Department, Cape Town, South Africa
- 4Provincial Government of the Western Cape Department of Health, Western Cape, South Africa
- 5Médecins Sans Frontières, Operational Centre Brussels (OCB), Cape Town Coordination, South Africa
- 6Faculty of Medicine, University of Parakou, Parakou, Benin
- 7Main Medical Department, Ministry of Justice, Azerbaijan
- 8Médecins sans Frontières, Medical Department (Operational Research), Operational Centre Brussels (OCB), Luxembourg, Luxembourg
- 9Department of Global Health, University of Washington, Seattle, Washington, USA
- 10Division of Medical Microbiology and the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa
- 11Department of Global Health & Social Medicine, Harvard Medical School, Boston, Massachusetts, USA
- Erika Mohr, Médecins Sans Frontières (MSF), The Isisivana Center, 1 Tsolo Road, Khayelitsha, 7784, South Africa. E-mail: msfocb-khayelitsha-drtb-epi{at}brussels.msf.org
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
This 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.
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