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Delamanid for rifampicin-resistant tuberculosis: a retrospective study from South Africa
Experience with delamanid (Dlm) is limited, particularly among HIV-positive individuals. We describe early efficacy and safety data from a programmatic setting in South Africa. This was a retrospective cohort study of patients receiving Dlm-containing treatment regimens between November 2015 and Aug...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
European Respiratory Society
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6485275/ https://www.ncbi.nlm.nih.gov/pubmed/29724920 http://dx.doi.org/10.1183/13993003.00017-2018 |
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author | Mohr, Erika Hughes, Jennifer Reuter, Anja Trivino Duran, Laura Ferlazzo, Gabriella Daniels, Johnny De Azevedo, Virginia Kock, Yulene Steele, Sarah Jane Shroufi, Amir Ade, Serge Alikhanova, Natavan Benedetti, Guido Edwards, Jeffrey Cox, Helen Furin, Jennifer Isaakidis, Petros |
author_facet | Mohr, Erika Hughes, Jennifer Reuter, Anja Trivino Duran, Laura Ferlazzo, Gabriella Daniels, Johnny De Azevedo, Virginia Kock, Yulene Steele, Sarah Jane Shroufi, Amir Ade, Serge Alikhanova, Natavan Benedetti, Guido Edwards, Jeffrey Cox, Helen Furin, Jennifer Isaakidis, Petros |
author_sort | Mohr, Erika |
collection | PubMed |
description | Experience with delamanid (Dlm) is limited, particularly among HIV-positive individuals. We describe early efficacy and safety data from a programmatic setting in South Africa. This was a retrospective cohort study of patients receiving Dlm-containing treatment regimens between November 2015 and August 2017. We report 12-month interim outcomes, sputum culture conversion (SCC) by months 2 and 6, serious adverse events (SAEs) and QT intervals corrected using the Frederica formula (QTcF). Overall, 103 patients were initiated on Dlm; 79 (77%) were HIV positive. The main indication for Dlm was intolerance to second-line anti-tuberculosis (TB) drugs (n=58, 56%). There were 12 months of follow-up for 46 patients; 28 (61%) had a favourable outcome (cure, treatment completion or culture negativity). Positive cultures were found for 57 patients at Dlm initiation; 16 out of 31 (52%) had SCC within 2 months and 25 out of 31 (81%) within 6 months. There were 67 SAEs reported in 29 patients (28%). There were four instances of QTcF prolongation >500 ms in two patients (2%), leading to permanent discontinuation in one case; however, no cardiac arrhythmias occurred. This large cohort of difficult-to-treat patients receiving Dlm for rifampicin-resistant TB treatment in a programmatic setting with high HIV prevalence had favourable early treatment response and tolerated treatment well. Dlm should remain available, particularly for those who cannot be treated with conventional regimens or with limited treatment options. |
format | Online Article Text |
id | pubmed-6485275 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | European Respiratory Society |
record_format | MEDLINE/PubMed |
spelling | pubmed-64852752019-04-30 Delamanid for rifampicin-resistant tuberculosis: a retrospective study from South Africa Mohr, Erika Hughes, Jennifer Reuter, Anja Trivino Duran, Laura Ferlazzo, Gabriella Daniels, Johnny De Azevedo, Virginia Kock, Yulene Steele, Sarah Jane Shroufi, Amir Ade, Serge Alikhanova, Natavan Benedetti, Guido Edwards, Jeffrey Cox, Helen Furin, Jennifer Isaakidis, Petros Eur Respir J Original Articles Experience with delamanid (Dlm) is limited, particularly among HIV-positive individuals. We describe early efficacy and safety data from a programmatic setting in South Africa. This was a retrospective cohort study of patients receiving Dlm-containing treatment regimens between November 2015 and August 2017. We report 12-month interim outcomes, sputum culture conversion (SCC) by months 2 and 6, serious adverse events (SAEs) and QT intervals corrected using the Frederica formula (QTcF). Overall, 103 patients were initiated on Dlm; 79 (77%) were HIV positive. The main indication for Dlm was intolerance to second-line anti-tuberculosis (TB) drugs (n=58, 56%). There were 12 months of follow-up for 46 patients; 28 (61%) had a favourable outcome (cure, treatment completion or culture negativity). Positive cultures were found for 57 patients at Dlm initiation; 16 out of 31 (52%) had SCC within 2 months and 25 out of 31 (81%) within 6 months. There were 67 SAEs reported in 29 patients (28%). There were four instances of QTcF prolongation >500 ms in two patients (2%), leading to permanent discontinuation in one case; however, no cardiac arrhythmias occurred. This large cohort of difficult-to-treat patients receiving Dlm for rifampicin-resistant TB treatment in a programmatic setting with high HIV prevalence had favourable early treatment response and tolerated treatment well. Dlm should remain available, particularly for those who cannot be treated with conventional regimens or with limited treatment options. European Respiratory Society 2018-06-14 /pmc/articles/PMC6485275/ /pubmed/29724920 http://dx.doi.org/10.1183/13993003.00017-2018 Text en Copyright ©ERS 2018. http://creativecommons.org/licenses/by-nc/4.0/ This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. |
spellingShingle | Original Articles Mohr, Erika Hughes, Jennifer Reuter, Anja Trivino Duran, Laura Ferlazzo, Gabriella Daniels, Johnny De Azevedo, Virginia Kock, Yulene Steele, Sarah Jane Shroufi, Amir Ade, Serge Alikhanova, Natavan Benedetti, Guido Edwards, Jeffrey Cox, Helen Furin, Jennifer Isaakidis, Petros Delamanid for rifampicin-resistant tuberculosis: a retrospective study from South Africa |
title | Delamanid for rifampicin-resistant tuberculosis: a retrospective study from South Africa |
title_full | Delamanid for rifampicin-resistant tuberculosis: a retrospective study from South Africa |
title_fullStr | Delamanid for rifampicin-resistant tuberculosis: a retrospective study from South Africa |
title_full_unstemmed | Delamanid for rifampicin-resistant tuberculosis: a retrospective study from South Africa |
title_short | Delamanid for rifampicin-resistant tuberculosis: a retrospective study from South Africa |
title_sort | delamanid for rifampicin-resistant tuberculosis: a retrospective study from south africa |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6485275/ https://www.ncbi.nlm.nih.gov/pubmed/29724920 http://dx.doi.org/10.1183/13993003.00017-2018 |
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