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Compassionate Use of Delamanid in Adults and Children for Drug-resistant TB: 5-year Update

Sambuddha Ghosh, Lusine Breitscheidel, Natasa Lazarevic, Alexandra Martin, Jeffrey Hafkin, Norbert Hittel
European Respiratory Journal 2020; DOI: 10.1183/13993003.02483-2020
Sambuddha Ghosh
1Otsuka Novel Products GmbH, Munich, Germany
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Lusine Breitscheidel
1Otsuka Novel Products GmbH, Munich, Germany
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  • ORCID record for Lusine Breitscheidel
Natasa Lazarevic
1Otsuka Novel Products GmbH, Munich, Germany
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Alexandra Martin
1Otsuka Novel Products GmbH, Munich, Germany
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Jeffrey Hafkin
2Otsuka Pharmaceutical Development & Commercialisation, Inc., Princeton, NJ, USA
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Norbert Hittel
1Otsuka Novel Products GmbH, Munich, Germany
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Abstract

Background Although delamanid has been approved for the treatment of multidrug-resistant tuberculosis (MDR-TB) in numerous regions, in areas where it is not yet registered, it can be accessed as part of salvage therapy—in particular, for those patients with limited treatment options—via the Otsuka Compassionate Use (CU) programme. Here we present the analysis of interim treatment outcomes by 24 weeks of more than 200 multidrug-resistant tuberculosis (MDR-TB) patients globally who received delamanid under the Otsuka CU programme.

Methods We evaluated the treatment efficacy, with respect to culture negativity at 24 weeks, and safety profile of delamanid in a MDR-TB cohort of patients treated under CU between 2014 and 2019.

Results Among patients who received delamanid as part of a multidrug regimen, 123/202 (61%) had extensively drug-resistant tuberculosis (XDR-TB), 66/202 (33%) had HIV co-infection, and 34/202 (17%) were children ages between 6 and 17 years. Of those patients who were culture positive at delamanid treatment initiation and completed 24 weeks of delamanid treatment in combination with other anti-TB drugs, culture negativity was achieved in 116/147 (79%). The corresponding rates of culture negativity for patients with XDR-TB, HIV co-infection, and the paediatric subgroup were 69/90 (77%), 44/48 (92%), and 20/25 (80%), respectively. QT interval prolongation was the most frequently observed serious adverse event (reported in 8% of patients receiving delamanid). Overall, treatment safety outcomes did not reveal any new or unidentified risks.

Conclusions The use of delamanid combined with other active drugs has the potential to achieve high rates of culture negativity in difficult-to-treat drug-resistant tuberculosis cases, with a favourable safety profile.

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: I, Dr Sambuddha Ghosh, hereby confirm that I am an employee of Otsuka Novel Products GmbH.

Conflict of interest: Dr. Breitscheidel reports being employed by Otsuka Novel Products GmbH, during the conduct of the Delamanid Compassionate Use Program.

Conflict of interest: Dr. Lazarevic reports, I am an employee of Otsuka Novel Products GmbH.

Conflict of interest: Mrs. Martin reports - I am an employee of Otsuka Novel Products GmbH.

Conflict of interest: Dr. Hafkin reports, I am an employee of Otsuka Pharmaceutical Development & Commercialisation, Inc.

Conflict of interest: Dr. Hittel reports, I am an employee of Otsuka Novel Products GmbH.

  • Received June 24, 2020.
  • Accepted November 13, 2020.
  • Copyright ©ERS 2020
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Compassionate Use of Delamanid in Adults and Children for Drug-resistant TB: 5-year Update
Sambuddha Ghosh, Lusine Breitscheidel, Natasa Lazarevic, Alexandra Martin, Jeffrey Hafkin, Norbert Hittel
European Respiratory Journal Jan 2020, 2002483; DOI: 10.1183/13993003.02483-2020

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Compassionate Use of Delamanid in Adults and Children for Drug-resistant TB: 5-year Update
Sambuddha Ghosh, Lusine Breitscheidel, Natasa Lazarevic, Alexandra Martin, Jeffrey Hafkin, Norbert Hittel
European Respiratory Journal Jan 2020, 2002483; DOI: 10.1183/13993003.02483-2020
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