Efficacy and safety data on pretomanid for drug-resistant TB

OBJECTIVE: To summarise the efficacy and safety of pretomanid (Pa) based regimens in patients with drug-resistant TB (DR-TB). METHODS: We included clinical trials, operational research and observational studies reporting the efficacy and safety of Pa-based regimens in DR-TB. The duration of the trea...

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Main Authors: H.T.T. Thuy, C. Padmapriyadarsini, C. Chuchottaworn, S. Foraida, S. Hadigal, A.R. Birajdar
Format: Article
Language:English
Published: International Union Against Tuberculosis and Lung Disease (The Union) 2025-02-01
Series:IJTLD Open
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Online Access:https://www.ingentaconnect.com/contentone/iuatld/ijtldo/2025/00000002/00000002/art00004
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author H.T.T. Thuy
C. Padmapriyadarsini
C. Chuchottaworn
S. Foraida
S. Hadigal
A.R. Birajdar
author_facet H.T.T. Thuy
C. Padmapriyadarsini
C. Chuchottaworn
S. Foraida
S. Hadigal
A.R. Birajdar
author_sort H.T.T. Thuy
collection DOAJ
description OBJECTIVE: To summarise the efficacy and safety of pretomanid (Pa) based regimens in patients with drug-resistant TB (DR-TB). METHODS: We included clinical trials, operational research and observational studies reporting the efficacy and safety of Pa-based regimens in DR-TB. The duration of the treatment was at least 24 weeks. Efficacy was reported as a favourable/unfavourable outcome and culture conversion. Safety was reported in terms of death and frequency of adverse events of special interest. RESULTS: Of the 127 articles identified, 13 were included. The proportion of favourable outcomes reported was 76−100%, and the median time to culture conversion was 4−6 weeks. Culture conversion rates ranged from 80–100% by the end of 3 months of treatment, regardless of the type of drug resistance. Treatment completion rates in the operational research studies varied between 18–93%. Safety events were not proportionate among the studies included, possibly due to the differing linezolid dosing (more frequent in the 1,200 mg dose regimen). CONCLUSION: Our review supports the use of Pa-based regimens in patients with DR-TB. The results indicate that Pa-based regimens are efficacious with tolerable safety profile in DR-TB patients.
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spelling doaj-art-5d63c7a725464eb9aef4b2ab60c56a512025-08-20T02:13:01ZengInternational Union Against Tuberculosis and Lung Disease (The Union)IJTLD Open3005-75902025-02-0122738210.5588/ijtldopen.24.03604Efficacy and safety data on pretomanid for drug-resistant TBH.T.T. Thuy0C. Padmapriyadarsini1C. Chuchottaworn2S. Foraida3S. Hadigal4A.R. Birajdar5National TB Control Programme of Vietnam, National Lung Hospital, Hanoi, Vietnam;National Institute for Research in Tuberculosis, Indian Council of Medical Research, Chennai, India;Department of Medical Services, Central Chest Institute of Thailand, Nonthaburi, Thailand;TB Alliance, New York, NY, USA;Department of Medical Affairs, Viatris, India.Department of Medical Affairs, Viatris, India.OBJECTIVE: To summarise the efficacy and safety of pretomanid (Pa) based regimens in patients with drug-resistant TB (DR-TB). METHODS: We included clinical trials, operational research and observational studies reporting the efficacy and safety of Pa-based regimens in DR-TB. The duration of the treatment was at least 24 weeks. Efficacy was reported as a favourable/unfavourable outcome and culture conversion. Safety was reported in terms of death and frequency of adverse events of special interest. RESULTS: Of the 127 articles identified, 13 were included. The proportion of favourable outcomes reported was 76−100%, and the median time to culture conversion was 4−6 weeks. Culture conversion rates ranged from 80–100% by the end of 3 months of treatment, regardless of the type of drug resistance. Treatment completion rates in the operational research studies varied between 18–93%. Safety events were not proportionate among the studies included, possibly due to the differing linezolid dosing (more frequent in the 1,200 mg dose regimen). CONCLUSION: Our review supports the use of Pa-based regimens in patients with DR-TB. The results indicate that Pa-based regimens are efficacious with tolerable safety profile in DR-TB patients.https://www.ingentaconnect.com/contentone/iuatld/ijtldo/2025/00000002/00000002/art00004tuberculosisextensively drug-resistant tuberculosispre-extensively drug-resistant tuberculosismultidrug-resistant tuberculosisadverse events
spellingShingle H.T.T. Thuy
C. Padmapriyadarsini
C. Chuchottaworn
S. Foraida
S. Hadigal
A.R. Birajdar
Efficacy and safety data on pretomanid for drug-resistant TB
IJTLD Open
tuberculosis
extensively drug-resistant tuberculosis
pre-extensively drug-resistant tuberculosis
multidrug-resistant tuberculosis
adverse events
title Efficacy and safety data on pretomanid for drug-resistant TB
title_full Efficacy and safety data on pretomanid for drug-resistant TB
title_fullStr Efficacy and safety data on pretomanid for drug-resistant TB
title_full_unstemmed Efficacy and safety data on pretomanid for drug-resistant TB
title_short Efficacy and safety data on pretomanid for drug-resistant TB
title_sort efficacy and safety data on pretomanid for drug resistant tb
topic tuberculosis
extensively drug-resistant tuberculosis
pre-extensively drug-resistant tuberculosis
multidrug-resistant tuberculosis
adverse events
url https://www.ingentaconnect.com/contentone/iuatld/ijtldo/2025/00000002/00000002/art00004
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AT shadigal efficacyandsafetydataonpretomanidfordrugresistanttb
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