Effectiveness and safety of fully oral modified shorter treatment regimen for multidrug-resistant tuberculosis in Georgia, 2019-2020

Tuberculosis treatment is challenging, especially among people with drug-resistant forms of tuberculosis. The introduction of fully oral modified short treatment regimen has a great potential to shorten duration of treatment, improve safety and ultimately increase treatment success rate. In 2019 Ge...

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Main Authors: Teona Avaliani, Yuliia Sereda, Hayk Davtyan, Nestani Tukvadze, Tamar Togonidze, Nana Kiria, Olga Denisiuk, Ogtay Gozalov, Sevim Ahmedov, Arax Hovhannesyan
Format: Article
Language:English
Published: PAGEPress Publications 2021-01-01
Series:Monaldi Archives for Chest Disease
Subjects:
Online Access:https://monaldi-archives.org/index.php/macd/article/view/1679
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spelling doaj-6d88eeaba1194b3d871c356defeecd442021-02-03T03:52:05ZengPAGEPress PublicationsMonaldi Archives for Chest Disease1122-06432532-52642021-01-0191110.4081/monaldi.2021.1679Effectiveness and safety of fully oral modified shorter treatment regimen for multidrug-resistant tuberculosis in Georgia, 2019-2020Teona Avaliani0Yuliia Sereda1Hayk Davtyan2Nestani Tukvadze3Tamar Togonidze4Nana Kiria5Olga Denisiuk6Ogtay Gozalov7Sevim Ahmedov8Arax Hovhannesyan9National Center for Tuberculosis and Lung Diseases, TbilisiWorld Health Organization, Regional Office for Europe, CopenhagenTuberculosis Research and Prevention Center, YerevanNational Center for Tuberculosis and Lung Diseases, TbilisiNational Center for Tuberculosis and Lung Diseases, TbilisiNational Center for Tuberculosis and Lung Diseases, TbilisiAlliance for Public Health, KyivWorld Health Organization, Regional Office for Europe, CopenhagenUnited States Agency for International Development, Washington DCWorld Health Organization, Regional Office for Europe, Copenhagen Tuberculosis treatment is challenging, especially among people with drug-resistant forms of tuberculosis. The introduction of fully oral modified short treatment regimen has a great potential to shorten duration of treatment, improve safety and ultimately increase treatment success rate. In 2019 Georgia has piloted the modified fully oral shorter treatment regimen in a routine programmatic condition. Our study aimed to evaluate effectiveness and safety of the modified shorter treatment regimen in Georgia among the first 25 consecutively enrolled patients with rifampicin-resistant tuberculosis with proven sensitivity to fluoroquinolone and without prior exposure to second-line tuberculosis drugs. Regimen consisted of 9-month daily administration of bedaquilline, linezolid, levofloxacin, clofazimine and cycloserine. Study patients were enrolled between March-August 2019. We used a national electronic surveillance system, medical records and active TB drug-safety monitoring and management database to extract study related data. The mean age of the study participants was 48 years, 68% were male, 8% were HIV positive, 16% had diabetes and 12% tested positive for hepatitis C infection. The median time to culture conversion among 16 patients who were culture positive at treatment initiation was 1.0 (95% CI: 1.0-2.0) month. Of those, by the end of treatment 15 patients converted to negative. Out of the 25 patients in the study cohort 22 (88%) had successful treatment outcome, one patient (4%) died and two (8%) were lost to follow up. The regimen was largely well tolerated. Three patients (12%) experienced serious adverse events, of which in two cases were possibly related to TB drugs in the regimen. Seven patients developed adverse events of interest in eight instances, including musculoskeletal (twice), psychiatric, gastrointestinal disorders, hepatotoxicity, peripheral neuropathy, cardiotoxicity and myelosuppression (once each). In four patients (16%) the duration of the treatment was extended beyond nine months due to insufficient radiological improvements. Our findings demonstrate that good treatment outcomes are achievable in people with fluoroquinolone-sensitive tuberculosis within routine programmatic conditions using fully oral modified short treatment regimen. The extensive use of fully oral modified shorter treatment regimen in Georgia and other high priority countries in the World Health Organization European Region is warranted. https://monaldi-archives.org/index.php/macd/article/view/1679MDR-TBmodified all-oral shorter treatment regimenrifampicin resistancetime to culture conversionadverse drug safety monitoring
collection DOAJ
language English
format Article
sources DOAJ
author Teona Avaliani
Yuliia Sereda
Hayk Davtyan
Nestani Tukvadze
Tamar Togonidze
Nana Kiria
Olga Denisiuk
Ogtay Gozalov
Sevim Ahmedov
Arax Hovhannesyan
spellingShingle Teona Avaliani
Yuliia Sereda
Hayk Davtyan
Nestani Tukvadze
Tamar Togonidze
Nana Kiria
Olga Denisiuk
Ogtay Gozalov
Sevim Ahmedov
Arax Hovhannesyan
Effectiveness and safety of fully oral modified shorter treatment regimen for multidrug-resistant tuberculosis in Georgia, 2019-2020
Monaldi Archives for Chest Disease
MDR-TB
modified all-oral shorter treatment regimen
rifampicin resistance
time to culture conversion
adverse drug safety monitoring
author_facet Teona Avaliani
Yuliia Sereda
Hayk Davtyan
Nestani Tukvadze
Tamar Togonidze
Nana Kiria
Olga Denisiuk
Ogtay Gozalov
Sevim Ahmedov
Arax Hovhannesyan
author_sort Teona Avaliani
title Effectiveness and safety of fully oral modified shorter treatment regimen for multidrug-resistant tuberculosis in Georgia, 2019-2020
title_short Effectiveness and safety of fully oral modified shorter treatment regimen for multidrug-resistant tuberculosis in Georgia, 2019-2020
title_full Effectiveness and safety of fully oral modified shorter treatment regimen for multidrug-resistant tuberculosis in Georgia, 2019-2020
title_fullStr Effectiveness and safety of fully oral modified shorter treatment regimen for multidrug-resistant tuberculosis in Georgia, 2019-2020
title_full_unstemmed Effectiveness and safety of fully oral modified shorter treatment regimen for multidrug-resistant tuberculosis in Georgia, 2019-2020
title_sort effectiveness and safety of fully oral modified shorter treatment regimen for multidrug-resistant tuberculosis in georgia, 2019-2020
publisher PAGEPress Publications
series Monaldi Archives for Chest Disease
issn 1122-0643
2532-5264
publishDate 2021-01-01
description Tuberculosis treatment is challenging, especially among people with drug-resistant forms of tuberculosis. The introduction of fully oral modified short treatment regimen has a great potential to shorten duration of treatment, improve safety and ultimately increase treatment success rate. In 2019 Georgia has piloted the modified fully oral shorter treatment regimen in a routine programmatic condition. Our study aimed to evaluate effectiveness and safety of the modified shorter treatment regimen in Georgia among the first 25 consecutively enrolled patients with rifampicin-resistant tuberculosis with proven sensitivity to fluoroquinolone and without prior exposure to second-line tuberculosis drugs. Regimen consisted of 9-month daily administration of bedaquilline, linezolid, levofloxacin, clofazimine and cycloserine. Study patients were enrolled between March-August 2019. We used a national electronic surveillance system, medical records and active TB drug-safety monitoring and management database to extract study related data. The mean age of the study participants was 48 years, 68% were male, 8% were HIV positive, 16% had diabetes and 12% tested positive for hepatitis C infection. The median time to culture conversion among 16 patients who were culture positive at treatment initiation was 1.0 (95% CI: 1.0-2.0) month. Of those, by the end of treatment 15 patients converted to negative. Out of the 25 patients in the study cohort 22 (88%) had successful treatment outcome, one patient (4%) died and two (8%) were lost to follow up. The regimen was largely well tolerated. Three patients (12%) experienced serious adverse events, of which in two cases were possibly related to TB drugs in the regimen. Seven patients developed adverse events of interest in eight instances, including musculoskeletal (twice), psychiatric, gastrointestinal disorders, hepatotoxicity, peripheral neuropathy, cardiotoxicity and myelosuppression (once each). In four patients (16%) the duration of the treatment was extended beyond nine months due to insufficient radiological improvements. Our findings demonstrate that good treatment outcomes are achievable in people with fluoroquinolone-sensitive tuberculosis within routine programmatic conditions using fully oral modified short treatment regimen. The extensive use of fully oral modified shorter treatment regimen in Georgia and other high priority countries in the World Health Organization European Region is warranted.
topic MDR-TB
modified all-oral shorter treatment regimen
rifampicin resistance
time to culture conversion
adverse drug safety monitoring
url https://monaldi-archives.org/index.php/macd/article/view/1679
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