Active surveillance for adverse events in patients on longer treatment regimens for multidrug-resistant tuberculosis in Viet Nam.

<h4>Objective</h4>Management of multidrug-resistant tuberculosis (MDR-TB) is a significant challenge to the global healthcare system due to the complexity and long duration of the MDR-TB treatment. This study analyzed the safety of patients on longer injectable-based MDR-TB treatment reg...

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Autores principales:	Nguyen Bao Ngoc, Hoa Vu Dinh, Nguyen Thi Thuy, Duong Van Quang, Cao Thi Thu Huyen, Nguyen Mai Hoa, Nguyen Hoang Anh, Phan Thuong Dat, Nguyen Binh Hoa, Edine Tiemersma, Nguyen Viet Nhung
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/7f5b0399cf2e4539b75af8a3bf5250db
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spelling	oai:doaj.org-article:7f5b0399cf2e4539b75af8a3bf5250db2021-12-02T20:04:42ZActive surveillance for adverse events in patients on longer treatment regimens for multidrug-resistant tuberculosis in Viet Nam.1932-620310.1371/journal.pone.0255357https://doaj.org/article/7f5b0399cf2e4539b75af8a3bf5250db2021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0255357https://doaj.org/toc/1932-6203<h4>Objective</h4>Management of multidrug-resistant tuberculosis (MDR-TB) is a significant challenge to the global healthcare system due to the complexity and long duration of the MDR-TB treatment. This study analyzed the safety of patients on longer injectable-based MDR-TB treatment regimens using active pharmacovigilance data.<h4>Method</h4>We conducted an observational, prospective study based on active pharmacovigilance within the national TB program. A total of 659 MDR-TB patients were enrolled and followed up at 9 TB- hospitals in 9 provinces of all 3 regions in Vietnam between 2014 and 2016. Patients received a treatment regimen (standardized or individualized) based on their drug susceptibility test result and their treatment history. Baseline and follow-up information was collected at the start and during treatment. Adverse events (AE) were defined and classified as serious adverse events (SAEs) or otherwise. Multivariate Cox regression following the Iterative Bayesian Model Averaging algorithm was performed to identify factors associated with AE occurrence.<h4>Results</h4>Out of 659 patients assessed, 71.3% experienced at least one AE, and 17.5% suffered at least one SAE. The most common AEs were gastrointestinal disorders (38.5%), arthralgia (34.7%), and psychiatric disorders (30.0%). The proportion of patients with nephrotoxicity and hearing loss or vestibular disorders were 7.4% and 15.2%, respectively. 13.1% of patients required modifications or interruption of one or more drugs. In 77.7% of patients, treatment was completed successfully, while 9.3% lost to follow-up, in 3.0% treatment failed, and 7.4% died. Some significant risk factors for nephrotoxicity included diabetes mellitus (HR = 8.46 [1.91-37.42]), renal dysfunction (HR = 8.46 [1.91-37.42]), alcoholism (HR = 13.28 [5.04-34.99]), and a higher average daily dose of injectable drugs (HR = 1.28 [1.14-1.43]).<h4>Conclusion</h4>While a majority of patients on the longer injectable-based regimens experienced non-serious AEs during MDR-TB treatment, one in six patients experienced at least an SAE. Active TB drug-safety monitoring is useful to understand the safety of MDR-TB treatment and explore the risk factors for toxicity. All-oral, shorter MDR-TB regimens might be able to reduce the inconvenience, discomfort, and toxicity of such regimens and increase adherence and likelihood of successful completion.Nguyen Bao NgocHoa Vu DinhNguyen Thi ThuyDuong Van QuangCao Thi Thu HuyenNguyen Mai HoaNguyen Hoang AnhPhan Thuong DatNguyen Binh HoaEdine TiemersmaNguyen Viet NhungPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 9, p e0255357 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Nguyen Bao Ngoc Hoa Vu Dinh Nguyen Thi Thuy Duong Van Quang Cao Thi Thu Huyen Nguyen Mai Hoa Nguyen Hoang Anh Phan Thuong Dat Nguyen Binh Hoa Edine Tiemersma Nguyen Viet Nhung Active surveillance for adverse events in patients on longer treatment regimens for multidrug-resistant tuberculosis in Viet Nam.
description	<h4>Objective</h4>Management of multidrug-resistant tuberculosis (MDR-TB) is a significant challenge to the global healthcare system due to the complexity and long duration of the MDR-TB treatment. This study analyzed the safety of patients on longer injectable-based MDR-TB treatment regimens using active pharmacovigilance data.<h4>Method</h4>We conducted an observational, prospective study based on active pharmacovigilance within the national TB program. A total of 659 MDR-TB patients were enrolled and followed up at 9 TB- hospitals in 9 provinces of all 3 regions in Vietnam between 2014 and 2016. Patients received a treatment regimen (standardized or individualized) based on their drug susceptibility test result and their treatment history. Baseline and follow-up information was collected at the start and during treatment. Adverse events (AE) were defined and classified as serious adverse events (SAEs) or otherwise. Multivariate Cox regression following the Iterative Bayesian Model Averaging algorithm was performed to identify factors associated with AE occurrence.<h4>Results</h4>Out of 659 patients assessed, 71.3% experienced at least one AE, and 17.5% suffered at least one SAE. The most common AEs were gastrointestinal disorders (38.5%), arthralgia (34.7%), and psychiatric disorders (30.0%). The proportion of patients with nephrotoxicity and hearing loss or vestibular disorders were 7.4% and 15.2%, respectively. 13.1% of patients required modifications or interruption of one or more drugs. In 77.7% of patients, treatment was completed successfully, while 9.3% lost to follow-up, in 3.0% treatment failed, and 7.4% died. Some significant risk factors for nephrotoxicity included diabetes mellitus (HR = 8.46 [1.91-37.42]), renal dysfunction (HR = 8.46 [1.91-37.42]), alcoholism (HR = 13.28 [5.04-34.99]), and a higher average daily dose of injectable drugs (HR = 1.28 [1.14-1.43]).<h4>Conclusion</h4>While a majority of patients on the longer injectable-based regimens experienced non-serious AEs during MDR-TB treatment, one in six patients experienced at least an SAE. Active TB drug-safety monitoring is useful to understand the safety of MDR-TB treatment and explore the risk factors for toxicity. All-oral, shorter MDR-TB regimens might be able to reduce the inconvenience, discomfort, and toxicity of such regimens and increase adherence and likelihood of successful completion.
format	article
author	Nguyen Bao Ngoc Hoa Vu Dinh Nguyen Thi Thuy Duong Van Quang Cao Thi Thu Huyen Nguyen Mai Hoa Nguyen Hoang Anh Phan Thuong Dat Nguyen Binh Hoa Edine Tiemersma Nguyen Viet Nhung
author_facet	Nguyen Bao Ngoc Hoa Vu Dinh Nguyen Thi Thuy Duong Van Quang Cao Thi Thu Huyen Nguyen Mai Hoa Nguyen Hoang Anh Phan Thuong Dat Nguyen Binh Hoa Edine Tiemersma Nguyen Viet Nhung
author_sort	Nguyen Bao Ngoc
title	Active surveillance for adverse events in patients on longer treatment regimens for multidrug-resistant tuberculosis in Viet Nam.
title_short	Active surveillance for adverse events in patients on longer treatment regimens for multidrug-resistant tuberculosis in Viet Nam.
title_full	Active surveillance for adverse events in patients on longer treatment regimens for multidrug-resistant tuberculosis in Viet Nam.
title_fullStr	Active surveillance for adverse events in patients on longer treatment regimens for multidrug-resistant tuberculosis in Viet Nam.
title_full_unstemmed	Active surveillance for adverse events in patients on longer treatment regimens for multidrug-resistant tuberculosis in Viet Nam.
title_sort	active surveillance for adverse events in patients on longer treatment regimens for multidrug-resistant tuberculosis in viet nam.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/7f5b0399cf2e4539b75af8a3bf5250db
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Active surveillance for adverse events in patients on longer treatment regimens for multidrug-resistant tuberculosis in Viet Nam.

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