scholarly journals “Side effects-part of the package” – A mixed methods approach to adverse events among patients with DR-TB under RNTCP Gujarat, India

2020 ◽  
Author(s):  
Arjunkumar Hardas Jakasania ◽  
Kalpita shringarpure ◽  
Dixit Kapadia ◽  
Radhika Sharma ◽  
Kedar Mehta ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Adverse Events ◽  
Healthcare Providers ◽  
Medical Officer ◽  
Treatment Seeking ◽  
Tb Treatment ◽  
Program Manager ◽  
Resistant Tuberculosis ◽  
Unsuccessful Treatment ◽  
Poor Treatment

Abstract Background Unsuccessful treatment outcomes among patients with drug resistant tuberculosis (DR-TB) are associated with poor treatment adherence due to high rates of adverse events (AEs). However, AEs are not systematically collected and managed under programmatic setting. The present study aims to assess the a) incidence and pattern of adverse events in first three months of DR-TB treatment; b) treatment seeking behaviour for AE management; and c) explore the challenges perceived by patients and healthcare providers in seeking treatment/reporting AEs. Methods This mixed methods study included all patients diagnosed and initiated on treatment during July-September 2018 at Ahmedabad DR-TB centre under RNTCP. The patients were interviewed telephonically and assessed for all AEs experienced by them during first three months of DR-TB treatment initiation. In-depth interviews and key-informant interviews were conducted among patients and DOTS supervisors, and programme staff (treatment supervisors, Medical Officer and District Program Manager). Results Total 207 AEs were reported by the 74 DR-TB patients who were interviewed. All patients experienced at least one AE during treatment. Incidence rate of AEs (experienced) was 3.11 (1 st month-4.6, 2 nd month-2.7, 3 rd month-2.02) per 100 person days of the 207 AEs, gastro-intestinal (59, 28.3%), ophthalmic (32, 15.4%) and otolaryngology (25, 11.9%) system related AEs were commonly experienced. Treatment was not sought in two-fifths of the AEs. Themes and subthemes related to challenges in treatment seeking or reporting of AEs were 1) Patient related-Misconceptions, accessibility and affordability of management, lack of counselling support, stigma and discrimination, past treatment experience; 2) Health system related- lack of guideline and training for AE management, poor coordination between hospital and tuberculosis centre.Conclusion The incidence of AEs was high among patients with DR-TB in the first three months of treatment and treatment seeking/reporting was low. Adequate health education and counselling of the patient should be done at initiation of treatment. An efficient real-time reporting and management of AE can be developed and tested for effective DR-TB control.

scholarly journals ”Side effects--part of the package”: A mixed methods approach to adverse events among patients being programmatically treated for DR-TB in Gujarat, India

2020 ◽  
Author(s):  
Arjunkumar Hardas Jakasania ◽  
Kalpita shringarpure ◽  
Dixit Kapadia ◽  
Radhika Sharma ◽  
Kedar Mehta ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Adverse Events ◽  
Medical Officer ◽  
Treatment Seeking ◽  
Tb Treatment ◽  
Program Manager ◽  
Resistant Tuberculosis ◽  
Initial Treatment Period ◽  
Unsuccessful Treatment ◽  
Depth Interviews

Abstract Background Unsuccessful treatment outcomes among patients with drug resistant tuberculosis (DR-TB) are due to high rates of adverse events (AEs). However, information related to AEs is not systematically collected and managed under programmatic setting. The present study assessed the a) incidence and pattern of adverse events in first three months of DR-TB treatment initiation; b) treatment seeking behaviour for AE management; and c) explore the challenges in seeking treatment and reporting AEs.Methods This mixed methods study included all patients diagnosed and initiated on treatment under RNTCP during July-September 2018 at Ahmedabad DR-TB centre. The patients were interviewed telephonically and assessed for all AEs experienced by them. In-depth interviews and key-informant interviews were conducted among patients, DOTS supervisors and programme staffs (treatment supervisors, medical officer and district program manager). Results Total 207 AEs were reported by the 74 DR-TB patients. All patients experienced at least one AE during initial treatment period. Incidence rate of AEs (experienced) was 3.11 (1st month-4.6, 2nd month-2.7, 3rd month-2.02) per 100 person days. Of the 207 AEs, gastro-intestinal (59, 28.3%), ophthalmic (32, 15.4%) and otolaryngology (25, 11.9%) system related AEs were commonly experienced. Treatment was not sought in two-fifths of the AEs. Themes and sub-themes related to challenges in treatment seeking or reporting of AEs were 1) Patient related-Misconceptions, accessibility and affordability of management, lack of counselling support, stigma and discrimination, and past treatment experience; 2) Health system related- lack of guidelines and training for AE management, 3) Poor coordination between hospital and tuberculosis centre. Conclusion The incidence of AEs was high among patients with DR-TB in the first three months of treatment and treatment seeking/reporting was low. Adequate health education and counselling of the patient and orientation of the health systems are the need of the hour. An efficient real-time reporting and management of AE can be developed and tested for effective DR-TB control.

scholarly journals “Side effects-part of the package” – A mixed methods approach to adverse events among patients with DR-TB under RNTCP Gujarat, India

2019 ◽  
Author(s):  
Arjunkumar Hardas Jakasania ◽  
Kalpita Shringarpure ◽  
Dixit Kapadia ◽  
Radhika Sharma ◽  
Kedar Mehta ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Adverse Events ◽  
Medical Officer ◽  
Treatment Seeking ◽  
Tb Treatment ◽  
Program Manager ◽  
Resistant Tuberculosis ◽  
Initial Treatment Period ◽  
Unsuccessful Treatment ◽  
Depth Interviews

Abstract Background: Unsuccessful treatment outcomes among patients with drug resistant tuberculosis (DR-TB) are due to high rates of adverse events (AEs). However, information related to AEs is not systematically collected and managed under programmatic setting. The present study assessed the a) incidence and pattern of adverse events in first three months of DR-TB treatment initiation; b) treatment seeking behaviour for AE management; and c) explore the challenges in seeking treatment and reporting AEs. Methods: This mixed methods study included all patients diagnosed and initiated on treatment under RNTCP during July-September 2018 at Ahmedabad DR-TB centre. The patients were interviewed telephonically and assessed for all AEs experienced by them. In-depth interviews and key-informant interviews were conducted among patients, DOTS supervisors and programme staffs (treatment supervisors, medical officer and district program manager). Results: A total 207 AEs were reported by the 74 DR-TB patients. All patients experienced at least one AE during initial treatment period. Incidence rate of AEs (experienced) was 3.11 (1st month-4.6, 2nd month-2.7, 3rd month-2.02) per 100 person days. Of the 207 AEs, gastro-intestinal (59, 28.3%), ophthalmic (32, 15.4%) and otolaryngology (25, 11.9%) system related AEs were commonly experienced. Treatment was not sought in two-fifths of the AEs. Themes and subthemes related to challenges in treatment seeking or reporting of AEs were 1) Patient related-Misconceptions, accessibility and affordability of management, lack of counselling support, stigma and discrimination, and past treatment experience; 2) Health system related- lack of guideline and training for AE management, and poor coordination between hospital and tuberculosis centre. Conclusion: The incidence of AEs was high among patients with DR-TB in the first three months of treatment and treatment seeking/reporting was low. Adequate health education and counselling of the patient and orientation of the health systems are the need of the hour. An efficient real-time reporting and management of AE can be developed and tested for effective DR-TB control.

scholarly journals “Side effects--part of the package”: A mixed methods approach to study adverse events among patients being programmatically treated for DR-TB in Gujarat, India

2020 ◽  
Author(s):  
Arjunkumar Hardas Jakasania ◽  
Kalpita shringarpure ◽  
Dixit Kapadia ◽  
Radhika Sharma ◽  
Kedar Mehta ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Adverse Events ◽  
Medical Officer ◽  
Treatment Seeking ◽  
Tb Treatment ◽  
Program Manager ◽  
Resistant Tuberculosis ◽  
Initial Treatment Period ◽  
Unsuccessful Treatment ◽  
Depth Interviews

Abstract Background High rates of Adverse Events (AEs) during treatment is one of the leading causes of unsuccessful treatment outcomes among patients with drug resistant tuberculosis (DR-TB). However, information related to AEs is not systematically collected and managed under programmatic setting. The present study assessed the a) incidence and pattern of adverse events in first three months of DR-TB treatment initiation; b) treatment seeking behaviour for AE management; and c) explore the challenges in seeking treatment and reporting AEs.Methods This mixed methods study included all patients diagnosed and initiated on treatment under RNTCP during July-September 2018 at Ahmedabad DR-TB centre. The patients were interviewed telephonically and assessed for all AEs experienced by them. In-depth interviews and key-informant interviews were conducted among patients, DOTS supervisors and programme staffs (treatment supervisors, medical officer and district program manager). Results Total 207 AEs were reported by the 74 DR-TB patients. All patients experienced at least one AE during initial treatment period. Incidence rate of AEs (experienced) was 3.11 (1st month-4.6, 2nd month-2.7, 3rd month-2.02) per 100 person days. Of the 207 AEs, gastro-intestinal (59, 28.3%), ophthalmic (32, 15.4%) and otolaryngology (25, 11.9%) system related AEs were commonly experienced. Treatment was not sought in two-fifths of the AEs. Themes and sub-themes related to challenges in treatment seeking or reporting of AEs were 1) Patient related-Misconceptions, accessibility and affordability of management, lack of counselling support, stigma and discrimination, and past treatment experience; 2) Health system related- lack of guidelines and training for AE management, 3) Poor coordination between hospital and tuberculosis centre. Conclusion The incidence of AEs was high among patients with DR-TB in the first three months of treatment and treatment seeking/reporting was low. Adequate health education and counselling of the patient and orientation of the health systems are the need of the hour. An efficient real-time reporting and management of AE should be developed and tested for effective DR-TB control.

scholarly journals “Side effects--part of the package”: A mixed methods approach to study adverse events among patients being programmatically treated for DR-TB in Gujarat, India

2020 ◽  
Author(s):  
Arjunkumar Hardas Jakasania ◽  
Kalpita shringarpure ◽  
Dixit Kapadia ◽  
Radhika Sharma ◽  
Kedar Mehta ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Adverse Events ◽  
Medical Officer ◽  
Treatment Seeking ◽  
Tb Treatment ◽  
Program Manager ◽  
Resistant Tuberculosis ◽  
Initial Treatment Period ◽  
Unsuccessful Treatment ◽  
Depth Interviews

Abstract BackgroundHigh rates of Adverse Events (AEs) during treatment is one of the leading causes of unsuccessful treatment outcomes among patients with drug resistant tuberculosis (DR-TB). However, information related to AEs is not systematically collected and managed under programmatic setting. The present study assessed the a) incidence and pattern of adverse events in first three months of DR-TB treatment initiation; b) treatment seeking behaviour for AE management; and c) explore the challenges in seeking treatment and reporting AEs.MethodsThis mixed methods study included all patients diagnosed and initiated on treatment under RNTCP during July-September 2018 at Ahmedabad DR-TB centre. The patients were interviewed telephonically and assessed for all AEs experienced by them. In-depth interviews and key-informant interviews were conducted among patients, DOTS supervisors and programme staffs (treatment supervisors, medical officer and district program manager). Results: Total 207 AEs were reported by the 74 DR-TB patients. All patients experienced at least one AE during initial treatment period. Incidence rate of AEs (experienced) was 3.11 (1st month-4.6, 2nd month-2.7, 3rd month-2.02) per 100 person days. Of the 207 AEs, gastro-intestinal (59, 28.3%), ophthalmic (32, 15.4%) and otolaryngology (25, 11.9%) system related AEs were commonly experienced. Treatment was not sought in two-fifths of the AEs. Themes and sub-themes related to challenges in treatment seeking or reporting of AEs were 1) Patient related-Misconceptions, accessibility and affordability of management, lack of counselling support, stigma and discrimination, and past treatment experience; 2) Health system related- lack of guidelines and training for AE management, 3) Poor coordination between hospital and tuberculosis centre. Conclusion: The incidence of AEs was high among patients with DR-TB in the first three months of treatment and treatment seeking/reporting was low. Adequate health education and counselling of the patient and orientation of the health systems are the need of the hour. An efficient real-time reporting and management of AE should be developed and tested for effective DR-TB control.

scholarly journals “Side effects-part of the package” – A mixed methods approach to adverse events among patients with DR-TB under RNTCP Gujarat, India

2019 ◽  
Author(s):  
Arjunkumar Hardas Jakasania ◽  
Kalpita Shringarpure ◽  
Dixit Kapadia ◽  
Radhika Sharma ◽  
Kedar Mehta ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Adverse Events ◽  
Medical Officer ◽  
Treatment Seeking ◽  
Drug Resistant ◽  
Drug Resistant Tuberculosis ◽  
Program Manager ◽  
Resistant Tuberculosis ◽  
Initial Treatment Period ◽  
Unsuccessful Treatment

Abstract Background: Unsuccessful treatment outcomes among patients with drug resistant tuberculosis (DR-TB) are due to high rates of adverse events (AEs). However, information related to AEs is not systematically collected and managed under programmatic setting. The present study assessed the a) incidence and pattern of adverse events in first three months of DR-TB treatment initiation; b) treatment seeking behaviour for AE management; and c) explore the challenges in seeking treatment and reporting AEs. Methods: This mixed methods study included all patients diagnosed and initiated on treatment under RNTCP during July-September 2018 at Ahmedabad DR-TB centre. The patients were interviewed telephonically and assessed for all AEs experienced by them. In-depth interviews and key-informant interviews were conducted among patients, DOTS supervisors and programme staffs (treatment supervisors, medical officer and district program manager). Results: A total 207 AEs were reported by the 74 DR-TB patients. All patients experienced at least one AE during initial treatment period. Incidence rate of AEs (experienced) was 3.11 (1st month-4.6, 2nd month-2.7, 3rd month-2.02) per 100 person days. Of the 207 AEs, gastro-intestinal (59, 28.3%), ophthalmic (32, 15.4%) and otolaryngology (25, 11.9%) system related AEs were commonly experienced. Treatment was not sought in two-fifths of the AEs. Themes and subthemes related to challenges in treatment seeking or reporting of AEs were 1) Patient related-Misconceptions, accessibility and affordability of management, lack of counselling support, stigma and discrimination, and past treatment experience; 2) Health system related- lack of guideline and training for AE management, and poor coordination between hospital and tuberculosis centre. Conclusion: The incidence of AEs was high among patients with DR-TB in the first three months of treatment and treatment seeking/reporting was low. Adequate health education and counselling of the patient and orientation of the health systems are the need of the hour. An efficient real-time reporting and management of AE can be developed and tested for effective DR-TB control. Keywords: Adverse event, Drug resistant tuberculosis, Operational research, Incidence, India, Treatment seeking.

scholarly journals “Side effects--part of the package”: a mixed methods approach to study adverse events among patients being programmatically treated for DR-TB in Gujarat, India

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Arjunkumar Jakasania ◽  
Kalpita Shringarpure ◽  
Dixit Kapadia ◽  
Radhika Sharma ◽  
Kedar Mehta ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Adverse Events ◽  
Medical Officer ◽  
Treatment Seeking ◽  
Tb Treatment ◽  
Resistant Tuberculosis ◽  
Initial Treatment Period ◽  
Unsuccessful Treatment ◽  
Depth Interviews ◽  
Experienced Treatment

Abstract Background High rates of Adverse Events (AEs) during treatment is one of the leading causes of unsuccessful treatment outcomes among patients with drug resistant tuberculosis (DR-TB). However, information related to AEs is not systematically collected and managed under programmatic setting. The present study assessed the a) incidence and pattern of adverse events in first three months of DR-TB treatment initiation; b) treatment seeking behaviour for AE management; and c) explore the challenges in seeking treatment and reporting AEs. Methods This mixed methods study included all patients diagnosed and initiated on treatment under RNTCP during July–September 2018 at Ahmedabad DR-TB centre. The patients were interviewed telephonically and assessed for all AEs experienced by them. In-depth interviews and key-informant interviews were conducted among patients, DOTS supervisors and programme staff (treatment supervisors, medical officer and district program managers). Results Total 207 AEs were reported by the 74 DR-TB patients. All patients experienced at least one AE during initial treatment period. Incidence rate of AEs (experienced) was 3.11 (1st month-4.6, 2nd month-2.7, 3rd month-2.02) per 100 person days. Of the 207 AEs, gastro-intestinal (59, 28.3%), ophthalmic (32, 15.4%) and otolaryngology (25, 11.9%) system related AEs were commonly experienced. Treatment was not sought in two-fifths of the AEs. Themes and sub-themes related to challenges in treatment seeking or reporting of AEs were 1) Patient related-Misconceptions, accessibility and affordability of management, lack of counselling support, stigma and discrimination, and past treatment experience; 2) Health system related- lack of guidelines and training for AE management, 3) Poor coordination between hospital and tuberculosis centre. Conclusion The incidence of AEs was high among patients with DR-TB in the first three months of treatment and treatment seeking/reporting was low. Adequate health education and counselling of the patient and orientation of the health systems is the need of the hour. An efficient real-time reporting and management of AE should be developed and tested for effective DR-TB control.

Multidrug-resistant tuberculosis in the Kharkiv Region, Ukraine

2020 ◽  
Vol 24 (5) ◽  
pp. 485-491
Author(s):  
D. Butov ◽  
C. Lange ◽  
J. Heyckendorf ◽  
I. Kalmykova ◽  
T. Butova ◽  
...  
Keyword(s):  
Treatment Outcomes ◽  
Drug Susceptibility ◽  
Multidrug Resistant ◽  
Drug Susceptibility Testing ◽  
Tb Treatment ◽  
Resistant Tuberculosis ◽  
Poor Treatment ◽  
Mdr Tb ◽  
Observational Cohort

OBJECTIVE: To document the level of drug resistance in MDR-TB patients and to characterize management capacities for their medical care and MDR-TB treatment outcomes in the Kharkiv region of Ukraine. This area has one of the highest frequencies of MDR-TB worldwide.METHODS: A retrospective observational cohort study was performed on registry data from the regional anti-TB dispensary in Kharkiv. All microbiologically confirmed MDR-TB patients registered in 2014 were included. Diagnostic, treatment and post-treatment follow-up data were analysed.RESULTS: Of 169 patients with MDR-TB, 55.0% had pre-extensively drug-resistant (pre-XDR) or XDR resistant patterns. Rapid molecular diagnosis by GeneXpert and liquid M. tuberculosis cultures were only available for 66.9% and 56.8% of patients, respectively. Phenotypic drug-susceptibility testing (DST) for high priority TB drugs (bedaquiline, linezolid, clofazimine) were not available. DST for later generation fluroquinolones was available only in 53.2% of patients. 50.9% of patients had less than 4 drugs in the treatment regimen proven to be effective by DST. More than 23.1% of patients with MDR-TB failed their treatment and only 45.0% achieved a cure.CONCLUSION: The high prevalence of MDR-TB and poor MDR-TB treatment outcomes in the Kharkiv region, is associated with substantial shortages in rapid molecular and phenotypic DST, a lack of high priority MDR-TB drugs, poor treatment monitoring and follow-up capacities.

scholarly journals Increasing multidrug-resistant tuberculosis in Ho Chi Minh City: a retrospective study of 2,266 cases from 2011 to 2015

2019 ◽  
Author(s):  
Le Hong Van ◽  
Phan Trieu Phu ◽  
Dao Nguyen Vinh ◽  
Vo Thanh Son ◽  
Nguyen Thi Hanh ◽  
...  
Keyword(s):  
Risk Factors ◽  
Treatment Outcome ◽  
Multidrug Resistant ◽  
Tb Treatment ◽  
Resistant Tuberculosis ◽  
Multidrug Resistant Tuberculosis ◽  
Poor Treatment ◽  
Mdr Tb ◽  
Poor Outcomes ◽  
Poor Treatment Outcome

Abstract Background: Multidrug resistant tuberculosis (MDR-TB) remains a serious public health problem with poor treatment outcome. Predictors of poor outcomes vary in different regions. Vietnam is among the 30 countries with high burden of MDR-TB. We aim to describe demographic characteristics and identify risk factors for poor outcome of MDR-TB in Ho Chi Minh City (HCMC), the most populous city in Vietnam. Methods: This retrospective study included 2,266 patients who initiated MDR-TB treatment from 2011 to 2015 in HCMC. Treatment outcomes were available in 2,240 patients. Data was collected from standardized paper-based treatment cards and electronic records. Kruskal Wallis test was used to diagnose the change of median of age and body mass index (BMI) over 5 years, and Wilcoxon test to compare median BMI of patients with and without diabetes mellitus. Chi squared test was used to compare categorical variables. Multivariate logistic regression on multiple imputation was used to identify risk factors for poor outcomes. Statistical analysis was performed using R program. Results: Among 2,266 eligible cases, 60.2% were failure of category I or II regimen, 57.7% were underweight, 30.2% had diabetes mellitus and 9.6% were HIV positive. Notification rate increased 24.7% from 2011 to 2015.Treatment success rate was 73.3%. Risk factors for poor treatment outcome included HIV co-infection (adjusted odds ratio (aOR): 2.94), advanced age (aOR: 1.45 for every increase of 5 years for patients 60 years or older), having history of MDR-TB treatment (aOR: 5.53), sputum smear grade scanty and 1+ (aOR: 1.47), smear grade 2+ or 3+ (aOR: 2.06), low BMI (aOR: 0.83 for every increase of 1kg/m2 of BMI for patients with BMI<21). Conclusion: Our study describes the increasing cases of MDR-TB in HCMC during 2011 to 2015. Patients with HIV, high smear grade, malnutrition and history of previous MDR-TB treatment should receive additional care. Keywords: multidrug resistant tuberculosis; retrospective; treatment outcome; risk factors; Vietnam

scholarly journals Risk factors for poor treatment outcomes of 2,266 multidrug-resistant tuberculosis cases in Ho Chi Minh City: a retrospective study

2020 ◽  
Author(s):  
Le Hong Van ◽  
Phan Trieu Phu ◽  
Dao Nguyen Vinh ◽  
Vo Thanh Son ◽  
Nguyen Thi Hanh ◽  
...  
Keyword(s):  
Risk Factors ◽  
Treatment Outcomes ◽  
Multidrug Resistant ◽  
Tb Treatment ◽  
Resistant Tuberculosis ◽  
Poor Treatment ◽  
Mdr Tb ◽  
History Of ◽  
Poor Outcomes ◽  
Poor Treatment Outcome

Abstract Background: Multidrug resistant tuberculosis (MDR-TB) remains a serious public health problem with poor treatment outcomes. Predictors of poor outcomes vary in different regions. Vietnam is among the top 30 high burden of MDR-TB countries. We describe demographic characteristics and identify risk factors for poor outcome among patients with MDR-TB in Ho Chi Minh City (HCMC), the most populous city in Vietnam.Methods: This retrospective study included 2,266 patients who initiated MDR-TB treatment between 2011-2015 in HCMC. Treatment outcomes were available for 2,240 patients. Data was collected from standardized paper-based treatment cards and electronic records. A Kruskal Wallis test was used to assess changes in median age and body mass index (BMI) over time, and a Wilcoxon test was used to compare the median BMI of patients with and without diabetes mellitus. Chi squared test was used to compare categorical variables. Multivariate logistic regression with multiple imputation for missing data was used to identify risk factors for poor outcomes. Statistical analysis was performed using R program.Results: Among 2,266 eligible cases, 60.2% had failed on a category I or II treatment regimen, 57.7% were underweight, 30.2% had diabetes mellitus and 9.6% were HIV positive. The notification rate increased 24.7% from 2011-2015. The treatment success rate was 73.3%. Risk factors for poor treatment outcome included HIV co-infection (adjusted odds ratio (aOR): 2.94), advanced age (aOR: 1.45 for every increase of 5 years for patients 60 years or older), having history of MDR-TB treatment (aOR: 5.53), sputum smear grade scanty or 1+ (aOR: 1.47), smear grade 2+ or 3+ (aOR: 2.06), low BMI (aOR: 0.83 for every increase of 1kg/m2 of BMI for patients with BMI<21).Conclusion: The number of patients diagnosed with MDR-TB in HCMC increased by almost a quarter between 2011-2015. Patients with HIV, high smear grade, malnutrition or a history of previous MDR-TB treatment are at greatest risk of poor treatment outcome.

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

PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0255357
Author(s):  
Nguyen Bao Ngoc ◽  
Hoa Vu Dinh ◽  
Nguyen Thi Thuy ◽  
Duong Van Quang ◽  
Cao Thi Thu Huyen ◽  
...  
Keyword(s):  
Risk Factors ◽  
Adverse Events ◽  
Bayesian Model Averaging ◽  
Multidrug Resistant ◽  
Treatment Regimens ◽  
Tb Treatment ◽  
Resistant Tuberculosis ◽  
Multidrug Resistant Tuberculosis ◽  
Mdr Tb

Objective 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. Method 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. Results 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]). Conclusion 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.

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