Correlates of Treatment Outcomes and Drug Resistance among Pulmonary Tuberculosis Patients Attending Tertiary Care Hospitals of Kolkata, India

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Abstract

Background

Worldwide highest number of new pulmonary tuberculosis (PTB) cases, was reported from India in 2012. Adverse treatment outcomes and emergence of drug resistance further complicated the prevailing scenario owing to increased duration, cost and toxicity associated with the treatment of drug-resistant cases. Hence to reinforce India’s fight against TB, identification of the correlates of adverse treatment outcomes and drug resistance, seemed critical.

Methods

To estimate the associations between diagnostic findings, patient types (based on treatment outcomes), drug resistance and socio-demographic characteristics of PTB patients, a cross-sectional study was conducted in two tertiary-care hospitals in Kolkata between April 2010 and March 2013. Altogether, 350 consenting Mycobacterium tuberculosis sputum-culture positive PTB patients were interviewed about their socio-demographic background, evaluated regarding their X-ray findings (minimal/moderately advanced/far advanced/cavities), sputum-smear positivity, and treatment history/outcomes (new/defaulter/relapse/treatment-failure cases). Multiple-allele-specific polymerase chain reaction (MAS-PCR) was conducted to diagnose drug resistance.

Results

Among all participants, 31.43% were newly diagnosed, while 44%, 15.43% and 9.14% patients fell into the categories of relapsed, defaulters and treatment-failures, respectively. 12.29% were multi-drug-resistant (MDR: resistant to at least isoniazid and rifampicin), 57.71% had non-MDR two-drug resistance and 12% had single-drug resistance. Subjects with higher BMI had lower odds of being a relapse/defaulter/treatment failure case while females were more likely to be defaulters and older age-groups had more relapse. Elderly, females, unmarried, those with low BMI and higher grade of sputum-smear positivity were more likely to have advanced X-ray features. Higher grade of sputum-smear positivity and advanced chest X-ray findings were associated with relapse/treatment-failures. Elderly, unmarried, relapse/defaulter/treatment-failure cases had higher odds and those with higher BMI and moderately/far advanced X-ray findings had lower odds of having MDR/non-MDR two-drug resistant PTB.

Conclusion

Targeted intervention and appropriate counseling are needed urgently to prevent adverse treatment outcomes and development of drug resistance among PTB patients in Kolkata.

Related collections

Most cited references 20

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Risk factors for multidrug resistant tuberculosis in Europe: a systematic review.

A Faustini, A J Hall, C A Perucci (2006)

The resurgence of tuberculosis (TB) in western countries has been attributed to the HIV epidemic, immigration, and drug resistance. Multidrug resistant tuberculosis (MDR-TB) is caused by the transmission of multidrug resistant Mycobacterium tuberculosis strains in new cases, or by the selection of single drug resistant strains induced by previous treatment. The aim of this report is to determine risk factors for MDR-TB in Europe. A systematic review was conducted of published reports of risk factors associated with MDR-TB in Europe. Meta-analysis, meta-regression, and sub-grouping were used to pool risk estimates of MDR-TB and to analyse associations with age, sex, immigrant status, HIV status, occurrence year, study design, and area of Europe. Twenty nine papers were eligible for the review from 123 identified in the search. The pooled risk of MDR-TB was 10.23 times higher in previously treated than in never treated cases, with wide heterogeneity between studies. Study design and geographical area were associated with MDR-TB risk estimates in previously treated patients; the risk estimates were higher in cohort studies carried out in western Europe (RR 12.63; 95% CI 8.20 to 19.45) than in eastern Europe (RR 8.53; 95% CI 6.57 to 11.06). National estimates were possible for six countries. MDR-TB cases were more likely to be foreign born (odds ratio (OR) 2.46; 95% CI 1.86 to 3.24), younger than 65 years (OR 2.53; 95% CI 1.74 to 4.83), male (OR 1.38; 95% CI 1.16 to 1.65), and HIV positive (OR 3.52; 95% CI 2.48 to 5.01). Previous treatment was the strongest determinant of MDR-TB in Europe. Detailed study of the reasons for inadequate treatment could improve control strategies. The risk of MDR-TB in foreign born people needs to be re-evaluated, taking into account any previous treatment.

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Risk factors associated with default, failure and death among tuberculosis patients treated in a DOTS programme in Tiruvallur District, South India, 2000.

T. Santha, R Garg, T R Frieden … (2002)

To identify risk factors associated with default, failure and death among tuberculosis patients treated in a newly implemented DOTS programme in South India. Analysis of all patients registered from May 1999 through April 2000. A community survey for active tuberculosis was underway in the area; patients identified in the community survey were also treated in this programme. In all, 676 patients were registered during the period of the study. Among new smear-positive patients (n = 295), 74% were cured, 17% defaulted, 5% died and 4% failed treatment. In multivariate analysis (n = 676), higher default rates were associated with irregular treatment (adjusted odds ratio [AOR] 4.3; 95%CI 2.5-7.4), being male (AOR 3.4; 95%CI 1.5-8.2), history of previous treatment (AOR 2.8; 95%CI 1.6-4.9), alcoholism (AOR 2.2; 95%CI 1.3-3.6), and diagnosis by community survey (AOR 2.1; 95%CI 1.2-3.6). Patients with multidrug-resistant tuberculosis (MDR-TB) were more likely to fail treatment (33% vs. 3%; P < 0.001). More than half of the patients receiving Category II treatment who remained sputum-positive after 3 or 4 months of treatment had MDR-TB, and a large proportion of these patients failed treatment. Higher death rates were independently associated with weight <35 kg (AOR 3.8; 95%CI 1.9-7.8) and history of previous treatment (AOR 3.3; 95%CI 1.5-7.0). During this first year of DOTS implementation with sub-optimal performance, high rates of default and death were responsible for low cure rates. Male patients and those with alcoholism were at increased risk of default, as were patients identified by community survey. To prevent default, directly observed treatment should be made more convenient for patients. To reduce mortality, the possible role of nutritional interventions should be explored among underweight patients.

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Risk factors for tuberculosis treatment failure, default, or relapse and outcomes of retreatment in Morocco

Kelly E. Dooley, Ouafae Lahlou, Iraqi Ghali … (2011)

Background Patients with tuberculosis require retreatment if they fail or default from initial treatment or if they relapse following initial treatment success. Outcomes among patients receiving a standard World Health Organization Category II retreatment regimen are suboptimal, resulting in increased risk of morbidity, drug resistance, and transmission.. In this study, we evaluated the risk factors for initial treatment failure, default, or early relapse leading to the need for tuberculosis retreatment in Morocco. We also assessed retreatment outcomes and drug susceptibility testing use for retreatment patients in urban centers in Morocco, where tuberculosis incidence is stubbornly high. Methods Patients with smear- or culture-positive pulmonary tuberculosis presenting for retreatment were identified using clinic registries in nine urban public clinics in Morocco. Demographic and outcomes data were collected from clinical charts and reference laboratories. To identify factors that had put these individuals at risk for failure, default, or early relapse in the first place, initial treatment records were also abstracted (if retreatment began within two years of initial treatment), and patient characteristics were compared with controls who successfully completed initial treatment without early relapse. Results 291 patients presenting for retreatment were included; 93% received a standard Category II regimen. Retreatment was successful in 74% of relapse patients, 48% of failure patients, and 41% of default patients. 25% of retreatment patients defaulted, higher than previous estimates. Retreatment failure was most common among patients who had failed initial treatment (24%), and default from retreatment was most frequent among patients with initial treatment default (57%). Drug susceptibility testing was performed in only 10% of retreatment patients. Independent risk factors for failure, default, or early relapse after initial treatment included male gender (aOR = 2.29, 95% CI 1.10-4.77), positive sputum smear after 3 months of treatment (OR 7.14, 95% CI 4.04-13.2), and hospitalization (OR 2.09, 95% CI 1.01-4.34). Higher weight at treatment initiation was protective. Male sex, substance use, missed doses, and hospitalization appeared to be risk factors for default, but subgroup analyses were limited by small numbers. Conclusions Outcomes of retreatment with a Category II regimen are suboptimal and vary by subgroup. Default among patients receiving tuberculosis retreatment is unacceptably high in urban areas in Morocco, and patients who fail initial tuberculosis treatment are at especially high risk of retreatment failure. Strategies to address risk factors for initial treatment default and to identify patients at risk for failure (including expanded use of drug susceptibility testing) are important given suboptimal retreatment outcomes in these groups.

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Author and article information

Contributors

Daniela Flavia Hozbor: Role: Editor

Journal

Journal ID (nlm-ta): PLoS One

Journal ID (iso-abbrev): PLoS ONE

Journal ID (publisher-id): plos

Journal ID (pmc): plosone

Title: PLoS ONE

Publisher: Public Library of Science (San Francisco, USA )

ISSN (Electronic): 1932-6203

Publication date Collection: 2014

Publication date (Electronic): 7 October 2014

Volume: 9

Issue: 10

Electronic Location Identifier: e109563

Affiliations

[1 ]Institute of Postgraduate Medical Education & Research, Kolkata, India

[2 ]Jonathan and Karin Fielding School of Public Health, University of California Los Angeles, Los Angeles, California, United States of America

[3 ]Burdwan Medical College & Hospital, Burdwan, India

[4 ]Bose Institute, Kolkata, India

[5 ]Calcutta National Medical College, Kolkata, India

[6 ]SSKM Hospital, Kolkata, India

Universidad Nacional de La Plata, Argentina

Author notes

* E-mail: nishithkpal53@ 123456gmail.com

Competing Interests: The authors have declared that no competing interests exist.

Conceived and designed the experiments: AG UC TJM SR SKD NKP. Performed the experiments: AG UC TJM BB SD. Analyzed the data: AG UC TM SM. Contributed reagents/materials/analysis tools: TM SM SR SKD NKP. Wrote the manuscript: AG UC TM SM AD BB NKP. Thorough copy-editing of the manuscript for language usage, spelling, and grammar: AD.

Article

Publisher ID: PONE-D-14-15376

DOI: 10.1371/journal.pone.0109563

PMC ID: 4188738

PubMed ID: 25289974

SO-VID: c18a28cc-23ae-4b53-8e6b-a9896c1ea215

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

History

Date received : 20 April 2014

Date accepted : 2 September 2014

Page count

Pages: 12

Funding

This study was supported by The Institute of Postgraduate Medical Education and Research, Kolkata, India by allowing the authors to use the existing infrastructure of the institute ( http://www.ipgmer.gov.in/). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Custom metadata

Data Availability The authors confirm that, for approved reasons, some access restrictions apply to the data underlying the findings. The data used for the article is freely available upon written request to the corresponding author. It is not uploaded in any public repository because, in a country like India, where Tuberculosis is still a disease associated with considerable amount of social stigma and fear, any possible linkage with the patients resulting from the individual identification numbers used in the dataset, may lead to social discrimination of the patients, especially for the resistant and defaulter cases. Hence this data has not been kept in any public repository. Instead it is confidentially preserved under the supervision of Institutional Ethics Committee of the Institute of Post-Graduate Medical Education and Research (IPGMER), Kolkata, India and anybody can obtain the data freely by communicating with the corresponding author using the contact information below. Prof. (Dr) Nishith Kumar Pal (Corresponding author) Institute of Postgraduate Medical Education & Research 244 B, A.J.C. Bose Road, Kolkata 700020, India Ph: +91-9433559514 Email: nishithkpal53@ 123456gmail.com