Approval Sheet Risk Factors for Poor Treatment Outcomes among Patients with Multi-Drug Resistant and Extensively Drug-Resistant (M/XDR) Tuberculosis in the Country of Georgia. Público

Abstract

Introduction: Resistance of M. tuberculosis to anti-tuberculosis drugs has become a
major public health problem in many countries, including Georgia. In 2008, Georgian
National Tuberculosis Program introduced treatment with second line anti-tuberculosis
drugs, which has allowed for treatment of multidrug or extensively drug-resistant
tuberculosis (M/XDR)-TB. The study objectives were to assess treatment outcomes
among the 1st cohort of patients with pulmonary M/XDR-TB and to determine risk factors
for poor treatment outcomes: defined as death, failure and default.
Methods: A prospective observational cohort study was performed. All patients with
M/XDR pulmonary TB who initiated treatment in 2008 were enrolled and followed until
2010. Descriptive statistics were used to determine associations between study
covariates. Binary logistic regression analysis was utilized to determine independent
association of prior treatment history with treatment outcome while controlling for
potential confounding variables.
Results: 380 patients were included: male (71%); mean age 38 years; median age 38.4
years. 13% had XDR-TB. 1.3% had HIV co-infection. Body Mass Index (BMI) was <18.5
among 24% of the cohort, and 52% had bilateral lesions on chest X-ray. Surgery was
performed in 10% (37) of cases. The treatment outcomes were as follows: 47% had a
poor outcome (death among 59 patients [15%], failure among 37 [10%], and 83 [22%] -
defaulted). In the final multivariable analysis, history of previous treatment (OR=2.8 95%
CI 1.2 - 6.3) was significantly associated with poor treatment after controlling for risk
factors. Other independent variables associated with poor treatment outcomes included
absence of adjunctive surgical therapy (OR 3.7, 95%CI 1.5, 8.7), no sputum culture
conversion to negative by 4 months (OR 3.0, 95%CI 1.9, 5.0), the presence of XDR-TB
(OR 2.3, 95% CI 1.2, 2.4), BMI < 18.5 (OR 2.0, 95%CI 1.1, 3.4) and bilateral lesions on
chest radiograph (OR 1.8, 95%CI 1.2, 2.9).
Conclusions: Overall, 47% of patients with M/XDR-TB had poor treatment outcome. In
multivariable analysis, independent risk factors for a poor treatment outcome included
prior TB treatment history, lack of adjunctive surgical intervention, no culture conversion
by month 4, XDR-TB, low BMI (<18.5) and bilateral lesions on chest X-ray.

Table of Contents

TABLE OF CONTENTS
INTRODUCTION ............................................................................................................ 1
BACKGROUND ............................................................................................................. 3
METHODS...................................................................................................................... 6
RESULTS..................................................................................................................... 15
DISCUSION.................................................................................................................. 18
CONCLUSION.............................................................................................................. 22
REFERENCES ............................................................................................................. 23
TABLES ....................................................................................................................... 25
APPENDIX ................................................................................................................... 29

About this Master's Thesis

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School	Laney Graduate School
Department	Clinical Research Curriculum Program
Degree	MS
Submission	Master's Thesis
Language	English
Research Field	Health Sciences, Epidemiology
Palabra Clave	risk factors outcome tuberculosis
Committee Chair / Thesis Advisor	Blumberg, Henry Michael, Emory University
Committee Members	Boring, John R, Emory University Ziegler, Thomas R, Emory University

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