Abstract

BackgroundIndia has the world’s highest tuberculosis burden, and Mumbai is particularly affected by multidrug resistant tuberculosis (MDR-TB). WHO recommends short, intensive treatment (“Short Course”) for previously untreated pulmonary MDR-TB patients but does not require universal drug susceptibility testing (DST) before Short Course. DST would likely screen out many MDR-TB patients in places like Mumbai with significant drug resistance.MethodsMDR-TB patients at a private clinic were recruited for a prospective observational cohort. Short Course eligibility was evaluated by clinical criteria and DST results. Eligibility by DST was classified as rifampin monoresistance (as tested by Xpert MTB/RIF), rifampin, fluoroquinolones, and 2nd-line injectable drugs resistance (as tested by line probe assays) and resistance to other drugs.ResultsOf 559 participants with MDR-TB, 33% met clinical eligibility for Short Course. DST for rifampin, fluoroquinolones, and 2nd-line injectable drugs excluded 74.7% of participants. Complete phenotypic DST excluded 96.6% of participants. Prior treatment with either 1st or 2nd-line drugs did not significantly affect eligibility.ConclusionsIn a global MDR-TB hotspot, < 5% of participants with MDR-TB were appropriate for Short Course by clinical characteristics and DST results. Rapid molecular testing would not sufficiently identify drug resistance in this population. Eligibility rates were not significantly reduced by prior TB treatment.

Highlights

  • India has the world’s highest tuberculosis burden, and Mumbai is affected by multidrug resistant tuberculosis (MDR-TB)

  • MDR-TB in Mumbai is known to have complex resistance profiles including high rates of fluoroquinolone resistance and totally drug resistant tuberculosis (TDR-TB). [10,11,12] In order identify the proportion of such patients who are eligible for Short A short (Course) therapy by clinical and drug susceptibility testing (DST) criteria, we reviewed clinical and laboratory data from an MDR-TB cohort in Mumbai

  • [32] this study confirms that the Short Course regimen would rely on drugs to which 96.8% of MDR-TB patients in our clinic are resistant. Though it may benefit the minority of participants for whom DST confirms susceptibility to component drugs, the Short Course regimen appears to be a suboptimal choice for empiric therapy in our setting

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Summary

Introduction

India has the world’s highest tuberculosis burden, and Mumbai is affected by multidrug resistant tuberculosis (MDR-TB). WHO recommends short, intensive treatment (“Short Course”) for previously untreated pulmonary MDR-TB patients but does not require universal drug susceptibility testing (DST) before Short Course. [4] To improve treatment success, WHO has recommended that MDR-TB patients be considered for a short, intensive treatment regimen (“Short Course”) if they have pulmonary disease, < 1 month of MDR-TB treatment, are not pregnant, and are unlikely to have additional drug resistance. Rates are presented using the number of participants with complete data available in the denominator

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