Abstract

Vietnam has been using a levofloxacin-based shorter treatment regimen (STR) for rifampicin resistant/multidrug-resistant tuberculosis (RR/MDR-TB) patients since 2016 on a pilot basis. This regimen lasts for 9–11 months and is provided to RR/MDR-TB patients without second-line drug resistance. We report the treatment outcomes and factors associated with unsuccessful outcomes. We conducted a cohort study involving secondary analysis of data extracted from electronic patient records maintained by the national TB program (NTP). Of the 302 patients enrolled from April 2016 to June 2018, 259 (85.8%) patients were successfully treated (246 cured and 13 ‘treatment completed’). Unsuccessful outcomes included: treatment failure (16, 5.3%), loss to follow-up (14, 4.6%) and death (13, 4.3%). HIV-positive TB patients, those aged ≥65 years and patients culture-positive at baseline had a higher risk of unsuccessful outcomes. In a sub-group of patients enrolled in 2016 (n = 99) and assessed at 12 months after treatment completion, no cases of relapse were identified. These findings vindicate the decision of the Vietnam NTP to use a levofloxacin-based STR in RR/MDR-TB patients without second-line drug resistance. This regimen may be considered for nationwide scale-up after a detailed assessment of adverse drug events.

Highlights

  • Multidrug-resistant tuberculosis (MDR-TB), defined as TB resistant to both isoniazid and rifampicin, is a global public health challenge

  • Owing to a large body of evidence accumulated over the past few years, WHO recommends use of standardized shorter treatment regimen (STR) for patients with MDR-TB [9,10,11,12,13,14,15]

  • None of the patients tested had TB. This is the first study from Vietnam providing information on treatment outcomes of a levofloxacin-based STR among RR/MDR-TB patients managed under routine program settings

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Summary

Introduction

Multidrug-resistant tuberculosis (MDR-TB), defined as TB resistant to both isoniazid and rifampicin, is a global public health challenge. In 2018, an estimated 484,000 people developed TB that was resistant to rifampicin (RR-TB), and of these, 78% had MDR-TB [1]. Only 32% of estimated RR/MDR-TB patients were treated in 2018, and only 56% of them were successfully treated [1], mostly because of challenges related to the long duration of the treatment and toxic drugs. There has been great progress in the development and availability of new diagnostic tools, new drugs and new treatment regimens for MDR-TB. Owing to a large body of evidence accumulated over the past few years, WHO recommends use of standardized shorter treatment regimen (STR) for patients with MDR-TB (in whom SLD resistance has been excluded) [9,10,11,12,13,14,15]

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