title: Possible impact of the standardized Category IV regimen on multidrug-resistant tuberculosis patients in Mumbai.
abstract: BACKGROUND
  Treatment of multidrug-resistant tuberculosis (MDR-TB) in the Programmatic Management of Drug-resistant TB program involves a standard regimen with a 6-month intensive phase and an 18-month continuation phase. However, the local drug resistance patterns in high MDR regions such as Mumbai may not be adequately reflected in the design of the regimen for that particular area.
  
  
  METHODS
  The study was carried out at a private Tertiary Level Hospital in Mumbai in a mycobacteriology laboratory equipped to perform the second-line drug susceptibility testing (DST).
  
  
  OBJECTIVE
  We attempted to analyze the impact of prescribing the standardized Category IV regimen to all patients receiving a DST at our mycobacteriology laboratory.
  
  
  METHODS
  All samples confirmed to be MDR-TB and tested for the second-line drugs at Hinduja Hospital's Mycobacteriology Laboratory in the year 2012 were analyzed.
  
  
  RESULTS
  A total of 1539 samples were analyzed. Of these, 464 (30.14%) were MDR-TB, 867 (56.33%) were MDR with fluoroquinolone resistance, and 198 (12.8%) were extensively drug-resistant TB. The average number of susceptible drugs per sample was 3.07 ± 1.29 (assuming 100% cycloserine susceptibility). Taking 4 effective drugs to be the cut or an effective regimen, the number of patients receiving 4 or more effective drugs from the standardized directly observed treatment, short-course plus regimen would be 516 (33.5%) while 66.5% of cases would receive 3 or less effective drugs.
  
  
  CONCLUSIONS
  Our study shows that a high proportion of patients will have resistance to a number of the first- and second-line drugs. Local epidemiology must be factored in to avoid amplification of resistance.
authors.affiliation: Department of Respiratory Medicine, P.D. Hinduja National Hospital and MRC, Mumbai, Maharashtra, India.
authors.forename: Zarir F
authors.initials: ZF
authors.lastname: Udwadia
authors.affiliation: Department of Respiratory Medicine, P.D. Hinduja National Hospital and MRC, Mumbai, Maharashtra, India.
authors.forename: Jai Bharat
authors.initials: JB
authors.lastname: Mullerpattan
authors.affiliation: Department of Respiratory Medicine, P.D. Hinduja National Hospital and MRC, Mumbai, Maharashtra, India.
authors.forename: Kushal D
authors.initials: KD
authors.lastname: Shah
authors.affiliation: Department of Microbiology, P.D. Hinduja National Hospital and MRC, Mumbai, Maharashtra, India.
authors.forename: Camilla S
authors.initials: CS
authors.lastname: Rodrigues
keywords: Category IV treatment; directly observed treatment short-course plus; drug-resistant tuberculosis