title: Is there an increased risk of TB relapse in patients treated with fixed-dose combination drugs in Indonesia?
abstract: METHODS
  South Sulawesi Province, Republic of Indonesia.
  
  
  OBJECTIVE
  To compare relapse rates among tuberculosis (TB) patients treated with fixed-dose combination drugs (FDCs) and patients treated with the same regimen using loose drugs.
  
  
  METHODS
  Between 1999 and 2001, new smear-positive TB patients were randomly allocated to treatment with four-drug FDCs or loose drugs to study differences in treatment outcomes. Although it was not in the original study design, in 2004-2005 we performed a follow-up study by home visit of cured patients. We conducted an interview and tried to collect a sputum sample from each patient. If the patient was absent or had died, a proxy interview was conducted. The sputum samples were examined by microscopy and culture.
  
  
  RESULTS
  The overall relapse rate was 7.0% in patients who were able to produce a sputum sample. Relapse appeared to be more frequent in the FDC group compared to the loose drug group (10.1% vs. 2.7%, P = 0.074).
  
  
  CONCLUSIONS
  This is the first documented long-term follow-up study of patients treated with four-drug FDCs. There is an indication that treatment of new sputum smear-positive TB patients with FDCs provides an increased risk of relapse compared to treatment with loose drugs. The long-term results of treatment with FDCs should be carefully evaluated in other settings.
authors.affiliation: Directly Communicable Diseases Section, Provincial Health Services, Makassar, Indonesia.
authors.forename: A A
authors.initials: AA
authors.lastname: Suryanto
authors.forename: J
authors.initials: J
authors.lastname: van den Broek
authors.forename: M
authors.initials: M
authors.lastname: Hatta
authors.forename: R
authors.initials: R
authors.lastname: de Soldenhoff
authors.forename: M J
authors.initials: MJ
authors.lastname: van der Werf
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007214:Indonesia; D008297:Male; D012008:Recurrence; D014397:Tuberculosis, Pulmonary / Q000188:drug therapy*
chemical_list: D000995:Antitubercular Agents