title: Serious treatment related adverse drug reactions amongst anti-retroviral naïve MDR-TB patients.
abstract: BACKGROUND
  Globally treatment outcomes for multidrug-resistant Mycobacterium tuberculosis (MDR-TB) remain poor and this is compounded by high drug toxicity. Little is known about the influence of adverse drug reactions (ADRs) on treatment outcomes in South Africa.
  
  
  METHODS
  We evaluated the impact of severe ADRs among a prospective cohort of MDR-TB patients in South Africa (2000-2004). The HIV-infected study participants were anti-retroviral naïve.
  
  
  RESULTS
  Of 2,079 patients enrolled, 1,390 (66.8%) were included in this analysis based on known HIV test results (39.1% HIV-infected). At least one severe ADR was reported in 83 (6.9%) patients with ototoxicity being the most frequent ADR experienced (38.9%).
  
  
  CONCLUSIONS
  We found that being HIV-infected but antiretroviral naïve did not increase occurrence of SADRs in patients on second-line anti-tuberculosis drugs. Early screening and proactive management of ADRs in this patient population is essential, especially given the rollout of decentralized care and the potential for overlapping toxicity of concomitant MDR-TB and HIV treatment.
authors.affiliation: Tuberculosis Epidemiology and Intervention Research Unit, South African Medical Research Council, Pretoria, South Africa. vdwalt@mrc.ac.za
authors.forename: Martha
authors.initials: M
authors.lastname: Van der Walt
authors.forename: Johanna
authors.initials: J
authors.lastname: Lancaster
authors.forename: Ronel
authors.initials: R
authors.lastname: Odendaal
authors.forename: Jeanne Garcia
authors.initials: JG
authors.lastname: Davis
authors.forename: Karen
authors.initials: K
authors.lastname: Shean
authors.forename: Jason
authors.initials: J
authors.lastname: Farley
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000009:adverse effects* / Q000627:therapeutic use; D060085:Coinfection; D003523:Cycloserine / Q000009:adverse effects* / Q000627:therapeutic use; D024901:Drug Resistance, Multiple, Bacterial; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy; D034381:Hearing Loss / Q000139:chemically induced; D006801:Humans; D007555:Isoxazoles / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009169:Mycobacterium tuberculosis; D015242:Ofloxacin / Q000009:adverse effects* / Q000627:therapeutic use; D023303:Oxazolidinones / Q000009:adverse effects* / Q000627:therapeutic use; D011446:Prospective Studies; D011605:Psychoses, Substance-Induced / Q000209:etiology; D013019:South Africa; D016896:Treatment Outcome; D018088:Tuberculosis, Multidrug-Resistant / Q000150:complications / Q000188:drug therapy*; D014397:Tuberculosis, Pulmonary / Q000150:complications / Q000188:drug therapy*
chemical_list: D000995:Antitubercular Agents; D007555:Isoxazoles; D023303:Oxazolidinones; C100142:terizidone; D003523:Cycloserine; D015242:Ofloxacin