title: Underreporting of side effects of standard first-line ART in the routine setting in Blantyre, Malawi.
abstract: BACKGROUND
  In the Malawi ART programme, 92% of 250,000 patients are using the standard first-line regime of stavudine-lamivudine-nevaripine. National ART reports indicate <4% experience ART side effects, much less than expected from literature.
  
  
  METHODS
  We interviewed adult patients on standard first-line ART for at least one year, after routine visits to an urban clinic in Blantyre, Malawi. We determined the prevalence of symptoms that are common side-effects, described discrepancies between symptoms that patients reported to us and those that had been recorded by attending staff as side-effects in the point-of-care electronic monitoring system, and studied factors associated with such discrepancies.
  
  
  RESULTS
  Of 170 participants, 75 (44%) reported at least one symptom, most common were symptoms suggesting peripheral neuropathy (n=57) and lipodystrophy (n=16). Forty-six (66%) symptomatic patients said they reported symptoms to attending ART staff. Side-effects were recorded in the clinic database for just 4 patients. Toxicity recording was too low for meaningful analysis of factors associated with discrepancies between reporting and recording of side-effects. The prevalence of symptoms indicating characteristic side-effects of the standard first-line regimen was 39% based on interviews, and 2% in the electronic monitoring system.
  
  
  CONCLUSIONS
  There was gross under-recording of side-effects in this setting, mainly due to not recording by ART staff. Pressure of work and insufficient perceived benefit of side-effect recording are suspected causes. Local and national ART reports do not reflect the true toxicity of the standard first line regimen.
authors: Department of Medicine College of Medicine Blantyre, Malawi.
authors: Julia
authors: J
authors: Tapsfield
authors: Teena
authors: T
authors: Mathews
authors: Molly
authors: M
authors: Lungu
authors: Joep J
authors: JJ
authors: van Oosterhout
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000554:Ambulatory Care Facilities; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D003430:Cross-Sectional Studies; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D007407:Interviews as Topic; D019259:Lamivudine / Q000009:adverse effects* / Q000627:therapeutic use; D008060:Lipodystrophy / Q000139:chemically induced / Q000150:complications / Q000453:epidemiology; D008295:Malawi / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D019829:Nevirapine / Q000009:adverse effects* / Q000627:therapeutic use; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced / Q000150:complications / Q000453:epidemiology; D015995:Prevalence; D018119:Stavudine / Q000009:adverse effects* / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D014505:Urban Population
chemical_list: D019380:Anti-HIV Agents; C516355:stavudine, lamivudine, nevirapine drug combination; D019259:Lamivudine; D019829:Nevirapine; D018119:Stavudine