Underreporting of side effects of standard first-line ART in the routine setting in Blantyre, Malawi

Malawi Med J. 2011 Dec;23(4):115-7.


Introduction: 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.

Conclusion: 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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Adverse Drug Reaction Reporting Systems / statistics & numerical data*
  • Ambulatory Care Facilities
  • Anti-HIV Agents / adverse effects*
  • Anti-HIV Agents / therapeutic use
  • Cross-Sectional Studies
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / epidemiology
  • Humans
  • Interviews as Topic
  • Lamivudine / adverse effects*
  • Lamivudine / therapeutic use
  • Lipodystrophy / chemically induced
  • Lipodystrophy / complications
  • Lipodystrophy / epidemiology
  • Malawi / epidemiology
  • Male
  • Middle Aged
  • Nevirapine / adverse effects*
  • Nevirapine / therapeutic use
  • Peripheral Nervous System Diseases / chemically induced
  • Peripheral Nervous System Diseases / complications
  • Peripheral Nervous System Diseases / epidemiology
  • Prevalence
  • Stavudine / adverse effects*
  • Stavudine / therapeutic use
  • Surveys and Questionnaires
  • Urban Population


  • Anti-HIV Agents
  • stavudine, lamivudine, nevirapine drug combination
  • Lamivudine
  • Nevirapine
  • Stavudine