Haemoglobin and anaemia in the SMART study

Antivir Ther. 2011;16(3):329-37. doi: 10.3851/IMP1746.


Background: Data from randomized trials on the development of anaemia after interruption of therapy are not well-described.

Methods: A total of 2,248 patients from the SMART study were included. We used Cox proportional hazards models to investigate development of new (≤12 mg/dl for females and ≤14 mg/dl for males) or worsening (≤8 mg/dl if anaemic at randomization) anaemia and Poisson regression analyses to explore the relationship between anaemia and the development of AIDS, death or non-AIDS events.

Results: Overall, 759 patients developed new or worsening anaemia: 420/1,106 (38.0%) in the drug conservation (DC) arm and 339/1127 (30.1%) in the viral suppression (VS) arm (P<0.0001). At 4 months after randomization, patients in the DC arm had a significantly increased risk of developing new or worsening anaemia (adjusted relative hazard 1.56, 95% CI 1.28-1.89). Currently anaemic patients had an increased incidence of AIDS (adjusted incidence rate ratio [IRR] 2.31, 95% CI 1.34-3.98), death (adjusted IRR 2.19, 95% CI 1.23-3.87) and non-AIDS events (adjusted IRR 2.98, 95% CI 2.01-4.40) compared to non-anaemic patients.

Conclusions: Patients who interrupted combination antiretroviral therapy had a higher risk of new or worsening anaemia. Anaemic patients had a higher incidence of AIDS, non-AIDS defining events or deaths, possibly due to deteriorating health and subclinical disease.

Trial registration: ClinicalTrials.gov NCT00027352.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Acquired Immunodeficiency Syndrome / epidemiology*
  • Acquired Immunodeficiency Syndrome / mortality
  • Acquired Immunodeficiency Syndrome / virology
  • Adult
  • Anemia / epidemiology*
  • Anemia / mortality
  • Anemia / physiopathology
  • Anti-HIV Agents / administration & dosage*
  • Anti-HIV Agents / therapeutic use
  • CD4 Lymphocyte Count
  • Drug Administration Schedule
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / epidemiology
  • HIV Infections / mortality
  • Hemoglobins / analysis*
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Prognosis
  • Proportional Hazards Models
  • Reverse Transcriptase Inhibitors / administration & dosage*
  • Reverse Transcriptase Inhibitors / therapeutic use
  • Risk
  • Risk Factors


  • Anti-HIV Agents
  • Hemoglobins
  • Reverse Transcriptase Inhibitors

Associated data

  • ClinicalTrials.gov/NCT00027352