title: Haemoglobin and anaemia in the SMART study.
abstract: 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.
authors.affiliation: University College Medical School, London, UK. a.mocroft@ucl.ac.uk
authors.forename: Amanda
authors.initials: A
authors.lastname: Mocroft
authors.forename: Alan R
authors.initials: AR
authors.lastname: Lifson
authors.forename: Giota
authors.initials: G
authors.lastname: Touloumi
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Neuhaus
authors.forename: Zoe
authors.initials: Z
authors.lastname: Fox
authors.forename: Adrian
authors.initials: A
authors.lastname: Palfreeman
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Vjecha
authors.forename: Sally
authors.initials: S
authors.lastname: Hodder
authors.forename: Stephane
authors.initials: S
authors.lastname: De Wit
authors.forename: Jens D
authors.initials: JD
authors.lastname: Lundgren
authors.forename: Andrew N
authors.initials: AN
authors.lastname: Phillips
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000453:epidemiology* / Q000401:mortality / Q000821:virology; D000328:Adult; D000740:Anemia / Q000453:epidemiology* / Q000401:mortality / Q000503:physiopathology; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology / Q000401:mortality; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D016016:Proportional Hazards Models; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage* / Q000627:therapeutic use; D012306:Risk; D012307:Risk Factors
chemical_list: D019380:Anti-HIV Agents; D006454:Hemoglobins; D018894:Reverse Transcriptase Inhibitors