title: Evidence for risk stratification when monitoring for toxicities following initiation of combination antiretroviral therapy.
abstract: OBJECTIVE
  Laboratory monitoring is recommended during combination antiretroviral therapy (cART), but the pattern of detected abnormalities and optimal monitoring are unknown. We assessed laboratory abnormalities during initial cART in 2000-2010 across the United States.
  
  
  METHODS
  Observational study in the Centers for AIDS Research Network of Integrated Clinical Systems Cohort.
  
  
  METHODS
  Among patients with normal results within a year prior to cART initiation, time to first significant abnormality was assessed by Kaplan-Meier curves stratified by event type, with censoring at first of regimen change, loss to follow-up, or 104 weeks. Incidence rates of first events were estimated using Poisson regression; multivariable analyses identified associated factors. Results were stratified by time (16 weeks) from therapy initiation.
  
  
  RESULTS
  A total of 3470 individuals contributed 3639 person-years. Median age, pre-cART CD4, and follow-up duration were 40 years, 206 cells/μl, and 51 weeks, respectively. Incidence rates for significant abnormalities (per 100 person-years) in the first 16 weeks post-cART initiation were as follows: lipid=49 [95% confidence interval (CI) 41-58]; hematologic=44 (40-49); hepatic=24 (20-27); and renal=9 (7-11), dropping substantially during weeks 17-104 of cART to lipid=23 (18-29); hematologic=5 (4-6); hepatic=6 (5-8); and renal=2 (1-3) (all P<0.05). Among patients receiving initial cART with no prior abnormality (N=1889), strongest associations for hepatic abnormalities after 16 weeks were hepatitis B and C [hazard ratio=2.3 (95% CI 1.2-4.5) and hazard ratio=3.0 (1.9-4.5), respectively]. The strongest association for renal abnormalities was hypertension [hazard ratio=2.8 (1.4-5.6)].
  
  
  CONCLUSIONS
  New abnormalities decreased after week 16 of cART. For abnormalities not present by week 16, subsequent monitoring should be guided by comorbidities.
authors: Infectious Diseases Division, Northwestern University, Chicago, IL 60611, USA. b-taiwo@northwestern.edu
authors: Babafemi
authors: B
authors: Taiwo
authors: Elizabeth L
authors: EL
authors: Yanik
authors: Sonia
authors: S
authors: Napravnik
authors: Patrick
authors: P
authors: Ryscavage
authors: Susan L
authors: SL
authors: Koletar
authors: Richard
authors: R
authors: Moore
authors: W Christopher
authors: WC
authors: Mathews
authors: Heidi M
authors: HM
authors: Crane
authors: Kenneth
authors: K
authors: Mayer
authors: Anne
authors: A
authors: Zinski
authors: James S
authors: JS
authors: Kahn
authors: Joseph J
authors: JJ
authors: Eron
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects*; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology*; D004359:Drug Therapy, Combination; D050171:Dyslipidemias / Q000139:chemically induced / Q000453:epidemiology*; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy*; D006402:Hematologic Diseases / Q000139:chemically induced / Q000453:epidemiology*; D006509:Hepatitis B; D006801:Humans; D015994:Incidence; D007674:Kidney Diseases / Q000139:chemically induced / Q000453:epidemiology*; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D019380:Anti-HIV Agents