title: Ethnicity, race, and gender. Differences in serious adverse events among participants in an antiretroviral initiation trial: results of CPCRA 058 (FIRST Study).
abstract: BACKGROUND
  Differences in adverse events by gender and race/ethnicity have not been described extensively in randomized clinical trials of HIV antiretroviral therapy (ART).
  
  
  METHODS
  Antiretroviral-naive HIV-infected participants enrolled in a long-term randomized clinical trial of 3 different initial ART strategies -- protease inhibitor (PI), nonnucleoside reverse transcriptase inhibitor (NNRTI), or PI plus NNRTI-based combinations -- with a median follow-up of 5 years, were compared by gender and race for 14 categories of grade 4 adverse events, discontinuation of initial antiretroviral regimen, and all-cause mortality. Multivariate analysis was used to identify predictors of events and death.
  
  
  RESULTS
  Among 1301 participants with complete data, there were 701 blacks, 225 Latinos, and 263 women. Several baseline characteristics differed by gender and race, including age, HIV transmission risk, hepatitis B or C coinfection, viral load, diagnosis of AIDS, body mass index, and baseline hypertension. Grade 4 events occurred in 409 participants (rate: 8.9/100 person-years). There were 176 deaths (rate: 3.0/100 person-years) and 523 discontinuations of regimen for any toxicity (rate: 13/100 person-years). In the fully adjusted regressions, blacks had greater risk for cardiovascular (hazard ratio [HR] = 2.64, 95% confidence interval [CI]: 1.04 to 6.67) and renal (HR = 3.83, 95% CI: 1.28 to 11.5) events. Black men had more psychiatric events (HR = 2.45, 95% CI: 1.13 to 5.30). Women had a higher risk for anemia (HR = 2.34, 95% CI: 1.09 to 4.99).
  
  
  CONCLUSIONS
  Among HIV-infected participants initiating ART, there were significant risk-adjusted differences for specific adverse events by gender and race but not in the overall adverse event rates, all-cause mortality, or rates of toxicity-related treatment discontinuations.
authors.affiliation: Temple Comprehensive HIV Program, Temple University School of Medicine, Philadelphia, PA 19140, USA. etedaldi@temple.edu
authors.forename: Ellen M
authors.initials: EM
authors.lastname: Tedaldi
authors.forename: Judith
authors.initials: J
authors.lastname: Absalon
authors.forename: Avis J
authors.initials: AJ
authors.lastname: Thomas
authors.forename: Judith C
authors.initials: JC
authors.lastname: Shlay
authors.forename: Mary
authors.initials: M
authors.lastname: van den Berg-Wolf
mesh_terms: D000328:Adult; D001741:Black or African American / Q000706:statistics & numerical data; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects / Q000379:methods*; D056486:Chemical and Drug Induced Liver Injury; D005260:Female; D005500:Follow-Up Studies; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000208:ethnology; D015658:HIV Infections / Q000188:drug therapy* / Q000208:ethnology*; D006630:Hispanic or Latino / Q000706:statistics & numerical data; D006801:Humans; D008107:Liver Diseases / Q000208:ethnology; D008297:Male; D012737:Sex Factors; D016896:Treatment Outcome; D044465:White People / Q000706:statistics & numerical data