title: Impact of baseline virologic, immunologic, and demographic characteristics on virologic responses in the Gemini study.
abstract: OBJECTIVE
  To determine the impact of baseline viral load (VL) and CD4+ cell count, race/ethnicity, and gender on response in a post hoc analysis of the Gemini study.
  
  
  METHODS
  In this 48-week study, treatment-naïve, HIV-infected participants received as initial therapy twice-daily saquinavir/ritonavir (SQV/r) 1000/100 mg (n=167) or lopinavir/ritonavir (LPV/r) 400/100 mg (n=170), each with emtricitabine 200 mg/tenofovir 300 mg daily. The proportion of participants achieving HIV RNA<50 copies/mL (primary endpoint) and median change from baseline in CD4+ cell count were compared by baseline VL (>100,000 vs ≤ 100,000 copies/ mL) and CD4+ cell count (>100 vs ≤ 100 cells/µL). The impact of baseline and demographic variables on virologic response was assessed by logistic regression analysis.
  
  
  RESULTS
  Responses were similar between arms (SQV/r vs LPV/r) with or without stratification. In a pooled analysis of SQV/r and LPV/r arms, CD4+ cell count >100 cells/µL (odds ratio [OR], 1.628;P = .0416), non-Thai/non-Black versus Black race (OR, 1.518;P = .0023), and non-Thai/non-Black versus Thai (OR, 0.467;P = .0046) were significant predictors of virologic response.
  
  
  CONCLUSIONS
  Treatment groups had similar efficacy. Baseline CD4+ cell count and race/ethnicity were independent predictors of virologic response, whereas baseline VL and gender were not.
authors.affiliation: HIV Netherlands Australia Thailand, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.
authors.forename: Anchalee
authors.initials: A
authors.lastname: Avihingsanon
authors.forename: Kiat
authors.initials: K
authors.lastname: Ruxrungtham
authors.forename: Harold
authors.initials: H
authors.lastname: Katner
authors.forename: Carol
authors.initials: C
authors.lastname: Jean Guittari
authors.forename: Sharon
authors.initials: S
authors.lastname: Walmsley
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology*; D006801:Humans; D008297:Male; D016017:Odds Ratio; D044469:Racial Groups; D019562:Viral Load / Q000187:drug effects
chemical_list: D019380:Anti-HIV Agents