Switch studies in virologically suppressed patients

Switch to RAL-containing regimen
Switch-ER Study: Switch EFV to RAL
Original article : AIDS. 2011 Jul 31;25(12):1481-7 – A Nguyen
Last update : 07/09/2015

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • Half of patients previously on a stable EFV preferred to switch to RAL, after double -blind exposure to RAL for 2 weeks
  • Substitution of EFV by RAL significantly impacted on lipid levels, stress, and anxiety scores
  • After study completion , 51 % of patients switched to RAL
  • Study limitations
    • Small sample size
    • Few women
    • Exclusion of patients not tolerating EFV

Design

Objective

  • Primary Endpoint: patient preference of first or second regimen, by questionnaire at W12
  • Standardized questionnaires: patient anxiety and depression, sleepiness during the day, sleep quality and antiretroviral satisfaction ( HIVTSQc )
  • Plasma drug concentration: D1 and end of both treatment phases

Baseline characteristics and outcome

HIVTSQc questionnaire (Treatment satisfaction)

  • Patients in the RAL-group were more satisfied by RAL than by EFV (p = 0.002)

Anxiety, depression and sleep assessment

  • No significant differences in depression or sleep quality between groups
  • Significant less anxiety and stress score with RAL (p = 0.04 and 0.03, respectively)

Safety and laboratory parameters

  • Serious adverse events, N = 1, unrelated to study drugs
  • Significantly lower lipid levels in patients on RAL when compared with patients on EFV
    • Total cholesterol (median change : - 0.4 mmol /l; IQR : 0.9, - 0.1; p < 0.0001)
    • LDL-cholesterol (median change : - 0.2 mmol /l; IQR : 0.6, - 0.2; p = 0.004)
    • HDL-cholesterol ( median change : - 0.1 mmol /l; IQR : 0.2, 0; p = 0.005)
    • Triglycerides ( median change : - 0.2 mmol /l ; IQR : 0.6, 0.1; p = 0.036)
    • HDL:Total cholesterol ratio (median change : - 0.1; IQR : 0.4, 0.3; p = 1 )

No loss of virological suppression over 3 months follow-up

 

 

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