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Switch studies in virologically suppressed patients

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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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