Switch NNRTI to NNRTI
Switch EFV to ETR: CNS toxicity
Original article : AIDS. 2011 Jan 2;25(1):65-71 – L Waters
Last update :
07/09/2015
Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK
- Switching EFV to ETR led to a significant reduction in overall grade 2-4 CNS adverse events, including insomnia, abnormal dreams and nervousness as individual adverse event
- No virological failures occurred in the 19 and 15 patients completing 24 and 12 weeks of once-daily ETR-based HAART
- Improvement in lipids with significant reductions in total and
LDL-cholesterol after 12 weeks of ETR
- Proactive switch away from EFV may yield significant reductions in CNS toxicity
Design
Objective
- Primary Endpoint: change in proportion of patients experiencing grade 2-4 CNS
toxicity at W12
- Secondary endpoints: change in CNS score at W12 and W24; combined change (immediate and delayed switch) 12 weeks after switch; median number of grade 2-4 CNS adverse events; viral suppression ; CD4 change; fasting lipids; safety
Baseline characteristics and disposition
*
Frequency of individual events similar in both groups except for insomnia (75% vs 39%, p = 0.024)
- Median duration of EFV exposure: 21.4 months
Primary endpoint
- Grade 2-4 CNS AE at W12: 60% in immediate switch vs 81.3% in deferred switch (significant decrease in immediate switch; p = 0.041)
- Abnormal dreams
- decrease from 50% to 20% in IS group (p = 0.041) vs no change in DS : 67% to 63%
- Median number of grade 2-4 CNS AE
- IS: 4 at baseline vs 1.5 at W12 (p = 0.003)
- DS: 3 at baseline vs 3 at W12
- CNS score: IS = change from 14 to 6 (p = 0.001); DS = 10 to 7.5 (NS)
Change from W12 to W24
- No further significant change in immediate switch group
- Significant improvement in deferrred group
Other results
- No virologic failure
- Improvement in lipids after switch to ETR
- Grade 2 AE deemed related to ETR: fatigue, headache, reduced libido
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