 |
|
|
| |
SWITCH-EE Study (Swiss-Cohort):
A Randomized Cross-over Study to Compare Etravirine and Efavirenz treatment
|
| |
| |
Reported by Jules Levin IAC Vienna July 2010
Nguyen A.1, Calmy A.1, Delhumeau C.1, Konig I.1, Cavassini M.2, Fayet-Mello A. 2, Elzi L.3, Genne D.4, Rauch A.5, Bernasconi E.6, Hirschel, B1.
HIV/AIDS Units of: 1University Hospital of Geneva, Switzerland, 2University Hospital of Lausanne, Switzerland, 3University Hospital of Basel, Switzerland,
4Hospital of Chaux-De-Fonds, Switzerland, 5University Hospital of Bern,
Author Conclusion
After double-blind substitution of EFV by ETR both once daily in patients stable on EFV, without NPS symptoms at baseline, patients expressed the same preference for any of the drug at week 12, in addition the measurable effect on neuropsychiatric symptoms and sleep quality was similar. Plasma cholesterol decreased significantly after ETR switch by 0.7 mmol (approximately 15%).
BACKGROUND
Efavirenz (EFV) causes neuropsychiatric side effects and sleep disturbance and may be associated with an unfavourable blood lipid
In this study we investigated the effect of replacing EFV with etravirine (ETR) on patient preference, sleep quality, daytime sleepiness, anxiety, and blood lipid levels in patients who were tolerating EFV.
The primary endpoint of the trial was patient preference for the first or the second regimen, assessed after 12 weeks. Inter and intra-subject variability between the 2 treatments phases were analyzed.
Results
58 subjects (87% male) were included in the study Age was 48 years (all values are medians) with duration of known HIV infection of
When asked about treatment preference after 12 weeks, 16 preferred EFV, and
22 preferred ETR, while 17 did not express a preference (p = NS).
Patients who started with EFV were more likely to prefer EFV (15/21, 71%),
whereas patients who started with ETR were more likely to prefer ETR (n=16/17,
94%). This order effect was strongly significant (p<0.0001).
Quality of sleep, depression, anxiety and stress scores did not differ significantly between groups at any time points (p > 0.2 for all comparisons). Almost all not report any neuropsychiatric dissatisfaction.
Overall there were no clinically relevant, or statistically significant differences
between the 2 treatment arms with regard to safety, tolerability and HIV-RNA from baseline.
Median total plasma cholesterol levels declined by 0.7 mmol (29 mg / 100 ml) after replacing efavirenz with etravirine (p < 0.002).
|
| |
|
|
|
|
|
