Titre
A randomized crossover study to compare efavirenz and etravirine treatment.
Type
article
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Périodique
Auteur(s)
Nguyen, A.
Auteure/Auteur
Calmy, A.
Auteure/Auteur
Delhumeau, C.
Auteure/Auteur
Mercier, I.K.
Auteure/Auteur
Cavassini, M.
Auteure/Auteur
Fayet-Mello, A.
Auteure/Auteur
Elzi, L.
Auteure/Auteur
Genné, D.
Auteure/Auteur
Rauch, A.
Auteure/Auteur
Bernasconi, E.
Auteure/Auteur
Hirschel, B.
Auteure/Auteur
Contributrices/contributeurs
Barth, J.
Battegay, M.
Bernasconi, E.
Böni, J.
Bucher, HC.
Bürgisser, P.
Burton-Jeangros, C.
Calmy, A.
Cavassini, M.
Dubs, R.
Egger, M.
Elzi, L.
Fehr, J.
Fischer, M.
Flepp, M.
Francioli, P.
Furrer, H.
Fux, CA.
Gorgievski, M.
Günthard, H.
Hasse, B.
Hirsch, HH.
Hirschel, B.
Hösli, I.
Kahlert, C.
Kaiser, L.
Keiser, O.
Kind, C.
Klimkait, T.
Kovari, H.
Ledergerber, B.
Martinetti, G.
Martinez de Tejada, B.
Müller, N.
Nadal, D.
Pantaleo, G.
Rauch, A.
Regenass, S.
Rickenbach, M.
Rudin, C.
Schmid, P.
Schultze, D.
Schöni-Affolter, F.
Schüpbach, J.
Speck, R.
Taffé, P.
Telenti, A.
Trkola, A.
Vernazza, P.
von Wyl, V.
Weber, R.
Yerly, S.
Groupes de travail
Swiss HIV Cohort Study
Liens vers les personnes
Liens vers les unités
ISSN
1473-5571
Statut éditorial
Publié
Date de publication
2011
Volume
25
Numéro
1
Première page
57
Dernière page/numéro d’article
63
Langue
anglais
Notes
Publication types: Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Résumé
BACKGROUND: Efavirenz (EFV) causes neuropsychiatric side-effects and an unfavourable blood lipid profile. We investigated the effect of replacing EFV with etravirine (ETR) on patient preference, sleep, anxiety and lipid levels.
METHOD: Study participants did not complain of side-effects, had tolerated EFV for at least 3 months, with less than 50 copies/ml HIV-RNA. After randomization, the ETR-first group started with ETR (400 mg daily) [DOSAGE ERROR CORRECTED] with EFV-placebo and the EFV-first group with EFV with ETR-placebo. After 6 weeks, both groups switched to the alternate regimen. Nucleoside reverse transcriptase inhibitors were continued without any change. The primary end point was patient preference for the first or the second regimen, assessed after 12 weeks.
RESULTS: Fifty-eight patients were enrolled with a median CD4 cell count of 589 cells/μl and the duration of previous EFV therapy was 3.9 years. Fifty-five patients completed the study. When asked about treatment preference after 12 weeks, 16 preferred EFV and 22 preferred ETR, whereas 17 did not express a preference (P = NS). Patients who continued EFV during the first phase of the trial preferred 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. Median plasma cholesterol levels decreased by 0.7 mmol (29 mg/100 ml) after replacing EFV with ETR (P < 0.002).
CONCLUSION: After substitution of EFV by ETR, patients did not express a significant preference for ETR. There was no measurable effect on neuropsychiatric symptoms and sleep. Cholesterol decreased.
METHOD: Study participants did not complain of side-effects, had tolerated EFV for at least 3 months, with less than 50 copies/ml HIV-RNA. After randomization, the ETR-first group started with ETR (400 mg daily) [DOSAGE ERROR CORRECTED] with EFV-placebo and the EFV-first group with EFV with ETR-placebo. After 6 weeks, both groups switched to the alternate regimen. Nucleoside reverse transcriptase inhibitors were continued without any change. The primary end point was patient preference for the first or the second regimen, assessed after 12 weeks.
RESULTS: Fifty-eight patients were enrolled with a median CD4 cell count of 589 cells/μl and the duration of previous EFV therapy was 3.9 years. Fifty-five patients completed the study. When asked about treatment preference after 12 weeks, 16 preferred EFV and 22 preferred ETR, whereas 17 did not express a preference (P = NS). Patients who continued EFV during the first phase of the trial preferred 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. Median plasma cholesterol levels decreased by 0.7 mmol (29 mg/100 ml) after replacing EFV with ETR (P < 0.002).
CONCLUSION: After substitution of EFV by ETR, patients did not express a significant preference for ETR. There was no measurable effect on neuropsychiatric symptoms and sleep. Cholesterol decreased.
Sujets
PID Serval
serval:BIB_8065AACE5872
PMID
Date de création
2010-12-20T10:01:27.438Z
Date de création dans IRIS
2025-05-20T21:30:37Z