A randomized crossover study to compare efavirenz and etravirine treatment

Article Article scientifique Article A randomized crossover study to compare efavirenz and etravirine treatment eng 2011-01-02 author Nguyen Le Quang Alain University Clinic of Infectious Diseases, University Hospital of Geneva, Switzerland. 516494 author Calmy Alexandra 0000-0002-1137-6826 41032 Département de médecine (DEMED) author Delhumeau-Cartier Cécile 514342 author Mercier Isabelle author Cavassini Matthias author Fayet-Mello Aurélie author Elzi Luigia author Genné Daniel author Rauch Andri author Bernasconi Enos author Hirschel Bernard Swiss HIV Cohort Study collaborator Burton-Jeangros Claudine 0000-0003-2258-9728 29914 Service enseignement, recherche, administratif et technique (SdS) (SCSPS) collaborator Kaiser Laurent 28229 Département de médecine (DEMED) collaborator Keiser Olivia 0000-0001-8191-2789 873427 Institut de santé globale (COSPR) collaborator Martinez De Tejada Weber Begona 590919 Département de Pédiatrie, Gynécologie et Obstétrique (PETRI) collaborator Yerly Ferrillo Sabine 23752 57-63 10.1097/QAD.0b013e32833f9f63 21076278 0269-9370 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. Adult Alkynes Antiretroviral Therapy, Highly Active Anxiety Disorders / chemically induced Anxiety Disorders / psychology Benzoxazines / adverse effects Benzoxazines / therapeutic use CD4 Lymphocyte Count Cyclopropanes Drug Administration Schedule Female HIV Infections / drug therapy HIV Infections / psychology HIV Protease Inhibitors / adverse effects HIV Protease Inhibitors / therapeutic use HIV-1 Humans Male Middle Aged Nitriles Practice Guidelines as Topic Pyridazines / administration & dosage Pyridazines / adverse effects Pyridazines / therapeutic use Pyrimidines Sleep Initiation and Maintenance Disorders / chemically induced Sleep Initiation and Maintenance Disorders / psychology Surveys and Questionnaires Treatment Outcome Dewey 616 56 Département de médecine 221 false 587 VIH/SIDA 930 AIDS 25 1 4d572762-0cc3-427c-bfed-e03d43c1ed51 Article (Published version) Restricted a_randomized_crossover_study_to_com.pdf 251738 application/pdf 5d044447216f382d06bdfefea4348053e72b79ffbabc7d13895e665936ef73d4 restrictedAccess Faculté de médecine / Section de médecine clinique / Département de médecine

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A randomized crossover study to compare efavirenz and etravirine treatment	AIDS			2011	112	0

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Nguyen, Le Quang Alain