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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Neurological and psychiatric tolerability of rilpivirine (TMC278) vs. efavirenz in treatment-naïve, HIV-1-infected patients at 48 weeks
HIV Medicine, Volume 14, No. 7, Year 2013
Notification
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Description
Objectives: The aim of the study was to compare the neuropsychiatric safety and tolerability of rilpivirine (TMC278) vs. efavirenz in a preplanned pooled analysis of data from the ECHO and THRIVE studies which compared the safety and efficacy of the two drugs in HIV-1 infected treatment naïve adults. Methods: ECHO and THRIVE were randomized, double-blind, double-dummy, 96-week, international, phase 3 trials comparing the efficacy, safety and tolerability of rilpivirine 25mg vs. efavirenz 600mg once daily in combination with two background nucleoside/tide reverse transcriptase inhibitors. Safety and tolerability analyses were conducted when all patients had received at least 48 weeks of treatment or discontinued earlier. Differences between treatments in the incidence of neurological and psychiatric adverse events (AEs) of interest were assessed in preplanned statistical analyses using Fisher's exact test. Results: At the time of the week 48 analysis, the cumulative incidences in the rilpivirine vs. efavirenz groups of any grade 2-4 treatment-related AEs and of discontinuation because of AEs were 16% vs. 31% (P<0.0001) and 3% vs. 8% (P=0.0005), respectively. The incidence of treatment-related neuropsychiatric AEs was 27% vs. 48%, respectively (P<0.0001). The incidence of treatment-related neurological AEs of interest was 17% vs. 38% (P<0.0001), and that of treatment-related psychiatric AEs of interest was 15% vs. 23% (P=0.0002). Dizziness and abnormal dreams/nightmares occurred significantly less frequently with rilpivirine vs. efavirenz (P<0.01). In both groups, patients with prior neuropsychiatric history tended to report more neuropsychiatric AEs but rates remained lower for rilpivirine than for efavirenz. Conclusions: Rilpivirine was associated with fewer neurological and psychiatric AEs of interest than efavirenz over 48 weeks in treatment-naïve, HIV-1-infected adults. © 2013 British HIV Association.
Authors & Co-Authors
Mills, Anthony M.
United States, Los Angeles
Anthony Mills Md Inc
Antinori, Andrea
Italy, Rome
Irccs Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
Clotet, Bonaventura
Spain, Badalona
Hospital Universitari Germans Trias I Pujol
Fourie, Jan
South Africa, Dundee
Dr j Fourie Medical Centre
Herrera, Gisela
Costa Rica, San Jose
Hospital Cima
Hicks, Charles B.
United States, Durham
Duke University Medical Center
Madruga, Jv
Brazil, Sao Paulo
Centro de Referência e Treinamento Dst/aids
Vanveggel, Simon
Belgium, Beerse
Janssen Pharmaceutica, Headquarters
Stevens, Marita C.
Belgium, Beerse
Janssen Pharmaceutica, Headquarters
Boven, Katia J.
United States, Titusville
Janssen Pharmaceuticals, Inc.
Statistics
Citations: 34
Authors: 10
Affiliations: 9
Identifiers
Doi:
10.1111/hiv.12012
ISSN:
14642662
e-ISSN:
14681293
Research Areas
Disability
Infectious Diseases
Mental Health
Study Design
Cohort Study