Neurological and psychiatric tolerability of rilpivirine (TMC278) vs. efavirenz in treatment-naïve, HIV-1-infected patients at 48 weeks

Am Mills, A. Antinori, B. Clotet, J. Fourie, G. Herrera, C. Hicks, Jv Madruga, S. Vanveggel, M. Stevens, K. Boven

Research output: Contribution to journalArticle

Abstract

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

Original languageEnglish
Pages (from-to)391-400
Number of pages10
JournalHIV Medicine
Volume14
Issue number7
DOIs
Publication statusPublished - Aug 2013

Keywords

  • Adverse events
  • Central nervous system
  • Efavirenz
  • Neuropsychiatric
  • Rilpivirine
  • Safety

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)
  • Health Policy

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    Mills, A., Antinori, A., Clotet, B., Fourie, J., Herrera, G., Hicks, C., Madruga, J., Vanveggel, S., Stevens, M., & Boven, K. (2013). Neurological and psychiatric tolerability of rilpivirine (TMC278) vs. efavirenz in treatment-naïve, HIV-1-infected patients at 48 weeks. HIV Medicine, 14(7), 391-400. https://doi.org/10.1111/hiv.12012