Premium
Neurological and psychiatric tolerability of rilpivirine ( TMC 278) vs. efavirenz in treatment‐naïve, HIV ‐1‐infected patients at 48 weeks
Author(s) -
Mills AM,
Antinori A,
Clotet B,
Fourie J,
Herrera G,
Hicks C,
Madruga JV,
Vanveggel S,
Stevens M,
Boven K
Publication year - 2013
Publication title -
hiv medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 79
eISSN - 1468-1293
pISSN - 1464-2662
DOI - 10.1111/hiv.12012
Subject(s) - rilpivirine , tolerability , medicine , efavirenz , adverse effect , incidence (geometry) , discontinuation , human immunodeficiency virus (hiv) , viral load , virology , antiretroviral therapy , physics , optics
Objectives The aim of the study was to compare the neuropsychiatric safety and tolerability of rilpivirine ( TMC 278) 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 25 mg vs. efavirenz 600 mg 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.