PMID- 23298380
OWN - NLM
STAT- MEDLINE
DCOM- 20140109
LR  - 20201209
IS  - 1468-1293 (Electronic)
IS  - 1464-2662 (Linking)
VI  - 14
IP  - 7
DP  - 2013 Aug
TI  - Neurological and psychiatric tolerability of rilpivirine (TMC278) vs. efavirenz 
      in treatment-naive, HIV-1-infected patients at 48 weeks.
PG  - 391-400
LID - 10.1111/hiv.12012 [doi]
AB  - 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 naive 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-naive, HIV-1-infected adults.
CI  - (c) 2013 British HIV Association.
FAU - Mills, A M
AU  - Mills AM
AD  - Anthony Mills MD Inc., Los Angeles, CA 90069, USA. tmills@tonymillsmd.com
FAU - Antinori, A
AU  - Antinori A
FAU - Clotet, B
AU  - Clotet B
FAU - Fourie, J
AU  - Fourie J
FAU - Herrera, G
AU  - Herrera G
FAU - Hicks, C
AU  - Hicks C
FAU - Madruga, J V
AU  - Madruga JV
FAU - Vanveggel, S
AU  - Vanveggel S
FAU - Stevens, M
AU  - Stevens M
FAU - Boven, K
AU  - Boven K
CN  - ECHO and THRIVE study groups
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130109
PL  - England
TA  - HIV Med
JT  - HIV medicine
JID - 100897392
RN  - 0 (Alkynes)
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Benzoxazines)
RN  - 0 (Cyclopropanes)
RN  - 0 (Nitriles)
RN  - 0 (Pyrimidines)
RN  - FI96A8X663 (Rilpivirine)
RN  - JE6H2O27P8 (efavirenz)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Alkynes
MH  - Anti-HIV Agents/*administration & dosage/pharmacology/therapeutic use
MH  - Benzoxazines/administration & dosage/*adverse effects/therapeutic use
MH  - Cyclopropanes
MH  - HIV Infections/*drug therapy/psychology/virology
MH  - *HIV-1/drug effects/physiology
MH  - Humans
MH  - Mental Disorders/*chemically induced
MH  - Middle Aged
MH  - Nervous System Diseases/*chemically induced
MH  - Nitriles/administration & dosage/*adverse effects/therapeutic use
MH  - Pyrimidines/administration & dosage/*adverse effects/therapeutic use
MH  - Rilpivirine
MH  - Viral Load/physiology
MH  - Young Adult
OTO - NOTNLM
OT  - adverse events
OT  - central nervous system
OT  - efavirenz
OT  - neuropsychiatric
OT  - rilpivirine
OT  - safety
EDAT- 2013/01/10 06:00
MHDA- 2014/01/10 06:00
CRDT- 2013/01/10 06:00
PHST- 2012/11/23 00:00 [accepted]
PHST- 2013/01/10 06:00 [entrez]
PHST- 2013/01/10 06:00 [pubmed]
PHST- 2014/01/10 06:00 [medline]
AID - 10.1111/hiv.12012 [doi]
PST - ppublish
SO  - HIV Med. 2013 Aug;14(7):391-400. doi: 10.1111/hiv.12012. Epub 2013 Jan 9.