Document Detail

Neurological and psychiatric tolerability of rilpivirine (TMC278) vs. efavirenz in treatment-naïve, HIV-1-infected patients at 48 weeks.
MedLine Citation:
PMID:  23298380     Owner:  NLM     Status:  MEDLINE    
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 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.
A M Mills; A Antinori; B Clotet; J Fourie; G Herrera; C Hicks; J V Madruga; S Vanveggel; M Stevens; K Boven;
Publication Detail:
Type:  Clinical Trial, Phase III; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2013-01-09
Journal Detail:
Title:  HIV medicine     Volume:  14     ISSN:  1468-1293     ISO Abbreviation:  HIV Med.     Publication Date:  2013 Aug 
Date Detail:
Created Date:  2013-07-02     Completed Date:  2014-01-09     Revised Date:  2014-02-06    
Medline Journal Info:
Nlm Unique ID:  100897392     Medline TA:  HIV Med     Country:  England    
Other Details:
Languages:  eng     Pagination:  391-400     Citation Subset:  IM    
Copyright Information:
© 2013 British HIV Association.
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MeSH Terms
Aged, 80 and over
Anti-HIV Agents / administration & dosage*,  pharmacology,  therapeutic use
Benzoxazines / administration & dosage,  adverse effects*,  therapeutic use
HIV Infections / drug therapy*,  psychology,  virology
HIV-1* / drug effects,  physiology
Mental Disorders / chemically induced*
Middle Aged
Nervous System Diseases / chemically induced*
Nitriles / administration & dosage,  adverse effects*,  therapeutic use
Pyrimidines / administration & dosage,  adverse effects*,  therapeutic use
Viral Load / physiology
Young Adult
Reg. No./Substance:
0/Anti-HIV Agents; 0/Benzoxazines; 0/Nitriles; 0/Pyrimidines; 500287-72-9/Rilpivirine; JE6H2O27P8/efavirenz

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