Document Detail


Rilpivirine vs. efavirenz in HIV-1 patients with baseline viral load 100,000 copies/ml or less: week 48 phase III analysis.
MedLine Citation:
PMID:  23276806     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: To compare efficacy, resistance development, and safety between rilpivirine and efavirenz in treatment-naive, HIV-1-infected adults with baseline viral load 100,000 copies/ml or less in the pooled 48-week dataset of the ECHO (Efficacy Comparison in treatment-naive HIV-infected subjects Of TMC278 and EFV) and THRIVE (TMC278 against HIV, in a once-daily RegImen Vs. Efavirenz) trials.
DESIGN: Phase III, double-blind, double-dummy, randomized trials.
METHODS: Patients received rilpivirine 25 mg once daily (q.d.) or efavirenz 600 mg q.d. with two nucleoside/tide reverse transcriptase inhibitors [N(t)RTIs]. This analysis considers the subpopulation of 368 rilpivirine and 330 efavirenz patients with baseline viral load 100,000 copies/ml or less.
RESULTS: Significantly higher 48-week response rates (viral load <50 copies/ml, intent-to-treat-time-to-loss-of-virological response) were observed with rilpivirine vs. efavirenz [90 vs. 84%, respectively; difference 6.6% (95% confidence interval 1.6-11.5%)]. The proportion of patients experiencing virological failure (VF(res)) was 5% in each treatment group. A comparable proportion of VF(res) patients in each group developed nonnucleoside reverse transcriptase inhibitor resistance-associated mutations (RAMs) [rilpivirine: 6/16 (38%) vs. efavirenz: 5/12 (42%)]. A numerically higher proportion of rilpivirine VF(res) patients developed N(t)RTI RAMs [7/16 (44%)] vs. efavirenz [2/12 (17%)]; P = 0.2232. A significantly lower incidence for rilpivirine vs. efavirenz was observed for the following events: treatment-related grade 2-4 overall adverse events (17 vs. 30%; P <0.0001), rash (any type; 2 vs. 12%; P <0.0001), and neurological adverse events (19 vs. 40%; P <0.0001), including dizziness (10 vs. 29%; P <0.0001). There was no significant difference between groups in the total cholesterol/high-density lipoprotein cholesterol ratio.
CONCLUSION: In treatment-naive patients with baseline viral load 100,000 copies/ml or less, rilpivirine along with two N(t)RTIs achieved a high response, with a comparable frequency of VF(res) and more favorable tolerability than efavirenz.
Authors:
Jean-Michel Molina; Nathan Clumeck; Karla Redant; Laurence Rimsky; Simon Vanveggel; Marita Stevens; ;
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Publication Detail:
Type:  Clinical Trial, Phase III; Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  AIDS (London, England)     Volume:  27     ISSN:  1473-5571     ISO Abbreviation:  AIDS     Publication Date:  2013 Mar 
Date Detail:
Created Date:  2013-05-24     Completed Date:  2013-10-24     Revised Date:  2014-02-06    
Medline Journal Info:
Nlm Unique ID:  8710219     Medline TA:  AIDS     Country:  England    
Other Details:
Languages:  eng     Pagination:  889-97     Citation Subset:  IM; X    
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Anti-HIV Agents / administration & dosage*,  adverse effects
Benzoxazines / administration & dosage*,  adverse effects
Double-Blind Method
Drug Resistance, Viral
Female
HIV Infections / drug therapy*,  virology
HIV-1 / drug effects,  isolation & purification*
Humans
Male
Middle Aged
Nitriles / administration & dosage*,  adverse effects
Pyrimidines / administration & dosage*,  adverse effects
Treatment Outcome
Viral Load*
Young Adult
Chemical
Reg. No./Substance:
0/Anti-HIV Agents; 0/Benzoxazines; 0/Nitriles; 0/Pyrimidines; 500287-72-9/Rilpivirine; JE6H2O27P8/efavirenz

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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