Abstract | 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: 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.
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Authors | Jean-Michel Molina, Nathan Clumeck, Karla Redant, Laurence Rimsky, Simon Vanveggel, Marita Stevens, ECHO and THRIVE Study Groups |
Journal | AIDS (London, England)
(AIDS)
Vol. 27
Issue 6
Pg. 889-897
(Mar 27 2013)
ISSN: 1473-5571 [Electronic] England |
PMID | 23276806
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Alkynes
- Anti-HIV Agents
- Benzoxazines
- Cyclopropanes
- Nitriles
- Pyrimidines
- Rilpivirine
- efavirenz
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Topics |
- Adult
- Aged
- Alkynes
- Anti-HIV Agents
(administration & dosage, adverse effects)
- Benzoxazines
(administration & dosage, adverse effects)
- Cyclopropanes
- 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)
- Rilpivirine
- Treatment Outcome
- Viral Load
- Young Adult
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