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Rilpivirine Versus Efavirenz with Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-Naïve HIV-1-Infected Patients with HIV-1 RNA ≤100,000 Copies/mL: Week 96 Pooled ECHO/THRIVE Subanalysis.
- Source :
- AIDS Patient Care & STDs; Apr2014, Vol. 28 Issue 4, p168-175, 8p
- Publication Year :
- 2014
-
Abstract
- The once daily, single-tablet regimen (STR) combining rilpivirine (RPV), emtricitabine (FTC), and tenofovir disoproxil fumarate (TDF) provides a simplified treatment option for antiretroviral therapy (ART)-naïve patients with baseline HIV-1 RNA (BLVL) of ≤100,000 copies/mL. The aim of this analysis is to compare long-term efficacy, safety, and tolerability of RPV+FTC/TDF vs. efavirenz (EFV)+FTC/TDF as individual components in subjects with BLVL ≤100,000 copies/mL. Week 96 efficacy and safety data from subjects with BLVL ≤100,000 copies/mL, who received daily RPV 25 mg or EFV 600 mg with FTC/TDF in the phase 3, randomized, double-blind, double-dummy, active-controlled, registrational trials ECHO and THRIVE, were analyzed. Virologic response was evaluated by intent-to-treat, time to loss of virological response (ITT-TLOVR), and Snapshot algorithms. Through Week 96, RPV+FTC/TDF demonstrated non-inferior efficacy to EFV+FTC/TDF (84% vs. 81%, respectively; ITT-TLOVR) in 543 subjects with BLVL ≤100,000 copies/mL, and overall rates of virologic failure (VF) were 5.9% vs. 2.4%, respectively. Resistance development was lower in Year 2 than Year 1. Subjects in both arms with suboptimal adherence (≤95%) had lower virologic responses (63% vs. 62%, respectively). Treatment with RPV+FTC/TDF was associated with significantly fewer treatment-related adverse events (AEs), grade 2-4 AEs, neurological and psychiatric AEs (including dizziness and abnormal dreams/nightmares), and rash. Additionally, grade 2-4 treatment-emergent laboratory abnormalities and grade 1-3 lipid abnormalities were significantly less common with RPV+FTC/TDF than EFV+FTC/TDF. RPV+FTC/TDF demonstrated non-inferior efficacy to EFV+FTC/TDF in ART-naïve subjects with BLVL ≤100,000 copies/mL and was associated with a higher rate of VF but a more favorable safety and tolerability profile through Week 96. [ABSTRACT FROM AUTHOR]
- Subjects :
- CONFIDENCE intervals
DRUG resistance
DRUG tolerance
HIV infections
MEDICAL cooperation
HEALTH outcome assessment
PATIENT safety
QUESTIONNAIRES
RESEARCH
RESEARCH funding
VIROLOGY
RANDOMIZED controlled trials
VISUAL analog scale
TREATMENT effectiveness
BLIND experiment
DATA analysis software
DESCRIPTIVE statistics
EFAVIRENZ-emtricitabine-tenofovir (Drug)
RILPIVIRINE
THERAPEUTICS
Subjects
Details
- Language :
- English
- ISSN :
- 10872914
- Volume :
- 28
- Issue :
- 4
- Database :
- Complementary Index
- Journal :
- AIDS Patient Care & STDs
- Publication Type :
- Academic Journal
- Accession number :
- 95394006
- Full Text :
- https://doi.org/10.1089/apc.2013.0310