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Three-year Safety and Efficacy of Emtricitabine (FTC)/Tenofovir DF (TDF) and Efavirenz (EFV) Compared to Fixed Dose Zidovudine/Lamivudine
(AZT/3TC) and EFV in Antiretroviral Treatment-Naive Patients
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Reported by Jules Levin
4th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention
July 22-25, 2007, Sydney, Australia
Poster Number
WEPEB029
JR Arribas,1 AL Pozniak,2 JE Gallant,3 E DeJesus,4 R Campo,5 SS Chen,6 D McColl,6
AK Cheng,6 and J Enejosa6 for the Study 934 Team
1Univ Hosp La Paz, Madrid, Spain; 2Chelsea & Westminster Hosp, London, UK;
3Johns Hopkins Univ School of Medicine, Baltimore, MD, USA;
4Orlando Immunology Center, Orlando, FL, USA; 5Univ Miami, Miami, FL, USA;
6Gilead Sciences, Inc., Foster City, CA, USA
AUTHOR CONCLUSIONS
The FTC/TDF+EFV arm was associated with significantly greater virologic suppression to HIV RNA < 400 c/mL
--Significantly less M184V/I was seen in the FTC/TDF+EFV arm
--No emergence of K65R mutation was demonstrated
--No patient discontinued due to renal adverse events ("adequate renal function at baselineÓ)
FTC/TDF+EFV was associated with significantly lower elevations in fasting cholesterol and triglycerides
Limb fat was significantly higher in the FTC/TDF+EFV arm than in the AZT/3TC+EFV arm at Weeks 96 and 144
There was a significant decrease in limb fat in the AZT/3TC+EFV arm and a significant increase in the FTC/TDF+EFV arm among patients with data at Weeks 48 and 144
Figure 1. Study Design
517 ART-naive patients were randomized to TDF/FTC+EFV QD or AZT/3TC bid + EFV qd.
--Adequate Renal and Hepatic Function at baseline
--FTC/TDF fixed dose combination tablet was used from Week 96-144;
--EFV/FTC/TDF fixed dose combination from Week 144
METHODS
Statistical Analysis
Non-inferiority trial with 48 week primary endpoint
Efficacy endpoint: Time to Loss of Virologic Response (TLOVR)
--Similar to ITT Missing = Failure, Switch = Failure (switching EFV to NVP due to CNS toxicity was not considered failure)
Week 144 Efficacy Population:
--Patients with baseline NNRTI-R mutations (n = 22) and patients who completed
Week 48 and Week 96 of the study with HIV RNA below limit of quantifi cation
but did not consent to participate in the study extension after Weeks 48 and 96
(n = 31) were excluded from Week 144 analysis
Results from analysis of Week 144 data are presented
STUDY POPULATION: 517 were randomized, 6 patients never dosed; 511 were safety population (2 patients treatment-experienced); ITT N=509.
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