Co-formulated efavirenz/emtricitabine/tenofovir (Atripla) is the first once-daily single tablet antiretroviral regimen approved in the United States and Canada. Prior studies have demonstrated the efficacy and safety of the components of Atripla, which is FDA-approved in the U.S. European regulators have issued a "positive opinion" on this fixed-dose combination.

Atripla can offer an option for antiretroviral regimen simplification to patients intolerant to or receiving more complex regimens.

In the current study, presented at the 11th European AIDS Conference (EACS) in Madrid (October 24-27, 2007), researchers evaluated whether patients with virological suppression who changed their current HAART regimen to the single-tablet Atripla regimen would have similar outcomes (efficacy, safety, and tolerability) compared with patients who remain on their unmodified HAART regimen through 48 weeks.

This was a Phase IV, multicenter, randomized, controlled study. Patients were on stable HAART (PI or NNRTI + 2 NRTIs ? 3 months) with HIV RNA < 200 copies/mL and no virological failures were randomized 2:1 (stratified by PI vs NNRTI use) to either switch to once-daily Atripla or stay on their baseline regimen.

The primary objective was to compare the proportions of patients with plasma HIV RNA <200 cps/mL at Week 48 in the 2 treatment arms using TLOVR (Time to Loss of Virological Response) analysis.

Assessments were based on intention-to-treat (ITT) analyses. The study used 2 statistical methods for the Week 24 analyses: missing = failure (M=F) and pure virological response (PVR) using Kaplan Meier method. Non-response for PVR was defined as 2 consecutive HIV RNA measurements > 50 and > 200 copies/mL or last observed HIV RNA measurement above threshold followed by study discontinuation.

Results

Conclusions

Orlando Immunology Center, Orlando, FL; Denver ID Consultants, Denver, CO; Gilead Sciences Inc., Foster City, CA; Bristol-Myers Squibb, Plainsboro, NJ, USA.

11/02/07

Reference
E DeJesus, B Young, A Fisher, and others. Virologic Suppression Is Maintained After Change To Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (EFV/FTC/TDF) vs. Continuation of Current Antiretroviral Therapy: Study 073 -Results of 24 24-week Interim Efficacy Analyses. 11th European AIDS Conference (EACS). Madrid, Spain. October 24-27, 2007. Abstract (late-breaker) PS7/6.