Truvada emtricitabine/tenofovir: Interim Phase IIIb data

Interim data from an ongoing, double-blind, U.S. Phase IIIb trial ACTG A5202 in 797 patients with screening HIV-1 RNA levels >=100,000 copies/mL showed that time to virologic failure was significantly shorter for Epzicom abacavir/lamivudine vs. Truvada (p<0.001). Epzicom led to virologic failure in 57 (14%) patients compared with 26 (7%) for Truvada. Time to first adverse event also was significantly shorter for Epzicom vs. Truvada (p<0.001). The trial, which was sponsored by NIH's National Institute of Allergy and Infectious Diseases (NIAID), enrolled 1,858 patients. Patients received Epzicom plus either Sustiva efavirenz or Reyataz atazanavir boosted with Norvir ritonavir or Truvada plus either Sustiva or Reyataz boosted with Norvir. Data were published in the New England Journal of Medicine. Last year, an independent DSMB recommended unblinding a portion of the trial and counseling patients receiving Epzicom about their treatment options because of the rate of virologic failure (see BioCentury, March 3, 2008). ...