Head-to-Head 96-Week Study Shows EPZICOM(R) is Comparable to Truvada(R) in Efficacy and Safety Measures in HIV Treatment-Naiv...(vels of both biomarkersdecreased from ba...),Health

Date:8/7/2008

vels of both biomarkers decreased from baseline at 48 weeks and 96 weeks. Further, there were no significant differences between EPZICOM and Truvada at any time points. Elevations of these markers have been associated with increased risk of cardiovascular events but the degree of association is still being evaluated.

HEAT Study Explained

HEAT is a head-to-head prospective, randomized, double-blind, placebo-matched, multicenter study evaluating the safety and efficacy of EPZICOM and Truvada. The study assigned 688 patients to receive either EPZICOM QD (n=343) or Truvada QD (n=345) both in combination with QD lopinavir/ritonavir. The primary efficacy endpoint was to determine the proportion of subjects with a viral load of <50 c/mL at 48 weeks and the primary safety endpoint was to evaluate safety and tolerability of both regimens at 96 weeks.

Results demonstrate that EPZICOM was comparable to Truvada in virologic and immunologic efficacy. At 48 weeks, 68% of subjects receiving EPZICOM versus 67% of subjects receiving Truvada achieved a viral load <50c/mL. At 96 weeks 60% of subjects receiving EPZICOM versus 58% of subjects receiving Truvada achieved a viral load <50c/mL. Of those patients who were able to achieve a viral load <50c/mL (ITT, M=F), both EPZICOM and Truvada saw similar success rates regardless of whether baseline viral load was <100,000c/mL (63% vs. 58%) or greater than or equal to 100,000c/mL (56% vs. 58%). Median CD4+ increase was comparable in both arms at week 96 (250 vs. 247).

Adverse events were similar in both arms. Both treatment arms had 6% of patients prematurely withdraw due to adverse events. In addition, 15% of patients had drug-related Grade 3-4 adverse events in both treatment arms. Patients receiving EPZICOM reported higher rates of suspected abacavir hypersensitivity reaction compared with Truvada (4% vs. <1%). Prospective HLA-B*5701 screening was not employed in this study. One percent of patients receiving T
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SOURCE GlaxoSmithKline Copyright©2008 PR Newswire. All rights reserved

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