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Head-to-Head 96-Week Study Shows EPZICOM(R) is Comparable to Truvada(R) in Efficacy and Safety Measures in HIV Treatment-Naive Patients
Date:8/7/2008

MEXICO CITY, Aug. 7 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) today announced that 96-week data from the HEAT study show that once-daily EPZICOM (abacavir + lamivudine) provides comparable efficacy to once-daily Truvada(R) (tenofovir DF + emtricitabine) as a first-line option for the treatment of HIV. The data were presented today at the 17th International AIDS Conference in Mexico City, Mexico.

HEAT is the first large, prospective, long-term, head-to-head trial to evaluate the safety and efficacy of EPZICOM and Truvada both combined with a boosted protease inhibitor (Kaletra) administered once-daily in adults who had no previous exposure to HIV medicines. The study involved 688 HIV therapy-naive patients: 343 randomized to treatment with EPZICOM and 345 randomized to treatment with Truvada.

Results of the study found that through 96 weeks efficacy endpoints for EPZICOM were comparable to Truvada, regardless of baseline viral load. At 96 weeks 60% of subjects receiving EPZICOM versus 58% of subjects receiving Truvada achieved a viral load <50 c/mL. Patients receiving EPZICOM also experienced similar median CD4+ cell increases to those patients receiving Truvada, 250 vs. 247. Overall, both regimens were generally well-tolerated with comparable safety profiles and few study discontinuations due to adverse events (6% for both treatment arms). Virologic failure occurred in 14% of patients for both groups.

"The result of the HEAT trial further demonstrates that EPZICOM is an effective first-line option for treatment-naive HIV patients with a well-established safety profile," said John Pottage, M.D., Vice President Global Clinical Development at GlaxoSmithKline. "This study provides the first, head-to-head, completed study comparing these two HIV treatments and demonstrates comparable results between the two."

Additionally, a review of two important inflammatory biomarkers, hs-CRP and IL-6, in the HEAT data set showed that le
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SOURCE GlaxoSmithKline
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