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Analysis of Six Clinical Trials Finds EPZICOM(R) Effective in Treatment-Naive HIV Patients With Both High and Low Baseline Viral Loads
Date:8/7/2008

MEXICO CITY, Aug. 7 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) announced that a retrospective analysis of six clinical trials found that anti-HIV regimens containing EPZICOM (abacavir + lamivudine) were effective in treatment-naive patients regardless of baseline viral loads. One of the trials analyzed was a large study comparing treatment with regimens containing EPZICOM versus regimens containing Truvada(R) (tenofovir DF + emtricitabine) in treatment-naive patients with both high and low baseline viral loads. The analysis was presented today at the 17th International AIDS Conference in Mexico City, Mexico.

GSK examined six clinical trials with 2,940 treatment-naive patients on regimens containing either EPZICOM or its individual components over 48 weeks of treatment, including the HEAT study, a head-to-head clinical trial comparing EPZICOM to Truvada. Patients were analyzed according to baseline viral load (<100,000c/mL being low and greater than or equal to 100,000c/mL being high) and efficacy was determined by time to virologic failure. The definition of virologic failure was similar to that utilized in the ACTG 5202 study. At 48 weeks, 87-95% of all patients in the analysis did not meet the definition for virologic failure. An additional retrospective analysis of the HEAT study found similar results in both EPZICOM- and Truvada-containing regimens regardless of baseline viral load.

The analysis was conducted after interim data from a single, ongoing study by the AIDS Clinical Trials Group (ACTG 5202) found results inconsistent with previous experience with EPZICOM. A routine review of ACTG 5202 by the data safety monitoring board (DSMB) found that although both the EPZICOM and Truvada treatment arms were effective in reducing HIV viral load, a statistically higher rate of protocol-defined virologic failure and protocol-defined safety endpoints were seen in patients with high screening viral loads in the EPZICOM-treatment arm. The
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SOURCE GlaxoSmithKline
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