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GlaxoSmithKline Comments on Epzicom Data Concerning Epzicom from ACTG Study
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February 28, 2008 - GlaxoSmithKline today commented that data from The AIDS Clinical Trials Group (ACTG 5202) are inconsistent with previous clinical trial and other study experience with Epzicom (abacavir sulfate and lamivudine).
The ACTG study shows that both the Epzicom and Truvada arms were effective in reducing viral load in patients with HIV, yet the rates of reduction in viral load are slightly below what we have seen in GSK clinical data on Epzicom. Data from six GSK studies with 2,595 patients show higher viral load reduction (94% and above in patients with viral load 100,000 copies at 24 weeks) than was seen in the ACTG study. In addition, 48-week results from the recently reported HEAT study - directly comparing Epzicom to Truvada combined with Kaletra - showed treatment with Epzicom reduced viral load to the target at 24 weeks in 94% of patients, compared to 95% in the Truvada arm - a comparable level of effectiveness.
Importantly, across the GSK studies, viral reduction between patients with high (>100,000 copies) and low (<100,000 copies) viral loads was similar.
The following confounding factors in the ACTG study may account for the unexpected results:
-- The ACTG study did not routinely exclude patients at risk for a known reaction with Epzicom, which might have accounted for some adverse events recorded.
-- The ACTG did not test all patients for baseline resistance to treatment. GSK clinical trials have shown that resistance reduces the ability to achieve a reduction in viral load, particularly in combination with the NNRTI, efavirenz.
We understand that the ACTG study did not identify any safety signals not already noted in the product labeling, and that the ACTG study is continuing. The trial remains unchanged in those patients with viral loads <100,000. These patients with lower viral loads will continue the study on Epzicom if randomized to one of the treatment arms containing Epzicom. We understand that trial investigators will be allowed the choice of changing treatments for patients with the viral loads greater than 100,000 copies who do not achieve the target viral load reduction.
GSK does not believe the interim results of this single, ongoing study warrant a change to clinical practice. Epzicom offers a potent, effective, and generally well-tolerated HIV treatment backbone for many patients with HIV.
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