Analysis of Six Clinical Trials Finds EPZICOM(R) Effective in Treatment-Naive HIV Patients With Both High and Low Baseline V...(rates of HIVviral load reduction with EP...),Health

Following these findings, the DSMB recommended unblinding patients receiving EPZICOM in the high viral load arm. Affected patients were notified of the results by the physicians and provided the option to stay on EPZICOM if the patient was having success with the regimen. The DSMB recommended that study participants with lower screening viral loads continue on their assigned blinded regimen and be followed in the study without change. The ACTG 5202 trial is ongoing and patients in the high viral load arm have the option to continue in the study, whereas those in the lower viral load group continue in the trial and remain blinded to their regimens.

"GlaxoSmithKline carefully considers any new information on our medicines and we are working closely with ACTG to understand why our analyses found conflicting results," said John Pottage, M.D., Vice President Global Clinical Development at GlaxoSmithKline. "This analysis, based on similar criteria to that utilized in ACTG 5202, demonstrates that EPZICOM continues to be an effective treatment option for treatment-naive patients. As always, physicians must consider each patient's individual health and treatment history when making treatment decisions."

Study Analysis Explained

GSK's retrospective analysis included 48-week data from six clinical trials in 2,940 treatment-naive HIV patients. Patients were analyzed based on baseline HIV viral load (<100,000c/mL and greater than or equal to 100,000c/mL) with a primary efficacy endpoint of time to virologic failure measured using Kaplan-Meier analysis. Virologic failure was defined as confirmed viral load greater than or equal to 1,000c/mL at or after 16 weeks and before 24 weeks, or viral load greater than or equal to 200c/mL at or after 24 weeks. These are similar to the virologic failure criteria used in ACTG
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