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EDURANTâ„¢ 96-Week Phase 3 Safety and Efficacy Data Presented at International AIDS Society Conference

Tue, 07/19/2011 - 7:41am
Bio-Medicine.Org

TITUSVILLE, N.J., July 19, 2011 /PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP, presented today 96-week findings from two pivotal Phase 3 clinical trials, known as ECHO and THRIVE, comparing the efficacy, safety and virology profile of its non-nucleoside reverse transcriptase inhibitor (NNRTI) EDURANT™ (rilpivirine) tablets versus efavirenz (EFV) in antiretroviral treatment-naive, HIV-1-infected adults. The pooled analysis at 96 weeks showed that 78 percent of patients achieved and sustained an undetectable plasma viral load (HIV-1 RNA less than 50 copies/mL) while taking EDURANT as part of combination therapy. These findings were presented today at the 6th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Rome, Italy.

Pooled ECHO and THRIVE results for EDURANT and EFV, each administered once daily with a nucleoside/nucleotide background regimen in treatment-naive, HIV-1-infected adults, showed that 78 percent of patients in both the EDURANT arm (n=686) and the EFV arm (n=682) reached an undetectable viral load at 96 weeks.  These data demonstrated non-inferiority (12 percent margin) of EDURANT to EFV in lowering viral load in this population at 96 weeks, consistent with the 48-week primary analysis.  Patients taking EDURANT had a virologic failure rate of 14 percent compared to 8 percent experienced by patients taking EFV, of which 3 percent and 2 percent occurred in the second year of treatment, respectively.  Upon virologic failure, the emergence of resistance and cross-resistance to the NNRTI class was higher in the EDURANT arm compared to the EFV arm.

"Finding safe and tolerable regimens over an extended period of time is so important in HIV care, and it is encouraging to see that the 96-week data for EDURANT remain fairly consistent with what we have seen previously," said Calvin J. Cohen, M.D., M.Sc., lead clinical investigator of EDURANT Phase 3 trials and Rese

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