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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