Janssen presents EDURANT 96-week Phase 3 trial data at International AIDS Society Conference

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.

"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 Research Director at Community Research Initiative of New England and Harvard Vanguard Medical Associates.  "EDURANT remains an important new option for treatment-naive patients and their physicians."

Adverse events (AEs) leading to discontinuation in the EDURANT arm were 4 percent compared to 9 percent in the EFV arm, and there were no new safety concerns with either NNRTI between 48 and 96 weeks.  The most common AEs of interest (all grades) reported in the EDURANT arm vs. the EFV arm at week 96 included dizziness (8 percent vs. 27 percent), abnormal dreams/nightmares (8 percent vs. 13 percent) and rash (4 percent vs. 15 percent).  The incidence of Grade 2-4 AEs at least possibly related to treatment over at least 96 weeks was 17 percent in the EDURANT arm vs. 33 percent in the EFV arm.