Tibotec Pharmaceuticals announced results from its two Phase 3 trials of TMC278 (rilpivirine) in treatment-naive, HIV-1-infected adults. These studies were double-blind, randomized clinical trials comparing the efficacy, safety and tolerability of TMC278 versus efavirenz (EFV), each administered once daily with a nucleoside/nucleotide background regimen in 1368 patients. These global trials, known as ECHO and THRIVE, reached their primary objective, which was to demonstrate non-inferiority of TMC278 vs. EFV in the proportion of patients achieving an undetectable viral load (less than 50 copies/mL) at week 48 (with a maximum allowable difference of 12 percent). ECHO and THRIVE pooled results showed that 84.3 percent of patients (n=686) in the TMC278 group reached an undetectable viral load, compared with 82.3 percent of patients (n=682) in the EFV group. The difference between the treatment groups was not significant.
TMC278 is an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) currently in development for use in treatment-naive HIV-1-infected adults.
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