TMC278 was approved in May 2011 by the US Food and Drug Administration, in combination with other antiretroviral (ARV) medications, for treatment of adults with HIV infection who are new to ARV therapy.
The trials compared the efficacy, safety and virology profile of its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine) versus efavirenz (EFV).
The Pooled ECHO and THRIVE results at 96 weeks showed that 77.6% of patients in both the TMC278 arm (n=686) and the EFV arm (n=682) reached an undetectable viral load at 96 weeks.
Patients taking TMC278 had a virologic failure rate of 14% compared to 7.6% experienced by patients taking EFV, of which 3.2% and 2.3% occurred in the second year of treatment, respectively.
Chelsea and Westminster Hospital Clinical Trials HIV Medicine and Clinical Lead consultant Marta Boffito said these results suggest that TMC278 may provide a welcome new option for treatment-naïve patients and their physicians.
The drug will be marketed in the US as EDURANT.