Tibotec said that TMC278 is an investigational product, and the safety and efficacy has not yet been established.
Echo (TMC278-TiDP6-C209) and Thrive (TMC278-TiDP6-C215) are pivotal Phase 3, double-blind, randomized studies that evaluated the efficacy, safety and tolerability of TMC278 in 1,368 treatment-naive, HIV-1-infected adults.
In the trials TMC278 and efavirenz (EFV) were administered once daily with a nucleoside/nucleotide background regimen in treatment-naive, HIV-1-infected adults.
In the Echo and Thrive trials, 84.3% of patients in the TMC278 group reached an undetectable viral load, compared with 82.3% of patients in the EFV group. The difference between the treatment groups was not significant.
Tibotec plans to submit the results to the FDA to support approval of TMC278 for use in treatment-naive adult patients.
Calvin Cohen, lead clinical investigator, said: “I’m very excited by the findings of these Phase 3 results for TMC278. These studies provide valuable information on the safety and tolerability of TMC278 and, specifically, its metabolic and CNS side effect profiles.”