Tibotec unveils efficacy results for investigational HIV drug

VIENNA An investigational treatment for HIV made by Johnson & Johnson subsidiary Tibotec Pharmaceuticals works as well in adults receiving treatment for the first time as drugs already on the market, according to results of a late-stage clinical trial presented Thursday at the 18th International AIDS Conference in Vienna.

Pooled results of the “ECHO” and “THRIVE” phase 3 trials found that 84.3% of patients taking TMC278 (rilpivirine) achieved undetectable viral loads, compared with 82.3% of those taking Bristol-Myers Squibb’s Sustiva (efavirenz). More than 1,300 patients participated in the trials.

Though the differences in efficacy were not significant, fewer patients taking TMC278 appeared to experience side effects than those taking Sustiva, with adverse reactions leading to discontinuation of use occurring in 3.4% of patients taking TMC278, compared with 7.6% of those taking Sustiva. Other side effects possibly related to use of the drugs occurred in 15.9% of patients taking TMC278, compared with 31.1% of those taking Sustiva.

“I’m very excited by the findings of these phase 3 results for TMC278,” lead study investigator Calvin Cohen said. “These studies provide valuable information on the safety and tolerability of TMC278, and, specifically, its metabolic and [central nervous system] side effect profiles.”