The FDA has approved Edurant (rilpivirine tablets; Tibotec Therapeutics) for use in combination with other antiretroviral agents in the treatment of HIV-1 in antiretroviral treatment-naive adult patients. Edurant, a diarylpyrimidine non-nucleoside reverse transcriptase inhibitor (NNRTI), inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase.
This approval was based on safety and efficacy analyses from Week 48 of two ongoing, randomized, double-blinded, active controlled, global Phase 3 trials, and Week 96 safety and efficacy analyses from a Phase 2b trial in treatment-naive patients. In the 48-week pooled analysis, 83% of patients (n=686) taking Edurant as part of combination therapy reached an undetectable viral load (less than 50 copies), compared with 80% of patients (n=682) in the efavirenz arm. The virologic failure rate was 13% in the Edurant arm and 9% in the efavirenz arm. The virologic failure rates were similar in both groups when the baseline viral load was less than or equal to 100,000 copies/mL, but were higher in patients in the Edurant arm who had higher baseline viral loads (>100,000). Upon virologic failure, the emergence of resistance and cross-resistance to the NNRTI class was higher in the Edurant treated subjects compared to the efavirenz arm.
Edurant will be available as a tablet in a 25mg dosage strength.
For more information call (877) 732-2488 or visit www.tibotectherapeutics.com.