Etravirine Approved to Treat Drug-Resistant HIV

By Michael Smith
ROCKVILLE, Md., Jan. 21 -- The FDA has approved etravirine (Intelence) as adjunct therapy for HIV patients who have failed to respond to other treatments.
A novel non-nucleoside reverse transcriptase inhibitor (NNRTI), etravirine was shown to be effective against strains resistant to other NNRTIs.
The drug, also known as TMC125, had been given priority review by the FDA.
The approval is based mainly on data from 599 highly treatment-experienced adults in two international, randomized, double-blind, placebo-controlled trials, DUET-1 and DUET-2. In those trials, researchers tested the protease inhibitor darunavir (Prezista) against the combination of darunavir and etravirine and found that the proportion of patients reaching an undetectable level of HIV -- defined as fewer than 50 copies of HIV RNA per milliliter of blood -- was 17% higher for patients on the combination in DUET-1 and 18% higher in DUET-2.
Typically, patients in the two trials had been treated with up to a dozen HIV drugs, had suffered one or more AIDS-defining illnesses, and had a CD4 cell count of about 100 per microliter of blood.
Their HIV also tended to be highly resistant to treatment -- two-thirds of the patients had two or more mutations that caused NNRTI resistance and half had four or more mutations that generated resistance to protease inhibitors.
The most common adverse events with etravirine were rash and nausea and the FDA said patients developing a rash while on the drug should contact a doctor.
During the development of the drug, some patients also developed serious skin reactions, such as Stevens-Johnson syndrome and erythema multiforme, but such cases were rare.
The FDA noted that the long-term effects of etravirine are not known, and its safety and effectiveness in children ages 16 or younger has not been studied.
Nor has the drug been studied in pregnant women.
Etravirine is distributed by Tibotec Therapeutics, a division of Ortho Biotech Products.