The FDA has approved a new non-nucleoside reverse transcriptase inhibitor (NNRTI) for use in treating persons with HIV who are resistant to other drugs in that class.
Etravirine, sold under the name Intelence, was developed by Tibotec Pharmaceuticals, a division of Johnson & Johnson. The announcement came on Jan. 18.
Existing drugs in the NNRTI class, nevirapine (Viramune) and efavirenz (Sustiva), are part of combination therapies that are widely used. However, experts say HIV develops resistance to them more rapidly than any other class of drugs.
Often only a single key genetic mutation is sufficient to confer resistance to both of those drugs.
The great strength of etravirine is that it works against the virus that has developed resistance to those two earlier drugs in the class, according to reports. In the DUET 1 and 2 clinical trials, patients resistant to the NNRTIs received an optimized background therapy and were randomized to receive either etravirine (599) or placebo (604) twice a day.
After 24 weeks, the patients receiving etravirine were more likely to have their viral load suppressed below 50 copies (59.8 percent vs. 40.2 percent), and had a greater increase in their CD4 T-cell count (81 vs. 64 T-cells).
Side effects generally were mild, according to study results. However, possible drug-to-drug interactions preclude its use with some drugs.
This article appeared in the Dallas Voice print edition January 25, 2008
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