New HIV Drug Sanctioned When Others Fail
MONDAY, Jan. 21 -- The anti-HIV medication etravirine has been approved by the U.S. Food and Drug Administration for adults who have failed treatment with other antiretrovirals.
Sold under the trade name Intelence, etravirine is a non-nucleoside reverse transcriptase inhibitor, which helps block an enzyme that the AIDS-causing virus needs to multiply, the FDA said in a statement. This is aimed at reducing the amount of HIV in the blood and boosting infection-fighting white blood cells.
In clinical testing, 599 adults who received etravirine and additional antiviral therapy had greater reductions in blood HIV levels than adults who received a non-medicinal placebo and the same additional therapy. The most common side effects reported were rash and nausea.
The long-term effects of etravirine haven't been studied, nor have the drug's effects in pregnant women or among people age 16 or younger, the agency said.
Etravirine is distributed by Tibotec Therapeutics, whose parent firm -- Ortho Biotech Products -- is based in New Jersey.
Here's more about this approval from the FDA.
Posted: January 2008