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FDA Approves New HIV Drug for Hard-to-Treat Patients

The U.S. Food and Drug Administration (FDA) has approved etravirine (brand name INTELENCE™) tablets to treat HIV infection in adults who have been treated unsuccessfully with other antiretroviral therapies. Etravirine, which is distributed by Tibotec Therapeutics, is approved for use in combination with other anti-HIV medications. It belongs to the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs).

When used with other therapies, NNRTIs can inhibit the replication of HIV in the blood by blocking an enzyme the virus needs to multiply. According to the FDA, approval was based largely on two randomized, double-blind, placebo-controlled trials involving 599 adult patients undergoing 24 weeks of anti-HIV therapy. Both studies showed that a greater number of patients on the etravirine/combination regimen had decreased HIV levels in their blood than those receiving a placebo/combination therapy. 

“This is another significant new product for many HIV-infected patients who are
NNRTI–resistant and whose infections are not responding to currently available medications,” said Debra B. Birnkrant, MD, director of the FDA’s Division of Antiviral Products.

The most common side effects of the drug were nausea and skin rashes. Patients who develop a rash while taking INTELENCE™ should call their physician.

Tibotec Therapeutics, which is based in Bridgewater, NJ, is a division of Ortho Biotech Products, L.P.

Read the FDA release

Source: FDA news release dated January 18, 2008


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