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Published on 22 January 2008

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FDA approves new HIV treatment

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The Food and Drug Administration (FDA) has approved Intelence (etravirine) for the treatment of HIV in adults who have failed to respond to other antiretrovirals.

The medication is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that helps to block an enzyme which the HIV disease needs to multiply.

Intelence was approved to be used in combination with other HIV drugs as it reduces the amount of HIV in the blood and increases white blood cells that help fight off infections.

Studies also show it can reduce the risk of death or infections that can occur when a patient’s immune system is weakened.

The FDA has come to its decision after looking at data from two randomised, double-blind, placebo-controlled trials.

After 24 weeks of treatment, more of the patients who received Intelence along with background therapy had less HIV in their blood than those who received a placebo.

The most common side-effects were rash and nausea, although some patients have previously reported cases of serious skin reactions such as Stevens-Johnson syndrome and erythema multiforme.

Dr Debra Birnkrant, the director of the FDA’s Division of Antiviral Products, said: “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.”

Copyright © PA Business 2008

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