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FDA OKs New HIV Drug Isentress

Isentress Is First FDA Approval in a New Class of HIV Drugs
By
WebMD Health News
Reviewed by Louise Chang, MD

FDA New HIV Drug

Oct. 16, 2007 -- The FDA has approved Isentress, the first in a new class of HIV drugs. Merck, the drug company that makes Isentress, announced the drug's approval in a news release.

Isentress targets an enzyme called integrase to make it harder for HIV (the virus that causes AIDS) to copy and infect new cells.

Isentress (raltegravir) is approved for use in combination with other HIV drugs. Patients would take a 400-milligram tablet of Isentress twice daily.

In two ongoing studies of nearly 700 HIV patients already on a combination of HIV drugs, Isentress worked better than a placebo over 24 weeks, according to Merck.

Isentress doesn't cure HIV or stop HIV from spreading among people.

The most common adverse events reported in Isentress studies were diarrhea, nausea, headache, and fever.

Isentress will be available at pharmacies in about two weeks, according to Merck.

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