As widely reported yesterday, an advisory committee to the FDA has unanimously voted to recommend approval for Isentress—the first of a new class of antiviral drug known as an integrase inhibitor—for use in people who’ve developed resistance to other drugs.
Isentress (raltegravir) blocks the insertion of HIV’s genetic material into the immune cell’s DNA, preventing immune cells from becoming “viral factories.” In studies presented to the FDA to support the drug’s approval, Isentress (plus a combination of other antiretrovirals) rendered HIV levels undetectable in up to 62 percent of treatment-experienced patients. Fewer than 36 percent of those who received a placebo plus other drugs had the same result.
Matt Sharp, a long time AIDS treatment activist who has been living with HIV for nearly twenty years, testified before the advisory committee in support of Isentress’s approval. He said, “(Before starting Isentress) I knew I was once again completely out of options as I had been many times before.…My case shows that raltegravir…will save lives.”
Isentress was generally well tolerated in studies; rash, nausea and diarrhea are its most common side effects. People taking Isentress were slightly more likely to be diagnosed with cancer than those taking the placebo. Though the committee debated the implications of this finding, they decided that the drug was unlikely to significantly increase the risk of cancer in those taking it, and therefore were unanimous in recommending that the FDA approve it. The FDA is expected to accept the panel’s recommendation and approve Isentress sometime before mid-October.
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