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FDA OK's Merck's Isentress to treat drug-resistant HIV

WHITEHOUSE STATION, N.J. - Merck & Co. said yesterday the Food and Drug Administration approved its Isentress twice-daily tablets as a treatment for patients who have strains of HIV resistant to multiple antiretroviral drugs.

Isentress is the first of a new class of antiretroviral drugs called integrase inhibitors, which work to prevent the virus from inserting its DNA into human DNA, thereby stunting its ability to replicate and infect new cells.

Drugs currently on the market inhibit two other enzymes critical to the HIV replication process - protease and reverse transcriptase - but Merck says Isentress is the only approved treatment which inhibits the integrase enzyme.

The FDA approval was based on a 24-week analysis of clinical trials that included nearly 700 patients.

Merck said it worked closely with the HIV community on pricing, and has priced Isentress at $27 per day, or less than $10,000 a year.

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