Integrase Inhibitor Gains FDA Approval (10/12)

[pinto]

:applause:

BETHESDA, MD, 15 October 2007 — Merck on Friday announced the approval of raltegravir, an HIV integrase inhibitor, as part of a combination regimen in treatment-experienced HIV-infected adults whose virus is active and resistant to multiple antiviral agents.

The product, which will be marketed as Isentress, is the first in its class and brings to six the number of antiretroviral drug classes available to U.S. patients for the treatment of HIV infection. Merck expects raltegravir to be available in pharmacies within two weeks.

Integrase is an HIV-1 enzyme that allows the virus to integrate its DNA into the cellular DNA of host cells, a critical part of the viral replication process. The FDA-approved labeling (PDF) for raltegravir describes the drug as an integrase strand inhibitor that blocks viral propagation.

Raltegravir was tested in clinical trials in patients 16 years or older whose HIV infection was characterized by resistance to at least one nonnucleoside reverse transcriptase inhibitor, one nucleoside reverse transcriptase inhibitor, and one protease inhibitor. Study participants were given an optimized regimen with or without raltegravir. Some treatment regimens included tipranavir and darunavir, which were investigational drugs at the time the studies began.

http://www.ashp.org/s_ashp/article_news.asp?CID=167&DID=2024&id=22441