Raltegravir tablets (Isentress, Merck) have been approved for the treatment of human immunodeficiency virus drug (HIV)-1 infection, in combination with other anti-retroviral agents, in patients who have received other therapies and who have evidence of viral replication and HIV-1 strains that are resistant to multiple antiretroviral agents.
Raltegravir is the first agent of the pharmacological class known as HIV integrase strand transfer inhibitors, which are designed to interfere with the enzyme needed by HIV-1 in order to multiply. When raltegravir is used with other anti-HIV medications, it may reduce the amount of HIV in the blood and may increase the number of white blood cells that help fight off other infections.
The FDA’s approval was based on two double-blind, placebo-controlled studies in 699 HIV-1 infected adults with a history of extensive antiretroviral use.
(Source: FDA, October 17, 2007.)