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news.Merck Frosst has reported that Health Canada has granted a notice of compliance with conditions to Isentress for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.
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The notice of compliance with conditions is based on an analysis of clinical trials in which raltegravir, in combination with other antiretroviral agents, was shown to be effective at reducing viral load and increasing CD4 cell counts, the two most widely recognized measures of efficacy against HIV/AIDS infection. Isentress (raltegravir) has been issued marketing authorization with conditions, pending the results of studies to verify its clinical benefit.
Raltegravir is the first medicine said to be approved in a new class of antiretroviral drugs called integrase inhibitors. Raltegravir is administered as a single 400mg tablet taken twice daily with or without food with other HIV medications.
Mark Wainberg, director of McGill AIDS Centre, said: “Isentress can make a difference in the lives of many patients who can no longer be adequately treated by traditional therapies.”