FDA Approves Merck Sharp Dohme's Isentress

Isentress is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Isentress is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Raltegravir is not a cure for HIV or AIDS.

Isentress is an integrase inhibitor manufactured by Merck & Company. It was approved by the U.S. Food and Drug Administration (FDA) in October 2007. Isentress is approved both for treatment-experienced patients who have HIV strains that are resistant to multiple antiretroviral (ARV) drugs and for people with drug-sensitive HIV strains, such as those starting antiretroviral therapy for the first time.

After HIV's genetic material is deposited inside a cell, its RNA must be converted (reverse transcribed) into DNA. A viral enzyme called integrase then helps to hide HIV's DNA inside the cell's DNA. Once this happens, the cell can begin producing genetic material for new viruses. Integrase inhibitors, such as Isentress, are designed to block the activity of the integrase enzyme and to prevent HIV DNA from meshing with healthy cell DNA.

Isentress must be used in combination with other HIV drugs.

Isentress is an orally available human immunodeficiency virus integrase strand transfer inhibitor. Once a cell is infected with HIV, its RNA must be converted (reverse transcribed) into DNA. Integrase, a viral enzyme, helps to hide HIV's DNA inside the cell's DNA. Integrase inhibitors work by blocking this process, known as integration. Thus, Isentress prevents HIV DNA from entering healthy cell DNA.

Isentress, in combination with other antiretroviral agents, is specifically indicated 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.

Isentress is supplied as a tablet designed for oral administration. The recommended initial dose of the drug is 400 mg administered orally, twice daily with or without food.