FDA Approves Tibotec's Intelence

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

Intelence is used with other medications to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Intelence is not a cure for HIV or AIDS.

Intelence is usually given after other antiviral drugs have been tried without successful treatment of HIV.

Intelence is a non-nucleoside reverse transcriptase inhibitor (NNRTI) manufactured by Tibotec Therapeutics, a division of Centocor Ortho Biotech products, LP. It was approved by the U.S. Food and Drug Administration (FDA) in January 2008. Intelence is approved for treatment-experienced patients who have HIV strains that are resistant to an NNRTI and other HIV drugs. It is not yet approved for people starting antiretroviral therapy for the first time.

Intelence works by blocking HIV’s reverse transcriptase enzyme. After HIV's genetic material is deposited inside a cell, its RNA must be converted (reverse transcribed) into DNA. NNRTIs stop this process and prevent HIV from infecting the CD4 cell and producing new virus particles.

Intelence must be used in combination with other HIV drugs.

Intelence is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1). Reverse transcriptase a viral DNA polymerase enzyme that HIV needs to reproduce. Intelence blocks the enzymatic function of reverse transcriptase and prevents completion of synthesis of the double-stranded viral DNA ,thus preventing HIV from multiplying.

Intelence, in combination with other antiretroviral agents, is specifically indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents.

Intelence is supplied as a tablet designed for oral administration. The recommended initial dose of the drug is 200 mg (two 100 mg tablets) taken twice daily following a meal. If a patient is unable to swallow a tablet whole, it may be dispersed in a glass of water.