FDA Approves Bristol Myers Squibb's Sustiva

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

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

Sustiva is an HIV medication. It is in a category of HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Sustiva prevents HIV from entering the nucleus of healthy CD4 cells. This prevents the cells from producing new virus and decreases the amount of virus in the body.

Sustiva was approved by the U.S. Food and Drug Administration for the treatment of HIV in 1998. It was originally produced by DuPont Pharmaceuticals and is now manufactured by Bristol-Myers Squibb for sale in the United States, Canada, and certain countries of the European Union. In Europe and many other parts of the world, Sustiva has a different brand name: Stocrin. Stocrin is manufactured by by Merck Sharp and Dohme. Stocrin and Sustiva are the same drug.

Sustiva must be used in combination with other drugs to treat HIV. It is usually combined with two nucleoside reverse transcriptase inhibitors (NRTIs).

Atripla, a combination tablet containing Sustiva and the NRTIs Viread (tenofovir) and Emtriva (emtricitabine), was approved for use in the United States in July 2006. Sustiva can still be purchased separately for use in combination with HIV drugs other than Viread, Emtriva, or Truvada (tenofovir and emtricitabine combined).

Efavirenz helps control your HIV infection, thereby improving your quality of life. It is used in combination with other anti-HIV medications. It helps to decrease the amount of HIV in your body so your immune system can work better. It also lowers your risk of getting HIV disease complications (such as new infections, cancer). Efavirenz belongs to a class of drugs known as non-nucleoside reverse transcriptase inhibitors (NNRTIs).

Efavirenz is not a cure for HIV infection and it does not prevent the spread of HIV to others through sexual contact or blood contamination (such as sharing used needles).

Sustiva was approved in 1998 in capsule formulation, for the treatment of human immunodeficiency virus (HIV) infection, in combination with other anti-retroviral agents. In February 2002, the tablet formulation of the drug was approved. It is now possible, instead of taking three 200 mg capsules once-daily, to take a single 600 mg tablet once-daily. Sustiva is listed by United States Department of Health and Human Services as the only non-nucleoside reverse transcriptase inhibitor "strongly recommended" for use in combination with nucleoside reverse transciptase inhibitors for HIV treatment.

Close to one million Americans are now infected with HIV, the virus that causes acquired immunodeficiency syndrome (AIDS). Each year only a little over one third of those infected receive anti-HIV treatments regimens. Most of those that do get treatment are forced to take numerous pills, often through out the day. Innovations in drug formulations, such as single once-daily doses of Sustiva, can help simplify daily dosing regimens.