FDA Approves Gilead's Truvada

Truvada contains a combination of emtricitabine and tenofovir.

Emtricitabine and tenofovir are antiviral drugs that work by preventing HIV (human immunodeficiency virus) cells from multiplying in the body.

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

Truvada is an HIV medication. It is in a category of HIV medicines called nucleoside reverse transcriptase inhibitors (NRTIs). Truvada prevents HIV from altering the genetic material of healthy CD4 cells. This prevents the cells from producing new virus and decreases the amount of virus in the body.

Truvada is marketed by Gilead Sciences. It was approved by the U.S. Food and Drug Administration (FDA) for use by people living with HIV in August 2004.

Truvada is a combination of two drugs: 300mg of Viread (tenofovir DF) and 200mg of Emtriva (FTC). Truvada should be prescribed by a healthcare provider for patients who need both of these drugs. Both of these drugs can still be purchased individually for use in combination with other HIV drugs.

Truvada must be combined with at least one other HIV drug, usually a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI).

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

Both the Viread and the Emtriva in Truvada are active against the hepatitis B virus (HBV), the virus responsible for causing hepatitis B. Although Emtriva and Viread have not been approved by the FDA for the treatment of hepatitis B, some doctors may prescribe Truvada to treat both hepatitis B and HIV. See What about side effects? below for more important information regarding Viread, Emtriva, and hepatitis B.

Truvada is a pill that contains two drugs used to fight HIV: Tenofovir (Viread) and emtricitabine (Emtriva). Truvada is manufactured by Gilead Sciences. Generic versions have been tentatively approved under PEPFAR (see fact sheet 475.)

The drugs in Truvada are called nucleoside analog reverse transcriptase inhibitors, or nukes. These drugs block the reverse transcriptase enzyme. This enzyme changes HIV’s genetic material (RNA) into the form of DNA. This has to occur before HIV’s genetic code gets inserted into an infected cell’s own genetic codes.

Truvada® (emtricitabine and tenofovir disoproxil fumarate) is a prescription medication used as a treatment for HIV and AIDS. It is approved for use only in combination with other HIV medications. Truvada contains two different medications: emtricitabine (Emtriva®) and tenofovir (Viread®).