FDA Approves Gilead's Atripla

Atripla (efavirenz, emtricitabine, and tenofovir) is an antiviral medication that prevents human immunodeficiency virus (HIV) from reproducing in your body.

It contains a combination of 3 reverse transcriptase inhibitors. It works by slowing the growth of HIV, the virus that causes AIDS.

Atripla treats HIV, which causes acquired immunodeficiency syndrome (AIDS). Atripla is not a cure for HIV or AIDS.

Atripla may also be used for other purposes not listed in this medication guide.

Atripla is a fixed dose combination drug for the treatment of HIV infection. It combines Gilead Sciences's tenofovir and emtricitabine (already available in the anti-HIV combination Truvada) with Bristol-Myers Squibb's efavirenz into a fixed-dose pill. Combining the three drugs into a single, once-daily pill reduces pill burden and simplifies dosing schedules, and therefore has the potential to increase adherence to antiretroviral therapy.

Atripla is the first multi-class antiretroviral drug available in the United States and represents the first collaboration between two U.S. pharmaceutical companies to combine their patented anti-HIV drugs into one product. The drug retails in the United States for US$1,400 for a one-month supply. As off 2007, annual cost in India is US$1,344, and US$528 in Africa. It was approved by the U.S. FDA on July 12, 2006. In the UK, the drug cost to the NHS is GB£620 per month.

Atripla is a fixed dose combination of 600 mg efavirenz, 300 mg tenofovir, and 200 mg emtricitabine. In adults, it is taken once daily on an empty stomach. Dosing at bedtime is recommended to improve tolerability of nervous system symptoms. Atripla is not recommended for patients under 18 years of age.

ATRIPLA contains three HIV medicines in one pill: SUSTIVA® (efavirenz), EMTRIVA® (emtricitabine) and VIREAD® (tenofovir disoproxil fumarate). This combination works to help lower the amount of HIV in the blood (called viral load) by interfering with the way HIV makes copies of itself (called viral replication). Lowering the amount of HIV in the blood may also help increase the number of T-cells (also called CD4+ cells). CD4+ cells are an important part of your immune system because they help the body fight infections.

For many patients, ATRIPLA may be a complete regimen, with three medicines from two different "classes," or types of drug, in one pill. For some patients, ATRIPLA may be taken with other medicines to treat HIV-1. ATRIPLA contains two NRTIs (emtricitabine and tenofovir disoproxil fumarate) and one NNRTI (efavirenz). Regimens that combine HIV medicines from different classes are effective because they help to slow HIV multiplication during several stages of the process.

ATRIPLA does not cure HIV-1 and has not been shown to prevent passing HIV-1 to others.

The FDA approved Atripla for the treatment of HIV-1 infection in adults on July 12, 2006. Atripla is a fixed-dose combination tablet containing three antiretroviral medications that belong to two separate classes of drugs:
NNRTIs (non-nucleoside reverse transcriptase inhibitors): efavirenz and
NRTIs (nucleoside/nucleotide reverse transcriptase inhibitors): emtricitabine and tenofovir.

One tablet of Atripla is equivalent to one 600 mg tablet of the NNRTI efavirenz, and one tablet of Truvada, a fixed-dose combination tablet containing two NRTIs, emtricitabine 200 mg and tenofovir disoproxil fumarate (tenofovir DF) 300 mg.

Prior to the development of Atripla, these 3 FDA-approved antiretrovirals have been administered as separate pills in combination for the treatment of HIV infection.