Questions and Answers on Atripla (efavirenz, emtricitabine, tenofovir)

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1. What is Atripla (efavirenz, emtricitabine, tenofovir)?

Atripla (efavirenz, emtricitabine, tenofovir), a fixed dose combination of three widely used antiretroviral drugs, to be taken as one tablet once a day, is indicated for use alone as a complete treatment option or in combination with other antiretroviral agents for the treatment of human immunodeficiency virus -1 (HIV-1) infection in adult patients.

2. Why is the approval of Atripla (efavirenz, emtricitabine, tenofovir) important?

The approval of Atripla is significant because it markedly simplifies the drug regimen for HIV-1 infected adults. This product offers a one pill, once a day treatment option for patients receiving antiretroviral therapy. There has been interest in simplifying treatment options which may potentially improve the patient�s ability to adhere to the treatment and result in long-term effective control of HIV-1.�

3. What is meant by a fixed-dose combination?

A fixed-dose combination package has two or three drugs in a single pill. Whereas a co-packaged product refers to two or three pills in a single package. Atripla combines three drugs (efavirenz, emtricitabine, tenofovir) in a single pill.

4. What were the efficacy results of the main studies that supported the indication?

The evidence of efficacy (viral load reduction and CD4+ cell count increase) of Atripla is based on the analyses of a 48 week-long clinical trial of 244 HIV-1 infected adult patients receiving the drugs contained in Atripla.

5. What does the FDA know regarding the safety profile of Atripla?

Each component (efavirenz, emtricitabine, and tenofovir) of Atripla is currently approved for use in combination with other antiretroviral agents to treat HIV-1 infected adults. The safety and effectiveness of each component were demonstrated in clinical trials to support their individual approval. FDA approved Sustiva (efavirenz) in 1998, Viread (tenofovir disoproxil fumarate) in 2001 and Emtriva (emtricitabine) in 2003. In addition, the safety and effectiveness of the combination of these three drugs were shown in a 48 week-long clinical study with 244 HIV-1 infected adults receiving the drugs contained in Atripla.

6. What adverse events are associated with Atripla?

The most common adverse events include headache, dizziness, abdominal pain, nausea, vomiting, and rash.

7. What other important safety information should I know about Atripla?

The labeling of Atripla includes a boxed warning that the drug�s use can cause lactic acidosis (buildup of an acid in the blood). Atripla is not indicated for use in patients with chronic Hepatitis B infection. However, discontinuation of the treatment for HIV-1 with Atripla in patients with chronic Hepatitis B infection can result in severe flare-ups of Hepatitis B infection. Other potential serious adverse events reported for the use of Atripla�s ingredients include serious liver toxicity, renal impairment and severe depression.