|
Atripla 600-200-300 mg
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.
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.
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.
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.
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.
|
