FDA has approved Atripla, an once-a-day three-drug combination in HIV-1 infection


The FDA ( Food and Drug Administration ) has approved Atripla, a fixed-dose combination of three widely-used antiretroviral drugs, in a single tablet taken once a day, alone or in combination with other antiretroviral products for the treatment of HIV-1 infection in adults.

Atripla, the first one-pill, once-a-day product to treat HIV/AIDS, combines the active ingredients of Efavirenz ( Sustiva ), Emtricitabine ( Emtriva ) and Tenofovir disoproxil ( Viread ).

" The approval of Atripla simplifies the treatment regimen for HIV-1 infected adults, and will potentially improve the ability of patients to adhere to treatment resulting in long-term effective control of HIV-1. This offers a particularly important advantage for patients in many countries that are most affected by the AIDS epidemic and will also have a major impact in the U.S.," said Andrew C. von Eschenbach, the Acting Commissioner of Food and Drugs.

FDA approved Sustiva in 1998, Viread in 2001 and Emtriva in 2003.

The safety and effectiveness of the combination of these three drugs were shown in a 48 week clinical study with 244 HIV-1 infected adults receiving the drugs contained in Atripla.
In this trial, 80 percent of the participants achieved a marked reduction of the human immunodeficiency virus and a substantial increase in the number of healthy CD4 cells.

The labeling of Atripla includes a boxed warning that the drug's use can cause lactic acidosis.

In patients with chronic hepatitis B infection, the discontinuation of the treatment with Atripla ( which is not approved for this use ) 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.

The most common adverse events experienced by participants in the combination trial included headache, dizziness, abdominal pain, nausea, vomiting and rash.

There are more than a million people living with HIV and AIDS in the United States today and 40,000 new cases are reported each year.
Currently, there are 28 FDA approved products in the United States used in the treatment of HIV infection.

Source: FDA, 2006


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