For Consumers

Changes to label for Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets

FDA approved updates to the Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablet label on 4/17/2013 to include the following information related to use with hepatitis drugs, boceprevir and telaprevir.

ATRIPLA is a combination of 2 nucleoside analog HIV-1 reverse transcriptase inhibitors and 1 non-nucleoside HIV-1 reverse transcriptase inhibitor, indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

Section 12.3 Pharmacokinetics

Boceprevir: Plasma trough concentrations of boceprevir were decreased when boceprevir was coadministered with efavirenz, which may result in loss of therapeutic effect. The combination should be avoided.

Telaprevir: Concomitant administration of telaprevir and efavirenz resulted in reduced steady-state exposures to telaprevir and efavirenz.

Atripla is a product of Gilead Sciences and Bristol-Myers Squibb.

The complete, revised labeling can be viewed at Drugs@FDA.

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

Page Last Updated: 09/15/2014
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