Atripla Label Adds Drug Interactions with Hepatitis C Protease Inhibitors Boceprevir and Telaprevir

The U.S. Food and Drug Administration (FDA) announced this week that the product label information for Atripla -- the HIV single-tablet regimen containing efavirenz/tenofovir/emtricitabine -- has been updated to include information about drug-drug interactions with the hepatitis C virus protease inhibitors boceprevir (Victrelis) and telaprevir (Incivek or Incivo).

The revised label states that co-administration reduces boceprevir concentrations and the drugs should not be used together. Co-administration with telaprevir also lowers drug levels, but the label does not recommend avoiding the combination.

Below is an edited excerpt from the FDA announcement of the changes.

Changes to Label forAtripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets

FDA recently approved updates to the Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablet label 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.

4/26/13

Source

R Klein, K Struble, and S Morin, FDA. Changes to Label forAtripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets. FDA Hepatitis Update. April 25, 2013.