Atripla

RSS

efavirenz / emtricitabine / tenofovir disoproxil

Authorised
This medicine is authorised for use in the European Union.

Overview

Atripla is an antiviral medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).

It is only used in patients whose levels of HIV in the blood (viral loads) have been below 50 copies/ml for more than three months on their current HIV treatment combination. It must not be used in patients in whom previous HIV treatment combinations have not worked or have stopped working.

Atripla must not be started in patients with HIV that is resistant to any of the three active substances in Atripla.

The three active substances in Atripla are: efavirenz (600 mg), emtricitabine (200 mg) and tenofovir disoproxil (245 mg).

This EPAR was last updated on 11/12/2018

Authorisation details

Product details
Name
Atripla
Agency product number
EMEA/H/C/000797
Active substance
  • efavirenz
  • emtricitabine
  • tenofovir disoproxil fumarate
International non-proprietary name (INN) or common name
efavirenz / emtricitabine / tenofovir disoproxil
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AR06
Publication details
Marketing-authorisation holder
Bristol-Myers Squibb and Gilead Sciences Limited
Revision
30
Date of issue of marketing authorisation valid throughout the European Union
13/12/2007
Contact address
Unit 13, Stillorgan Industrial Park
Blackrock
Co. Dublin
Ireland

Product information

22/11/2018 Atripla - EMEA/H/C/000797 - II/0130

Contents

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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Atripla is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate. It is indicated for the treatment of human-immunodeficiency-virus-1 (HIV-1) infection in adults with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Atripla prior to initiation of their first antiretroviral treatment regimen.

The demonstration of the benefit of Atripla is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to Atripla.

No data are currently available from clinical studies with Atripla in treatment-naive or in heavily pretreated patients.

No data are available to support the combination of Atripla and other antiretroviral agents.

Assessment history

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