Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 06 September 2018

Indication(s)

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 aged 18 years and over 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-naïve or in heavily pretreated patients.
 
No data are available to support the combination of Atripla and other antiretroviral agents.

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Category Value
Agency product number EMEA/H/C/000797
Orphan designation No
Date First Approved 13-12-2007
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Bristol-Myers Squibb and Gilead Sciences Ltd.