EPARs human use - Atripla//efavirenz / emtricitabine / tenofovir disoproxil (as fumarate)

FICHA FARMACOLÓGICA de efavirenz / emtricitabine / tenofovir disoproxil (as fumarate). Contiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Cerasale. MAYO 18, 2009.-

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EPARs for authorised medicinal products for human use - Atripla

Active Substance
efavirenz / emtricitabine / tenofovir disoproxil (as fumarate)
International Nonproprietary Name or Common Name
efavirenz / emtricitabine / tenofovir disoproxil fumarate
Pharmaco-therapeutic Group
Antivirals for treatment of HIV infections, combinations
ATC Code
J05AR06

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 (see SPC sections 4.4 and 5.1).

The demonstration of the benefit of Atripla is primarily based on 24‑week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to Atripla (see SPC section 5.1). 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.

Date of issue of Marketing Authorisation valid throughout the European Union
13 December 2007