Atripla

efavirenz / emtricitabine / tenofovir disoproxil

  • Email
  • Help

About

An overview of Atripla and why it is authorised in the EU

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).

How is Atripla used?

Atripla can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.

The recommended dose of Atripla is one tablet once a day. It is recommended that Atripla is taken on an empty stomach, preferably at bedtime. Patients should take the medicine regularly and not miss doses.

For more information about using Atripla, see the package leaflet or contact a doctor or pharmacist.

How does Atripla work?

Atripla contains three active substances: efavirenz, which is a non‑nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug’ of tenofovir, meaning that it is converted into the active substance tenofovir in the body. Tenofovir is a nucleotide reverse transcriptase inhibitor. Both nucleoside and nucleotide reverse transcriptase inhibitors are commonly known as NRTIs. All three active substances block the activity of reverse transcriptase, an enzyme produced by HIV that allows the virus to infect cells and make more viruses. Atripla keeps the amount of HIV in the blood at a low level. It does not cure HIV infection or AIDS, but it can hold off damage to the immune system and the development of infections and diseases associated with AIDS.

In the European Union (EU), efavirenz has been approved since 1999, emtricitabine has been approved since 2003, and tenofovir disoproxil has been approved since 2002.

What benefits of Atripla have been shown in studies?

The main study of Atripla included 300 patients whose HIV infection was already being successfully treated with various combinations of antiviral medicines. The study compared the effectiveness of switching to Atripla tablets with that of continuing their successful HIV treatment combination. The main measure of effectiveness was the proportion of patients whose viral loads were below 200 copies/ml after 48 weeks. The study showed that switching to Atripla was as effective as remaining on the previous treatment combination. After 48 weeks, 89% of the patients taking Atripla (181 out of 203) and 88% of those remaining on previous treatment (85 out of 97) had viral loads below 200 copies/ml.

Another study, which looked at how the combined tablet was absorbed in the body, showed that the combination tablet was absorbed in the same way as the separate medicines, when they were taken on an empty stomach.

What are the risks associated with Atripla?

The most common side effects with Atripla (which may affect more than 1 patient in 10) are dizziness, headache, diarrhoea, nausea (feeling sick), vomiting, rash, asthenia (weakness), hypophosphataemia (low blood levels of phosphates) and elevated levels of creatine kinase (an enzyme found in muscles). For the full list of side effects reported with Atripla, see the package leaflet.

Atripla must not be used in patients with severe liver disease, patients whose close relative has died suddenly or has had QT prolongation (an alteration of the electrical activity of the heart), patients who have had arrhythmia (unstable heartbeat), patients with abnormal levels of electrolytes in the blood (for example, potassium or magnesium).

Atripla must also not be used in patients who are taking any of the following:

  • medicines that cause QT prolongation;
  • certain medicines whose breakdown is blocked by Atripla;
  • St John’s wort (a herbal preparation used to treat depression);
  • voriconazole (used to treat fungal infections).

See the package leaflet for further details and for the full list of restrictions.

Why is Atripla authorised in the EU?

The European Medicines Agency noted that Atripla needs to be taken on an empty stomach to prevent certain side effects, but that this could result in low tenofovir levels in the blood. Therefore, the Agency concluded that Atripla could be a convenient ‘one-tablet once-a-day’ treatment for maintaining low viral loads in patients already taking HIV treatment, but there is not enough information to be certain about its effects in patients who have not been treated before.

The Agency also noted that demonstration of Atripla’s benefit is based mainly on 48-week data from a study in patients with stable suppression of HIV on an HIV treatment combination who then switched to Atripla. There is no information on its effects in patients who have not been treated before or who have been treated with many different HIV medicines in the past. There is also no information on using Atripla with other HIV medicines.

The Agency decided that Atripla’s benefits are greater than its risks and recommended that it can be authorised for use in the EU.

What measures are being taken to ensure the safe use of Atripla?

The company that markets Atripla will ensure that all doctors expected to prescribe the medicine are provided with an educational pack that includes information on the increased risk of kidney disease with tenofovir disoproxil-containing medicines such as Atripla. The educational pack also contains recommendations for monitoring kidney function in patients taking the medicine.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atripla have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Atripla are continuously monitored. Side effects reported with Atripla are carefully evaluated and any necessary action taken to protect patients.

Other information about Atripla

Atripla received a marketing authorisation valid throughout the EU on 13 December 2007.

Name Language First published Last updated
Atripla : EPAR - Medicine overview BG = bălgarski 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview ES = español 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview CS = čeština 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview DA = dansk 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview DE = Deutsch 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview ET = eesti keel 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview EL = elliniká 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview EN = English 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview FR = français 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview IT = italiano 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview LV = latviešu valoda 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview LT = lietuvių kalba 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview HU = magyar 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview MT = Malti 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview NL = Nederlands 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview PL = polski 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview PT = português 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview RO = română 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview SK = slovenčina 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview SL = slovenščina 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview FI = suomi 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview SV = svenska 2009-10-21 2018-05-23
Atripla : EPAR - Medicine overview HR = Hrvatski 2009-10-21 2018-05-23

This EPAR was last updated on 05/09/2018 .

Authorisation details

Product details

Product details for Atripla
NameAtripla
Agency product numberEMEA/H/C/000797
Active substance

efavirenz / emtricitabine / tenofovir disoproxil fumarate

International non-proprietary name (INN) or common name

efavirenz / emtricitabine / tenofovir disoproxil

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AR06

Publication details

Publication details for Atripla
Marketing-authorisation holder

Bristol-Myers Squibb and Gilead Sciences Limited

Revision28
Date of issue of marketing authorisation valid throughout the European Union13/12/2007

Contact address:

Bristol-Myers Squibb and Gilead Sciences Limited
Unit 13, Stillorgan Industrial Park
Blackrock
Co. Dublin
Ireland

Product information

Product information

25/07/2018  Atripla -EMEA/H/C/000797 -N/0131

Name Language First published Last updated
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05
Atripla : EPAR - Product Information HR = Hrvatski 2009-10-13 2018-09-05

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  
Atripla : EPAR - All Authorised presentations HR = Hrvatski 2008-07-07  

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Atripla : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2009-10-13 2018-09-05

Initial marketing-authorisation documents

Name Language First published Last updated
Atripla : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2007-12-18  
Atripla : EPAR - Scientific Discussion HR = Hrvatski 2007-12-18