Evotaz

atazanavir / cobicistat

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This is a summary of the European public assessment report (EPAR) for Evotaz. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Evotaz.

For practical information about using Evotaz, patients should read the package leaflet or contact their doctor or pharmacist.

What is Evotaz and what is it used for?

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

Evotaz contains the active substances atazanavir and cobicistat. The medicine is for use only in patients whose infection is not expected to be resistant to atazanavir.

How is Evotaz used?

Evotaz can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection. Evotaz is available as tablets that contain 300 mg of atazanavir and 150 mg of cobicistat. The recommended dose is one tablet a day, taken with food.

How does Evotaz work?

Evotaz contains two active substances: atazanavir and cobicistat. Atazanavir is a protease inhibitor. It blocks an HIV enzyme called protease from working. The virus needs protease to make more viruses. When the enzyme is blocked, the virus cannot reproduce itself and its spread in the body slows down. Cobicistat increases the level of atazanavir in the blood by slowing its breakdown. This therefore boosts atazanavir’s antiviral effect.

Evotaz, taken with other HIV medicines, reduces HIV in the blood and keeps the virus at a low level. It does not cure HIV infection, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.

The active substances in Evotaz are already available in the EU as individual medicines: atazanavir is available as Reyataz and cobicistat as Tybost.

What benefits of Evotaz have been shown in studies?

Because atazanavir and cobicistat have both previously been shown to be effective and are authorised for use in the treatment of HIV infection, studies were mainly carried out to show that Evotaz produced similar levels of atazanavir in the blood to the two active substances given separately, and to atazanavir given with a different booster medicine, ritonavir (an established combination).

In addition, the use of atazanavir with cobicistat has been evaluated in one main study in 698 HIV patients who had not been treated previously. Atazanavir and cobicistat were compared with atazanavir and ritonavir; all patients also received the HIV medicines emtricitabine and tenofovir disoproxil. The main measure of effectiveness was the proportion of patients in whom the HIV-1 count in the blood (known as viral load) was reduced to less than 50 copies/ml after 48 weeks of treatment. Overall, 85% of patients (293 out of 344) treated with atazanavir and cobicistat achieved this reduction. This was comparable to a reduction in 87% of patients (304 of 348) treated with atazanavir and ritonavir.

What are the risks associated with Evotaz?

The most common side effects with Evotaz (which may affect more than 1 in 10 people) are jaundice, which may show as yellow discoloration of the eye, and nausea (feeling sick).

For the full list of all side effects reported with Evotaz, see the package leaflet.

Evotaz must not be taken by patients who have moderately or severely reduced liver function. It must also not be taken by patients taking certain medicines because of the possibility of interactions which could be harmful. For the full list of restrictions, see the package leaflet.

Why is Evotaz approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Evotaz’s benefits are greater than its risks and recommended that it be approved for use in the EU. Both active substances have already been shown to be effective and Evotaz may be a useful substitute for atazanavir accompanied by ritonavir as a booster. Combining atazanavir and cobicistat in a single tablet has the potential of simplifying the dosing regimen. Evotaz’s adverse effects were similar to those that occur with the individual medicines.

What measures are being taken to ensure the safe and effective use of Evotaz?

A risk management plan has been developed to ensure that Evotaz is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Evotaz, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Evotaz

The European Commission granted a marketing authorisation valid throughout the European Union for Evotaz on 13 July 2015.

For more information about treatment with Evotaz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Evotaz : EPAR - Summary for the public BG = bălgarski 2015-08-10  
Evotaz : EPAR - Summary for the public ES = español 2015-08-10  
Evotaz : EPAR - Summary for the public CS = čeština 2015-08-10  
Evotaz : EPAR - Summary for the public DA = dansk 2015-08-10  
Evotaz : EPAR - Summary for the public DE = Deutsch 2015-08-10  
Evotaz : EPAR - Summary for the public ET = eesti keel 2015-08-10  
Evotaz : EPAR - Summary for the public EL = elliniká 2015-08-10  
Evotaz : EPAR - Summary for the public EN = English 2015-08-10  
Evotaz : EPAR - Summary for the public FR = français 2015-08-10  
Evotaz : EPAR - Summary for the public IT = italiano 2015-08-10  
Evotaz : EPAR - Summary for the public LV = latviešu valoda 2015-08-10  
Evotaz : EPAR - Summary for the public LT = lietuvių kalba 2015-08-10  
Evotaz : EPAR - Summary for the public HU = magyar 2015-08-10  
Evotaz : EPAR - Summary for the public MT = Malti 2015-08-10  
Evotaz : EPAR - Summary for the public NL = Nederlands 2015-08-10  
Evotaz : EPAR - Summary for the public PL = polski 2015-08-10  
Evotaz : EPAR - Summary for the public PT = português 2015-08-10  
Evotaz : EPAR - Summary for the public RO = română 2015-08-10  
Evotaz : EPAR - Summary for the public SK = slovenčina 2015-08-10  
Evotaz : EPAR - Summary for the public SL = slovenščina 2015-08-10  
Evotaz : EPAR - Summary for the public FI = suomi 2015-08-10  
Evotaz : EPAR - Summary for the public SV = svenska 2015-08-10  
Evotaz : EPAR - Summary for the public HR = Hrvatski 2015-08-10  
Name Language First published Last updated
Evotaz : EPAR - Risk-management-plan summary (English only) 2015-08-10  

This EPAR was last updated on 08/02/2017 .

Authorisation details

Product details

Product details for Evotaz
NameEvotaz
Agency product numberEMEA/H/C/003904
Active substance

atazanavir sulfate / cobicistat

International non-proprietary name (INN) or common name

atazanavir / cobicistat

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AR
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Evotaz
Marketing-authorisation holder

Bristol-Myers Squibb Pharma EEIG

Revision2
Date of issue of marketing authorisation valid throughout the European Union13/07/2015

Contact address:

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park 
Sanderson Road 
Uxbridge 
UB8 1DH 
United Kingdom

Product information

Product information

20/01/2017  Evotaz -EMEA/H/C/003904 -IAIN/0012

Name Language First published Last updated
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08
Evotaz : EPAR - Product Information EN = English 2015-08-10 2017-02-08

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
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  
Evotaz : EPAR - All Authorised presentations EN = English 2015-08-10  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Evotaz is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Evotaz : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-03-31 2017-02-08

Initial marketing-authorisation documents

Name Language First published Last updated
Evotaz : EPAR - Public assessment report EN = English 2015-08-10  
CHMP summary of positive opinion for Evotaz EN = English 2015-05-22  

Authorised

This medicine is approved for use in the European Union