Evotaz
Authorised
This medicine is authorised for use in the European Union
atazanavir / cobicistat
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
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.
Evotaz is an antiviral medicine used in combination with other medicines to treat human immunodeficiency virus type 1 (HIV-1) infection in adults and in adolescents aged 12 years and above weighing at least 35 kg. HIV-1 is 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.
Evotaz can only be obtained with a prescription, and treatment should be started by a doctor experienced in managing HIV infection. Evotaz is available as tablets that contain atazanavir and cobicistat. The recommended dose is one tablet a day, taken with food.
Evotaz contains two active substances: atazanavir and cobicistat. Atazanavir is a protease inhibitor that blocks an HIV enzyme, called HIV protease, from working. The virus needs HIV protease to make more viruses. When the enzyme is blocked, the virus cannot reproduce and its spread in the body slows down. Cobicistat acts as a ‘booster’ that increases the level of atazanavir in the blood by slowing its breakdown, which boosts atazanavir’s antiviral effect.
Evotaz, taken with other HIV medicines, reduces HIV-1 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 also available in the EU as individual medicines: atazanavir is available as Reyataz and cobicistat as Tybost.
Because atazanavir and cobicistat have both previously been shown to be effective and are authorised for use in the treatment of HIV-1 infection, studies were mainly carried out to show that Evotaz produced levels of atazanavir in the blood similar to those produced by the two active substances given separately or by 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, which was comparable to 87% of patients (304 of 348) who achieved it with atazanavir and ritonavir.
The use of atazanavir with cobicistat has also been evaluated in a study involving 14 adolescents aged 12 to 17 years old and weighing at least 35 kg, whose HIV infection was well controlled on a combination of three HIV medicines that included two from the class of nucleoside reverse transcriptase inhibitors (NRTI). The patients received atazanavir with cobicistat in addition to the two existing NRTIs. After 48 weeks, HIV infection remained well controlled (meaning the viral load was below 50 copies/ml) in 93% of patients (13 out of 14 patients).
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 using certain medicines because of the possibility of interactions that could be harmful. For the full list of restrictions, see the package leaflet.
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 has also been shown to be effective in adolescents whose HIV infection is well controlled on existing treatment. Evotaz’s side effects were similar to those that occur with the individual medicines.
The European Medicines Agency therefore decided that Evotaz’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Evotaz have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Evotaz are continuously monitored. Suspected side effects reported with Evotaz are carefully evaluated and any necessary action taken to protect patients.
Evotaz received a marketing authorisation valid throughout the European Union on 13 July 2015.
Product information
Latest procedure affecting product information:
II/0044
16/03/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Evotaz
- Active substance
- cobicistat
- atazanavir
- International non-proprietary name (INN) or common name
- atazanavir
- cobicistat
- Therapeutic area (MeSH)
- HIV Infections
- Anatomical therapeutic chemical (ATC) code
- J05AR15
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic indication
EVOTAZ is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults and adolescents (aged 12 years and older weighing at least 35 kg) without known mutations associated with resistance to atazanavir (see sections 4.4 and 5.1).
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