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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/360271/2015

EMEA/H/C/003904

EPAR summary for the public

Evotaz

atazanavir / cobicistat

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.

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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 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 also not be taken by patients taking certain medicines because of the possibility 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.

Evotaz

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Other information about Evotaz

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

The full EPAR and risk management plan summary for Evotaz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Evotaz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 07-2015.

Evotaz

EMA/360271/2015