Evotaz - Atazanavir and Cobicistat

What is Evotaz - Atazanavir and Cobicistat 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 ingredients atazanavir and cobicistat. It should only be used in patients whose infection is not predictably resistant to atazanavir.

How is Evotaz - Atazanavir and Cobicistat used?

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

How does Evotaz - Atazanavir and Cobicistat work?

Evotaz contains two active ingredients: atazanavir and cobicistat. Atazanavir is a protease inhibitor. It blocks the action of an HIV enzyme called protease, which the virus needs to replicate. When the enzyme is blocked, the virus cannot reproduce and its spread in the body slows down. Cobicistat increases the level of atazanavir in the blood, slowing down its degradation. It thus enhances the antiviral effect of atazanavir.

Evotaz, taken with other anti-HIV medicines, reduces the amount of HIV in the blood and keeps the level of the virus low. It does not cure HIV infection, but it can delay the damage to the immune system and prevent the development of infections and diseases associated with AIDS.

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

What benefit has Evotaz - Atazanavir and Cobicistat shown during the studies?

Since atazanavir and cobicistat have already proved effective and their use is authorized in the treatment of HIV infection, studies have been conducted mainly to highlight that Evotaz produces levels of atazanavir in the blood similar to those of the two active ingredients administered separately and to those of atazanavir administered with a different potentiating medicine, ritonavir (a consolidated association).

Furthermore, the use of atazanavir with cobicistat was evaluated in one main study in 698 previously untreated HIV patients. Atazanavir and cobicistat were compared with atazanavir and ritonavir; all patients were also given anti-HIV medicines emtricitabine and tenofovir disoproxil. The main measure of effectiveness was the percentage of patients whose HIV-1 blood count (known as viral load) was reduced to less than 50 copies / ml after 48 weeks of treatment. Overall, 85% of patients (293 of 344) treated with atazanavir and cobicistat achieved this reduction. This result was comparable to a reduction observed in 87% of patients (304 out of 348) treated with atazanavir and ritonavir.

What is the risk associated with Evotaz - Atazanavir and Cobicistat?

The most common side effects with Evotaz (which may affect more than 1 in 10 people) are jaundice, which can occur with yellowing of the eye, and nausea.

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

Evotaz should not be used in patients with moderate to severe hepatic impairment. It must also not be used in patients who are taking certain medicines because of the possibility of interactions that could be harmful. For the full list of limitations, see the package leaflet.

Why has Evotaz - Atazanavir and Cobicistat been 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. The two active ingredients have already proved effective and Evotaz can be a useful substitute for atazanavir accompanied by ritonavir as an enhancer. The combination of atazanavir and cobicistat in a single tablet can simplify the dosage regimen. The adverse effects of Evotaz are similar to those that occur with individual medicines.

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

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.