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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/649997/2015 EM EA/H/C/004042

EPAR summary for the public

Genvoya

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

This is a summary of the European public assessment report (EPAR) for Genvoya. 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 Genvoya.

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

What is Genvoya and what is it used for?

Genvoya is an antiviral medicine used to treat individuals infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It is used in adults and adolescents aged over 12 years whose disease is not expected to be resistant to any of the antiviral substances in Genvoya.

Genvoya contains the active substances elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.

How is Genvoya used?

The medicine can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection. Genvoya is available as tablets, each containing 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide. The recommended dose is one tablet a day, taken with food.

How does Genvoya work?

Genvoya contains four active substances. Elvitegravir is a type of antiviral agent called an 'integrase inhibitor'. By blocking an enzyme called integrase, elvitegravir stops the virus's genetic material from integrating into the genetic material of the cells it has infected. This reduces the virus's ability to

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replicate and slows down the spread of infection. Cobicistat increases the level of elvitegravir by slowing its breakdown. This boosts elvitegravir's antiviral effect.

Tenofovir alafenamide is a 'prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body. Tenofovir and emtricitabine are related antiviral agents called reverse transcriptase inhibitors. They block the activity of reverse transcriptase, a virus enzyme that allows HIV-1 to replicate in the cells it has infected. By blocking reverse transcriptase, Genvoya reduces the amount of HIV-1 in the blood and keeps it at a low level.

Genvoya does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.

What benefits of Genvoya have been shown in studies?

Genvoya was investigated in two main studies involving 1,733 adults infected with HIV-1 who had not been treated previously. In both studies, Genvoya was compared with another antiviral medicine which contained the active ingredients elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil. The main measure of effectiveness was based on the reduction of the amount of HIV-1 in the blood. The infection was considered to have responded to treatment if the viral load in the patient's blood was less than 50 of HIV-1 RNA copies/ml.

After 48 weeks around 90% of patients treated with both Genvoya (800 of 866 patients) and the comparator (784 of 867 patients) had responded to treatment.

In a supporting study, patients who were being treated with effective HIV treatment either continued with the same treatment or were switched to Genvoya. After 48 weeks a viral load of less than 50 copies/ml was seen in 97% (932 of 959) of patients switched to Genvoya and 93% (444 of 477) of patients who continued with their usual treatment.

In another study, Genvoya was given to adolescents aged 12 to 18 years with HIV-1 infection who had not been treated previously. The viral load was reduced to less than 50 copies/ml after 24 weeks in 90% (45 of 50) of patients.

What are the risks associated with Genvoya?

The most common side effect with Genvoya (which may affect more than 1 in 10 people) is nausea (feeling sick). Other side effects include abnormal dreams, dizziness, feeling tired, and diarrhoea. For the full list of all side effects reported with Genvoya, see the package leaflet.

Genvoya must not be taken with certain other medicines because of the possibility of harmful interactions. For the full list of restrictions, see the package leaflet.

Why is Genvoya approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Genvoya's benefits are greater than its risks and recommended that it be approved for use in the EU. Three of the active substances, elvitegravir, cobicistat and emtricitabine have already been shown to be effective. The fourth, tenofovir alafenamide, is effective at a lower dose than the established medicine tenofovir disoproxil and offers the possibility of reduced side effects.

In studies, the effectiveness of Genvoya was high and comparable to that of a medicine containing elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil. Genvoya's side effects were similar to those of the individual medicines. Tenofovir alafenamide had a milder effect on the kidney than

Genvoya

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tenofovir disoproxil. The CHMP also considered that combining the medicines in a single tablet simplifies treatment.

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

A risk management plan has been developed to ensure that Genvoya 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 Genvoya, 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 Genvoya

The European Commission granted a marketing authorisation valid throughout the European Union for Genvoya on 19 November 2015.

The full EPAR and risk management plan summary for Genvoya 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 Genvoya, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 11/2015.

Genvoya

EMA/649997/2015