Genvoya

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

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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 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 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.

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

Name Language First published Last updated
Genvoya : EPAR - Summary for the public BG = bălgarski 2015-12-01  
Genvoya : EPAR - Summary for the public ES = español 2015-12-01  
Genvoya : EPAR - Summary for the public CS = čeština 2015-12-01  
Genvoya : EPAR - Summary for the public DA = dansk 2015-12-01  
Genvoya : EPAR - Summary for the public DE = Deutsch 2015-12-01  
Genvoya : EPAR - Summary for the public ET = eesti keel 2015-12-01  
Genvoya : EPAR - Summary for the public EL = elliniká 2015-12-01  
Genvoya : EPAR - Summary for the public EN = English 2015-12-01  
Genvoya : EPAR - Summary for the public FR = français 2015-12-01  
Genvoya : EPAR - Summary for the public IT = italiano 2015-12-01  
Genvoya : EPAR - Summary for the public LV = latviešu valoda 2015-12-01  
Genvoya : EPAR - Summary for the public LT = lietuvių kalba 2015-12-01  
Genvoya : EPAR - Summary for the public HU = magyar 2015-12-01  
Genvoya : EPAR - Summary for the public MT = Malti 2015-12-01  
Genvoya : EPAR - Summary for the public NL = Nederlands 2015-12-01  
Genvoya : EPAR - Summary for the public PL = polski 2015-12-01  
Genvoya : EPAR - Summary for the public PT = português 2015-12-01  
Genvoya : EPAR - Summary for the public RO = română 2015-12-01  
Genvoya : EPAR - Summary for the public SK = slovenčina 2015-12-01  
Genvoya : EPAR - Summary for the public SL = slovenščina 2015-12-01  
Genvoya : EPAR - Summary for the public FI = suomi 2015-12-01  
Genvoya : EPAR - Summary for the public SV = svenska 2015-12-01  
Genvoya : EPAR - Summary for the public HR = Hrvatski 2015-12-01  
Name Language First published Last updated
Genvoya : EPAR - Risk-management-plan summary (English only) 2015-12-01  

This EPAR was last updated on 07/07/2017 .

Authorisation details

Product details

Product details for Genvoya
NameGenvoya
Agency product numberEMEA/H/C/004042
Active substance

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

International non-proprietary name (INN) or common name

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

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 Genvoya
Marketing-authorisation holder

Gilead Sciences International Ltd

Revision9
Date of issue of marketing authorisation valid throughout the European Union19/11/2015

Contact address:

Gilead Sciences International Ltd
Flowers Building 
Granta Park 
Great Abington 
Cambridge 
CB21 6GT 
United Kingdom

Product information

Product information

05/05/2017  Genvoya -EMEA/H/C/004042 -WS/1152

Name Language First published Last updated
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07
Genvoya : EPAR - Product Information EN = English 2015-12-01 2017-07-07

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
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  
Genvoya : EPAR - All Authorised presentations EN = English 2015-12-01  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Genvoya is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 1 (HIV 1) without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Genvoya : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-03-31 2017-07-07

Initial marketing-authorisation documents

Name Language First published Last updated
Genvoya : EPAR - Public assessment report EN = English 2015-12-01  
CHMP summary of positive opinion for Genvoya EN = English 2015-09-25  

Authorised

This medicine is approved for use in the European Union