Eviplera

emtricitabine / rilpivirine / tenofovir disoproxil

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This is a summary of the European public assessment report (EPAR) for Eviplera. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Eviplera.

What is Eviplera?

Eviplera is a medicine that contains the active substances emtricitabine (200 mg), rilpivirine (25 mg) and tenofovir disoproxil (245 mg). It is available as tablets.

What is Eviplera used for?

Eviplera is used to treat adults infected with human immunodeficiency virus 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).

It is only used in patients where the virus has not developed resistance to certain anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs), tenofovir or emtricitabine, and who have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml.

The medicine can only be obtained with a prescription.

How is Eviplera used?

Treatment with Eviplera should be started by a doctor who has experience in the management of HIV infection. The recommended dose is one tablet once a day and it must be taken with a meal.

If patients need to stop taking one of the active substances or if they need to modify their dose, patients should be switched to separate preparations of emtricitabine, rilpivirine and tenofovir disoproxil. If Eviplera is given together with rifabutin, the doctor should prescribe an additional 25 mg of rilpivirine per day during rifabutin treatment.

How does Eviplera work?

Eviplera contains three active substances: emtricitabine, which is a nucleoside reverse-transcriptase inhibitor; rilpivirine, which is a non-nucleoside reverse-transcriptase inhibitor (NNRTI); and tenofovir disoproxil, which is a ‘prodrug’ of tenofovir, meaning that it is converted into the active substance tenofovir in the body. Tenofovir is a nucleotide reverse-transcriptase inhibitor. Both nucleoside and nucleotide reverse-transcriptase inhibitors are commonly known as NRTIs.

All three active substances block the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses. By blocking this enzyme, Eviplera reduces the amount of HIV in the blood and keeps it at a low level. Eviplera does not cure HIV infection or AIDS, but it may slow the damage to the immune system and the development of infections and diseases associated with AIDS.

All three active substances are already available in separate medicines in the European Union (EU).

How has Eviplera been studied?

Eviplera has been studied in two main studies in patients with HIV-1 who had not received HIV treatment before. In the first main study involving 690 patients, Eviplera was compared with a similar combination that had efavirenz in place of rilpivirine. The second main study involving 678 patients compared rilpivirine with efavirenz, both being taken with emtricitabine and tenofovir disoproxil or two other nucleotide reverse transcriptase inhibitors.

The main measure of effectiveness was based on the reduction in viral load. Patients who attained a viral load of less than 50 HIV-1 RNA copies/ml after 48 weeks of treatment were considered to have responded to treatment.

Eviplera has also been evaluated in 532 patients who were switched from their current HIV treatment to Eviplera. Patient’s previous treatment consisted either of two nucleotide reverse transcriptase inhibitors and another HIV medicine called a boosted protease inhibitor, or the medicine Atripla. The main measure of effectiveness was based on the reduction in viral load.

The company also presented studies showing that the tablet containing all three substances is absorbed in the body in the same way as the separate tablets given concurrently under similar conditions.

What benefit has Eviplera shown during the studies?

The Eviplera combination compared well with combinations containing efavirenz. In the first study in previously untreated patients, 83% of the patients taking the Eviplera combination responded to treatment compared with 84% of the patients taking a combination with efavirenz. In the second study, 87% of the patients in the rilpivirine group (which included patients taking the Eviplera combination) responded to treatment. This compared with 83% of patients in the efavirenz group.

The two studies evaluating the effects of switching patients to Eviplera showed that Eviplera was as effective as the previous treatment and maintained the reduction in viral load.

What is the risk associated with Eviplera?

The most common side effects seen with Eviplera in patients who had not received previous HIV treatment were: nausea, dizziness, abnormal dreams, headache, diarrhoea and insomnia. In patients who had received previous HIV treatment, the most common side effects were fatigue, diarrhoea, nausea and insomnia. Rarely, kidney problems may occur in patients taking tenofovir disoproxil, while lactic acidosis (a build-up of lactic acid in the body) and severe hepatomegaly (enlarged liver) have been reported with tenofovir disoproxil and emtricitabine. For the full list of all side effects, see the package leaflet.

Patients who have HIV and hepatitis B may see a worsening of their liver problems when stopping Eviplera.

Eviplera must not be used with the following medicines as they may lead to reduced blood levels of rilpivirine, and thereby reduce the effectiveness of Eviplera:

  • carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for fits);
  • rifampicin, rifapentine (antibiotics);
  • omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors for reducing stomach acid);
  • systemic dexamethasone (a steroid inflammatory and immunosuppressant medicine) except when used as a single dose treatment;
  • St John’s wort (a herbal medicine to treat depression).

For the full list of restrictions, see the package leaflet.

Why has Eviplera been approved?

The CHMP concluded that Eviplera was as effective as combinations containing efavirenz. It also causes fewer side effects in the early stages of treatment and offers the benefit of being taken as one tablet once per day. However, the CHMP noted that there was some risk of HIV-1 developing resistance to rilpivirine and that this risk appeared to be lower in patients with a lower viral load. Therefore, the CHMP considered that the benefits of Eviplera outweigh its risks in patients with a low HIV-1 viral load, and recommended that it be granted marketing authorisation for this group of patients.

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

A risk management plan has been developed to ensure that Eviplera 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 Eviplera, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Eviplera

The European Commission granted a marketing authorisation valid throughout the European Union for Eviplera on 28 November 2011.

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

Name Language First published Last updated
Eviplera : EPAR - Summary for the public BG = bălgarski 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public ES = español 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public CS = čeština 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public DA = dansk 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public DE = Deutsch 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public ET = eesti keel 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public EL = elliniká 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public EN = English 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public FR = français 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public IT = italiano 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public LV = latviešu valoda 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public LT = lietuvių kalba 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public HU = magyar 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public MT = Malti 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public NL = Nederlands 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public PL = polski 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public PT = português 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public RO = română 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public SK = slovenčina 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public SL = slovenščina 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public FI = suomi 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public SV = svenska 12/12/2011 20/12/2013
Eviplera : EPAR - Summary for the public HR = Hrvatski 12/12/2011 20/12/2013

This EPAR was last updated on 21/08/2014 .

Authorisation details

Product details

Product details for Eviplera
NameEviplera
Agency product numberEMEA/H/C/002312
Active substance

emtricitabine / rilpivirine hydrochloride / tenofovir disoproxil fumarate

International non-proprietary name (INN) or common name

emtricitabine / rilpivirine / tenofovir disoproxil

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AR08
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 Eviplera
Marketing-authorisation holder

Gilead Sciences International Ltd.
 

Revision8
Date of issue of marketing authorisation valid throughout the European Union28/11/2011

Contact address:

Gilead Sciences International Ltd.
Cambridge
CB21 6GT
United Kingdom

Product information

Product information

26/07/2014  Eviplera -EMEA/H/C/002312 -WS/0586

Name Language First published Last updated
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014
Eviplera : EPAR - Product Information HR = Hrvatski 12/12/2011 21/08/2014

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
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  
Eviplera : EPAR - All Authorised presentations HR = Hrvatski 12/12/2011  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Eviplera is indicated for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load ≤ 100,000 HIV-1 RNA copies/mL (see sections 4.2, 4.4 and 5.1). As with other antiretroviral medicinal products, genotypic resistance testing and/or historical resistance data should guide the use of Eviplera (see sections 4.4 and 5.1).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Eviplera : EPAR - Public assessment report HR = Hrvatski 12/12/2011  
CHMP summary of positive opinion for Eviplera HR = Hrvatski 23/09/2011