Truvada

emtricitabine / tenofovir disoproxil

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This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is Truvada?

Truvada is a medicine that contains two active substances, emtricitabine (200 mg) and tenofovir disoproxil (245 mg). It is available as blue capsule-shaped tablets.

What is Truvada used for?

Truvada is used in combination with at least one other antiviral medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).

The medicine can only be obtained with a prescription.

How is Truvada used?

Treatment with Truvada should be started by a doctor who has experience in the management of HIV infection.

The recommended dose of Truvada is one tablet once a day, taken with food. The tablets may need to be taken less frequently in patients with kidney disease. In exceptional cases, patients who have difficulty swallowing can crush the tablet and mix it in about 100 ml of water, orange juice or grape juice before taking it immediately. If patients need to stop taking emtricitabine or tenofovir, or need to take different doses, they will need to take medicines containing emtricitabine or tenofovir disoproxil separately. For more information, see the Package Leaflet.

How does Truvada work?

Truvada contains two active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug’ of tenofovir. This means that it is converted into tenofovir in the body. Tenofovir is a nucleotide reverse transcriptase inhibitor. Both groups of medicines are known as NRTIs.

Both emtricitabine and tenofovir work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses. Truvada, taken in combination with at least one other antiviral medicine, reduces the amount of HIV in the blood and keeps it at a low level. Truvada does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.

Both active substances have been authorised in the European Union (EU) since the early 2000s: emtricitabine was authorised as Emtriva in 2003, and tenofovir disoproxil was authorised as Viread in 2002.

How has Truvada been studied?

There have been two main studies, which examined the effects of Truvada’s active substances, emtricitabine and tenofovir disoproxil, in adults infected with HIV-1 who had not been treated before. The first study compared the combination of emtricitabine and tenofovir disoproxil with the combination of lamivudine and zidovudine (other antiviral medicines), both taken in combination with efavirenz (another antiviral medicine) in 487 patients. The second study examined the effects of emtricitabine and tenofovir disoproxil, taken with lopinavir and ritonavir (other antiviral medicines) in 196 patients. The main measure of effectiveness was the proportion of patients whose HIV levels in the blood (viral loads) had fallen to below 400 or 50 copies per millilitre and were maintained below these levels until the 48th week of treatment.

The company also carried out studies to show that the active substances in the combined tablet are absorbed by the body in the same way as the two medicines given separately.

What benefit has Truvada shown during the studies?

Truvada’s active substances, taken in combination with other antiviral medicines, reduced viral loads in the majority of patients and were more effective than the comparator medicines. In the first study, 84% of the patients taking Truvada (206 out of 244) had achieved and maintained viral loads below 400 copies/ml by 48 weeks, compared with 73% of the patients taking the comparator medicines (177 out of 243). Around two thirds of the patients in the second study had achieved and maintained viral loads below 50 copies/ml after 48 weeks.

What is the risk associated with Truvada?

The most common side effects with Truvada (seen in more than 1 patient in 10) are hypophosphataemia (low levels of phosphates in the blood), headache, dizziness, diarrhoea, vomiting, nausea (feeling sick) and raised blood levels of creatine kinase (an enzyme found in muscles). For the full list of all side effects reported with Truvada, see the Package Leaflet.

Truvada should not be used in patients who may be hypersensitive (allergic) to emtricitabine, tenofovir disoproxil or any of the other ingredients.

As with other anti-HIV medicines, patients taking Truvada may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system). Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Truvada. As with all other NRTIs, Truvada may also cause lactic acidosis (a build-up of lactic acid in the body) and, in the babies of mothers taking Truvada during pregnancy, mitochondrial dysfunction (damage to the energy-producing components within cells than can cause problems in the blood).

Why has Truvada been approved?

The Committee for Medicinal Products for Human Use (CHMP) noted that the benefit of Truvada has only been shown in patients who have not taken HIV treatment before, but that the simplified dosing regimen offered by the combination tablet taken once a day may help patients to stick to their treatment. The Committee concluded that Truvada’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Truvada

The European Commission granted a marketing authorisation valid throughout the EU for Truvada to Gilead Sciences International Limited on 21 February 2005. The marketing authorisation is valid for an unlimited period.

Name Language First published Last updated
Truvada : EPAR - Summary for the public BG = bălgarski 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public ES = español 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public CS = čeština 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public DA = dansk 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public DE = Deutsch 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public ET = eesti keel 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public EL = elliniká 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public EN = English 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public FR = français 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public IT = italiano 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public LV = latviešu valoda 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public LT = lietuvių kalba 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public HU = magyar 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public MT = Malti 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public NL = Nederlands 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public PL = polski 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public PT = português 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public RO = română 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public SK = slovenčina 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public SL = slovenščina 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public FI = suomi 03/07/2007 16/02/2010
Truvada : EPAR - Summary for the public SV = svenska 03/07/2007 16/02/2010

This EPAR was last updated on 28/04/2016 .

Authorisation details

Product details

Product details for Truvada
NameTruvada
Agency product numberEMEA/H/C/000594
Active substance

emtricitabine / tenofovir disoproxil fumarate

International non-proprietary name (INN) or common name

emtricitabine / tenofovir disoproxil

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AR03

Publication details

Publication details for Truvada
Marketing-authorisation holder

Gilead Sciences International Limited

Revision32
Date of issue of marketing authorisation valid throughout the European Union21/02/2005

Contact address:

Gilead Sciences International Limited
Cambridge
CB21 6GT
United Kingdom

Product information

Product information

01/04/2016  Truvada -EMEA/H/C/000594 -WS/0829

Name Language First published Last updated
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016
Truvada : EPAR - Product Information SV = svenska 11/06/2009 28/04/2016

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
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015
Truvada : EPAR - All Authorised presentations SV = svenska 15/09/2008 11/02/2015

Pharmacotherapeutic group

Antivirals for treatment of HIV infections, combinations

Therapeutic indication

Truvada is a fixed dose combination of emtricitabine and tenofovir disoproxil fumarate. It is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.

The demonstration of the benefit of the combination emtricitabine and tenofovir disoproxil fumarate in antiretroviral therapy is based solely on studies performed in treatment-naive patients.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Truvada : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 15/06/2009 28/04/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Truvada : EPAR - Procedural steps taken before authorisation SV = svenska 22/11/2005  
Truvada : EPAR - Scientific Discussion SV = svenska 22/11/2005