Triumeq

abacavir sulfate / dolutegravir sodium / lamivudine

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

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

What is Triumeq and what is it used for?

Triumeq is an antiviral medicine used to treat patients with human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS). It is used in patients from 12 years of age and weighing at least 40 kg.

Triumeq contains three active substances: dolutegravir, abacavir and lamivudine.

How is Triumeq used?

Triumeq can only be obtained with a prescription and treatment should be prescribed by a doctor who is experienced in managing HIV infections.

Before starting treatment with Triumeq, all patients should have a test to find out if they have a gene called ‘HLA-B (type 5701)’. Patients with this gene are at an increased risk of having an allergic reaction to abacavir, so they should not take Triumeq.

Triumeq is available as tablets (50 mg dolutegravir / 600 mg abacavir /300 mg lamivudine) and the recommended dose is one tablet a day, taken with or without food.

How does Triumeq work?

One of the active substances in Triumeq, dolutegravir, is an integrase inhibitor. This is an antiviral medicine that blocks an enzyme called integrase that is needed by the HIV virus to make new copies of itself in the body. The other two active substances, abacavir and lamivudine, are nucleoside reverse-transcriptase inhibitors (NRTIs). They both 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.

Triumeq reduces the amount of HIV in the blood and keeps it at a low level. Triumeq 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.

All three active substances in Triumeq are already available in the European Union (EU) as single-component medicines: abacavir has been authorised as Ziagen since 1999, lamivudine as Epivir since 1996, and dolutegravir as Tivicay since January 2014. The combination of abacavir and lamivudine has been authorised as Kivexa since 2004.

What benefits of Triumeq have been shown in studies?

The combination of dolutegravir, abacavir and lamivudine (as found in Triumeq) was evaluated in one main study involving 833 previously untreated patients. Data from this study had already been used in the authorisation of Tivicay.

Patients were either given the Triumeq combination or a different three-drug combination (Atripla) that did not include an integrase inhibitor. The main measure of effectiveness was the response rate, which was the proportion of patients with a reduction of the levels of virus in the blood (viral load) to fewer than 50 copies of HIV RNA per ml. After 48 weeks, 88% of the patients given the combination found in Triumeq (364 out of 414) responded to treatment, compared with 81% of the patients who were given Atripla (338 out of 419). Data from this study collected until week 96 showed that this effect was maintained over time.

The company also looked at the way Triumeq was absorbed in the body in comparison with two separate tablets (dolutegravir and abacavir/lamivudine) containing the three medicines that make it up. Results from this study showed that Triumeq was absorbed into the body in the same way as the separate medicines.

What are the risks associated with Triumeq?

The most common side effects with Triumeq (which may affect more than 1 in 10 people) are insomnia (difficulty sleeping), headache, nausea (feeling sick), diarrhoea and fatigue (tiredness). In patients taking some of the components of Triumeq, certain serious side effects have been seen including hypersensitivity (allergic). For the full list of all side effects reported with Triumeq, see the package leaflet.

Triumeq must not be used together with dofetilide, a medicine used to control cardiac arrhythmia (unstable heartbeat). For the full list of restrictions with Triumeq, see the package leaflet.

Why is Triumeq approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Triumeq’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that the medicine had demonstrated its effectiveness in previously untreated patients, and that similar benefits are expected in patients who have received previous treatment.

The CHMP also noted that giving the combination of dolutegravir, abacavir and lamivudine as a single tablet is an additional treatment option for patients with HIV infection and without the HLA-B (type 5701) gene. Giving the combined medicine rather than the single medicines reduces the number of tablets patients have to take, helping them to adhere to their treatment. The CHMP also considered the fact that Triumeq can be taken with or without food as an additional advantage compared with other similar medicines which have to be taken strictly either with food or on an empty stomach. Regarding Triumeq’s safety profile, this was expected to be similar to the safety profile of the single components and comparable to that of other HIV treatments.

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

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

In addition, the company that markets Triumeq will provide educational material for healthcare professionals expected to prescribe Triumeq that addresses the risk of abacavir-associated hypersensitivity.

Further information can be found in the summary of the risk management plan.

Other information about Triumeq

The European Commission granted a marketing authorisation valid throughout the European Union for Triumeq on 1 September 2014.

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

Name Language First published Last updated
Triumeq : EPAR - Summary for the public BG = bălgarski 15/10/2014  
Triumeq : EPAR - Summary for the public ES = español 15/10/2014  
Triumeq : EPAR - Summary for the public CS = čeština 15/10/2014  
Triumeq : EPAR - Summary for the public DA = dansk 15/10/2014  
Triumeq : EPAR - Summary for the public DE = Deutsch 15/10/2014  
Triumeq : EPAR - Summary for the public ET = eesti keel 15/10/2014  
Triumeq : EPAR - Summary for the public EL = elliniká 15/10/2014  
Triumeq : EPAR - Summary for the public EN = English 15/10/2014  
Triumeq : EPAR - Summary for the public FR = français 15/10/2014  
Triumeq : EPAR - Summary for the public IT = italiano 15/10/2014  
Triumeq : EPAR - Summary for the public LV = latviešu valoda 15/10/2014  
Triumeq : EPAR - Summary for the public LT = lietuvių kalba 15/10/2014  
Triumeq : EPAR - Summary for the public HU = magyar 15/10/2014  
Triumeq : EPAR - Summary for the public MT = Malti 15/10/2014  
Triumeq : EPAR - Summary for the public NL = Nederlands 15/10/2014  
Triumeq : EPAR - Summary for the public PL = polski 15/10/2014  
Triumeq : EPAR - Summary for the public PT = português 15/10/2014  
Triumeq : EPAR - Summary for the public RO = română 15/10/2014  
Triumeq : EPAR - Summary for the public SK = slovenčina 15/10/2014  
Triumeq : EPAR - Summary for the public SL = slovenščina 15/10/2014  
Triumeq : EPAR - Summary for the public FI = suomi 15/10/2014  
Triumeq : EPAR - Summary for the public SV = svenska 15/10/2014  
Triumeq : EPAR - Summary for the public HR = Hrvatski 15/10/2014  
Name Language First published Last updated
Triumeq : EPAR - Risk-management-plan summary (English only) 15/10/2014  

This EPAR was last updated on 16/08/2016 .

Authorisation details

Product details

Product details for Triumeq
NameTriumeq
Agency product numberEMEA/H/C/002754
Active substance

abacavir sulfate / dolutegravir sodium / lamivudine

International non-proprietary name (INN) or common name

abacavir sulfate / dolutegravir sodium / lamivudine

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AR13
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 Triumeq
Marketing-authorisation holder

ViiV Healthcare UK Limited

Revision5
Date of issue of marketing authorisation valid throughout the European Union01/09/2014

Contact address:

ViiV Healthcare UK Limited
980 Great West Road 
Brentford TW8 9GS 
United Kingdom

Product information

Product information

21/07/2016  Triumeq -EMEA/H/C/002754 -II/0026/G; WS/0948

Name Language First published Last updated
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016
Triumeq : EPAR - Product Information EN = English 15/10/2014 16/08/2016

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
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  
Triumeq : EPAR - All Authorised presentations EN = English 15/10/2014  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Triumeq is indicated for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents above 12 years of age weighing at least 40 kg.

Before initiating treatment with abacavir-containing products, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Triumeq : EPAR - Procedural steps taken and scientific information after authorisation EN = English 08/06/2015 16/08/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Triumeq : EPAR - Public assessment report EN = English 15/10/2014  
CHMP summary of positive opinion for Triumeq EN = English 27/06/2014  

Authorised

This medicine is approved for use in the European Union