Trizivir

abacavir (as sulfate) / lamivudine / zidovudine

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This is a summary of the European Public Assessment Report (EPAR) for Trizivir. 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 Trizivir.

What is Trizivir?

Trizivir is a medicine that contains three active substances: abacavir, lamivudine and zidovudine. It is available as tablets (300 mg/150 mg/300 mg).

What is Trizivir used for?

Trizivir is used to treat adults who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS). It is used to replace treatment with the three active substances (abacavir, lamivudine and zidovudine) taken separately at doses similar to those in Trizivir. Patients should have been taking the three active substances separately for at least six to eight weeks before switching to Trizivir. Before prescribing Trizivir, doctors should consider the expected improved ability of the patient to stick to their treatment, the expected effectiveness of the medicine, and the risks associated with the active substances.

In patients with high levels of HIV in the blood (above 100,000 copies/ml), the choice of treatment requires special consideration.

Overall, since certain other combination treatments could be more effective, the use of Trizivir should only be considered under special circumstances such as co-infection with tuberculosis (as other HIV treatments can interact with the medicines being taken by the patient).

The medicine can only be obtained with a prescription.

How is Trizivir used?

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

Before starting treatment with abacavir, 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 Trizivir.

The recommended dose of Trizivir is one tablet twice a day. If patients need to stop taking abacavir, lamivudine or zidovudine, or need to take different doses because of problems with their kidneys, liver or blood, they will need to take medicines containing abacavir, lamivudine or zidovudine separately. For more information, see the package leaflet.

How does Trizivir work?

All three active substances in Trizivir, abacavir, lamivudine, and zidovudine, are nucleoside reverse transcriptase inhibitors (NRTIs). They all 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. Trizivir reduces the amount of HIV in the blood and keeps it at a low level. Trizivir 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 have been available in the European Union (EU) for a number of years: abacavir has been authorised as Ziagen since 1999, lamivudine has been authorised as Epivir since 1996, and zidovudine has been available in the EU since the mid‑1980s.

How has Trizivir been studied?

No specific clinical studies have been carried out to assess the safety and effectiveness of the combined tablet. The company presented the results of studies with abacavir, lamivudine and zidovudine taken together, which were carried out during the development of Ziagen. The company also looked at the way the combined tablet was absorbed in the body in comparison with the separate tablets.

What benefit has Trizivir shown during the studies?

In the studies carried out for the development of Ziagen, the combination of the three active substances was shown to be at least as effective as the comparator combinations in keeping viral loads low. The combination tablet was absorbed in the body in the same way as the separate tablets.

What is the risk associated with Trizivir?

The most common effects with Trizivir (seen in more than 1 patient in 10) are headache and nausea (feeling sick). For the full list of all side effects reported with Trizivir, see the package leaflet.

Hypersensitivity reactions (allergic reactions) occur in patients taking Trizivir, usually within the first six weeks of treatment, and can be life-threatening. The risk of hypersensitivity is higher in patients who have the HLA‑B (type 5701) gene. Symptoms almost always include fever or rash, but also very commonly include nausea, vomiting, diarrhoea, abdominal pain (stomach ache), headache, signs of liver damage in the blood, myalgia (muscle pain), dyspnoea (difficulty breathing), cough, lethargy (lack of energy) and malaise (feeling unwell). Treatment with Trizivir should be stopped promptly if the patient has a hypersensitivity reaction. For more information, see the package leaflet.

Trizivir must not be used in patients who have kidney failure. Because it contains zidovudine, Trizivir must not be used by patients with low neutrophil counts (low levels of a type of white blood cell) or anaemia (low red blood cell counts). For the full list of restrictions, see the package leaflet.

Why has Trizivir been approved?

The CHMP noted that the reduction in the number of tablets that patients need to take may help patients stick to their treatment. It also noted that the benefit of Trizivir has mainly been shown in patients who have had little or no previous HIV treatment and who do not have advanced disease. The Committee decided that Trizivir’s benefits are greater than its risks and recommended that it be given marketing authorisation.

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

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

In addition, the company that markets Trizivir provides educational materials for doctors about hypersensitivity reactions with the medicine, including the need to test patients for the HLA-B (type 5701) gene and to remind patients to contact their doctor immediately if they develop symptoms suggestive of hypersensitivity. Patients will also receive an alert card summarising key safety information on hypersensitivity reactions with this medicine.

Other information about Trizivir

The European Commission granted a marketing authorisation valid throughout the EU for Trizivir on 28 December 2000.

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

Name Language First published Last updated
Trizivir : EPAR - Summary for the public BG = bălgarski 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public ES = español 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public CS = čeština 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public DA = dansk 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public DE = Deutsch 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public ET = eesti keel 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public EL = elliniká 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public EN = English 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public FR = français 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public IT = italiano 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public LV = latviešu valoda 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public LT = lietuvių kalba 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public HU = magyar 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public MT = Malti 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public NL = Nederlands 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public PL = polski 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public PT = português 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public RO = română 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public SK = slovenčina 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public SL = slovenščina 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public FI = suomi 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public SV = svenska 2008-01-28 2016-06-02
Trizivir : EPAR - Summary for the public HR = Hrvatski 2008-01-28 2016-06-02

This EPAR was last updated on 13/09/2016 .

Authorisation details

Product details

Product details for Trizivir
NameTrizivir
Agency product numberEMEA/H/C/000338
Active substance

abacavir (as sulfate) / lamivudine / zidovudine

International non-proprietary name (INN) or common name

abacavir (as sulfate) / lamivudine / zidovudine

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AR04

Publication details

Publication details for Trizivir
Marketing-authorisation holder

ViiV Healthcare UK Limited
 

Revision30
Date of issue of marketing authorisation valid throughout the European Union28/12/2000

Contact address:

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

Product information

Product information

21/07/2016  Trizivir -EMEA/H/C/000338 -WS/0956/G

Name Language First published Last updated
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13
Trizivir : EPAR - Product Information HR = Hrvatski 2009-12-09 2016-09-13

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
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27
Trizivir : EPAR - All Authorised presentations HR = Hrvatski 2006-08-07 2015-04-27

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Trizivir is indicated for the treatment of human-immunodeficiency-virus (HIV) infection in adults.

This fixed combination replaces the three components (abacavir, lamivudine and zidovudine) used separately in similar dosages. It is recommended that treatment is started with abacavir, lamivudine,and zidovudine separately for the first six to eight weeks. The choice of this fixed combination should be based not only on potential adherence criteria, but mainly on expected efficacy and risk related to the three nucleoside analogues.

The demonstration of the benefit of Trizivir is mainly based on results of studies performed in treatment naive patients or moderately antiretroviral experienced patients with non-advanced disease.

In patients with high viral load (>100,000 copies/ml) choice of therapy needs special consideration.

Overall, the virologic suppression with this triple nucleoside regimen could be inferior to that obtained with other multitherapies notably including boosted protease inhibitors or non-nucleoside reverse-transcriptase inhibitors, therefore the use of Trizivir should only be considered under special circumstances (e.g. co-infection with tuberculosis).

Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Screening is also recommended prior to re-initiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir (see 'management after an interruption of Trizivir therapy'). Abacavir should not be used in patients known to carry the HLA-B*5701 allele, unless no other therapeutic option is available in these patients, based on the treatment history and resistance testing.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Trizivir : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2006-08-07  
Trizivir : EPAR - Scientific Discussion HR = Hrvatski 2006-08-07  

Authorised

This medicine is approved for use in the European Union

More information on Trivizir