Trizivir

RSS

abacavir (as sulfate) / lamivudine / zidovudine

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 14/11/2018

Authorisation details

Product details
Name
Trizivir
Agency product number
EMEA/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 (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AR04
Publication details
Marketing-authorisation holder
ViiV Healthcare BV
Revision
32
Date of issue of marketing authorisation valid throughout the European Union
27/12/2000
Contact address

Huis ter Heideweg 62
3705 LZ Zeist
The Netherlands

Product information

24/10/2018 Trizivir - EMEA/H/C/000338 - IAIN/0110

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.

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

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