Trizivir

Withdrawn

This medicine's authorisation has been withdrawn

abacavir / lamivudine / zidovudine

Overview

On 23 October 2026, the European Commission withdrew the marketing authorisation for Trizivir (lamivudine / abacavir / zidovudine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, ViiV Healthcare B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Trizivir was granted marketing authorisation in the EU on 28 December 2000 for the treatment of HIV. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2010. 

Trizivir : EPAR - Summary for the public

Reference Number: EMA/197378/2020

Product information

Trizivir : EPAR - Product Information

Trizivir : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Trizivir
• Active substance:
  • abacavir (as sulfate)
  • lamivudine
  • zidovudine
• International non-proprietary name (INN) or common name:
  • abacavir
  • lamivudine
  • zidovudine
• Therapeutic area (MeSH):
  HIV Infections
• Anatomical therapeutic chemical (ATC) code:
  J05AR04

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000338
• Marketing authorisation holder:
  ViiV Healthcare BV

  Van Asch van Wijckstraat 55H; 3811 LP Amersfoort; The Netherlands

• Opinion adopted:
  21/09/2000
• Marketing authorisation issued:
  27/12/2000
• Withdrawal of marketing authorisation:
  23/10/2026
• Revision:
  44

Assessment history

Changes since initial authorisation of medicine

Trizivir : EPAR - Procedural steps taken and scientific information after authorisation

Trizivir : EPAR - Procedural steps taken and scientific information after authorisation (archive)

Trizivir-H-C-PSUSA-00003144-202212 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Reference Number: EMA/395778/2023

Trizivir : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Trizivir : EPAR - Scientific Discussion

Trizivir : EPAR - Procedural steps taken before authorisation