Trizivir
abacavir (as sulfate) / lamivudine / zidovudine
Table of contents
Overview
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 6 weeks before switching to Trizivir.
Trizivir contains three active substances: abacavir, lamivudine and zidovudine.
Authorisation details
Product details | |
---|---|
Name |
Trizivir
|
Agency product number |
EMEA/H/C/000338
|
Active substance |
|
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 |
36
|
Date of issue of marketing authorisation valid throughout the European Union |
27/12/2000
|
Contact address |
Van Asch van Wijckstraat 55H |
Product information
14/01/2021 Trizivir - EMEA/H/C/000338 - WS/1917
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.