abacavir / lamivudine / zidovudine - EPARs for authorised medicinal products for human use - Trizivir

FICHA FARMACOLÓGICA de abacavir / lamivudine / zidovudine . Contiene la Monografía en distintos idiomas (de la Unión Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. JUNIO 23, 2010.-

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EPARs for authorised medicinal products for human use - Trizivir

Active Substance
Abacavir
Lamivudine
Zidovudine
International Nonproprietary Name or Common Name
abacavir / lamivudine / zidovudine
Pharmaco-therapeutic Group
Antivirals for treatment of HIV infections, combinations
ATC Code
J05AR04

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 6-8 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 (see section 5.1).


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 (see section 4.4 and 4.8).


Date of issue of Marketing Authorisation valid throughout the European Union
28 December 2000

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use