Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
Trizivir is indicated for the treatment of Human Immunodeficiency Virus (HIV) infection in adults (see sections 4.4 and 5.1). This fixed combination replaces the three components (abacavir, lamivudine and zidovudine) used separately in similar doses. It is recommended that treatment is started with abacavir, lamivudine, and zidovudine separately for the first 6-8 weeks (see section 4.4). 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).
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 (see section 4.4). Abacavir should not be used in patients known to carry the HLA-B*5701 allele.
Therapy should be prescribed by a physician experienced in the management of HIV infection.
The recommended dose of Trizivir in adults (18 years and over) is one tablet twice daily.
Trizivir can be taken with or without food.
Where discontinuation of therapy with one of the active substances of Trizivir is indicated, or where dose reduction is necessary separate preparations of abacavir, lamivudine and zidovudine are available.
Whilst no dose adjustment of abacavir is necessary in patients with renal dysfunction, lamivudine and zidovudine concentrations are increased in patients with renal impairment due to decreased clearance (see section 4.4). Therefore, as dose adjustments of these may be necessary, it is recommended that separate preparations of abacavir, lamivudine and zidovudine be administered to patients with severe renal impairment (creatinine clearance ≤30 mL/min). Physicians should refer to the individual summary of product characteristics of these medicinal products. Trizivir should not be administered to patients with end-stage renal disease (see sections 4.3 and 5.2).
Abacavir is primarily metabolised by the liver. No clinical data are available in patients with moderate or severe hepatic impairment, therefore the use of Trizivir is not recommended unless judged necessary. In patients with mild hepatic impairment (Child-Pugh score 5-6) close monitoring is required, including monitoring of abacavir plasma levels if feasible (see sections 4.4 and 5.2).
No pharmacokinetic data are currently available in patients over 65 years of age. Special care is advised in this age group due to age associated changes such as the decrease in renal function and alteration of haematological parameters.
The safety and efficacy of Trizivir in adolescents and children has not been established. No data are available.
Dose adjustment of zidovudine may be necessary if the haemoglobin level falls below 9 g/dl or 5.59 mmol/l or the neutrophil count falls below 1.0 × 109/l (see sections 4.3 and 4.4). As dose adjustment of Trizivir is not possible, separate preparations of abacavir, lamivudine and zidovudine should be used. Physicians should refer to the individual summary of product characteristics of these medicinal products.
There is limited experience of overdose with Trizivir. No specific symptoms or signs have been identified following acute overdose with abacavir, zidovudine or lamivudine apart from those listed as adverse reactions.
If overdose occurs the patient should be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary. Since lamivudine is dialysable, continuous haemodialysis could be used in the treatment of overdose, although this has not been studied. Haemodialysis and peritoneal dialysis appear to have a limited effect on elimination of zidovudine, but enhance the elimination of the glucuronide metabolite. It is not known whether abacavir can be removed by peritoneal dialysis or haemodialysis.
2 years.
Do not store above 30°C.
Trizivir tablets are available in opaque white PCTFE/PVC-Al blister packs or child-resistant foil PVC/PCTFE/PVC-Al/Paper blister packs containing 60 tablets, or child resistant HDPE bottles containing 60 tablets.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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