欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Trizivir
适用类别Human
治疗领域HIV Infections
通用名/非专利名称abacavir;lamivudine;zidovudine
活性成分abacavir (as sulfate);lamivudine;zidovudine
产品号EMEA/H/C/000338
患者安全信息No
许可状态Authorised
ATC编码J05AR04
是否额外监管No
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2000/12/27
上市许可开发者/申请人/持有人ViiV Healthcare BV
人用药物治疗学分组Antivirals for systemic use
兽用药物治疗学分组
审评意见日期2000/09/21
欧盟委员会决定日期2023/11/15
修订号43
治疗适应症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.
适用物种
兽用药物ATC编码
首次发布日期2018/01/25
最后更新日期2023/11/29
产品说明书https://www.ema.europa.eu/en/documents/product-information/trizivir-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/trizivir
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