[转移贴]艾伯维丙肝新药Viekira + Exviera获欧洲药品委员会批准

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原贴由wwwkkk83发表于 2015-1-17 16:14

不到一个月时间内，艾伯维继获美国FDA批准之后，其口服、无干扰素的丙肝药物Viekirax加上Exviera获欧洲委员会批准，对艾伯维而言，无疑是好事连连。

Viekirax (ombitasvir/paritaprevir/ritonavir)和Exviera (dasabuvir)的优势在于口服给药、无需干扰素且疗程较短，Exviera (dasabuvir)在美国的商品名为Viekira Pak。该疗法适用于那些被1型慢性丙型肝炎病毒感染的人群，包括那些并发肝硬化、同时感染HIV-1病毒、使用阿片类药物替代疗法或是肝移植的患者，可以与利巴韦林联用，也可以不用。此外，Viekirax还被批准与利巴韦林联合用药治疗4型丙肝患者。

此次批准是遵照了欧洲药品管理局加速审批的意见，因为欧洲感染慢性HCV的患者大约为900万，这是一个不容小觑的数字。

艾伯维的董事长Richard Gonzalez表示，如此快速的审批通过无疑是为欧洲的患者提供了新的有效治疗方式。同时，这也为艾伯维提供了与吉利德在欧洲丙肝药市场上竞争的机会，目前吉利德的Harvoni与Sovaldi (sofosbuvir)对治疗1型和4型丙肝病毒感染很有优势。

尽管目前吉利德大热的丙肝新药效果极好，但是高昂的价格也是许多患者难以承受的，至少在欧洲就是如此。Gonzalez表示，艾伯维正在与欧洲各国政府与医疗系统合作，争取扩大Viekira + Exviera的使用，其价格优势也是与吉利德竞争的亮点。

原文 Europe approves AbbVie multi-pill regimen for HCV

Less than a month after getting the green light in the USA， AbbVie has secured approval in Europe for its all-oral， interferon-free regimen

hepatitis C regimen Viekirax plus Exviera.

The European Commission has granted marketing authorisations for its all-oral， short-course， interferon-free treatment of Viekirax (ombitasvir/paritaprevir/ritonavir)， plus Exviera (dasabuvir) approved in the USA as Viekira Pak. The treatment has been approved with or without ribavirin for patients with genotype 1 chronic HCV infection， including those with compensated liver cirrhosis， HIV-1 co-infection， patients on opioid substitution therapy and liver transplant recipients； additionally， Viekirax has been approved with ribavirin in genotype 4 patients.

The approvals follow a review under accelerated assessment by the European Medicines Agency. Approximately nine million people in the Old Continent are infected with chronic HCV.

AbbVie chief executive Richard Gonzalez said the approval “offers patients across Europe a new and effective treatment to cure this serious disease”. It will compete with Gilead Science’s Harvoni， which combines the mega-blockbuster Sovaldi (sofosbuvir)， a nucleotide analogue polymerase inhibitor， with the NS5A inhibitor ledipasvir， for HCV genotype 1 and 4 infection.

While these new HCV drugs are being lauded for their stunning efficacy， there  is concern over the very high cost of these life-saving， highly-innovative treatments， not least in Europe. Mr Gonzalez added that “we are committed to working with local governments and healthcare systems to support broad access to Viekira + Exviera”.