颤抖吧吉利德！艾伯维丙肝鸡尾酒Viekira Pak获FDA批准

2014年12月20日讯 /生物谷BIOON/ --颤抖吧！吉利德！！艾伯维（AbbVie）全口服丙肝鸡尾酒Viekira Pak获FDA批准啦！！！Viekira Pak的上市，也标志着丙肝治疗领域吉利德一家独大的局面宣告瓦解。业界预测，Viekira Pak的年销售峰值将达到30亿美元。不过，Harvoni每日一次的用药优势将帮助吉利德继续主导丙肝市场。Viekira Pak是一种全口服无干扰素丙肝鸡尾酒疗法，由固定剂量mbitasvir/paritaprevir/ritonavir（25mg/150mg/100mg，每日一次）和dasabuvir（250mg，每日两次）组成。根据Viekira Pak的处方信息，该治疗方案的推荐用量为：每天2片固定剂量组合（ombitasvir/paritaprevir/ritonavir，12.5mg/75mg/50mg，早餐时服药）和每日2片dasabuvir（250mg，早餐、晚餐时各服一片）。Viekira的获批，是基于该药III期项目的临床数据，该项目由6个III期研究组成，在这些研究中，Viekira 12周治疗方案取得了令人印象深刻的治愈率（SVR12），在某些丙肝群体中甚至高达99%，包括最难治的基因型1丙肝群体。分析师预计，Viekira的年销售峰值将突破30亿美元，不过吉利德丙肝鸡尾酒Harvoni年销售峰值高达120亿美元。另外，尽管2种鸡尾酒的疗效相似，但吉利德的Harvoni每天只需服用一片，艾伯维的Viekira Pak鸡尾酒方案每天至少需服4片药物，这一差异可能会影响Viekira Pak的处方率。不过艾伯维可以从定价方面进行平衡。Harvoni 12周治疗方案的价格为94500美元，这一价格遭到了全球各地纳税人的抱怨和抗议。这一局势让艾伯维有机会通过降低价格来蚕食吉利德的市场份额。目前，艾伯维尚未披露Viekira Pak的价格，只是表示Viekira Pak 12周方案可能定价83319美元，比吉利德丙肝明星药Sovaldi略低一点。去年，吉利德凭借丙肝明星药Sovaldi垄断了各大网站头条，该药12周方案定价为84000美元，全口服鸡尾酒Harvoni 12周方案定价为94500美元，不过部分患者可能只需治疗8周便能治愈，因此治疗成本可降至63000美元。艾伯维发言人表示，该公司在对Viekira Pak定价时考虑了许多因素，包括成本利益及短期和长期成本。目前尚无法立刻明晰艾伯维的定价会对吉利德Harvoni的销售带来何种影响。然而，艾伯维鸡尾酒Viekira Pak每天需服用4片药物，吉利德Harvoni每日仅需服用1片，因此业界普遍预期，Harvoni的用药优势将帮助吉利德继续主导丙肝市场。不过，无论哪家公司胜出，对于美国320万丙肝患者而言，第二种新一代丙肝鸡尾酒的上市无论如何都是一个大好消息。吉利德自2013年底推出丙肝明星药Sovaldi，重新定义了丙型肝炎的临床治疗标准，开启了全口服护理的新时代。FDA抗菌产品办公室主任Edward Cox在一份声明中表示，新一代丙肝鸡尾酒疗法正在改变丙肝的临床治疗模式，与以往基于注射药物干扰素的丙肝治疗方案相比，新一代全口服鸡尾酒具有非常高的病毒学治愈率及更好的安全性。（生物谷Bioon.com）

英文原文：U.S. FDA approves AbbVie hepatitis C drug, costs $83,319 for 12 weeks

Dec 19 (Reuters) - U.S. health regulators on Friday approved AbbVie's all-oral treatment for hepatitis C, and the company said the drug would cost $83,319 for a typical 12-week plan, a bit below its huge selling competitor Solvadi from Gilead Sciences.Gilead's Sovaldi treatment stole headlines last year with its $84,000 price tag and set off a national debate about whether drug prices have climbed too high.AbbVie's newly approved regimen is also less costly than Gilead's newest one-pill regimen that combines Sovaldi with another drug and costs $94,500 for 12 weeks.With Gilead's newly improved Harvoni, some patients can take the treatment for just eight weeks, which sells for about $63,000.Some insurers and analysts had said that AbbVie might price its drug, which will be sold under the brand name Viekira Pak, lower than Gilead because of pricing pressure.Gilead has come under intense pressure from U.S. health insurers, politicians and pharmacy benefit managers over the high cost of Sovaldi and more recently, Harvoni. It argues the price is justified because the treatment cures nearly all patients of the liver-destroying virus.An AbbVie spokeswoman said the company considered many factors in setting the price such as the cost effectiveness of the treatment and its value in offsetting other short and long term costs.The AbbVie regimen consists of four different anti-viral drugs to be taken as three pills in the morning and one in the evening. The U.S. Food and Drug Administration approved the regimen for patients with genotype 1 form of the virus, the most common type of hepatitis C and the most difficult to treat.It was not immediately clear how the AbbVie pricing would impact Harvoni sales, which is widely expected to dominate the market given its advantage of fewer pills.Gilead's Sovaldi, which was approved a year ago, had been selling at the rate of about $3 billion per quarter due to huge pent up demand.The AbbVie regimen has demonstrated similar efficacy to Gilead's, with cure rates of 95 to 100 percent, the company said, and minimal negative side effects. AbbVie said that 95 percent of patients will require a 12 week treatment.Enanta Pharmaceuticals Inc, which helped develop the Abbvie drug, saw its shares rise 4.2 percent in after-hours trading while AbbVie's shares gained 1.1 percent. (Reporting by Bill Berkrot and Caroline Humer in New York and Amrutha Penumudi in Bengalaru; Editing by Chizu Nomiyama and Diane Craft)