FDA批准sofosbuvir用于慢性丙型肝炎治疗

美国食品药品管理局(FDA)已批准sofosbuvir用于慢性丙型肝炎感染治疗。Sofosbuvir是首个获批的丙型肝炎病毒(HCV)NS5B聚合酶核苷酸类似物抑制剂，该酶在HCV复制过程中起重要作用。Sofosbuvir口服给药，1次/日，400 mg/次，由吉利德科学公司以商品名Sovaldi销售。

该药物获准用于2种慢性丙型肝炎适应证：联合聚乙二醇干扰素和利巴韦林用于成人HCV基因1型和4型感染初治患者以及联合利巴韦林用于成人HCV基因2型和3型感染患者，后者是首次获批的不含干扰素的慢性丙肝治疗方案。

FDA药物评价与研究中心抗菌产品办公室主任Edward Cox博士在声明中指出：“此批准令标志着某些慢性丙肝患者治疗模式的重大转变。”

西奈山医学院HIV项目医学主任Demetre Daskalakis博士在10月25日FDA抗病毒药物专家委员会sofosbuvir审评会议上说：“这真的是一个历史性时刻。我们迫切期待该药物早日进入临床，我们都非常兴奋。”该专家委员会于当日投票一致推荐批准sofosbuvir上市。

该批准令是基于共计纳入1,947例初治和已接受治疗患者的6项临床试验数据，其中包括部分HIV阳性患者。

据FDA称，临床试验中接受sofosbuvir和利巴韦林治疗患者报告的最常见副作用是疲乏和头痛，接受sofosbuvir、利巴韦林和聚乙二醇干扰素α治疗患者最常见副作用为疲乏、头痛、恶心、失眠和贫血。

据吉利德公司称，sofosbuvir也即将在欧盟获准上市。Sofosbuvir是FDA在过去2周内批准的第2种慢性HCV感染治疗用药，另一获批药物为simeprevir，于11月22日获准上市。

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By: ALICIA AULT, Internal Medicine News Digital Network

The Food and Drug Administration has approved sofosbuvir, a first-in-its-class antiviral, to treat chronic hepatitis C infection.

Sofosbuvir is a nucleotide analogue inhibitor of the hepatitis C virus (HCV) NS5B polymerase enzyme, which plays an important role in HCV replication. It is taken orally once a day at a 400-mg dose. It will be marketed as Sovaldi by Gilead Sciences.

The drug is approved for two chronic hepatitis C indications: In combination with pegylated interferon and ribavirin for treatment-naïve adults with genotype 1 and 4 infections, and in combination with ribavirin for adults with genotypes 2 and 3 infection.

The second indication is the first approval of an interferon-free regimen for the treatment for chronic hepatitis C.

"Today’s approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C," Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA Center for Drug Evaluation and Research, said in a statement.

This is "truly a historic moment," Dr. DemetreDaskalakis, medical director of the HIV program at Mt. Sinai School of Medicine, New York, said at an FDA advisory committee meeting on the drug held Oct. 25. "I can’t wait to get this drug into the clinic. We are all excited," he added. The Antiviral Drugs Advisory Committee voted unanimously that day to recommend approval for sofosbuvir.

Sofosbuvir was approved based on data from six clinical trials consisting of 1,947 patients – both treatment-naïve and treatment experienced – some of whom were also HIV positive.

The most common side effects reported in clinical study participants treated with sofosbuvir and ribavirin were fatigue and headache. In participants treated with sofosbuvir, ribavirin, and peginterferon-alfa, the most common side effects reported were fatigue, headache, nausea, insomnia, and anemia, according to the FDA.

According to Gilead, sofosbuvir is also on the verge of receiving marketing approval in the European Union. Sofosbuvir is the second drug approved by the FDA in the past two weeks to treat chronic HCV infection. Simeprevir was approved Nov. 22.

Elizabeth Mechcatie contributed to this report.