特拉普韦改为每日2次用药 增加新的禁忌

丙型肝炎抗病毒药物特拉普韦的说明书已变更，其中包含新的用药建议和禁忌合并用药，描述见生产商发布的“致敬爱的医疗卫生专业人士”信函。

特拉普韦是一种丙型肝炎病毒(HCV)NS3/4A蛋白酶抑制剂，于2011年经核准与聚乙二醇干扰素和利巴韦林联合，用于治疗成年代偿性肝病患者的基因1型慢性HCV感染。其商品名为Incivek，由Vertex制药公司销售。

根据10月28日发布的信函，目前建议的剂量为1,125 mg（375 mg片剂3片）口服，每日2次，间隔10~14小时。信函中指出，“这一用药频率的变更是基于一项临床试验的数据，该试验显示，每日2次用药和每8小时用药1次的持续病毒学应答和安全特性均相似。”

此外，在禁忌合并用药清单中补充了卡马西平、苯巴比妥和苯妥英，原因为一项药代动力学研究中发现，在特拉普韦用药的同时使用这些药物“可能导致暴露量降低，因此，可能降低特拉普韦的疗效。”

新的每日两次用药包装将于2014年1月末上市。在此之前，当前的每个铝塑条包装中包含片剂6片，其中包括3个泡壳，每个泡壳含片剂2片，也可用于每日用药2次的建议用法。信函中指出，可将一个泡壳中的2片片剂和另一泡壳中的1片片剂同时使用，也就是说，每次服用3片片剂，每日用药2次。

更新的说明书见pi.vrtx.com/files/uspi_telaprevir.pdf。

如有问题，可致电877-824-4281联系Vertex公司。如发生与特拉匹韦相关的严重不良事件，应拨打这一电话号码报告Vertex公司，也可致电800-332-1088或登录www.fda.gov/medwatch向美国食品药品管理局报告。

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By: ELIZABETH MECHCATIE, Internal Medicine News Digital Network

The label of the hepatitis C antiviral drug telaprevir has been changed to include new dosing recommendations and contraindications, described in a "Dear Healthcare Professional" letter issued by the manufacturer.

Telaprevir is a hepatitis C virus (HCV) NS3/4A protease inhibitor approved in 2011 for the treatment of genotype 1 chronic HCV infection in adults with compensated liver disease, in combination with peginterferon alfa and ribavirin. It is marketed as Incivek, by Vertex Pharmaceuticals.

The recommended dose is now 1,125 mg (three 375-mg tablets) taken orally twice a day, 10-14 hours apart with food that is not low fat, according to the Oct. 28 letter. "This change in dosing frequency was based on data from a clinical trial demonstrating similar sustained virologic response and safety profile between the twice-daily dosing and the every-8-hour dosing," the letter stated.

In addition, carbamazepine, phenobarbital, and phenytoin are now on the list of contraindicated drugs, based on a pharmacokinetics study that found coadministration of these drugs with telaprevir "has the potential to lower exposure and, thus, may result in a loss of efficacy" of telaprevir, according to the letter.

New twice-daily-dosing packaging will be available at the end of January 2014. Until then, the current packaging that contains six tablets per blister strip – with three blister sections containing two tablets each – can be used for the twice-daily recommendation. Two tablets from one blister section and one tablet from another section can be taken for the three-pill dose, administered twice a day, the letter pointed out.

The updated label is available at pi.vrtx.com/files/uspi_telaprevir.pdf.

Vertex can be contacted for questions at 877-824-4281. Serious adverse events associated with telaprevir should be reported to Vertex at that number, or to the Food and Drug Administration at 800-332-1088 or at www.fda.gov/medwatch.