部份中文达卡他韦处方资料（仅供参考） 商品名：Daklinza 通用名：daclatasvir 中文名：达卡他韦 给药途径：片剂，为口服使用 上市日期：2014年7月4日 生产厂家：百时美施贵宝（Bristol-Myers Squibb） 适应证和用途 DAKLINZA是一种丙型肝炎病毒(HCV)NS5A抑制剂适用为与索非布韦(sofosbuvir)使用为慢性HCV基因型3感染的治疗 剂量和给药方法 ⑴ 60mg口服每天1次有或无食物与索非布韦联用。 ⑵ 推荐治疗时间：12周。 ⑶ 剂量修饰与强CYP3A抑制剂减低剂量至30mg每天1次和与中度CYP3A诱导剂增加剂量至90mg每天1次。 剂型和规格 薄膜衣片：60mg和30mg Daklinza（daclatasvir）用于联合Sovaldi（sofosbuvir，索非布韦）用于基因型3慢性丙型肝炎（GT-3 HCV）成人患者的治疗。Daklinza是已经证明安全性和功效的治疗基因3的HCV感染，而不需要干扰素或利巴韦林共同给药的第一种药物 2014年7月4日，百时美施贵宝丙肝新药Daklinza（daclatasvir）获欧盟批准，联合其他药物，用于所有1、2、3、4基因型慢性丙型肝炎（HCV）成人感染者的治疗。 Daklinza是一种强效泛基因型NS5A复制复合体抑制剂，在临床试验中，当与吉利德丙肝明星药物Sovaldi组成一种每日一次、全口服、无干扰素鸡尾酒疗法（Daklinza+Sovaldi）时，取得了100%的治愈率，包括伴有晚期肝脏疾病、基因型3 HCV及既往经蛋白酶抑制剂治疗失败的患者群。 数据表明，Daklinza+Sovaldi组合疗法在基因型1HCV初治患者中的治愈率达到了99%，在既往对特拉匹韦或boceprevir治疗失败的基因型1HCV群体中的治愈率达100%，在基因型2和基因型3 HCV中的治愈率分别为96%和89%。 此外，Daklinza治疗丙型肝炎的安全性，已在横跨各种不同群体中得到证明，包括老年患者、伴有晚期肝病群体、肝移植后受者群体及HIV/HCV共感染群体。 本品原处方资料附件：https://www.medicines.org.uk/emc/medicine/29129 Daklinza (Daclatasvir) DAKLINZA is indicated for use with sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) genotype 3 infection. Limitations of Use: Sustained virologic response (SVR) rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving DAKLINZA in combination with sofosbuvir for 12 weeks ------------------------------------------------------------------- Daklinza® (daclatasvir) launched in the UK, with a new treatment combination for chronic hepatitis C • Daclatasvir is an oral, once-a-day pill, used in combination with other medicinal products, to treat adult patients with chronic hepatitis C.2 • Daclatasvir, in combination with other agents, works across multiple hepatitis C genotypes. In clinical studies, different daclatasvir-based combinations have shown clinical cure rates of up to 98% in patients with hepatitis C genotype 1,  89% in patients with genotype 3 and 100% in genotype 4. • For around 90% of cases in the UK[5], daclatasvir offers the option of a curative oral regimen that does not require interferon2, which is commonly associated with sustained flu-like side effects. Twenty-four or 48 weeks of daclatasvir plus interferon and ribavirin cured 82 percent of people with genotype 4 of hepatitis C virus (HCV), including those with cirrhosis, in a recent trial, HCP Live reports. Researchers in the COMMAND-4 study conducted a placebo-controlled trial of people with genotype 4 of the virus, including 82 participants who received the NS5A inhibitor daclatasvir plus interferon and ribavirin, and 42 participants who received a placebo plus interferon and ribavirin. The findings were announced at IDWeek 2014 in Philadelphia. At weeks 4 and 12, 79 percent of participants taking daclatasvir had an undetectable HCV viral load, known as an extended rapid virologic response (eRVR). They spent 24 weeks on the three-drug regimen. Those in the daclatasvir arm who did not achieve an eRVR took an additional 24 weeks of just interferon and ribavirin. All of those in the placebo arm were treated for 48 weeks. Of this group, just 12 percent achieved an eRVR Eighty-two percent of the participants taking daclatasvir achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), compared with 43 percent taking the placebo. Cure rates in the daclatasvir arm were not affected by IL28B genotype, age, race, gender, cirrhosis status or baseline viral load. A total of 9.8 percent of those in the daclatasvir group experienced severe adverse side effects, compared with 4.8 percent of the placebo group. However, 7.1 percent of those in the placebo group experienced adverse side effects that led to discontinuation of treatment, compared with 4.9 percent of those in the daclatasvir arm. Combination Treatment with Daclatasvir Produces Good Results in Patients with Genotype 4 Hepatitis C. In the study, 82 patients with genotype 4 HCV were treated with 60 mg once daily of the NS5A inhibitor daclatasvir in combination with peginterferon alfa 180 µg once weekly and weight-based ribavirin (1000-1200 mg/day) twice daily. In the study’s other arm, 42 patients received placebo plus peginterferon alfa and ribavirin. Researchers evaluated the safety and efficacy of this combination in treatment-naïve patients with genotype 4 HCV, including patients with cirrhosis. The primary endpoint of the study was sustained virologic response at 12 weeks (SVR12). Patients treated with the daclatasvir combination who had undetectable HCV RNA at weeks 4 and 12 (extended rapid virologic response, or eRVR) received 24 weeks of treatment with the daclatasvir/peginterferon alfa/ribavirin combination. Patients who did not have an eRVR received an additional 24 weeks of treatment with peginterferon alfa/ribavirin. All patients in the placebo group received 48 weeks of treatment with --------------------------------------------------      产地国家：英国 原产地英文商品名: Daklinza filmcoated tablets 30mg/Tabs 28Tabs/box 原产地英文药品名: daclatasvir 中文参考商品译名: Daklinza薄膜片 30毫克/片 28片/盒 中文参考药品译名: 达卡他韦 生产厂家中文参考译名: 百时美施贵宝 EEIG 生产厂家英文名: Bristol-Myers Squibb Pharma EEIG -------------------------------------------------- 产地国家：英国 原产地英文商品名: Daklinza filmcoated tablets 60mg/Tabs 28Tabs/box 原产地英文药品名: daclatasvir 中文参考商品译名: Daklinza薄膜片 60毫克/片 28片/盒 中文参考药品译名: 达卡他韦 生产厂家中文参考译名: 百时美施贵宝  EEIG 生产厂家英文名: Bristol-Myers Squibb Pharma EEIG -------------------------------------------------- 产地国家：英国 原产地英文商品名: Daklinza filmcoated tablets 90mg/Tabs 28Tabs/box 原产地英文药品名: daclatasvir 中文参考商品译名: Daklinza薄膜片 90毫克/片 28片/盒 中文参考药品译名: 达卡他韦 生产厂家中文参考译名: 百时美施贵宝 EEIG 生产厂家英文名: Bristol-Myers Squibb Pharma EEIG