2016年12月19日，新型肝硬化，丙型肝炎治疗药的组合片Ximency Combination Tablets（Daclatasvir Hydrochloride/Asunaprevir/Beclabuvir Hydrochloride）被日本批准用于“慢性丙型肝炎或C病毒血症的改善补偿血清1（基因型1）的肝硬化类型。 商品名：Ximency组合片剂 通用名：盐酸Dakuratasubiru/Asunapurebiru/Bekurabubiru盐酸盐 成份：含有盐酸Dakuratasubiru16.5mg（15毫克为Dakuratasubiru）/100毫克Asunapurebiru/Bekurabubiru盐酸盐39.6mg（37.5mg作为Bekurabubiru）在一片 上市日期：2016年12月19日 适应症： 血清群1℃慢性肝炎或C型（基因型1）改善肝硬化代偿血症 用法与用量： 每天二次，每次2片，服药时间12周 包装规格： 16.5mg/100mg/39.6mg 56片/盒 制造商：施贵宝有限公司 Novel hepatitis C therapeutic combination drug suppressed the appearance of drug resistance On February 15, 2017, antiviral chemotherapeutic drug Daclatasville hydrochloride · asnaprevir · beclabu hydrochloride (trade name: dimensy combination tablets) was released with drug price listing. Manufacture and sales of this product was approved on December 19, 2016. Adaptation is "Improvement of viremia in serogroup 1 (genotype 1) chronic hepatitis C or C type compensatory cirrhosis." Take 2 tablets once a day twice a day, after meals for 12 weeks orally. When using this drug, it is necessary to confirm that hepatitis C virus RNA is positive and that it is not decompensated cirrhosis in view of hepatic reserve capacity and clinical symptoms etc. It is said that Japan is one of the countries with a large number of liver cancer patients, which is mainly caused by hepatitis C virus (HCV). HCV infected people are estimated to be 170 million people worldwide, 1.5 million to 2 million people in Japan. As a treatment of chronic hepatitis C (genotype 1), a combination therapy of interferon (IFN) preparation and ribavirin (Copegus, Rebetol) has been conventionally used. In recent years, however, several oral direct viral inhibitors (DAAs) such as Dacrathasville (Dacrystein) and Asnapreville (Sumbepla) which have improved sustainable virus negative rate have been developed and approved. In addition, in September 2015, the combination formulation of DAAs Respasville and Sophosbuville (Herbony), DAAs Ombitusville and Parita revil in November 2015, Ritonavir as a pharmacokinetic booster formulation (Vickilux) will be used clinically , And the convenience of patients is increasing. It is said that Japan is one of the countries with a large number of liver cancer patients, which is mainly caused by hepatitis C virus (HCV). HCV infected people are estimated to be 170 million people worldwide, 1.5 million to 2 million people in Japan. As a treatment of chronic hepatitis C (genotype 1), a combination therapy of interferon (IFN) preparation and ribavirin (Copegus, Rebetol) has been conventionally used. In recent years, however, several oral direct viral inhibitors (DAAs) such as Dacrathasville (Dacrystein) and Asnapreville (Sumbepla) which have improved sustainable virus negative rate have been developed and approved. In addition, in September 2015, the combination formulation of DAAs Respasville and Sophosbuville (Herbony), DAAs Ombitusville and Parita revil in November 2015, Ritonavir as a pharmacokinetic booster formulation (Vickilux) will be used clinically , And the convenience of patients is increasing. Gimensee is an NS5A inhibitor Daclatusus inhibiting the function of nonstructural protein 5A (NS5A), a protein essential for HCV replication, and NS3 / 4A protease that competitively inhibits the active site of nonstructural protein 3 / 4A protease The inhibitor asnaprevir, and the novel beaklabuville three component DAAs are used as active ingredients. Beklabville is the same nonstructural protein 5B (NS5B) polymerase inhibitor as Sophosubville, the active ingredient of existing harbony. As a difference between the two components, while Sophosbuville is a nucleic acid type, Beklabuville is non-nucleic acid type. In the clinical setting, Daclatasville is recognized as a combination therapy with asnaprevir for 24 weeks, and the response rate is dramatically improved. However, on the other hand, it has been known that in this combination therapy, both genetic polymorphism (drug resistance mutation) that greatly attenuates the therapeutic effect is expressed in both Dacrathasville and Asnaprevir. Gimensee enhances the HCV genomic elimination effect by adding Beklabuville to Dakrathasville and Asnaprevir and enhances its effectiveness for drug resistance mutation (confirmed in vitro). In addition, combination therapy with Dakrathasville and asnaprevir was administered for 24 weeks, but treatment with 12 minutes of dosimacy became possible. In domestic clinical trials of untreated and pretreated Genotype 1 type C chronic hepatitis C or type C compensated cirrhosis patients with untreated and IFN preparations, the status of development of tolerance-related mutations before the start of treatment, Good antiviral effect was confirmed regardless of presence or absence. In domestic clinical trials, pay attention to the fact that side effects including laboratory test value abnormality are recognized in 56.7%. Major side effects include ALT (GPT) increase (23.0%), AST (GOT) increase (19.4%), eosinophilia (17.1%), fever (16.6%), hyperbilirubinemia (14.7%) etc. There are reported serious side effects of liver dysfunction, liver failure, erythema multiforme, thrombocytopenia, interstitial pneumonia. Product name: Dimency compound tablet Main ingredient: Daclatasvir hydrochloride (Daclatasvir Hydrochloride) Asnaprevir (Asunaprevir) Beclabuvir hydrochloride (Beclabuvir Hydrochloride) Dosage form: light green elliptical tablet, long diameter 15.3 mm, short diameter 7.2 mm, thickness 5.6 mm Sheet description: (Table) Combination tablet, BMS 224, (back) Ximency, compounded tablet with Bimb 224 On the action and effect of this medicine (Antiviral effect) that inhibits multifunctional protein (NS5A), NS3/4A protease complex and NS5B-RNA dependent RNA polymerase involved in hepatitis C virus replication and suppresses the increase of hepatitis C virus indicate. It is usually used for treatment of type C chronic hepatitis, type C compensated cirrhosis. Be sure to tell your doctor and pharmacist before using any one of the following people. • If you used medicine before, it may have allergic symptoms such as itching, rash. There is liver dysfunction. There is renal dysfunction. It has been infected with hepatitis B virus, it has been infected with hepatitis B virus in the past. • Pregnant, may be pregnant, or breast-feeding • You are using other medicines etc. (There is also the possibility of strengthening or weakening each other 's actions, so please be careful including other general - use medicines and foods in use). Dosage regimen (how to use this medicine) • Your usage and dose (filled in with medical staff) • Usually, adults take 2 tablets once a day twice a day after meals. The dose period is 12 weeks. Please follow the directions given by your doctor. • If you forget to take the medicine immediately after taking 4 hours or more until the next dose, please take as expected afterwards. If it is less than 4 hours to the next dose, skip once and take one dose at the next dose. Never drink two doses at the same time. • If you drink too much accidentally, please consult your doctor or pharmacist. • Do not stop drinking at your own discretion without the instruction of your doctor. Living attention • Avoid foods containing H. otogillis, because St. John's Wort (St John's Wort) lowers the blood concentration of the drug and may reduce its effect. Be careful after using this medicine (side effects) Fever, headache, malaise, diarrhea, etc. are reported as major side effects. If you notice such symptoms, please consult your doctor or pharmacist. The following symptoms appear rarely and may be the initial symptoms of the side effects shown inside. In such cases, please stop using it and get medical attention immediately. • Lumpy body, nausea, vomiting, itching, white eyes, skin, urine turn yellow [Liver function disorder, liver failure] • Red or rash red red rash, fever, joint pain [multiform erythema] • Easy to bleed (nosebleeds, bleeding gums, subcutaneous bleeding), prone to bruising [thrombocytopenia] • fever, cough, dyspnea [interstitial pneumonia] These side effects do not describe everything. If any other symptoms are noted besides the above, please consult your doctor or pharmacist. Storage method Other • Please keep out of direct sunlight, high temperature and moisture in infants and children, out of the reach of hands. • If medicine remains, please discard it without storing it. For disposal please consult the pharmacy or medical institution you received. Internal medicine Created in December 2016 Medicines have side effects (risks) as well as effects (benefits). It is important to minimize side effects and maximize effect. For that, we need understanding and cooperation of patients who use this medicine。 ------------------------------------------ 添付文書 （PDF・714KB）