英文药名：Stribild(Elvitegravir,Cobicistat,Emtricitabine,Tenofovir DF treat) 中文药名：埃替拉韦/恩曲他滨/富马酸/替诺福韦酯复方片 生产厂家：吉利德科学 药品介绍 近日，美国食品药品监督管理局(FDA)批准Stribild (elvitegravir，cobicistat，恩曲他滨[emtricitabine]，富马酸替诺福韦酯[tenofovir disoproxil fumarate])，一种新一天次组合丸治疗从来未被治疗的HIV感染成年中HIV-1感染。 Stribild含两种以前批准的HIV药加两种新药，elvitegravir和cobicistat。Elvitegravir是一种HIV整合酶链转移抑制剂，干扰HIV繁殖需要的酶之一。Cobicistat，药代动力学增强剂，一种抑制代谢某些HIV药的酶和被用于延长elvitegravir效应。2004年批准恩曲他滨和富马酸替诺福韦酯的组合，和以商品名Truvada上市，阻断在人机体中HIV复制需要的另一种酶作用。这些药物在一起提供对HIV感染一个完整治疗方案。 批准日期：2012年8月 27日；公司：Gilead Sciences，Inc STRIBILD™ (elvitegravir，cobicistat，恩曲他滨[emtricitabine]，富马酸替诺福韦酯[tenofovir disoproxil fumarate])片，为口服使用 美国初次批准：2012 作用机制 STRIBILD是一种固定剂量抗病毒药物elvitegravir被药代动力学增强剂cobicistat，恩曲他滨,和替诺福韦DF提升的组合。[见微生物学]. 适应证和用途 STRIBILD，1个整合酶链转移抑制剂，1个药代动力学增强剂，和2个核苷类(酸)似物HIV-1逆转录酶抑制剂的组合，使用作为一个完整方案为在未用抗逆转录病毒治疗过成年中治疗HIV-1感染。 剂量和给药方法 （1）推荐剂量：一片每天1次与食物服用。 （2）在肾受损中给药：估算的肌酐清除率低于70mL每分钟患者中不应开始用STRIBILD。在估算的肌酐清除率低于50 mL每分钟患者中终止。 剂型和规格 片：150mg的elvitegravir，150mg的 cobicistat，200mg的 恩曲他滨，和300 mg的富马酸替诺福韦酯。 禁忌证 （1）STRIBILD与以下药物共同给药： 1）对清除盖度依赖于CYP3A和因为升高血浆浓度伴随严重和/或危及生命不良事件。 2）强烈诱导CYP3A可能导致降低一个或更多组分的暴露和丧失STRIBILD的疗效可能导致丧失病毒学反应和可能耐药。 警告和注意事项 （1）肾受损新发作或变坏：可能包括急性肾衰和范科尼综合征。开始用STRIBILD治疗前评估肌酐清除率(CLcr)，尿葡萄糖和尿蛋白。在所有患者中监视CLcr，尿葡萄糖，和尿蛋白。处在肾受损风险患者监视血清磷。有同时或最近使用肾毒性药物避免给予STRIBILD。 （2）与其他产品共同给药：不要与含恩曲他滨或富马酸替诺福韦酯药物包括ATRIPLA[依非韦伦/恩曲他滨/富马酸替诺福韦片]，COMPLERA[恩曲他滨/利匹韦林/替诺福韦酯]，EMTRIVA[恩曲他滨]，TRUVADA[恩曲他滨和富马酸替诺福韦酯]，或VIREAD[富马酸替诺福韦酯]；与药物含拉米夫定[lamivudine];或与药物或方案含利托那韦同时使用。不要与HEPSERA[阿德福韦酯]联用。 （3）骨矿物质密度(BMD)减低：病理学骨折史或骨质疏松症或骨丢失的其他危险因素患者中考虑监控BMD。 （4）机体脂肪再分布/积蓄：在接受抗逆转录病毒治疗患者中观察到。 （5）免疫重建综合征：可能需要进一步的评估和治疗。 不良反应 对STRIBILD最常见不良药物反应(发生率大于或等于10%，所有级别)是恶心和腹泻。 药物相互作用 （1）STRIBILD是一个为HIV-1感染治疗完整方案；因此，STRIBILD不应与其他为治疗HIV-1感染抗逆转录病毒药物给药。 （2）STRIBILD可改变被CYP3A或CYP2D6代谢药物的浓度。诱导CYP3A药物可能改变STRIBILD一个或更多组分的浓度。治疗前和期间为潜在药物-药物相互作用咨询完整处方资料。 特殊人群中使用 （1）妊娠：妊娠期间只有如潜在获益胜过潜在危险时才使用。 （2）哺乳母亲：应指导感染HIV妇女不要哺乳由于传播HIV潜能。 包装规格 STRIBILD TAB 30  ELVITEG/COB/EMTRI/TENOFO DISOP  GILEAD SCIENCES INC  61958-1201-01  完整说明书附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1e0e3e2-f0f0-4cf9-99f1-adda63003b99 Stribild® (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg or E/C/F/TDF) STRIBILD® is a one-pill, once-a-day complete HIV-1 treatment. STRIBILD is a prescription medicine used to treat HIV-1 in people 12 years and older who weigh at least 77 pounds. It can either be used in people who are starting HIV-1 treatment and have never taken HIV-1 medicines before, or in people who are replacing their current HIV-1 medicines, have an undetectable viral load (less than 50 copies/mL of virus in their blood), and whose healthcare provider determines that they meet certain other requirements. IMPORTANT SAFETY INFORMATION What is the most important information I should know about STRIBILD®? STRIBILD can cause serious side effects: Worsening of hepatitis B (HBV) infection. STRIBILD is not approved for the treatment of HBV. If you have both HIV-1 and HBV and stop taking STRIBILD, your HBV may suddenly get worse. Do not stop taking STRIBILD without first talking to your healthcare provider, as they will need to monitor your health. Who should not take STRIBILD? Do not take STRIBILD if you take: Certain prescription medicines for other conditions. It is important to ask your healthcare provider or pharmacist about medicines that should not be taken with STRIBILD. Do not start a new medicine without telling your healthcare provider. The herbal supplement St. John's wort. Any other medicines to treat HIV-1 infection, or the medicine adefovir (Hepsera®). What are the other possible side effects of STRIBILD? Serious side effects of STRIBILD may also include: New or worse kidney problems, including kidney failure. Your healthcare provider should do regular blood and urine tests to check your kidneys before and during treatment with STRIBILD. If you develop kidney problems, your healthcare provider may tell you to stop taking STRIBILD. Too much lactic acid in your blood (lactic acidosis), which is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat. Severe liver problems, which in rare cases can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain. Bone problems, including bone pain or bones getting soft or thin, which may lead to fractures. Your healthcare provider may do tests to check your bones. Changes in your immune system. Your immune system may get stronger and begin to fight infections. Tell your healthcare provider if you have any new symptoms after you start taking STRIBILD. The most common side effects of STRIBILD include nausea and diarrhea. Tell your healthcare provider if you have any side effects that bother you or don’t go away. What should I tell my healthcare provider before taking STRIBILD? All your health problems. Be sure to tell your healthcare provider if you have or have had any kidney, bone, or liver problems, including hepatitis virus infection. All the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. STRIBILD may affect the way other medicines work, and other medicines may affect how STRIBILD works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Do not start any new medicines while taking STRIBILD without first talking with your healthcare provider. If you take antacids. Take antacids at least 2 hours before or after you take STRIBILD. If you are pregnant or plan to become pregnant. It is not known if STRIBILD can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking STRIBILD. If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or Call 1-800-FDA-1088. WHAT IS STRIBILD? STRIBILD is a prescription medicine used to treat HIV-1 in people 12 years and older who weigh at least 77 pounds. It can either be used in people who are starting HIV-1 treatment and have never taken HIV-1 medicines before, or in people who are replacing their current HIV-1 medicines and whose healthcare provider determines that they meet certain requirements. These include having an undetectable viral load (less than 50 copies/mL of virus in their blood) for 6 months or more on their current HIV-1 treatment. STRIBILD combines 4 medicines into 1 pill to be taken once a day with food. STRIBILD is a complete single tablet regimen and should not be used with other HIV-1 medicines. STRIBILD does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-related illnesses, you must keep taking STRIBILD. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance of sexual contact with body fluids. Never reuse or share needles or other items that have body fluids on them. 吉利德四合一型抗HIV新药Stribild获EC批准 2013年5月30日，吉利德科学（Gilead Sciences）宣布，四合一型抗HIV新药Stribild（elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 245 mg)上市许可申请（MAA）获得了欧盟委员会（EC）的批准，该批准适用于欧盟所有27个成员国。 Stribild为日服一次的单一片剂，由2种在售艾滋病毒药物emtricitabine (恩曲他滨)和tenofovir(泰诺福韦)及2种新型艾滋病毒药物elvitegravir(埃替拉韦)和cobicistat组成。emtricitabine和tenofovir是吉利德公司组合型药物Truvada(特鲁瓦达)的2种成分，同时也是3合1型药物Atripla 的有效成分，特鲁瓦在2004年获批上市。 Stribild是由Gilead开发并在欧洲上市的第3种单一片剂HIV药物。首个单一片剂抗HIV药物为Atripla，该药于2007年获欧盟批准，由Gilead、百时美施贵宝（BMS）及默沙东（Merck & Co）联合推广。第二种单一片剂抗HIV药物为Eviplera，于2011年获欧盟批准，由Gilead和强生旗下杨森（Jassen）联合推广。 目前，Stribild已获美国、加拿大、澳大利亚、韩国、日本、土耳其等国批准上市。 Stribild在欧洲的获批，是基于2项为期48周的关键性III期临床试验的数据：Study 102和Study 103。在这2项试验中，Stribild分别达到了相对于Atripla(依非韦伦600 mg/恩曲他滨200 mg/富马酸替诺福韦酯300 mg)和一种包含利托那韦强化的阿扎那韦加Truvada(恩曲他滨/富马酸替诺福韦酯)治疗方案的非劣性（non-inferiority）主要终点。这些研究旨在评估治疗48周后血液中检测不出HIV水平的患者百分率，结果显示，Stribild、Atripla和Truvada+阿扎那韦+利托那韦治疗组，血液中检测不出HIV水平的患者分别占88%~90%、84%和87%。 在所有关于Stribild的研究中，多数不良事件为轻至中度。临床试验中观察到的常见不良反应包括恶心和腹泻。严重不良反应包括新发肾功能受损或肾功能受损加重、骨密度降低、脂肪再分配和免疫重建综合征。