二合一HIV新组合药：emtricitabine/tenofovir disoproxil fumarate（商标名 Truvada）是一种HIV整合酶抑制剂，该药为每日一次的口服药物，已获FDA批准与其他抗逆转录病毒制剂联合用于既往已治疗过、或初治HIV-1成人和12岁及以上青少年感染者的治疗。 批准日期：2011年4月25日 公司： Gilead Sciences, Inc. TRUVADA（恩曲他滨/替诺福韦酯片富马酸盐[emtricitabine/tenofovir disoproxil fumarate]）片剂，供口服使用 最初的美国批准：2004年 警告： 使用TRUVADA预处理急性分离的乙型肝炎和使用TRUVADA预防接触预感预防艾滋病毒1型感染的预防（预防），看完整的装箱警告完整的处方信息。 TRUVADA未被批准用于治疗慢性乙型肝炎病毒（HBV）感染。在合并感染HIV-1和HBV的患者中已报告已经停止使用TRUVADA的乙型肝炎严重急性加重。因此，在停用TRUVADA的HBV感染患者中应密切监测肝功能。如果合适的话，可能需要开始抗乙肝治疗。 用于PrEP指示的TRUVADA只能在初次使用前立即确认为HIV阴性的患者，并在使用过程中定期使用。在未发现急性HIV-1感染后，已使用TRUVADA对PrEP指征进行了耐药性HIV-1变异体的鉴定。如果出现急性HIV感染迹象或症状，除非确认阴性感染状态，否则不要启动TRUVADA治疗PrEP适应症。 最近的主要变化 盒装警告，乳酸酸中毒/严重肝肿大伴脂肪变性 已删除04/2017 适应症和用法，治疗HIV-1感染：04/2017 警告和注意事项，乳酸酸中毒/严重肝脏肿大伴脂肪变性：04/2017 警告和注意事项，与其他产品合作：04/2017 警告和注意事项，脂肪再分配删除：04/2017 作用机制 TRUVADA是抗病毒药物恩曲他滨和替诺福韦DF的固定剂量组合[见MICROBIOLOGY]。 适应症和用法 TRUVADA是EMTRIVA和VIREAD的核苷类似物HIV-1逆转录酶抑制剂的组合。 TRUVADA与其他抗逆转录病毒药物组合用于治疗成人和体重至少17kg的儿科患者中的HIV-1感染。 TRUVADA与预防暴露前预防（PrEP）的安全性行为相结合，以降低高危人群性接触HIV-1的风险。 剂量和给药 治疗HIV-1感染 成人和体重大于或等于35kg的儿科患者的推荐剂量：一种TRUVADA片剂（含有200mg/300mg恩曲他滨和替诺福韦二异丙酯延胡索酸盐）每天一次口服或不食用。 在体重大于或等于17kg且能够吞咽整片的儿科患者中的推荐剂量：一种TRUVADA低强度片剂（基于体重为；100mg/150mg，133mg/200mg或167mg/250mg）每天一次口服或不食用。 肾受损HIV-1感染成人患者推荐剂量： 肌酐清除率30-49毫升/分钟：每48小时1片。 CrCl低于30mL/min或血液透析：不要使用TRUVADA。 暴露前预防。 未感染HIV-1成人的推荐剂量：一片（含200mg/300mg恩曲他滨和替诺福韦disoproxil富马酸盐）每天一次口服或不食用。 未受艾滋病毒感染的人的推荐剂量：如果CrCl低于60mL/min，则不要在HIV未感染的个体中使用TRUVADA。如果在使用TRUVADA治疗PrEP时未感染个体观察到CrCl降低，评估潜在原因并重新评估继续使用的潜在风险和益处。 剂型和强度 片剂：分别为200mg/300mg，167mg/250mg，133mg/200mg和100mg/150mg恩曲他滨和替诺福韦二吡呋酯富马酸盐。 禁忌症 不要在HIV-1未知或阳性的个体中使用TRUVADA预接触预防。TRUVADA应仅用于艾滋病毒感染患者，只能与其他抗逆转录病毒药物联合使用。 警告和注意事项 新发作或恶化的肾脏损害：可包括急性肾功能衰竭和Fanconi综合征。在开始用TRUVADA治疗之前评估估计的肌酸酐清除率。对于有肾功能障碍风险的患者，在开始用TRUVADA治疗之前以及在治疗期间定期评估估计的肌酐清除率，血清磷，尿葡萄糖和尿蛋白。避免同时或最近使用肾毒性药物给予TRUVADA。 乳酸性酸中毒/伴有脂肪变性的严重肝肿大：对症状或实验室检查结果提示乳酸中毒或明显肝毒性的患者停止治疗。 包装提供/储存和处理 TRUVADA片剂可用于含有30片带防儿童封口的瓶子，如下所示： 100mg恩曲他滨和150mg替诺福韦DF（相当于123mg替诺福韦disoproxil）片剂是蓝色的，椭圆形的，薄膜包衣的，在一侧上用“GSI”凹陷并且在另一侧上用“703”（NDC 61958-0703 -1）。 133毫克恩曲他滨和200毫克替诺福韦DF（相当于163毫克替诺福韦二吡呋酯）为蓝色，矩形，薄膜包被，在一侧上用“GSI”凹陷，在另一侧上用“704”凹陷（NDC 61958-0704- 1）。 167mg恩曲他滨和250mg替诺福韦DF（相当于204mg替诺福韦disoproxil）为蓝色，改性胶囊形状，薄膜包衣，在一面上用“GSI”和另一面上为“705”（NDC 61958-0705 -1）。 200mg恩曲他滨和300mg替诺福韦DF（相当于245mg替诺福韦二吡呋酯）为蓝色，胶囊形，膜包衣，在一侧上用“GILEAD”压印，在另一侧用“701”压印（NDC 61958-0701- 1）。 在25°C（77°F）下储存，允许偏差为15°C-30°C（59°F-86°F）（参见USP受控室温）。 保持容器密闭 仅在原始容器中分配 如果瓶盖上的密封破裂或缺失，请勿使用 完整说明书附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e82b13-a037-49ed-b4b3-030b37c0ecdd ---------------------------------------------- 产地国家：美国 原产地英文商品名: Truvada 167mg/250mg(which is equivalent to 204mg of tenofovir disoproxil)/tablets 30tablets/bottle 原产地英文药品名: Tenofovir/Emtricitabine 中文参考商品译名: Truvada复方片 167毫克/250毫克（相当于204毫克替诺福韦）/片 30片/瓶 中文参考药品译名: 恩曲他滨/替诺福韦酯 生产厂家英文名: Gilead Sciences ---------------------------------------------- 产地国家：美国 原产地英文商品名: Truvada 133mg/200mg(which is equivalent to 163mg of tenofovir disoproxil)/tablets 30tablets/bottle 原产地英文药品名: Tenofovir/Emtricitabine 中文参考商品译名: Truvada复方片 133毫克/200毫克（相当于163毫克替诺福韦）/片 30片/瓶 中文参考药品译名: 恩曲他滨/替诺福韦酯 生产厂家英文名: Gilead Sciences ---------------------------------------------- 产地国家：美国 原产地英文商品名: Truvada 300mg/200mg(which is equivalent to 245 mg of tenofovir disoproxil)/tablets 30tablets/bottle 原产地英文药品名: Tenofovir/Emtricitabine 中文参考商品译名: Truvada复方片 300毫克/200毫克（相当于245毫克替诺福韦）/片 30片/瓶 中文参考药品译名: 恩曲他滨/替诺福韦酯 生产厂家英文名: Gilead Sciences ---------------------------------------------- 产地国家：美国 原产地英文商品名: Truvada 100mg/150mg(which is equivalent to 123mg of tenofovir disoproxil)/tablets 30tablets/bottle 原产地英文药品名: Tenofovir/Emtricitabine 中文参考商品译名: Truvada复方片 100毫克/150毫克（相当于123毫克替诺福韦）/片 30片/瓶 中文参考药品译名: 恩曲他滨/替诺福韦酯 生产厂家英文名: Gilead Sciences ----------------------------------------------- 产地国家：瑞士 原产地英文商品名: Truvada 200mg/245mg/tablets 30tablets/bottle 原产地英文药品名: Tenofovir/Emtricitabine 中文参考商品译名: Truvada复方片 200毫克/245毫克/片 30片/瓶 中文参考药品译名: 恩曲他滨/替诺福韦酯 生产厂家英文名: Gilead Sciences Switzerland Sàrl ----------------------------------------------- 产地国家： 加拿大  原产地英文商品名: Truvada（200mg/300mg）/tablets 30tablets/bottle 原产地英文药品名: Tenofovir/Emtricitabine 中文参考商品译名: Truvada复方片（200毫克/300毫克）/片 30片/瓶 中文参考药品译名: 恩曲他滨/替诺福韦酯 生产厂家英文名: Gilead Sciences Inc ----------------------------------------------- 产地国家：土耳其  原产地英文商品名: Truvada（200mg/240mg）/tablets 30tablets/bottle  原产地英文药品名: Tenofovir/Emtricitabine 中文参考商品译名: Truvada复方片（200毫克/240毫克）/片 30片/瓶  中文参考药品译名: 恩曲他滨/替诺福韦酯 生产厂家英文名: Gilead Sciences Inc ----------------------------------------------- 产地国家：英国  原产地英文商品名: Truvada（200mg/240mg）/tablets 30tablets/bottle  原产地英文药品名: Tenofovir/Emtricitabine 中文参考商品译名: Truvada复方片（200毫克/240毫克）/片 30片/瓶  中文参考药品译名: 恩曲他滨/替诺福韦酯  生产厂家英文名: Gilead Sciences Inc --------------------------------------------------- Truvada(恩曲他滨替诺福韦 emtricitabine/tenofovir)新组合片剂 Truvada（恩曲他滨和替诺福韦[Tenofovir/Emtricitabine]），与其他抗艾滋病毒药物结合使用用于治疗成人HIV-1感染。 一天只需要一次服用一片, 可以同食物一起, 也可以不同食物一起服用。 Truvada（Tenofovir/Emtricitabine）是一种称为艾滋病毒核苷类似物逆转录酶抑制剂（NRTI）。它并不能治愈艾滋病病毒感染，也不能减少艾滋病毒传染给他人的风险。用于年龄在18岁以上的成年人。 最常见的副作用: 头晕，腹泻，恶心，呕吐，头痛，皮疹。皮肤变色（小斑点或雀斑）也可能会出现。但很少有人停止服用此抗艾滋病毒药物 Truvada(Tenofovir/Emtricitabine) Truvada-Antiretroviral Treatment to Prevent HIV, United States of America Truvada (emtricitabine and tenofovir disoproxil fumarate) is an antiretroviral indicated for preventing or reducing the risk of acquiring HIV-1. The drug is developed and manufactured by Gilead Sciences. Gilead Sciences received approval for truvada for HIV prevention from the US Food and Drug Administration (FDA), in July 2012. Details of human immunodeficiency virus Human immunodeficiency virus (HIV) is a lentivirus, which can deliver a significant amount of genetic information into the DNA of the host cell. It causes acquired immunodeficiency syndrome (AIDS), a life-threatening disease which weakens the immune system and makes people much more susceptible to infections and diseases. HIV is categorised into two types, HIV-1 and HIV-2. HIV-1 is more virulent and infective than HIV-2. It is currently estimated that about 1.2 million people in the US are living with HIV and more than 50,000 new cases of infections are being registered each year. It is also found that about 23% of the new HIV cases are found in women, while in men it is 61%. How truvada helps prevent HIV Truvada is made with a combination of two nucleoside reverse transcriptase inhibitors (NRTI) drugs, which include emtricitabine and tenofovir disoproxil fumarate. Emtricitabine restrains reverse transcriptase, an enzyme that copies HIV RNA into new viral DNA. It also lowers the amount of HIV and increases the immune system cells in the patient's body. Tenofovir disoproxil fumarate also blocks the reverse transcriptase. Clinical trials on the antiretroviral drug FDA approval for truvada was based on a Phase III clinical trial, known as the Pre-Exposure Prophylaxis Initiative (iPrEx). It was a randomised, double-blind and parallel assignment conducted on 2,499 HIV uninfected males. It was sponsored by the US National Institutes of Health (NIH) and the Bill and Melinda Gates Foundation. The primary outcome measure of the study was finding anti-HIV seroconversion and safety endpoints in 36 months. The secondary outcome measures included finding changes in bone mineral density, drug resistance in HIV patients and prevalence of sexually transmitted infections in 42 months. The results of the iPrEx study showed that truvada reduced the risk of acquiring HIV infection by 42%. The study also found that truvada reduced infection rates by 43.8% in homosexual men. Another Phase III clinical trial on the drug was also considered for the FDA approval. It is known as partners PrEP trial which enrolled 4,758 heterosexual couples, where one partner was HIV-infected and the other was not. It was sponsored by University of Washington and Bill and Melinda Gates Foundation. It was conducted between May 2008 and June 2012. It was a randomised, double-blind and parallel assignment. The trial evaluated the safety and efficacy of truvada in comparison with a placebo. The results of the partners PrEP trial showed that truvada reduced the risk of becoming HIV-infected by 75% when compared to the placebo. The general side effects of the drug included pain, weight loss and diarrhoea. Gilead conducted Phase IV clinical trials on truvada between July 2008 and April 2011. It was an open label, randomised, multicentre and parallel assignment. It evaluated the safety and efficacy of the drug in the treatment of HIV-1 infected subjects. The primary outcome measure of the study was finding the percentage of participants with HIV-1 Ribonucleic Acid after 48 weeks. The secondary outcome measures included finding the percentage of people with Pure Virologic Response (PVR) and change from baseline in cluster determinant 4 after 48 weeks. Marketing commentary on Gilead's HIV prevention drugs Gilead has commercially launched truvada in the US market. The company faces competition from other medications available in the US market for the same indication, which include Gilead's own drugs Viread (tenofovir) and Emtriva (emtricitabine), Crixivan (indinavir) manufactured by Merck, Edurant (rilpivirine) manufactured by Johnson & Johnson and Tibotec.