近日，是由吉利德研发的乙肝治疗的新药Tenofovir Alafenamide（替诺福韦艾拉酚胺，TAF，商品名Vemlidy，25mg，每日一次）已获得美国FDA批准，用于成人慢性乙肝且没有失代偿期肝病患者的治疗。 批准日期：2016年11月10日，公司：吉利德科学公司 VEMLIDY（替诺福韦艾拉酚胺[tenofovir alafenamide，TAF]）片剂，供口服使用 首次美国批准：2015 警告： 急性重症后处理乙型肝炎加重 见完整处方信息完整盒装警告。 停止抗乙型肝炎治疗可能导致乙型肝炎急性加重。 对于停止VEMLIDY的患者，应密切监测肝功能。如果合适的话，恢复抗乙型肝炎治疗可能是必要的。 近期重大变化 VimLyDy启动前的剂量和给药试验：07/2018 警告和预防，新发或恶化的肾损害：07/2018 作用机理 Tenofovir alafenamide是一种对抗乙型肝炎病毒的抗病毒药物[参见微生物学]。 适应症及用法 VEMLIDY是一种乙型肝炎病毒（HBV）核苷类似物逆转录酶抑制剂，用于治疗成人代偿性肝病慢性乙型肝炎病毒感染。 剂量与给药 测试：在VimLyDy启动前，测试患者是否感染HIV。VimLyDY不应单独用于HIV感染患者。在VEMLIDY开始前或开始时，以及在治疗期间临床上适当的时间表，评估血清肌酐、估计肌酐清除率、尿葡萄糖和尿蛋白所有患者。同时评价慢性期患者的血清磷水平。 推荐剂量：25毫克（一片），每日口服一次。 肾功能损害：对于肌酐清除率低于每分钟15mL的患者，不建议使用VEMLIDY。 肝功能损害：对于失代偿（Child-Pugh B或C）肝功能损害的患者，不建议使用VEMLIDY。 剂型和强度 片剂：25毫克替诺福韦阿拉芬胺。 禁忌症 没有。 警告和注意事项 乙肝病毒和HIV-1联合感染：VimLyDY单独不推荐用于治疗HIV-1感染。HIV-1的耐药性可能在这些患者中发展。 新起病或加重性肾损害：在VEMLIDY开始之前或开始时，以及在按照临床适当时间表进行治疗期间，评估所有患者的血清肌酐、估计肌酐清除率、尿葡萄糖和尿蛋白。还评估慢性肾脏病患者的血清磷水平。 乳酸酸中毒/伴有脂肪变性的严重肝肿大：在发展为乳酸酸中毒或明显肝毒性症状或实验室发现的患者中停止治疗。 不良反应 最常见的不良反应（发病率大于或等于10%，所有级别）是头痛。 要报告预期的广告反应，请联系GileadSciences公司1-800-GILEAD-5或FDA 1-800-FDA-1088或www.fda.gov/med.。 药物相互作用 VimLyDy是P-糖蛋白（P-gp）和BCRP的底物。强烈影响P-gp和BCRP活性的药物可能导致VEMLIDY吸收的变化。在治疗期间咨询完整的处方信息，了解潜在的药物-药物相互作用。 包装供应/储存和搬运 含有25毫克替诺福韦-阿拉芬那酰胺的VimLyDy片剂为黄色、圆形、薄膜包衣，另一边是“GSI”，另一边是“25”。每个瓶子 包含30片（NDC 61958—2301-1），硅胶干燥剂，聚酯线圈。 低于30°C（86°F）。 保持容器密闭。 仅在原容器中分配。 完整资料附件： 1）：https://vemlidyhcp.com/important_safety_information/ 2）：https://www.gilead.com/~/media/files/pdfs/medicines/liver-disease/vemlidy/vemlidy_pi.pdf?la=en VEMLIDY(tenofovir alafenamide) tablets, for oral use Vemlidy(Tenofovir Alafenamide Fumarate, TAF) was developed by gilead for the treatment of patients with chronic hepatitis b (HBV) infection with compensatory liver disease. It was approved by the food and drug administration (FDA) of the United States on November 10, 2016, by the comprehensive agency for pharmaceuticals and medical devices of Japan on December 19, 2016, and by the European drug administration on January 9, 2017. Vemlidy ® became Europe approed for sale in nearly 10 years of the first hepatitis b of new drugs. ---------------------------------------------------------- VEMLIDY®(tenofovir alafenamide) is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease. IMPORTANT SAFETY INFORMATION BOXED WARNING: POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted. Warnings and Precautions Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected Patients: Due to this risk, VEMLIDY alone should not be used for the treatment of HIV-1 infection. Safety and efficacy of VEMLIDY have not been established in HBV/HIV-1 coinfected patients. HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with VEMLIDY, and, if positive, an appropriate antiretroviral combination regimen that is recommended for HBV/HIV-1 coinfected patients should be used. New Onset or Worsening Renal Impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of VEMLIDY, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue VEMLIDY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all patients – See Dosage and Administration. Lactic Acidosis and Severe Hepatomegaly with Steatosis: Fatal cases have been reported with the use of nucleoside analogs, including tenofovir DF. Discontinue VEMLIDY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations. Adverse Reactions Most common adverse reactions (incidence≥5%; all grades) were headache, abdominal pain, cough, back pain, fatigue, nausea, arthralgia, diarrhea, and dyspepsia. Drug Interactions Coadministration of VEMLIDY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and the risk of adverse reactions. Coadministration of VEMLIDY is not recommended with the following: oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John’s wort. Such coadministration is expected to decrease the concentration of tenofovir alafenamide, reducing the therapeutic effect of VEMLIDY. Drugs that strongly affect P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) activity may lead to changes in VEMLIDY absorption. Consult the full prescribing information for VEMLIDY for more information on potentially significant drug interactions, including clinical comments. Dosage and Administration Dosage: Adults; 1 tablet taken once daily with food. Renal Impairment, Screening, and Monitoring: VEMLIDY is not recommended in patients with CrCl <15 mL/min. In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein prior to initiating and during treatment, on a clinically appropriate schedule. In patients with chronic kidney disease, also assess serum phosphorus. Hepatic Impairment: Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment. Testing Prior to Initiation: HIV infection. INDICATION VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.