2017年8月3日，美国FDA批准艾伯维旗下Mavyret（glecaprevir和pibrentasvir）用于治疗没有肝硬化（肝脏疾病）或有轻微肝硬化的慢性丙型肝炎病毒（HCV）基因型1-6成年患者，包括有中重度肾病的患者及透析患者。Mavyret也被批准用于既往以含一种NS5A抑制剂或一种NS3/4A蛋白酶抑制剂（但两种药物不同时使用）方案治疗过的HCV基因型1感染患者。
对于既往未治疗的无肝硬化成年患者来说，Mavyret是获批用于所有HCV基因型1-6的首个治疗时间为 8周的药物。之前的标准治疗时间为12周或更长时间。这次的批准为许多患者提供了一个更短的治疗时间，也为某些基因型1感染患者提供了一种治疗选择，基因型1是美国最常见的HCV基因型，这些患者以往使用其它直接起作用的抗病毒药物得不到成功治疗，FDA药物评价与研究中心抗微生物产品办公室主任、医学博士Cox称。
丙型肝炎是一种病毒性疾病，它可引起导致肝功能减弱或肝衰竭的肝脏炎症。据美国疾病控制与预防中心的数据，美国估计有270万至390万人患有慢性HCV。多年以后，一些遭受慢性 HCV 感染的患者可能出现黄疸（眼睛或皮肤发黄）与并发症，如出血、腹部积液、感染、肝癌和死亡。
至少有6种不同的HCV基因型（或病毒株），它们在基因上属于不同的病毒组。弄清病毒株可帮助提供治疗建议。大约75%的美国感染者的HCV属于基因型1；20%-25%的患者属于基因型2或3；少量患者感染有基因型4、5或6。
Mavyret的安全性及有效性在临床试验期间得到评价，试验的受试者为大约2300名无肝硬化或有轻微肝硬化的基因型1、2、3、5或6 HCV感染成年患者。试验结果证明，92%-100%治疗8周、12周或16周的患者在完成治疗后的 12周内其血液中已检测不到病毒，这表明患者的感染已得到治愈。
Mavyret的治疗时间因治疗史、病毒基因型及肝硬化程度而不同。Mavyret用药患者最常见的副作用是头痛、疲劳和恶心。Mavyret 不建议用于有中度肝硬化的患者，禁用于严重肝硬化患者。该药物也禁用于服用阿扎那韦与利福平的患者。
在正进行或已完成HCV直接作用抗病毒药物治疗，且未接受HBV抗病毒治疗的HCV/HBV合并感染患者中，有乙型肝炎病毒（HBV）再活化报道。在以直接作用抗病毒药物治疗的患者中，HBV再活化可使某些患者导致严重的肝脏问题或死亡。医疗保健专业人员在以Mavyret开始治疗前，应对所有患者目前或之前的 HBV 感染证据进行筛查。FDA授予了这款药物的上市申请优先审评资格与突破性疗法资格。FDA将Mavyret的批准授予了艾伯维。
AbbVie Receives U.S. FDA Approval of MAVYRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT 1-6) in as Short as 8 Weeks
- MAVYRET is a new 8-week, pan-genotypic treatment for hepatitis C patients without cirrhosis and who are new to treatment
- FDA approval is supported by an overall 98 percent cure rate (rates ranged between 92-100 percent) in patients who received the recommended duration of treatment
- MAVYRET is a pan-genotypic treatment approved for use in patients across all stages of chronic kidney disease
- MAVYRET may be used in up to 95 percent of HCV patients, depending on stage of liver disease and prior treatment history*
U.S. Food and Drug Administration (FDA) approved MAVYRET™ (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). MAVYRET is an 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment. Up to 95 percent of HCV patients in the U.S. may be eligible for treatment with MAVYRET, including patients with compensated cirrhosis or without cirrhosis and those with limited treatment options, such as patients with chronic kidney disease (CKD).*
"With MAVYRET, physicians and patients now have a treatment option that is highly effective and has the potential to cure the majority of HCV patients in as short as 8 weeks, regardless of genotype," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "The approval of MAVYRET demonstrates AbbVie's commitment to advancing science to help address unmet needs by delivering a new cure for patients who historically had limited treatment options, including those with genotype 3 HCV, individuals with CKD and certain DAA failure patients."
Approximately 3.4 million Americans are chronically infected with HCV.1 Additionally, HCV is common among people with severe CKD, with an estimated more than 500,000? people having both chronic HCV and CKD.2 MAVYRET was designed to deliver a cure** across all major genotypes and specific treatment challenges, such as patients with severe CKD, and GT1 patients not cured by a NS5A inhibitor or a NS3/4A protease inhibitor (PI) direct-acting antiviral (DAA) treatment, but not both. MAVYRET combines two new DAAs that target and inhibit proteins essential for the replication of the hepatitis C virus.
"The clinical trial program for MAVYRET resulted in high cure rates across a range of patient populations, from those who have never been treated and who do not have cirrhosis, all the way to patients with compensated cirrhosis," said Fred Poordad, M.D., vice president, academic and clinical affairs, Texas Liver Institute and professor of medicine, University of Texas Health, San Antonio. "This approval helps achieve physicians' goals of delivering effective options for a broad range of patients."
The approval of MAVYRET is supported by data from nine registrational studies in AbbVie's clinical development program, which eva luated more than 2,300 patients in 27 countries across all major HCV genotypes (GT1-6) and special populations.
Approval of MAVYRET follows an FDA-granted Breakthrough Therapy Designation for the treatment of GT1 HCV patients who were not cured with prior DAA therapy, as well as Priority Review. According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of therapies for serious or life-threatening conditions, which may offer substantial improvement over available therapies.
AbbVie's pan-genotypic regimen was also recently granted marketing authorization by the European Commission. AbbVie's treatment is now licensed for use in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.
*Ipsos Healthcare HCV Monitor, 2017. New York, NY: Ipsos in North America. ©Ipsos 2017, all rights reserved.
**Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.
?Based on IMS Dx (Oct. 2016) distribution of 15.7% Renal patients in diagnosed population applied to ~3.4M HCV preva lence population of all major HCV genotypes.
About MAVYRET™ (glecaprevir/pibrentasvir)
MAVYRET™ is approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis C virus (HCV) infection in adults across all major genotypes (GT1-6). MAVYRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral tablets, taken with food.
MAVYRET is an 8-week, pan-genotypic option for patients without cirrhosis and who are new to treatment, who comprise the majority of people living with HCV. MAVYRET is also approved as a treatment for patients with specific treatment challenges, including those (GT1) not cured by prior treatment experience to either a protease inhibitor or NS5A inhibitor (but not both), and in patients with limited treatment options, such as those with severe chronic kidney disease (CKD) or those with genotype 3 chronic HCV. MAVYRET is a pan-genotypic treatment approved for use in patients across all stages of CKD.
Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. |
