咔唑网9月25日消息：
吉利德（Gilead）近日宣布，已向日本药品与医疗器械管理局 (PMDA）提交丙肝鸡尾酒疗*L法**DV/SOF新药申请（NDA），寻求批准用于基因型1慢性丙型肝炎（HCV）成人患者的治疗，在临床试验中，LDV/SOF治愈率达到了100%。
鸡尾酒疗*L法**DV/SOF（ledipasvir/sofosbuvir，90mg/400mg）为每日一次的固定剂量复方片，其中ledipasvir（LDV）为NS5A*制剂抑**，sofosbuvir（SOF）为核苷酸类似物聚合酶*制剂抑**。如果获批，LDV/SOF将简化基因型1丙肝患者的临床治疗，仅需每日口服给药，而无需注射干扰素及联合利巴韦林（RBV）。
丙肝鸡尾酒疗*L法**DV/SOF新药申请（NDA）的数据包，包括一项在日本丙肝患者中开展的III期研究（GS-US-337-0113）的顶线数据。该项研究中，经LDV/SOF（无RBV）治疗12周后，初治治疗组（n=83/83，100%）和经治治疗组（n=88/88，100%）均实现了100%治愈率（SVR12），伴有肝硬化的丙肝群体（n=75/76）治愈率达99%。
在工业化国家中，日本的肝癌发病率最高，这主要是由于丙型肝炎病毒（HCV）感染所致。在日本，有超过100万丙肝患者，基因型1 HCV是最常见的毒株，约占70%-80%，该国当前基因型1 HCV感染的标准治疗方案，涉及长达48周的聚乙二醇化干扰素注射、口服RBV片剂其他药物，对于某些特定患者可能不适合。
LDV/SOF NDA的数据包，还包括另外3项III期研究（ION-1，ION-2，ION-3）的数据，分别评估了8周、12周、24周LDV/SOF方案治疗基因型1丙肝患者的疗效和安全性。数据表明，3项研究中，LDV/SOF（无利巴韦林）治疗组治愈率达到了94%-99%。
目前，丙肝鸡尾酒疗*L法**DV/SOF正在接受FDA和EMA的监管审查。今年6月，吉利德向日本PMDA提交了Sovaldi（sofosbuvir，SOF）的新药申请，寻求批准Sovaldi联合利巴韦林（RBV）用于基因型2 HCV的治疗。（生物谷Bioon.com）
英文原文：Gilead Submits New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for Fixed-Dose Combination of Ledipasvir/Sofosbuvir for Chronic Hepatitis C Genotype 1 Infection
-- 12-Week Course of Ledipasvir/Sofosbuvir Achieved 100 Percent Sustained Virologic Response (SVR12) in Japanese Phase 3 Study --
-- Ledipasvir/Sofosbuvir Simplifies Hepatitis C Treatment to a Single, Once-Daily Tablet --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 24, 2014-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for approval of an investigational once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection in adults. The data submitted in the NDA, which include a Japanese Phase 3 study showing 100 percent SVR12 rates, support the use of LDV/SOF for 12 weeks in treatment-naïve and treatment-experienced patients with chronic genotype 1 HCV infection, including those with cirrhosis. Patients who achieve SVR12 are cured of HCV infection. If approved, LDV/SOF would simplify HCV treatment for genotype 1 patients in Japan to one daily tablet, eliminating the need for interferon and ribavirin (RBV).
Primarily due to HCV, Japan has one of the highest rates of liver cancer of any industrialized country. Of the more than one million people in Japan chronically infected with HCV, 70-80 percent are infected with the genotype 1 strain of the virus.
The NDA is based on data from a Phase 3 clinical trial conducted in Japan (GS-US-337-0113) among 341 treatment-naïve and treatment-experienced genotype 1 patients. In the study, 100 percent (n=83/83) of treatment-naïve and 100 percent (n=88/88) of treatment-experienced patients receiving 12 weeks of LDV/SOF without RBV achieved SVR12. Adverse events observed with LDV/SOF without RBV were generally mild and included nasopharyngitis (28 percent), headache (6 percent) and malaise (5 percent).
The NDA is also supported by SVR12 results from three Phase 3 studies (ION-1, ION-2 and ION-3) evaluating eight, 12 or 24 weeks of LDV/SOF among genotype 1 HCV patients. Trial participants included patients from the United States, Europe and Puerto Rico who were treatment-naïve or who had failed previous treatment, including protease inhibitor-based regimens, and also included patients with compensated cirrhosis. Trial participants in the ribavirin-free arms (n=863) achieved SVR12 rates of 94 to 99 percent.
LDV/SOF is currently under regulatory review in the United States and European Union.
On June 27, 2014 Gilead submitted an NDA to Japan’s PMDA for SOF as a single agent in combination with RBV for the treatment of genotype 2 HCV infection. SOF as a single agent has been approved by regulatory authorities in the United States, European Union, Australia and Canada under the tradename Sovaldi®.
LDV/SOF and SOF are investigational products in Japan and their safety and efficacy have not yet been established.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.
【原标题：吉利德欲在日本上市丙肝鸡尾酒疗法新药】