2015年3月26日讯 /生物谷BIOON/ --过去的一年里，生物制药巨头吉利德（Gilea）凭借突破性的丙肝明星药Sovaldi和丙肝鸡尾酒Harvoni在丙肝治疗领域叱咤风云，成功实现“鲤鱼跃龙门”并跻身《2014年全球制药巨头营收TOP15榜单》前10名。近日，该公司再度传来喜讯，丙肝明星药Sovaldi成功拿到亚洲丙肝大国——日本国的上市批文。
该市场对吉利德而言非常重要，日本在所有工业化国家中肝癌发病率最高，这主要是由于慢性丙型肝炎病毒（HCV）感染所致。在日本，HCV感染者总数超过100万人，其中20-30%为基因型2 HCV毒株感染。该国目前基因型2丙肝的临床治疗需要注射24-48周聚乙二醇干扰素，而这可能不适合许多患者。
根据吉利德官方文件，Sovaldi已获日本劳动卫生福利部（MHLW）批准，用于基因型2 HCV感染者的治疗，治疗方式为Sovaldi联合利巴韦林（RBV）治疗12周。Sovaldi联合RBV是日本市场的首个全口服无干扰素治疗方案，该药也是吉利德在日本市场推出的首个丙肝治疗药物。此外，吉利德去年9月还向日本监管机构提交了新一代丙肝鸡尾酒Harvoni的上市申请，该药预计也将很快拿到批文。
Sovaldi是吉利德研发的一款突破性、革命性丙肝药物，变革了丙肝的临床治疗。Harvoni则是新一代全口服丙肝鸡尾酒，完全消除了利巴韦林（RBV）和注射药物干扰素（interferon），该药将成为丙肝临床治疗的金标准。
值得注意的是，吉利德近日紧急发布重要安全信息，告知医疗机构丙肝患者在服用Sovaldi和Harvoni时禁止服用心脏病药物胺碘酮（amiodarone）。根据其信息，已有9例患者服用Sovaldi或Harvoni治疗的同时接受胺碘酮治疗出现了异常缓慢的心跳，其中1例死亡，3例植入心脏起搏器。
英文原文：Japan’s Ministry of Health Labour and Welfare Approves Gilead’s Sovaldi? (sofosbuvir) for the Treatment of Genotype 2 Chronic Hepatitis C
Gilead Sciences Inc. (Nasdaq:GILD) today announced that the Japanese Ministry of Health Labour and Welfare (MHLW) has approved Sovaldi? (sofosbuvir) a once-daily nucleotide analog polymerase inhibitor for the suppression of viremia in patients with genotype 2 chronic hepatitis C virus (HCV) infection with or without compensated cirrhosis. Sovaldi is indicated for use in combination with ribavirin (RBV) for 12 weeks. Sovaldi (in combination with RBV) is the first all-oral interferon-free treatment regimen for genotype 2 HCV infection. Sovaldi is also the first product to be marketed by Gilead in Japan.
“Today’s approval represents an important step forward in the management of hepatitis C in Japan enabling genotype 2 infected patients the opportunity of a cure in 12 weeks with an all-oral regimen that eliminates the need for interferon” said Masao Omata MD Yamanashi Prefectural Hospital Organization.
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 chronically infected with HCV 20-30 percent have the genotype 2 strain of the virus. Currently approved therapies in Japan for genotype 2 HCV infection involve 24-48 weeks of injections with pegylated interferon which may not be suitable for many patients.
Sovaldi’s approval is supported by data from a Phase 3 clinical trial conducted in Japan (Study GS-US-334-0118) among treatment-na?ve and treatment-experienced genotype 2 patients. Approval was based on 96 percent (n=135/140) of genotype 2 HCV-infected patients who received 12 weeks of an all-oral regimen of Sovaldi plus RBV 600–1000 mg/day achieving a sustained virologic response 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV infection. The approval is also supported by SVR12 results from four international Phase 3 studies (FISSION FUSION POSITRON and VALENCE) which included genotype 2 HCV patients.
“There is a need in Japan for new HCV treatment options that are more effective and better tolerated and we have been pleased to partner with the medical community here in Japan to demonstrate the efficacy and safety of Sovaldi” said Norbert Bischofberger PhD Gilead’s Executive Vice President Research and Development and Chief Scientific Officer. “We look forward to making Sovaldi available in Japan as quickly as possible while simultaneously continuing to work with the agency on its review of our second application for an all-oral sofosbuvir-based regimen for the treatment of genotype 1 HCV infection.”
Gilead filed a New Drug Application (NDA) in Japan for a single-tablet regimen of sofosbuvir and the NS5A inhibitor ledipasvir for the treatment of genotype 1 HCV infected patients on September 24 2014. The ledipasvir/sofosbuvir single tablet regimen is an investigational product in Japan and its safety and efficacy have not yet been established.