FDA审查了同时使用simeprevir（SMV）和sofosbuvir（SOF）的不良事件（AE）监测报告。SMV和SOF是直接作用的抗病毒药物，适用于慢性丙型肝炎的治疗，作为抗病毒治疗方案的组成部分。SMV是丙型肝炎病毒（HCV）NS3 / 4A
本研究旨在明确同时使用SMV和SOF上市后的潜在安全性问题报告。研究结果将在AASLD2014上公布。
研究方法
检索FAERS数据库，以明确同时使用SMV和SOF自获得FDA批准（2013年11月/12月）至2014年6月3日间的上市后AE报告。AE被编码成《药事管理的标准医学术语集》（MedDRA）中的术语。根据搜索结果和AE回顾的全面评估，对意外或高频报道的AE进一步仔细评价分析。此外，使用EmpiricaSignal®软件对FAERS进行数据挖掘分析。
研究结果
总共对155份报告进行了鉴定。大多数报告来自美国（n=146），平均年龄为59岁（范围为24-77岁）。按照常规定义（CFR 314.80）严重AE经历的情况，报告了6例死亡、3例危及生命事件、33例住院治疗、4例残疾和74例其他危急重大医疗事件（如需要医疗或外科干预以防止死亡、危及生命情况、住院治疗或残疾）。个案分析表明，大多数AE已包含于药物说明书中，混淆了合并用药和合并症，或包含信息有限。药物说明书中所列AE严重程度没有增加，没有归因于SMV和SOF使用的死亡病例。
结论
在6个月的FAERS SMV和SOF同时使用上市后报告回顾中，经确定没有潜在的安全问题。因为FAERS是被动监控系统，局限之一是低估AE。 FDA将继续监视两个药物产品的安全性。
英文原文
Concomitant Use of Simeprevir and Sofosbuvir for Treatment of Chronic Hepatitis C: A Review of Post-marketing Surveillance Using the FDA Adverse Event Reporting System (FAERS)（摘要号：LB-35）
Background: The FDA reviewed post-marketing reports of adverse events (AEs) with the concomitant use of simeprevir (SMV) and sofosbuvir (SOF). SMV and SOF are direct-acting antiviral agents indicated for the treatment of chronic hepatitis C as components of an antiviral treatment regimen. SMV is an inhibitor of hepatitis C Virus (HCV) NS3/4A serine protease and SOF is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase. The American Association for the Study of Liver Diseases and Infectious Diseases Society of America 2014 Hepatitis C Guidance recommends a 12-week course of SMV and SOF with/without weight-based ribavirin for patients (treatment- naïve interferon-ineligible and non-responders to pegylated interferon/ribavirin regardless of interferon eligibility) with HCV genotype 1 infection.
Aims: Identify potential safety issues reported with the concomitant use of SMV and SOF post-marketing.
Methods: The FAERS database was searched to identify post-marketing reports of AEs with concomitant SMV and SOF use from FDA approval (November/December 2013) through June 3, 2014. AEs are coded to terms in the Medical Dictionary for Regulatory Activities (MedDRA) terminology. Based on the search results and a thorough evaluation of the AEs retrieved, AEs that were unexpected or reported in high frequency were further analyzed with a hands-on review. Additionally, a data mining analysis of FAERS was performed using Empirica Signal® software.
Results: A total of 155 reports were identified. The majority of cases were from the US (n=146) and the median age was 59 years (range 24-77). The cases with a serious AE experience per regulatory definition (CFR 314.80) reported 6 deaths, 3 life-threatening events, 33 hospitalizations, 4 disabilities, and 74 other serious important medical events (i.e., situations requiring medical or surgical intervention to prevent death, a life-threatening event, hospitalization, or disability). An analysis of the individual cases revealed that most AEs were already included in the prescribing information, confounded by concomitant medications and comorbidities, or contained limited information. There was no increased severity of AEs listed in the prescribing information and no deaths that can be attributed to SMV and SOF use.
Conclusions: No potential safety concerns were identified in this 6-month review of FAERS post-marketing reports of SMV and SOF concomitant use. Because FAERS is a passive surveillance system, one of its limitations is underreporting of AEs. FDA continues to monitor the safety of both drug products.
查看会议专题》》》第65届美国肝病学会年会（AASLD2014）
(本网站所有内容，凡注明来源为“医脉通”，版权均归医脉通所有，未经授权，任何媒体、网站或个人不得转载，否则将追究法律责任，授权转载时须注明“来源：医脉通”。本网注明来源为其他媒体的内容为转载，转载仅作观点分享，版权归原作者所有，如有侵犯版权，请及时联系我们。)
