2016年9月29日，美国生物技术巨头艾伯维（AbbVie）近日公布,全口服丙肝鸡尾酒疗法Viekirax+Exviera一项IIIb期临床研究GARNET的新数据。该研究是一项多中心、开放标签、单组研究，在既往未接受治疗（初治）的无肝硬化基因型1b（GT1b）慢性丙型肝炎（HCV）患者中开展，调查了Viekirax+Exviera 8周治疗方案的疗效和安全性。该研究共招募了166例患者，其中163例为GT1b丙肝，另3例为其他基因型丙肝已从疗效分析中剔除。主要终点是治疗完成后12周实现持续病毒学应答（SVR12，即病毒学治愈）的患者比例。
GARNET是首个调查Viekirax+Exviera 8周治疗方案疗效的研究。数据显示，Viekirax+Exviera 8周治疗方案的病毒学治愈率（SVR12）高达98%（n=160/163）。安全性方面，最常见的不良事件(≥5%)包括头痛（21%）、疲劳（17%）、鼻咽炎（8%）、皮肤瘙痒（8%）、恶心（6%）、乏力（5%），这些不良反应多为轻度，仅有1例患者因不良事件停止治疗，有2例患者治疗后病情复发。相关数据已于近日在法国巴黎举行的2016年欧洲肝脏研究学会（EASL）特别会议上公布，同时已被纳入最新出版的《2016年EASL丙型肝炎治疗推荐意见》。
Viekirax+Exviera是一种全口服无干扰素丙肝鸡尾酒疗法，由Viekirax（ombitasvir/paritaprevir/ritonavir，25mg/150mg/100mg，每日一次）和Exvirea（dasabuvir，250mg，每日两次）组成。在美国，Viekirax+Exviera已以品牌名Viekira Pak上市销售。
目前，Viekirax+Exviera 12周治疗方案也已获欧盟批准，用于无肝硬化或伴有代偿性肝硬化的GT1b丙肝患者。
德国法兰克福歌德大学医院医学部主任Stefan Zeuzem医师表示，在临床上，Viekirax+Exviera 12周治疗方案已经取得了非常高的治愈率（SVR12），而此次公布的新数据显示，在无肝硬化的初治GT1b丙肝群体中，Viekirax+Exviera 8周治疗方案就能够实现非常高的治愈率（SVR12）。这一发现非常重要，因为GT1b丙肝是全世界最常见的丙肝亚型。
据估计，全球大约有1.6亿丙肝患者，GT1在6种主要丙肝基因型中最为普遍，影响大约8300万例患者。在欧洲，大约有900万丙肝患者，GT1b是最主要的亚型，占到了47%。
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VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets)+EXVIERA®
AbbVie Announces New Phase 3b Results in Genotype 1b Chronic Hepatitis C Patients with Compensated Liver Cirrhosis
–100 percent SVR(12) rate achieved with
VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets)+EXVIERA®(dasabuvir tablets) without ribavirin(1)NORTH CHICAGO, Ill., June 24, 2015 /PRNewswire/—AbbVie (NYSE: ABBV), a global biopharmaceutical company, todayannounced TURQUOISE-III study results demonstrating 100 percent(n=60/60) sustained virologic response at 12 weeks post-treatment (SVR12) in genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected adult patients with compensated liver cirrhosis.
Patients received 12 weeks of VIEKIRAX(ombitasvir/paritaprevir/ritonavir tablets)+EXVIERA(dasabuvir tablets) without ribavirin (RBV).
These new results from AbbVie’s Phase 3b study will be presented at the 15th Annual International Symposium on Viral Hepatitis and Liver Diseases in Berlin, Germany.
Approximately 160 million people worldwide are infected with HCV.2 Genotype 1 is the most common type of HCV genotype, accounting for 60 percent of cases worldwide3 and in Europe, the most preva lent genotype is 1b (47 percent).
Over time, chronic HCV may lead to liver complications, including
compensated cirrhosis, in about 10-20 percent of people infected.
“Genotype 1b represents a large portion of HCV patients globally, as it is the most preva lent sub-genotype, and there is a need to continue to explore additional treatment regimens,” said Jordan J. Feld, M.D., MPH, research director and clinician scientist, Toronto Center for Liver Disease, Toronto, Canada.
“The results of TURQUOISE-III are promising, demonstrating that
genotype 1b HCV patients with compensated liver cirrhosis have the
potential to achieve high response rates with an interferon and
ribavirin-free treatment in 12 weeks.”
Patients in TURQUOISE-III were either treatment-naïve or treatment-experienced (failed previous therapy with pegylated interferon and RBV). No patients discontinued treatment due to adverse events.
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