艾伯维（AbbVie）获得MAVIRET®的CHMP积极

StephenW

AbbVie Receives Positive CHMP Opinion for MAVIRET® (glecaprevir/pibrentasvir) to Shorten Treatment Duration to Eight Weeks in Genotype 3, Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis
- If approved by the European Commission (EC), MAVIRET will be the only pan-genotypic (GT1-6) 8-week treatment option for treatment-naïve, chronic hepatitis C (HCV) patients, without cirrhosis or with compensated cirrhosis
- Final European Commission decision expected in 2020

NORTH CHICAGO, Ill., Jan. 31, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a change to the marketing authorization for MAVIRET® (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT) 3 infection. MAVIRET is currently indicated as an 8-week, pan-genotypic (GT1-6), once-daily regimen for treatment-naïve HCV patients without cirrhosis, and as an 8-week, once-daily regimen for treatment-naïve GT 1, 2, 4, 5 and 6 HCV patients with compensated cirrhosis.1* If approved by the European Commission (EC), MAVIRET will be the only 8-week treatment option for treatment-naïve chronic HCV patients, without cirrhosis or with compensated cirrhosis, regardless of genotype.*

"The HCV treatment pathway can be a complicated journey for the millions of patients affected by the disease," said Janet Hammond M.D., Ph.D., vice president, general medicine and virology therapeutic area, AbbVie. "Today's positive CHMP opinion for MAVIRET moves us further toward our goal of providing an effective 8-week therapeutic option with the potential to simplify the treatment journey for the majority of people living with HCV, regardless of disease genotype."

The CHMP positive opinion is supported by data from the Phase 3b EXPEDITION-8 study, which showed that with 8 weeks of MAVIRET, 97.7 percent (n=335/343) of GT1- 6 patients achieved a sustained virologic response 12 weeks after treatment (SVR12) (ITT). For patients with GT3, the SVR12 rate was 95.2% (n= 60/63) (ITT). To date, one virologic failure has been reported in these patients and no patients have discontinued treatment due to adverse events. Adverse events (frequency >5%) reported in the study include pruritus (8%), fatigue (9%), headache (8%) and nausea (6%). Six serious adverse events (2%) occurred during the study, none of which were deemed to be related to glecaprevir/pibrentasvir. No new safety signals were identified in this study.2

The Phase 3b EXPEDITION-8 study evaluated the safety and efficacy of MAVIRET in treatment-naïve chronic HCV patients with compensated cirrhosis across all major genotypes (GT1-6). The results have been reported for GT1, 2, 3, 4, 5, and 6 (n=343) patients.2
Efficacy and Safety of 8-Week Glecaprevir/Pibrentasvir in Treatment-Naïve Patients With Chronic Hepatitis C Virus Genotype 1, 2, 3, 4, 5, or 6 Infection and Compensated Cirrhosis: EXPEDITION-8 Complete Results

"Successfully treating people with HCV has historically been challenging, in part because of the length of the treatment duration and the need for additional testing to determine the patient's disease genotype and fibrosis stage to match them with the most appropriate therapy," said Stefan Zeuzem, M.D., chief of the department of medicine at the J.W. Goethe University Hospital in Frankfurt, Germany. "A clinically validated HCV therapeutic option that can reduce both the treatment timeframe and diagnostic burden may help providers treat more patients and reduce how many are lost to follow-up, ultimately potentially helping to hasten elimination of the disease globally."

About the EXPEDITION-8 Study2
EXPEDITION-8 is a single-arm, open-label, Phase 3b study in treatment-naïve, GT1-6 chronic HCV patients with compensated cirrhosis (n=343) who received MAVIRET for 8 weeks.

The primary efficacy endpoints were SVR12 in patients with GT1, 2, 4, 5, and 6 in a per-protocol (PP) and intent-to-treat (ITT) population versus historical SVR12 rates based on the efficacy of MAVIRET for 12 weeks in treatment-naïve patients with compensated cirrhosis. The key secondary efficacy endpoints were the percentages of GT1-6 patients achieving SVR12 in a PP and ITT population.

Additional information on the clinical trials for MAVIRET is available at www.clinicaltrials.gov/.

About MAVIRET® (glecaprevir/pibrentasvir)1

StephenW

艾伯维（AbbVie）获得MAVIRET®（glecaprevir / pibrentasvir）的CHMP积极评价，可将基因型3，未接受治疗的慢性丙型肝炎和代偿性肝硬化患者的治疗时间缩短至八周
-如果获得欧洲委员会（EC）的批准，MAVIRET将成为唯一的全基因型（GT1-6）8周治疗方案，适用于未经治疗，无肝硬化或代偿性肝硬化的慢性丙型肝炎（HCV）患者
-预计2020年欧盟委员会的最终决定

2020年1月31日，伊利诺斯州北芝加哥市/ PRNewswire /-研究型全球生物制药公司AbbVie（纽约证券交易所：ABBV）今天宣布，欧洲药品用人用药品欧洲委员会（CHMP）代理商（EMA）建议更改MAVIRET®（glecaprevir / pibrentasvir）的销售授权，以将初治，经补偿的肝硬化，慢性丙型肝炎（HCV）基因型患者的每日治疗时间从12周缩短至8周（ GT）3感染。目前，MAVIRET被认为是未经肝硬化的初次治疗的HCV患者的8周全基因型（GT1-6）每天一次的治疗方案，而对于未经治疗的GT1，则为8周的每天一次的治疗方案， 2、4、5和6例患有代偿性肝硬化的HCV患者。1*如果获得欧盟委员会（EC）的批准，MAVIRET将成为未接受过治疗，无肝硬化或代偿性肝硬化的慢性HCV患者的唯一8周治疗选择，不考虑基因型。*

AbbVie普通药物和病毒学治疗领域副总裁Janet Hammond博士说：“ HCV治疗途径对于数百万受该病影响的患者而言可能是一个复杂的过程。” “今天，CHMP对MAVIRET的积极评价使我们进一步朝着我们的目标迈进，即提供有效的8周治疗选择，并有可能简化大多数HCV感染者的治疗过程，而不论其基因型如何。”

CHMP阳性意见得到3b EXPEDITION-8期研究数据的支持，该研究表明，在MAVIRET治疗8周后，GT1-6患者的97.7％（n = 335/343）在治疗后12周达到了持续的病毒学应答（ SVR12）（ITT）。对于GT3患者，SVR12率为95.2％（n = 60/63）（ITT）。迄今为止，已经报道了这些患者中的一种病毒学衰竭，并且没有患者因不良事件而中断治疗。该研究报告的不良事件（频率> 5％）包括瘙痒（8％），疲劳（9％），头痛（8％）和恶心（6％）。在研究过程中发生了6个严重不良事件（占2％），没有一个与glecaprevir / pibrentasvir有关。在这项研究中没有发现新的安全信号2。

3b EXPEDITION-8期研究评估了MAVIRET在所有主要基因型（GT1-6）中未治疗的慢性HCV代偿性肝硬化患者中的安全性和有效性。已报告GT1、2、3、4、5和6名患者（n = 343）的结果。2
8周格列卡韦韦/吡布那韦治疗初治的慢性丙型肝炎病毒基因型1、2、3、4、5或6感染和代偿性肝硬化的疗效和安全性：实验8的完整结果

Stefan Zeuzem说：“成功治疗HCV一直以来都是一个挑战，部分原因是治疗持续时间长，需要进行额外的测试来确定患者的疾病基因型和纤维化阶段，以使其与最合适的疗法相匹配。”医学博士，JW医学系主任德国法兰克福歌德大学医院。 “经过临床验证的HCV治疗方案可以减少治疗时间和减少诊断负担，可以帮助提供者治疗更多的患者，并减少失访的人数，最终有可能在全球范围内加速消除这种疾病。”

关于EXPEDITION-8 Study2
EXPEDITION-8是一项单臂，开放标签的3b期研究，用于初治的GT1-6代偿性肝硬化的慢性HCV初治患者（n = 343），接受MAVIRET治疗8周。

主要疗效终点是按协议（PP）和意向治疗（ITT）人群中GT1、2、4、5和6的患者中的SVR12与基于MAVIRET 12周疗效的历史SVR12比率在未接受过治疗的肝硬化患者中次要疗效的关键终点是PP和ITT人群中实现SVR12的GT1-6患者的百分比。

有关MAVIRET临床试验的更多信息，请访问www.clinicaltrials.gov/。