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Viekirax+Exviera 8周方案一线治疗GT1b丙肝治愈率高达98%
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, today
announced 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 prevalent 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 prevalent 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.
The most commonly reported adverse events (>10 percent) were fatigue
(22 percent), diarrhea (20 percent) and headache (18 percent).
“In the TURQUOISE-III study, GT1b patients with compensated liver
cirrhosis achieved a 100 percent cure rate with VIEKIRAX+EXVIERA without ribavirin,” said Scott Brun,M.D., vice president, pharmaceutical development, AbbVie.
“TURQUOISE-III is part of our Phase 3b program, which aims to further
enhance our understanding of AbbVie’s regimen in HCV populations seen in
clinical practice, and supports our commitment to continuedinvestigation in this field.”
About TURQUOISE-III Study TURQUOISE-III is a multi-center, open-label Phase 3b study to evaluate the safety andefficacy of 12 weeks of treatment with VIEKIRAX® + EXVIERA® without ribavirin (RBV) in adult patients (n=60) with genotype 1b chronic hepatitis C virus infection and compensated liver cirrhosis who were treatment-naïve or treatment-experienced (failed previous therapy with
pegylated interferon and RBV).
The primary endpoint is the rate of sustained virologic response 12 weeks after treatment (SVR12).
No patients experienced virologic failure during treatment and no patients experienced virologic relapse following the end of treatment.
About VIEKIRAX®+EXVIERA®
VIEKIRAX+EXVIERA is approved in the European Union for the treatment of
genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including
patients with compensated cirrhosis.
VIEKIRAX is approved in theEuropean Union for the treatment of genotype 4 (GT4) chronic HCVinfection.
VIEKIRAX tablets consist of the fixed-dose combination of
paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with
ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA tablets
consist of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor)
dosed twice daily.
VIEKIRAX + EXVIERA are taken with or withoutribavirin (RBV), dosed twice daily based on patient type.
VIEKIRAX +EXVIERA is taken for 12 weeks with or without RBV, except in genotype 1a
and GT4 patients with compensated cirrhosis, who should take it for 24
weeks with RBV.
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors.
Paritaprevir has been developed by AbbVie for use in combination with AbbVie’s other investigational medicines for the treatment of chronic
hepatitis C.
Additional information about AbbVie’s hepatitis C development program can be found on www.clinicaltrials.gov.
About AbbVie’s HCV Clinical Development ProgramThe
AbbVie HCV clinical development program is intended to advancescientific knowledge and clinical care by investigating interferon-free,all-oral treatments with or without ribavirin with the goal ofachieving high sustained virologic response rates in as many patients aspossible.
AbbVie’s global Phase 3b program plans to include more than2,800 genotype 1 patients in over 200 study centers worldwide, includingthe U.S., Canada, Europe, Russia and Brazil.
Additional information about AbbVie’s hepatitis C development program can be found on www.clinicaltrials.gov.
VIEKIRAX® + EXVIERA® EU IndicationVIEKIRAX is indicated in combination with other medicinal products for thetreatment of chronic hepatitis C (CHC) in adults.
EXVIERA is indicated in combination with other medicinal products for the treatment ofchronic hepatitis C (CHC) in adults.
Important EU Safety Information
Contraindications:VIEKIRAX+ EXVIERA are contraindicated in patients with severe hepaticimpairment (Child-Pugh C).
Patients taking ethinyl estradiol-containingmedicinal products must discontinue them and switch to an alternativemethod of contraception prior to initiating VIEKIRAX+EXVIERA.
Do notgive VIEKIRAX with certain drugs that are sensitive CYP3A substrates or
strong inhibitors of CYP3A. Do not give VIEKIRAX and EXVIERA with strong
or moderate enzyme inducers. Do not give EXVIERA with certain drugsthat are strong inhibitors of CYP2C8.
Special warnings and precautions for use:VIEKIRAXand EXVIERA are notrecommended as monotherapy and should be used incombination with other medicinal products for the treatment of hepatitisC infection.
Pregnancy and concomitant use with ribavirinWhenVIEKIRAX+EXVIERA are used in combination with ribavirin, women ofchildbearing potential or their male partners must use an effective formof contraception during the treatment and 6 months after the treatment.
Refer to the Summary of Product Characteristics for ribavirin foradditional information.
ALT elevationsTransientelevations of ALT to >5x ULN without concomitant elevations ofbilirubin occurred in clinical trials with VIEKIRAX + EXVIERA and weremore frequent in a subgroup who were using ethinyl estradiol-containing
contraceptives.
Use with concomitant medicinal productsUsecaution when administering VIEKIRAX with fluticasone or otherglucocorticoids that are metabolized by CYP3A4. A reduction incolchicine dosage or interruption in colchicine is recommended in
patients with normal renal or hepatic function.
VIEKIRAX with or withoutEXVIERA is expected to increase exposure of statins so certain statinsneed to be discontinued or dosages reduced. Low dose ritonavir, which ispart of VIEKIRAX, may select for PI resistance in HIV co-infected
patients without ongoing antiretroviral therapy.
HIV co-infectedpatients without suppressive antiretroviral therapy should not betreated with VIEKIRAX.
Adverse ReactionsMost common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with RBV were fatigue and nausea.
Full summary of product characteristics is available at www.ema.europa.eu
Globally, prescribing information varies; refer to the individual country product label for complete information.
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