Click here to close now.

SYS-CON MEDIA Authors: Liz McMillan, Carmen Gonzalez, Pat Romanski, AppDynamics Blog, Roger Strukhoff

News Feed Item

AbbVie to Present Late-Breaking Results from TURQUOISE-II Study in Chronic Hepatitis C Patients with Cirrhosis at the 2014 International Liver Congress™

- In patients with compensated liver cirrhosis and genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, a difficult-to-treat population, TURQUOISE-II demonstrated SVR(12) rates of 91.8 and 95.9 percent after 12 and 24 weeks of treatment, respective

LONDON, April 12, 2014 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced that new, detailed results from its hepatitis C development program will be presented today at the International Liver CongressTM (ILC) 2014. Data from a pivotal phase III study, TURQUOISE-II, featured in the ILC press conference on Friday, will be presented as a late-breaker. Additionally, results from the study have been published online in The New England Journal of Medicine.

TURQUOISE-II is a global, multi-center, randomized, open-label study evaluating the efficacy and safety of 12 weeks or 24 weeks of treatment with AbbVie's regimen with ribavirin (RBV) in adult patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection with compensated liver cirrhosis. Patients achieved sustained virologic response rates 12 weeks post-treatment (SVR12) of 91.8 percent and 95.9 percent in the 12-week and 24-week treatment arms, respectively. Patients in the study were either new to therapy or treatment-experienced (failed previous treatment with pegylated interferon and RBV).

TURQUOISE-II Results


12-Week Arm SVR12

(n=208)

24-Week Arm SVR12

(n=172)

All GT1

91.8% (n=191/208)

95.9% (n=165/172)

GT1a

88.6% (n=124/140)

94.2% (n=114/121)

     New to therapy

92.2% (n=59/64)

92.9% (n=52/56)

GT1a treatment-experienced



     Prior null responders

80.0% (n= 40/50)

92.9% (n=39/42)

     Prior relapsers

93.3% (n= 14/15)

100.0% (n=13/13)

     Prior partial responders

100.0% (n= 11/11)

100.0% (n=10/10)

GT1b

98.5% (n=67/68)

100.0% (n=51/51)

     New to therapy

100.0% (n= 22/22)

100.0% (n=18/18)

GT1b treatment-experienced



     Prior null responders

100.0% (n=14/14)

100.0% (n=10/10)

     Prior relapsers

100.0% (n=25/25)

100.0% (n=20/20)

     Prior partial responders

85.7% (n= 6/7)

100.0% (n=3/3)

"Results from the TURQUOISE-II study demonstrate that high SVR12 rates can be achieved in GT1 patients with compensated liver cirrhosis in both 12-week and 24-week treatment durations," said Fred Poordad, M.D., lead clinical investigator for TURQUOISE-II and Clinical Professor of Medicine at the University of Texas Health Science Center at San Antonio. "These data are encouraging, as cirrhotic patients are often a difficult-to-treat population in the HCV community."

Discontinuation rates due to adverse events were 1.9 percent (four patients) and 2.3 percent (four patients) in the 12-week and 24-week arms, respectively. The most commonly reported adverse events (>10 percent in either arm) in TURQUOISE-II were fatigue, headache, nausea, pruritus, insomnia, diarrhea, asthenia, rash, cough, irritability, anemia and dyspnea.

On-treatment virologic failure occurred in one patient (0.5 percent) in the 12-week arm and three patients (1.7 percent) in the 24-week arm. In addition, 12 patients (5.9 percent) in the 12-week arm and one patient (0.6 percent) in the 24-week arm experienced relapse within 12 weeks post-treatment.

"We designed our comprehensive HCV clinical trial program to generate important information about treating a range of GT1 patients," said Scott Brun, M.D., Vice President, Pharmaceutical Development, AbbVie. "These data will help the medical community better understand the use of our regimen for specific patient types they encounter with GT1 infection in actual practice."

In addition, AbbVie will present the following at the ILC today:

  • PEARL-III late-breaker poster: A phase III study examining the AbbVie regimen for 12 weeks with or without RBV in non-cirrhotic GT1b HCV-infected adult patients who were new to therapy
  • M12-999 oral presentation: Interim results of a phase II study examining the AbbVie regimen with RBV for 24 weeks in non-cirrhotic adult liver transplant recipients with recurrent GT1 HCV infection

Additional information about AbbVie's studies can be found on www.clinicaltrials.gov.

About AbbVie's Investigational HCV Regimen
The AbbVie investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ombitasvir (ABT-267) 25mg, dosed once daily, and dasabuvir (ABT-333) 250mg with or without RBV (weight-based), dosed twice daily. The combination of three different mechanisms of action interrupts the HCV replication process with the goal of optimizing SVR rates across different patient populations.

AbbVie's HCV Development Program
The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating an interferon-free, all-oral regimen with and without RBV with the goal of producing high SVR rates in as many patients as possible, including those that typically do not respond well to treatment, such as previous non-responders to interferon-based therapy or patients with advanced liver fibrosis or cirrhosis.

ABT-450 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of HCV.

Safety Information for Ribavirin and Ritonavir
Ribavirin and ritonavir are not approved for the investigational use discussed above, and no conclusions can or should be drawn regarding the safety or efficacy of these products for this use.

There are special safety considerations when prescribing these drugs in approved populations.

Ritonavir must not be used with certain medications due to significant drug-drug interactions and in patients with known hypersensitivity to ritonavir or any of its excipients.

Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus and must not be used alone for this use. Ribavirin causes significant teratogenic effects and must not be used in women who are pregnant or breast-feeding and in men whose female partners are pregnant. Ribavirin must not be used in patients with a history of severe pre-existing cardiac disease, severe hepatic dysfunction or decompensated cirrhosis of the liver, autoimmune hepatitis, hemoglobinopathies, or in combination with peginterferon alfa-2a in HIV/HCV co-infected patients with cirrhosis and Child-Pugh score ≥6.

See approved product labels for more information.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. 

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2013 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission.

AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

SOURCE AbbVie

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
P2P RTC will impact the landscape of communications, shifting from traditional telephony style communications models to OTT (Over-The-Top) cloud assisted & PaaS (Platform as a Service) communication services. The P2P shift will impact many areas of our lives, from mobile communication, human interactive web services, RTC and telephony infrastructure, user federation, security and privacy implications, business costs, and scalability. In his session at @ThingsExpo, Robin Raymond, Chief Architect...
The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that produce software that is obsolete at launch. DevOps may be disruptive, but it is essential. The DevOps Summit at Cloud Expo – to be held June 3-5, 2015, at the Javits Center in New York City – will expand the DevOps community, enable a wide...
Enterprises are fast realizing the importance of integrating SaaS/Cloud applications, API and on-premises data and processes, to unleash hidden value. This webinar explores how managers can use a Microservice-centric approach to aggressively tackle the unexpected new integration challenges posed by proliferation of cloud, mobile, social and big data projects. Industry analyst and SOA expert Jason Bloomberg will strip away the hype from microservices, and clearly identify their advantages and d...
With worldwide spending on cloud services and infrastructure growing by 23% in 2015 to $118B, it is clear that cloud services are here to stay. Yet, the rate of cloud adoption varies by companies and markets around the world. With thousands of outages and hijacks across the Internet every day, one reason for hesitation is the faith in quality Internet performance. In his session at 16th Cloud Expo, Michael Kane, Senior Manager at Dyn, will explore how Internet performance affects your end-user...
Cloud Expo, Inc. has announced today that Andi Mann returns to DevOps Summit 2015 as Conference Chair. The 4th International DevOps Summit will take place on June 9-11, 2015, at the Javits Center in New York City. "DevOps is set to be one of the most profound disruptions to hit IT in decades," said Andi Mann. "It is a natural extension of cloud computing, and I have seen both firsthand and in independent research the fantastic results DevOps delivers. So I am excited to help the great team at ...
Organizations today are confounded by an avalanche of data that needs to be processed and managed on a daily basis. Through relevant use cases and a thought-provoking dialogue on an organization’s ‘Data to Decisions’ journey, Andrew Clyne, Chief Data Officer at CenturyLink Cognilytics, will reveal in his session at Big Data Expo how your organization can monetize data as a strategic asset. State-of-the-art Big Data and Advanced Analytics capabilities provided as a managed service can enable da...
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at Internet of @ThingsExpo, James Kirkland, Chief Ar...
With SaaS use rampant across organizations, how can IT departments track company data and maintain security? More and more departments are commissioning their own solutions and bypassing IT. A cloud environment is amorphous and powerful, allowing you to set up solutions for all of your user needs: document sharing and collaboration, mobile access, e-mail, even industry-specific applications. In his session at 16th Cloud Expo, Shawn Mills, President and a founder of Green House Data, will discus...
Move from reactive to proactive cloud management in a heterogeneous cloud infrastructure. In his session at 16th Cloud Expo, Manoj Khabe, Innovative Solution-Focused Transformation Leader at Vicom Computer Services, Inc., will show how to replace a help desk-centric approach with an ITIL-based service model and service-centric CMDB that’s tightly integrated with an event and incident management platform. Learn how to expand the scope of operations management to service management. He will al...
For IoT to grow as quickly as analyst firms’ project, a lot is going to fall on developers to quickly bring applications to market. But the lack of a standard development platform threatens to slow growth and make application development more time consuming and costly, much like we’ve seen in the mobile space. In his session at @ThingsExpo, Mike Weiner is Product Manager of the Omega DevCloud with KORE Telematics Inc., will discuss the evolving requirements for developers as IoT matures and co...
There is no question that the cloud is where businesses want to host data. Until recently hypervisor virtualization was the most widely used method in cloud computing. Recently virtual containers have been gaining in popularity, and for good reason. In the debate between virtual machines and containers, the latter have been seen as the new kid on the block – and like other emerging technology have had some initial shortcomings. However, the container space has evolved drastically since coming on...
Mobile commerce traffic is surpassing desktop, yet less than 20% of sales in the U.S. are mobile commerce sales. In his session at 15th Cloud Expo, Dan Franklin, Segment Manager, Commerce, at Verizon Digital Media Services, defined mobile devices and discussed how next generation means simplification. It means taking your digital content and turning it into instantly gratifying experiences.
SYS-CON Events announced today that DragonGlass, an enterprise search platform, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. After eleven years of designing and building custom applications, OpenCrowd has launched DragonGlass, a cloud-based platform that enables the development of search-based applications. These are a new breed of applications that utilize a search index as their backbone for data...
Converging digital disruptions is creating a major sea change - Cisco calls this the Internet of Everything (IoE). IoE is the network connection of People, Process, Data and Things, fueled by Cloud, Mobile, Social, Analytics and Security, and it represents a $19Trillion value-at-stake over the next 10 years. In her keynote at @ThingsExpo, Manjula Talreja, VP of Cisco Consulting Services, will discuss IoE and the enormous opportunities it provides to public and private firms alike. She will shar...
Container frameworks, such as Docker, provide a variety of benefits, including density of deployment across infrastructure, convenience for application developers to push updates with low operational hand-holding, and a fairly well-defined deployment workflow that can be orchestrated. Container frameworks also enable a DevOps approach to application development by cleanly separating concerns between operations and development teams. But running multi-container, multi-server apps with containers ...