AbbVie Demonstrates Commitment to Continued Research in Hepatitis C with Investigational Data from Clinical Program Being Presented at The Liver Meeting®

NORTH CHICAGO, Ill., Oct. 1, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced that data from its ongoing Phase 1 through Phase 3 hepatitis C clinical development programs will be presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, November 7-11, 2014.

Abstracts will be presented highlighting results from AbbVie's investigational treatment combining three direct-acting antivirals (ABT-450/ritonavir, ombitasvir and dasabuvir) with or without ribavirin (RBV) in patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection. These abstracts include a Phase 2/3 study in patients co-infected with human immunodeficiency virus type 1 (HIV-1) (TURQUOISE-I) and a Phase 2 study in liver transplant recipients without cirrhosis (CORAL-I). 

Additionally, Phase 2 data will be presented from investigational studies evaluating the combination of ABT-450/ritonavir and ombitasvir with or without RBV in genotype 4 (GT4) patients (PEARL-I). AbbVie will also be presenting data from its two additional pipeline HCV compounds, ABT-493 and ABT-530.

Key AbbVie HCV Data at AASLD 2014 includes:

• TURQUOISE-I: SVR₁₂ data in HCV/HIV-1 Co-infected Patients Treated with ABT-450/r/Ombitasvir and Dasabuvir and Ribavirin
  Poster # 1939
  November 11, 2014, 8:00 a.m. – 12:00 p.m. EST, Poster Hall
  This study evaluates a treatment of ABT-450/ritonavir, ombitasvir and dasabuvir plus RBV in treatment-naïve and peginterferon/RBV-experienced adults co-infected with GT1 HCV and HIV-1, with and without cirrhosis (Child-Pugh A).
  
  
• Sustained Virologic Response Rates in Liver Transplant Recipients with Recurrent HCV Genotype 1 Infection Receiving ABT-450/r/Ombitasvir + Dasabuvir Plus Ribavirin
  Oral Presentation at the Hepatitis Plenary Session
  November 11, 2014, 9:15 a.m. – 9:30 a.m. EST
  This ongoing Phase 2 study examines safety and efficacy of ABT-450/ritonavir, ombitasvir and dasabuvir plus RBV in non-cirrhotic HCV treatment-naïve since liver transplant recipients with recurrent GT1 HCV infection.
  
  
• Interferon-Free Regimens of Ombitasvir and ABT-450/r with or without Ribavirin in Patients with HCV Genotype 4 Infection: PEARL-I Study Results
  Poster # 1928
  November 11, 2014, 8:00 a.m. – 12:00 p.m. EST, Poster Hall
  The PEARL-I study assesses safety and efficacy of an all-oral regimen of ABT-450/ritonavir and ombitasvir with or without RBV in treatment-naïve and peginterferon/RBV-experienced non-cirrhotic patients with GT1b and GT4 HCV infection.

Additional HCV Data Highlights

• Antiviral Activity of ABT-493 and ABT-530 with 3-Day Monotherapy in Patients with and without Compensated Cirrhosis with Hepatitis C Virus (HCV) Genotype 1 Infection
  Poster # 1956
  November 11, 2014, 8:00 a.m. – 12:00 p.m. EST, Poster Hall
  This study evaluates antiviral activity, safety, and tolerability of ABT-493 and ABT-530 administered as monotherapy for three days in treatment-naive adults with chronic GT1 HCV infection with and without compensated cirrhosis.
  

• Pharmacokinetics and Safety of Pan-Genotypic, Direct Acting Protease Inhibitor, ABT-493, and NS5A Inhibitor, ABT-530, Following 3-Day Monotherapy in HCV Genotype-1 Infected Subjects with or without Compensated Cirrhosis
  Poster # 1986
  November 11, 2014, 8:00 a.m. – 12:00 p.m. EST, Poster Hall
  This study explores the safety, pharmacokinetics and antiviral activity of ABT-493 and ABT-530 administered as monotherapy for three days in GT1 HCV infected patients with or without compensated cirrhosis.

The full list of accepted abstracts for The Liver Meeting can be accessed on www.aasld.org.

About AbbVie's HCV Clinical Development Program
The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating interferon-free, all-oral treatments with and without ribavirin with the goal of producing high sustained virologic response rates in as many patients as possible. AbbVie's multinational Phase 3 program using an investigational treatment combining three direct-acting antivirals includes more than 2,300 patients in over 25 countries. The program is designed to identify ways to maximize response rates in a broad spectrum of GT1 patient populations, including those with compensated cirrhosis, liver transplant recipients and those with human immunodeficiency virus type 1 co-infection. AbbVie's development programs using all-oral investigational treatments combining two direct-acting antivirals are studying additional hepatitis C virus (HCV) genotypes.

AbbVie's pipeline of multiple direct-acting antiviral compounds for the treatment of hepatitis C aims to investigate interferon-free treatments that target multiple HCV genotypes. 

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 hepatitis C.

Safety Information for Ribavirin and Ritonavir
Ribavirin and ritonavir are not approved for the investigational uses 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/A, 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