Full Press Release Details
NORTH CHICAGO, Ill. , Oct. 1, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV ), a global research-based biopharmaceutical company, today announced that 34 abstracts from its chronic hepatitis C clinical development program have been accepted for presentation at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco from November 13-17 , further demonstrating AbbVie's strong leadership and ongoing commitment to patients with chronic hepatitis C virus (HCV) infection.
Presentations will highlight new data from Phase 3b studies of AbbVie's FDA-approved VIEKIRA PAK™ (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets), taken with or without ribavirin (RBV), for adults with genotype 1 (GT1) chronic HCV infection, including studies of GT1 patients with chronic kidney disease and genotype 1b (GT1b) patients with compensated cirrhosis. Additionally, new clinical studies will be presented on AbbVie's HCV pipeline medicines, ABT-493 and ABT-530, focused on investigating pan-genotypic, ribavirin-free, once-daily treatment options that may allow for shorter treatment durations of as little as eight weeks.
"We are pleased to present new data from studies of the VIEKIRA PAK regimen in HCV patients, including those with chronic kidney disease and GT1b compensated cirrhosis," said Michael Severino , M.D., executive vice president, research and development and chief scientific officer, AbbVie. "These data, as well as our findings from our investigational compounds, further demonstrate AbbVie's firm commitment to supporting the care of patients with chronic HCV infection."
Select AbbVie clinical presentations include:
Select Health Economics and Outcomes Research (HEOR) abstracts include:
The full AASLD 2015 scientific program can be found at www.aasld.org .
About VIEKIRA PAK
VIEKIRA PAK™ (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) is a prescription medicine used with or without ribavirin to treat adults with genotype 1 chronic (lasting a long time) hepatitis C (hep C) virus infection, including people who have a certain type of cirrhosis (compensated).
VIEKIRA is not for people with advanced cirrhosis (decompensated). If people have cirrhosis, they should talk to a healthcare provider before taking VIEKIRA.
IMPORTANT SAFETY INFORMATION
When taking VIEKIRA in combination with ribavirin, people should also read the Medication Guide that comes with ribavirin, especially the important pregnancy information.
What is the most important information to know about VIEKIRA? VIEKIRA can cause increases in liver function blood test results, especially if people use ethinyl estradiol-containing medicines (such as some birth control products).
VIEKIRA must not be taken if people:
What should people tell a healthcare provider before taking VIEKIRA?
What are the common side effects of VIEKIRA?
These are not all of the possible side effects of VIEKIRA. A healthcare provider should be notified if there is any side effect that is bothersome or that does not go away.
This is the most important information to know about VIEKIRA. For more information, talk with a healthcare provider.
People are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information, including the Medication Guide.
If people cannot afford their medication, they should contact www.pparx.org for assistance.
Additional Information about VIEKIRA PAK™
VIEKIRA PAK™ (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) has been studied in a broad range of genotype 1 (GT1) patients with chronic hepatitis C virus (HCV) infection, ranging from treatment-naive to some of the most difficult to treat, such as patients with compensated (mild, Child-Pugh A) cirrhosis of the liver, HCV/HIV-1 co-infection, liver transplant recipients with normal hepatic function and mild fibrosis, and those who have failed previous treatment with pegylated interferon (pegIFN) and ribavirin (RBV). VIEKIRA PAK is not recommended in patients with moderate hepatic impairment (Child-Pugh B), and is contraindicated in patients with severe hepatic impairment (Child-Pugh C). VIEKIRA PAK consists of the fixed-dose combination of ombitasvir 25mg (an NS5A inhibitor), paritaprevir 150mg (an NS3/4A protease inhibitor), and ritonavir 100mg (an HIV-1 protease inhibitor), dosed once daily with a meal, and dasabuvir 250mg (a non-nucleoside NS5B palm polymerase inhibitor), dosed twice daily with a meal. VIEKIRA PAK is taken for 12 weeks, except in GT1a patients with cirrhosis, who should take it for 24 weeks. Ribavirin should be co-administered in GT1a patients, and in all patients who have cirrhosis or who have received a liver transplant.
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA ) for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir is being investigated by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.
For VIEKIRA PAK Full Prescribing Information, including the Medication Guide, click here .
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. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 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 2014 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.