AbbVie to Present Detailed Results from Phase III Studies in Patients with Chronic Hepatitis C at the 2014 International Liver Congress(TM)
NORTH CHICAGO, Ill., March 24, 2014 /PRNewswire/ — AbbVie (NYSE: ABBV) will present new data from its phase III hepatitis C development program at the 2014 International Liver Congress(TM) (ILC) in London, April 9-13. Detailed results from the SAPPHIRE-I, SAPPHIRE-II, PEARL-III, and TURQUOISE-II studies will be presented at the ILC on April 10-12.
In presentations at the ILC, investigators will share detailed data results of four studies from AbbVie’s phase III clinical trial program, the largest phase III program of an investigational, all-oral, interferon-free regimen for the treatment of chronic hepatitis C virus (HCV) infection in genotype 1 (GT1) adult patients.
Following is a list of AbbVie’s phase III clinical trial program data being presented at the ILC:
-- SAPPHIRE-II: Phase III Placebo-Controlled Study of an Investigational Interferon-Free, 12-Week Regimen in 394 Treatment-Experienced Adults with HCV GT1Oral Presentation: General Session 1 and OpeningApril 10, 14:00-14:15 BST; ICC Auditorium -- SAPPHIRE-I: Phase III Placebo-Controlled Study of an Investigational Interferon-Free, 12-Week Regimen in 631 Treatment-Naive Adults with HCV GT1Oral Presentation: General Session 2 and Awards 1April 11, 10:15-10:30 BST; ICC Auditorium -- PEARL-III: Sustained Virologic Response 12 Weeks Post-treatment (SVR(12)) with an Investigational 12-Week Regimen in 419 Treatment-Naive HCV GT1b-Infected Adults Late Breaker Poster: Poster P1299 April 12, 9:00-18:00 BST; Poster Exhibition -- TURQUOISE-II: SVR(12) Rates in 380 HCV GT1-Infected Adults with Compensated Cirrhosis Treated with an Investigational Regimen Oral Presentation: Late Breakers April 12, 15:30-15:45 BST; ICC Auditorium
AbbVie will present additional data in presentations throughout the Congress. The full ILC 2014 scientific program can be found at www.ilc-congress.eu/.
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 ABT-267 (25mg), dosed once daily, and ABT-333 (250mg) with or without ribavirin (RBV) (weight-based), dosed twice daily. The combination of three different mechanisms of action interrupts the HCV replication process with the goal of optimizing sustained virologic response (SVR) rates across different patient populations.
Additional information about AbbVie’s phase III studies can be found on www.clinicaltrials.gov.
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 ³6.
See approved product labels for more information.
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.
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.
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