AbbVie to Present Detailed Results from Phase III Studies in Patients with
Chronic Hepatitis C at the 2014 International Liver Congress™
NORTH CHICAGO, Ill., March 24, 2014
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™ (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)
Following is a list of AbbVie's phase III clinical trial program data being
presented at the ILC:
oSAPPHIRE-II: Phase III Placebo-Controlled Study of an Investigational
Interferon-Free, 12-Week Regimen in 394 Treatment-Experienced Adults with
Oral Presentation: General Session 1 and Opening
April 10, 14:00-14:15 BST; ICC Auditorium
oSAPPHIRE-I: Phase III Placebo-Controlled Study of an Investigational
Interferon-Free, 12-Week Regimen in 631 Treatment-Naive Adults with HCV
Oral Presentation: General Session 2 and Awards 1
April 11, 10:15-10:30 BST; ICC Auditorium
oPEARL-III: Sustained Virologic Response 12 Weeks Post-treatment (SVR)
with an Investigational 12-Week Regimen in 419 Treatment-Naive HCV
Late Breaker Poster: Poster P1299
April 12, 9:00-18:00 BST; Poster Exhibition
oTURQUOISE-II: SVR 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
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
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
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 Facebookor
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.
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