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) 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 GT1
Oral Presentation:
General Session 1 and Opening
April 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 GT1
Oral Presentation:
General Session 2 and Awards 1
April 11, 10:15-10:30 BST; ICC
Auditorium
- PEARL-III: Sustained Virologic Response 12 Weeks
Post-treatment (SVR12) 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: SVR12 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.
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