AbbVie to Present Late-Breaking Results from TURQUOISE-II Study in Chronic Hepatitis C Patients with Cirrhosis at the 2014

  AbbVie to Present Late-Breaking Results from TURQUOISE-II Study in Chronic
Hepatitis C Patients with Cirrhosis at the 2014 International Liver Congress™

- In patients with compensated liver cirrhosis and genotype 1 (GT1) chronic
hepatitis C virus (HCV) infection, a difficult-to-treat population,
TURQUOISE-II demonstrated SVR(12) rates of 91.8 and 95.9 percent after 12 and
24 weeks of treatment, respectively

- TURQUOISE-II is the largest phase III study of an all-oral, interferon-free
treatment regimen conducted to date exclusively in GT1 HCV patients with

- Results from TURQUOISE-II demonstrated high virologic response and similar
tolerability profile as seen in GT1 patients in other AbbVie phase III studies

- Results from TURQUOISE-II were published online today in The New England
Journal of Medicine

- AbbVie will also present detailed data from the phase II M12-999 study and
phase III PEARL-III study

PR Newswire

LONDON, April 12, 2014

LONDON, April 12, 2014 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced that new,
detailed results from its hepatitis C development program will be presented
today at the International Liver Congress^TM (ILC) 2014. Data from a pivotal
phase III study, TURQUOISE-II, featured in the ILC press conference on Friday,
will be presented as a late-breaker. Additionally, results from the study have
been published online in The New England Journal of Medicine.

TURQUOISE-II is a global, multi-center, randomized, open-label study
evaluating the efficacy and safety of 12 weeks or 24 weeks of treatment with
AbbVie's regimen with ribavirin (RBV) in adult patients with genotype 1 (GT1)
chronic hepatitis C virus (HCV) infection with compensated liver cirrhosis.
Patients achieved sustained virologic response rates 12 weeks post-treatment
(SVR[12]) of 91.8 percent and 95.9 percent in the 12-week and 24-week
treatment arms, respectively. Patients in the study were either new to therapy
or treatment-experienced (failed previous treatment with pegylated interferon
and RBV).


                              12-Week Arm SVR[12] 24-Week Arm SVR[12]

                              (n=208)             (n=172)
All GT1                       91.8% (n=191/208)   95.9% (n=165/172)
GT1a                          88.6% (n=124/140)   94.2% (n=114/121)
 New to therapy           92.2% (n=59/64)     92.9% (n=52/56)
GT1a treatment-experienced
 Prior null responders    80.0% (n= 40/50)    92.9% (n=39/42)
 Prior relapsers          93.3% (n= 14/15)    100.0% (n=13/13)
 Prior partial responders 100.0% (n= 11/11)   100.0% (n=10/10)
GT1b                          98.5% (n=67/68)     100.0% (n=51/51)
 New to therapy           100.0% (n= 22/22)   100.0% (n=18/18)
GT1b treatment-experienced
 Prior null responders    100.0% (n=14/14)    100.0% (n=10/10)
 Prior relapsers          100.0% (n=25/25)    100.0% (n=20/20)
 Prior partial responders 85.7% (n= 6/7)      100.0% (n=3/3)

"Results from the TURQUOISE-II study demonstrate that high SVR[12] rates can
be achieved in GT1 patients with compensated liver cirrhosis in both 12-week
and 24-week treatment durations," said Fred Poordad, M.D., lead clinical
investigator for TURQUOISE-II and Clinical Professor of Medicine at the
University of Texas Health Science Center at San Antonio. "These data are
encouraging, as cirrhotic patients are often a difficult-to-treat population
in the HCV community."

Discontinuation rates due to adverse events were 1.9 percent (four patients)
and 2.3 percent (four patients) in the 12-week and 24-week arms, respectively.
The most commonly reported adverse events (>10 percent in either arm) in
TURQUOISE-II were fatigue, headache, nausea, pruritus, insomnia, diarrhea,
asthenia, rash, cough, irritability, anemia and dyspnea.

On-treatment virologic failure occurred in one patient (0.5 percent) in the
12-week arm and three patients (1.7 percent) in the 24-week arm. In addition,
12 patients (5.9 percent) in the 12-week arm and one patient (0.6 percent) in
the 24-week arm experienced relapse within 12 weeks post-treatment.

"We designed our comprehensive HCV clinical trial program to generate
important information about treating a range of GT1 patients," said Scott
Brun, M.D., Vice President, Pharmaceutical Development, AbbVie. "These data
will help the medical community better understand the use of our regimen for
specific patient types they encounter with GT1 infection in actual practice."

In addition, AbbVie will present the following at the ILC today:

  oPEARL-III late-breaker poster: A phase III study examining the AbbVie
    regimen for 12 weeks with or without RBV in non-cirrhotic GT1b
    HCV-infected adult patients who were new to therapy
  oM12-999 oral presentation: Interim results of a phase II study examining
    the AbbVie regimen with RBV for 24 weeks in non-cirrhotic adult liver
    transplant recipients with recurrent GT1 HCV infection

Additional information about AbbVie's studies can be found on

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 ombitasvir (ABT-267) 25mg,
dosed once daily, and dasabuvir (ABT-333) 250mg with or without RBV
(weight-based), dosed twice daily. The combination of three different
mechanisms of action interrupts the HCV replication process with the goal of
optimizing SVR rates across different patient populations.

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 ≥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 @abbvie on Twitter or view careers on our Facebookor
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.


Contact: Media: Elizabeth Hoff, +1 (847) 935-4236,,
Javier Boix, +1 (847) 937-6113,, Investor Relations:
Liz Shea, +1 (847) 935-2211,
Press spacebar to pause and continue. Press esc to stop.