AbbVie to Present Detailed Phase III Results from SAPPHIRE-I and SAPPHIRE-II Studies in Chronic Hepatitis C Patients at the 2014

 AbbVie to Present Detailed Phase III Results from SAPPHIRE-I and SAPPHIRE-II
   Studies in Chronic Hepatitis C Patients at the 2014 International Liver
                                  Congress™

-SVR(12) rates of 96 percent were achieved in both SAPPHIRE-I (new to therapy)
and SAPPHIRE-II (treatment-experienced with pegylated interferon and
ribavirin) in adult patients with genotype 1 chronic hepatitis C virus
infection

-All treatment-experienced sub-populations in the SAPPHIRE-II study achieved
SVR(12) rates of 95-100 percent

-SAPPHIRE-I and SAPPHIRE-II results were published online in The New England
Journal of Medicine

PR Newswire

LONDON, April 11, 2014

LONDON, April 11, 2014 /PRNewswire/ --AbbVie (NYSE: ABBV) announced that
detailed results from its phase III pivotal study, SAPPHIRE-I, will be
presented today at the International Liver Congress™ (ILC) 2014 and featured
in the ILC press conference. Results from the pivotal phase III study,
SAPPHIRE-II, were also presented at the congress yesterday. Additionally,
results from both SAPPHIRE-I and SAPPHIRE-II have been published online in The
New England Journal of Medicine.

In the SAPPHIRE-I (N=631) and SAPPHIRE-II (N=394) placebo-controlled studies,
adult, non-cirrhotic patients with chronic genotype 1 (GT1) hepatitis C virus
(HCV) infection receiving the investigational AbbVie regimen with ribavirin
(RBV) for 12 weeks achieved sustained virologic response rates 12 weeks
post-treatment (SVR[12]) of 96.2 percent (n=455/473) and 96.3 percent
(n=286/297), respectively.

In SAPPHIRE-II, treatment-experienced sub-populations randomized to the AbbVie
regimen with RBV were prior null responders (49.2 percent), prior relapsers
(29.0 percent) and prior partial responders (21.9 percent) to pegylated
interferon and RBV. 

"Patients with chronic hepatitis C who have not responded well to treatment in
the past have historically been more difficult to treat," said Stefan Zeuzem,
M.D., lead clinical investigator on SAPPHIRE-II and Chief of the Department of
Medicine at the J.W. Goethe University Hospital in Frankfurt, Germany. "These
data show very promising results in people who are infected with either
subtype of the GT1 hepatitis C virus and who are either new to therapy or
treatment-experienced."

SAPPHIRE-I and SAPPHIRE-II Results

                              SAPPHIRE-I SVR[12] SAPPHIRE-II SVR[12]

                              (n=473)            (n=297)
All GT1                       96.2% (n=455/473)  96.3% (n=286/297)*
GT1a                          95.3% (n=307/322)  96.0% (n=166/173)
GT1b                          98.0% (n=148/151)  96.7% (n=119/123)
Treatment-experienced (GT1a and GT1b)
 Prior null responders    n/a                95.2% (n=139/146)
 Prior relapsers          n/a                95.3% (n=82/86)
 Prior partial responders n/a                100.0% (n=65/65)

*Subgenotype could not be determined for one patient

In SAPPHIRE-I, high response rates were seen across patients with certain
variable characteristics, including gender, race, body mass index, fibrosis
stage and baseline HCV viral load, as some of these patients have historically
had a reduced response to treatment.

"These data provide further evidence that AbbVie's regimen can achieve high
SVR[12] rates across a range of GT1 patients with varying prior treatment
experience and response," said Scott Brun, M.D., Vice President,
Pharmaceutical Development, AbbVie. "We are excited to be able to share these
results at the ILC and as publications in The New England Journal of
Medicine."

Discontinuations due to adverse events were reported in 0.6 percent of
patients in both arms in SAPPHIRE-I and in 1.0 percent of patients receiving
the AbbVie regimen in SAPPHIRE-II and no patients receiving placebo. The most
commonly reported treatment-emergent adverse events (>10 percent in either
arm) for both SAPPHIRE-I and SAPPHIRE-II were fatigue, headache, nausea,
asthenia, insomnia, pruritus and diarrhea. Additional common adverse events
occurring in the studies were rash in SAPPHIRE-I and dyspnea, cough and
myalgia in SAPPHIRE-II. In SAPPHIRE-I, the adverse events that occurred with a
significantly greater frequency in the treatment arm compared to placebo were
pruritus, insomnia, diarrhea, nausea and asthenia; in SAPPHIRE-II, only
pruritus.

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.

About Study M11-646 (SAPPHIRE-I)
SAPPHIRE-I is a global, multi-center, randomized, double-blind,
placebo-controlled study to evaluate the efficacy and safety of 12 weeks of
treatment with AbbVie's regimen with RBV in non-cirrhotic, GT1a and GT1b
HCV-infected adult patients new to therapy.

The study population consisted of 631 patients: 473 were randomized to the
AbbVie regimen with RBV for 12 weeks, and 158 patients were randomized to
placebo for the initial 12 weeks. Patients initially randomized to placebo for
the first 12 weeks then received open-label treatment with the AbbVie regimen
with RBV for 12 weeks.

Of the 473 patients randomized to the AbbVie regimen with RBV, one case (0.2
percent) of on-treatment virologic failure occurred and seven patients (1.5
percent) experienced post-treatment relapse. In addition, three patients (0.6
percent) were lost to follow-up and seven patients (1.5 percent) discontinued
the study prematurely. Patients lost to follow-up were considered treatment
failures.

About Study M13-098 (SAPPHIRE-II)
SAPPHIRE-II is a global, multi-center, randomized, double-blind,
placebo-controlled study to evaluate the efficacy and safety of 12 weeks of
treatment with AbbVie's regimen with RBV in non-cirrhotic, GT1a and GT1b
HCV-infected, treatment-experienced adult patients who previously failed
treatment with pegylated interferon and RBV.

The study population consisted of 394 patients: 297 were randomized to the
AbbVie regimen with RBV for 12 weeks, and 97 patients were randomized to
placebo for the initial 12 weeks. Patients initially randomized to placebo for
the first 12 weeks then received open-label treatment with the AbbVie regimen
with RBV for 12 weeks.

Of the 297 patients randomized to the AbbVie regimen with RBV, there were no
cases of on-treatment virologic failure and seven patients (2.4 percent)
experienced post-treatment relapse. Of these patients, six were prior null
responders and one was a prior relapser. Three patients (1.0 percent)
prematurely discontinued therapy due to adverse events and one patient (0.3
percent) prematurely discontinued the study.

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 > 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
www.abbvie.com.Follow @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.

SOURCE AbbVie

Website: http://www.abbvie.com
Contact: Media: Elizabeth Hoff, +1 (847) 935-4236, elizabeth.hoff@abbvie.com,
Javier Boix, +1 (847) 937-6113, javier.boix@abbvie.com, Investor Relations:
Liz Shea, +1 (847) 935-2211, liz.shea@abbvie.com
 
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