AbbVie Releases First of Six Phase III Results from Investigational All-Oral, Interferon-Free, 12-week Regimen, Showing 96

AbbVie Releases First of Six Phase III Results from Investigational All-Oral,
   Interferon-Free, 12-week Regimen, Showing 96 Percent SVR12 in Genotype 1
                     Hepatitis C Patients New to Therapy

- Confirms results of phase II studies, with consistent virologic response and
tolerability profile

- Largest all-oral, interferon-free clinical program in genotype 1 (GT1)
patients to date(1)

- On track for major regulatory submissions in Q2 2014

- Worldwide, about 160 million people are chronically infected with hepatitis
C(2), most with GT1

PR Newswire

NORTH CHICAGO, Ill., Nov. 18, 2013

NORTH CHICAGO, Ill., Nov. 18, 2013 /PRNewswire/ -- AbbVie (NYSE: ABBV)
released the first phase III results for the investigational three
direct-acting-antiviral (3D) regimen plus ribavirin in patients chronically
infected with genotype 1 (GT1) hepatitis C virus (HCV). In the 631-patient
SAPPHIRE-I study, patients new to therapy receiving 12 weeks of AbbVie's 3D
regimen achieved a sustained virologic response at 12 weeks post-treatment
(SVR[12]) of 96 percent. The majority of patients were GT1a, considered the
more difficult-to-treat subtype, and the SVR[12] rates of GT1a and GT1b were
95 percent and 98 percent, respectively. The rate of virologic relapse or
breakthrough was low, occurring in 1.7 percent of patients receiving the 3D
regimen. In addition, discontinuation rates due to adverse events were low,
and of an equal percentage (0.6 percent) in both active and placebo groups.

AbbVie's multinational HCV program is the largest all-oral, interferon-free
clinical program in GT1 patients being conducted to date. GT1 (with subtypes
1a and 1b) is the most prevalent genotype worldwide, with a higher prevalence
of 1a in the U.S. and 1b in Europe. SAPPHIRE-I is the first of six phase III
trials supporting AbbVie's investigational 3D regimen for the treatment of GT1
hepatitis C patients.

"SAPPHIRE-I demonstrates that patients new to therapy with genotype 1 HCV
achieved high rates of virologic response with AbbVie's interferon-free,
all-oral 3D regimen plus ribavirin, and the SVR rate is consistent with
results from our phase II studies," said Scott Brun, M.D., vice president,
pharmaceutical development, AbbVie. "SAPPHIRE-I is the first of these studies
to report results, and based on the progress of our clinical program to date,
we are on track for major regulatory submissions in the second quarter of

AbbVie will disclose detailed SAPPHIRE-I results at future scientific
congresses and in publications.

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 ABT-333 (250mg), ribavirin (weight-based), both dosed twice
daily, and the fixed-dose combination of ABT-450/ritonavir (150/100mg)
co-formulated with ABT-267 (25mg) and dosed once daily in non-cirrhotic, GT1a
and GT1b HCV-infected, treatment-naive adult patients.

The study population consisted of 631 GT1 treatment-naive patients with no
evidence of liver cirrhosis with 473 patients randomized to the 3D regimen
plus ribavirin for 12 weeks, and 158 patients 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 3D regimen plus ribavirin
for 12 weeks.

Following 12 weeks of treatment with AbbVie's 3D regimen plus ribavirin, 96
percent (n=455/473) of patients achieved SVR[12] based on intent-to-treat
analysis where patients with missing values for any reason were considered
treatment failures. In the active treatment arm, patients with GT1b infection
achieved 98 percent SVR[12] (148/151), while patients with GT1a achieved 95
percent SVR[12] (307/322).

The most commonly reported adverse events in the 3D and placebo arms,
respectively, were fatigue, headache and nausea. Discontinuations due to
adverse events were reported in 0.6 percent of patients receiving the 3D
regimen and 0.6 percent of patients receiving placebo. The rate of virologic
relapse or breakthrough was low, occurring in 1.7 percent of patients
receiving the 3D regimen. 

Additional information about AbbVie's phase III studies can be found on

AbbVie's HCV Development Program
The clinical program supporting our 3D regimen includes more than 2,300
genotype 1 patients in greater than 25 countries around the world. The AbbVie
HCV clinical development program is intended to advance scientific knowledge
and clinical care by investigating an interferon-free, all-oral 3D regimen
with or without ribavirin 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. Results from the remaining
five studies in AbbVie's phase III program will be available in the coming
months, supporting regulatory submissions starting in the second quarter of

Overview of AbbVie's phase III clinical programs is as follows:

Study        Patients (N)                        Treatment      Treatment
                                                 Regimen        Duration
                                                 • ABT-450/r^b
                                                                12 weeks
             GT1, treatment-naive                • ABT-333
             (631)                               • Ribavirin
                                                                12 weeks, then
                                                 • Placebo    active
                                                                treatment for
                                                                12 weeks
                                                 • ABT-450/r
                                                 +ABT-267 ^
                                                                12 weeks
             GT1, treatment-experienced          • ABT-333
             (400^a)                             • Ribavirin
                                                                12 weeks, then
                                                 • Placebo    active
                                                                treatment for
                                                                12 weeks
                                                 • ABT-450/r
                                                 +ABT-267 ^
                                                                12 weeks
             GT1b, treatment-experienced         • ABT-333
             (210 ^ a)                           • Ribavirin
                                                 • ABT-450/r
                                                 +ABT-267 ^     12 weeks

                                                 • ABT-333
                                                 • ABT-450/r
                                                 +ABT-267 ^
                                                                12 weeks
                                                 • ABT-333
             GT1b, treatment-naive
PEARL-III                                        • Ribavirin
             (400 ^ a)                           • ABT-450/r
                                                 +ABT-267 ^
                                                                12 weeks
                                                 • ABT-333

                                                 • Placebo
                                                 • ABT-450/r
                                                 +ABT-267 ^
                                                                12 weeks
                                                 • ABT-333
             GT1a, treatment-naive
PEARL-IV                                         • Ribavirin
             (300 ^ a)                           • ABT-450/r
                                                 +ABT-267 ^
                                                                12 weeks
                                                 • ABT-333

                                                 • Placebo
                                                 • ABT-450/r
                                                 +ABT-267 ^
                                                                12 weeks
             GT1, treatment-naive and            • ABT-333
             treatment-experienced (with
TURQUOISE-II compensated cirrhosis)              • Ribavirin
                                                 • ABT-450/r
             (380 ^ a)                           +ABT-267 ^
                                                                24 weeks
                                                 • ABT-333

                                                 • Ribavirin

^a projected study population
^b ABT-450/ritonavir ^
^c ABT-267 is co-formulated with ABT-450/r, administered as two pills once

The 3D regimen consists of boosted protease inhibitor ABT-450/ritonavir, NS5A
inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333. The
combination of three different mechanisms of action interrupts the HCV
replication process with the goal of optimizing SVR rates across different
patient populations. In May of 2013, AbbVie's investigational 3D regimen with
and without ribavirin for HCV GT1 was designated as a Breakthrough Therapy by
the U.S. Food and Drug Administration (FDA).

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 for 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,
automimmune 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. 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. In 2013, AbbVie employs approximately 21,000 people
worldwide and markets medicines in more than 170 countries. For further
information on the company and its people, portfolio and commitments, please
visit 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 2012 Annual Report on Form
10-K/A, 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.

[1] Comparison based on review of data from for phase 3a
programs of Gilead, BMS and BI as of November 15, 2013

[2] Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol
Infect. 2011; 17(2):107-15.


Contact: Media, Elizabeth Hoff, +1 (847) 935-4236,,
or Javier Boix, +1 (847) 937-6113,; or Investor
Relations, Elizabeth Shea, +1 (847) 935-2211,
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