New Data from AbbVie's Phase IIb Aviator Trial Demonstrate High Sustained Viral Response Rates Across Multiple Patient Types

  New Data from AbbVie's Phase IIb Aviator Trial Demonstrate High Sustained
    Viral Response Rates Across Multiple Patient Types with HCV Genotype 1

- 96 percent of treatment-naive patients and 93 percent of prior null
responders treated with AbbVie's investigational IFN-free, triple-DAA
combination therapy achieve SVR24

- Additional analyses looks at response rates in patients with differing
baseline factors including gender, viral load and fibrosis stage

PR Newswire

AMSTERDAM, April 23, 2013

AMSTERDAM, April 23, 2013 /PRNewswire/ --(NYSE: ABBV) – Results from
"Aviator," AbbVie's phase IIb clinical trial of its investigational
direct-acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV)
infection, continue to demonstrate high sustained viral response (SVR) rates
against genotype 1 HCV, across patient types. Data show greater than 90
percent SVR were achieved in patients new to treatment and in patients who had
previously failed treatment with pegylated interferon and ribavirin (null
responders). In addition, similar high SVR rates observed after 12 and 24
weeks of treatment in the Phase IIb trial reinforce the adequacy of the
12-week treatment duration for the investigational interferon-free, triple DAA
combination. The triple-DAA combination is currently being studied in Phase
III clinical trials. Results will be featured in the official press conference
at the 2013 International Liver Congress^® (ILC) in Amsterdam on Wednesday,
April 24 at 11:00 CEST and presented on Thursday, April 25.

"These new results from the Aviator study further demonstrate that this
investigational all-oral therapy combination can achieve high sustained viral
response after 12 weeks of treatment," said Kris Kowdley, M.D., Director of
the Liver Center of Excellence and Director of Research in the Digestive
Disease Institute at Virginia Mason Medical, and Clinical Professor of
Medicine at the University of Washington in Seattle. "The consistency of high
sustained viral response rates that we have seen in clinical trials across
populations is encouraging, especially given the proportion of patients with
these characteristics who have failed with interferon plus ribavirin
treatment."

"AbbVie's clinical development program aims to improve virologic cure rates,
including in patients who have historically been harder to treat with current
therapies, such as prior null responders. While further studies are required
to confirm these findings, we remain encouraged by the high viral response
rates and the safety profile we have seen in the Aviator study," said Barry
Bernstein, divisional vice president, infectious disease development, AbbVie.
"Our Phase III trials are progressing well and we remain focused on bringing
an interferon-free treatment option to patients with HCV genotype 1
infection."

About Study M11-652 (Aviator)
The objective of this phase 2b study was to assess the safety, and efficacy of
ABT-450/r (dosed 100/100 to 200/100mg once daily), ABT-267 (25mg once daily),
ABT-333 (400mg twice daily) and ribavirin in non-cirrhotic treatment-naive
patients and prior peg-interferon/ribavirin null responders administered for
8, 12 or 24 weeks. Enrollment was open to GT1-infected patients regardless of
IL28B host genotype and ribavirin dosing was weight-based.

A summary of key data from the trial is below:

             Treatment-Naive                                             Null Responders
Duration     8 weeks   12 weeks                                24 Weeks  12 weeks            24 weeks
             ABT-450/r ABT-450/r ABT-450/r ABT-450/r ABT-450/r ABT-450/r ABT-450/r ABT-450/r ABT-450/r

             ABT-267            ABT-267   ABT-267   ABT-267   ABT-267   ABT-267   ABT-267   ABT-267
Regimen
             ABT-333   ABT-333            ABT-333   ABT-333   ABT-333            ABT-333   ABT-333

             RBV       RBV       RBV                RBV       RBV       RBV       RBV       RBV
Number dosed 80        41        79        79        79        80        45        45        43
Breakthrough 0         1         1         1         0         0         0         3         1
Relapse      10        4         8         5         1         2         5         0         0
SVR[12       89%       85%       91%       90%       99%       93%       89%       93%       98%
](ITT)
SVR[24]      88%       83%       89%       87%       96%       90%       89%       93%       95%
(ITT)

For the 12-week triple-DAA regimen with ribavirin being studied in Phase 3
trials:

  o99% of treatment-naive patients achieved SVR[12], 96% achieved SVR[24] in
    this intent-to-treat analysis
  o93% of prior null responders achieved SVR[12] and SVR[24]
  oThe single relapse with this regimen occurred at post-treatment week two

With the triple-DAA plus ribavirin regimen, comparable SVR[24] response rates
were also seen in treatment naive patients and null responder patients across
HCV subtype, IL28B genotype and baseline HCV-RNA levels and severity of
fibrosis.

SVR[24] by patient subtype in the "Aviator" study

Characteristic          Treatment Naive Null Responders
GT1a                    91% (n=108)     93% (n=55)
GT1b                    98% (n=50)      97% (n=33)
Non-CC IL28B genotype  95% (n=115)     94% (n=85)
CC IL28B genotype       89% (n=44)      100% (n=3)
Viral Load (≥7 log)     89% (n=35)      91% (n=22)
Viral load (<7 log)     94% (n=124)     96% (n=66)
Fibrosis Stage (F0-F1)* 94% (n=113)     95% (n=41)
Fibrosis Stage (F2-F3)* 91% (n=42)      93% (n=45)
Male                    92% (n=78)      93% (n=55)
Female                  94% (n=81)      97% (n=33)

*The fibrosis analysis was post-hoc based on biopsy or non-invasive testing at
screening.

The safety profile seen in this study is consistent with the initial
presentation of results in November 2012. Of the 247 patients included in this
analysis, four patients (1.6 percent) discontinued the study because of
drug-related adverse events. Serious adverse events were noted in 4 patients
(1.6 percent), with one (arthralgia) considered possibly drug-related. Other
events reported in more than 10 percent of patients included headache,
fatigue, nausea, insomnia, and diarrhea. Grade 3-4 laboratory abnormalities
in total bilirubin (six patients) and ALT (one patient) were noted; all
resolved with continued dosing.

About Study M11-652 (Aviator)
The objective of this phase 2b study was to assess the safety, and efficacy of
ABT-450/r (dosed 100/100 to 200/100mg once daily), ABT-267 (25mg once daily),
ABT-333 (400mg twice daily) and ribavirin in non-cirrhotic treatment-naive
patients and prior peg-interferon/ribavirin null responders administered for
8, 12 or 24 weeks. Enrollment was open to GT1-infected patients regardless of
IL28B host genotype and ribavirin dosing was weight-based.

About the Hepatitis C Virus
Across the world, about 160 million people are chronically infected with
hepatitis C.^1 Hepatitis C is an inflammation of the liver caused by an
infection with the hepatitis C virus (HCV).^2 HCV is transmitted when an
infected person's blood enters the bloodstream of another person.^3

For the hepatitis C virus, there are six major HCV genotypes (GT1-6).^^4
Presently, there is no vaccine for the hepatitis C virus (HCV) infection.^3
Decision to treat is dependent on a number of factors such as the amount of
liver damage present, other conditions the patient may have, amount of virus
in the body, and viral genotype.^4 If treatment is needed, a hepatitis C
infection is typically treated with a combination of antivirals.^3

About AbbVie's HCV Development Programs
AbbVie's HCV portfolio includes investigational medicines with three different
mechanisms of action, including protease (ABT-450/r), polymerase (ABT-333) and
NS5A (ABT-267) inhibitors, currently being studied in clinical trials. ABT-450
is being developed with low dose ritonavir which enhances the pharmacokinetic
properties of ABT-450. The use of ritonavir 100mg with ABT-450 for the
treatment of HCV is investigational.

ABT-450 was discovered during the course of a collaboration between AbbVie and
Enanta Pharmaceuticals 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. AbbVie is well-positioned to explore combinations and co-formulations of
these medicines.

Ritonavir Use in the Treatment of HIV
Ritonavir is in a class of medicines called the HIV protease inhibitors.
Ritonavir is used in combination with other anti-HIV medicines to treat people
with human immunodeficiency virus (HIV) infection. Ritonavir is for adults and
for children greater than 1 month in age and older.

Ritonavir does not cure HIV infection or AIDS and does not reduce the risk of
passing HIV to others. People taking ritonavir may still get opportunistic
infections or other conditions that happen with HIV infection. Some of these
conditions are pneumonia, herpes virus infections, and Mycobacterium avium
complex (MAC) infections.

Ritonavir Safety in Treatment of HIV
Patients should not take ritonavir with certain medicines, as these can cause
serious or life-threatening problems such as irregular heartbeat, breathing
difficulties, or excessive sleepiness. Patients should not take ritonavir if
they have had a serious allergic reaction to any of its ingredients. Some
patients taking ritonavir may develop liver and pancreas problems, which can
cause death.

Patients may develop large increases in triglycerides and cholesterol,
diabetes, high blood sugar, changes in body fat, increased bleeding in people
with hemophilia, allergic reactions, and/or changes in heart rhythm. Patients
may develop signs and symptoms of infections that they already have after
starting anti-HIV medicines.

For more information, please see Important Safety Information and Full
Prescribing Information.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013
following separation from Abbott. With its 125-year history, 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 www.abbvie.com. Follow @abbvie on Twitter or
view careers on our Facebookor LinkedIn page.

1. Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol
   Infect. 2011; 17(2):107-15.
   World Health Organization. Global Alert and Response (GAR): Hepatitis C.
2. 2003.
   http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index1.html.
   Accessed April 9, 2013.
   World Health Organization. Hepatitis C Fact Sheet 2012.
3.
   http://www.who.int/mediacentre/factsheets/fs164/en/ Accessed April 9, 2013.
   European Association for the Study of the Liver. Clinical Practice
4. Guidelines: Management of hepatitis C virus infection. Journal of
   Hepatology. 2011; 55: 245–264.

SOURCE AbbVie

Website: http://www.abbvie.com
Contact: Media: Tracy Sorrentino, +1 (847) 937-8712; Roseanne Durril, +1 (847)
938-6114; Investors: Larry Peepo, +1(847) 935-6722; Liz Shea, +1 (847)
935-2211
 
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