Abbott's Investigational Interferon-Free Hepatitis C Treatment Regimen Achieved SVR12 (Observed Data) Rates in 99 Percent of

    Abbott's Investigational Interferon-Free Hepatitis C Treatment Regimen
 Achieved SVR12 (Observed Data) Rates in 99 Percent of Treatment-Naive and 93
  Percent in Prior Null Responders for Genotype 1 Patients in Phase 2b Study

PR Newswire

ABBOTT PARK Ill., Oct. 15, 2012

ABBOTT PARK Ill., Oct. 15, 2012 /PRNewswire/ --Abbott (NYSE: ABT) today
announced initial results from "Aviator," a phase 2b study of its
interferon-free, investigational regimen for the treatment of hepatitis C
(HCV). Initial results show sustained virological response at 12 weeks post
treatment (SVR12) in 99 percent of treatment-naive (n=77) and 93 percent of
null responders (n=41) for genotype 1 (GT1) HCV patients taking a combination
of ABT-450/r, ABT-267, ABT-333 and ribavirin for 12 weeks, based on an
observed data analysis.

Full results from the study will be presented at the Latebreaker Session of
The Liver Meeting, the Annual Meeting of the American Association for the
Study of Liver Disease (AASLD) in Boston, November 9-13. Abstracts are
available at

The observed data analysis used in this abstract does not include six patients
who had not yet reached post-treatment week 12 or had missing values (data
points) at the time of the abstract submission. All virologic failures and
safety discontinuations were included in the analysis.

"There is a significant unmet medical need for genotype 1, the most common
form of HCV in the U.S. and Europe," said Kris Kowdley, M.D., director of the
Liver Center of Excellence in the Digestive Disease Institute at Virginia
Mason Medical Center, and Clinical Professor of Medicine at the University of
Washington in Seattle. "Results from this phase 2b study suggest that
sustained virological response can be achieved without interferon in a high
proportion of genotype-1 patients, including patients who have not responded
to previous treatment. This is exciting news as we continue to study treatment
options for patients."

"Based on the promising results we've seen, Abbott has selected a triple
direct acting antiviral regimen, with and without ribavirin for phase 3
development," said Scott Brun, M.D., divisional vice president, Infectious
Disease Development, Abbott. "The ability to show sustained virological
response in these patient populations, without the use of interferon, is
extremely encouraging."

Study M11-652 (Aviator)

Kris Kowdley, et al.; Monday, November 12 (3:00-3:15 p.m. ET)

  "A 12-Week Interferon-free Treatment Regimen with ABT-450/r, ABT-267,
  ABT-333 and Ribavirin Achieves SVR12 Rates (Observed Data) of 99% in
  Treatment-Naïve Patients and 93% in Prior Null Responders with HCV Genotype1

The objective of this phase 2b study was to assess the safety, and efficacy of
ABT-450/r (dosed 100/100 to 200/100mg QD), ABT-267 (25mg QD), ABT-333 (400mg
BID) and ribavirin in non-cirrhotic treatment-naive patients and prior
peg-interferon/ribavirin null responders for 8, 12 or 24 weeks.

Enrollment was open to GT1-infected patients regardless of IL28B host genotype
and ribavirin dosing was weight-based.

The 12-week regimen of three direct acting antivirals plus ribavirin had the
highest SVR12 rates among the 8 and 12 week arms. Results from the 12 week
treatment groups containing three direct acting antivirals plus ribavirin are
summarized in the chart below.

                                                            Null responders
                                 Treatment-naïve (N=79)
BL HCV RNA (log[10] IU/mL)       6.5+/-0.6                  6.6+/-0.5
BL IL28B non-CC genotype         72%                        96%
SVR[4]                           78/79 (99%)                42/45 (93%)
OD SVR[12]                       76/77 (99%)                38/41 (93%)
PTW12 data missing*              2                          4
Breakthrough                     0                          3
Relapse                          1                          0
OD SVR[12] (GT1a)                52/53 (98%)                24/27 (89%)
OD SVR[12] (GT1b)                24/24 (100%)               14/14 (100%)
OD SVR[12] (IL28B non-CC)        54/55 (98%)                36/39 (92%)
*Did not follow up (2 treatment-naïve patients and 1 null responder) or have
not yet reached PTW12 (3 null responders)

Additional data presented in the abstract represent all 8- and 12-week arms
(n=448) of this 14-arm study (571 patients enrolled: 438 treatment-naive and
133 prior null responders). SVR[12] rates for other 8- and 12-week regimens
ranged from 89-92 percent. Complete SVR[12] data for 8- and 12-week arms will
be presented at the Liver Meeting.

Four of 448 patients (one percent) in the 8- and 12-week arms discontinued due
to adverse events. Of five serious AEs (1 percent), 1 (arthralgia or joint
pain) was possibly study drug-related. In the trial, the most common adverse
events were fatigue (28 and 27 percent) and headache (28 and 31 percent) for
treatment naïve and null responders respectively.

Abbott Data at AASLD

In addition to Aviator, there are four poster presentations on Abbott's
investigational medicines for the treatment of HCV:

Tami Pilot-Matias et al.; Sunday, November 11 (8:00 a.m.-5:30 p.m. ET)

  "Characterization of Resistant Variants in NS3 and NS5B Detected in Subjects
  Treated with ABT-450/r, Ribavirin, and Either ABT-072 or ABT-333 in the
  Pilot and Co-Pilot Studies Who Experienced Virologic Breakthrough or

Preethi Krishnan et al.; Tuesday, November 13 (8:00 a.m.-12:00 p.m. ET)

  "Antiviral Activity and Resistance Profiles for ABT-267, a Novel HCV NS5A
  Inhibitor, In Vitro and During 3-Day Monotherapy in HCV Genotype-1
  (GT1)-Infected Treatment-Naive Subjects"

Lane Kirbach et al.; Tuesday, November 13 (8:00 a.m.-12:00 p.m. ET)

  "Evaluation of Patient Preferences for Treatment Outcomes in Hepatitis C
  Virus (HCV)"

Amit Khatri et al.; Sunday, November 11 (8:00 a.m.-5:30 p.m. ET)

  "Pharmacokinetics and Safety of Co-administered ABT-450 plus Ritonavir
  (ABT-450/r), ABT-267 and ABT-333 as a Single Dose in Subjects with Normal
  Hepatic Function and in Subjects with Mild, Moderate and Severe Hepatic

About the Hepatitis C Virus

Hepatitis C is a liver disease affecting as many as 170 million people
worldwide. The virus is primarily spread through direct contact with the blood
of an infected person. HCV increases a person's risk of developing chronic
liver disease, cirrhosis, liver cancer and death; and liver disease associated
with HCV infection is growing rapidly.

About Abbott's HCV Development Programs

Abbott'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 100 mg with ABT-450 for the
treatment of HCV is investigational. ABT-450 was discovered during the course
of a collaboration between Abbott and Enanta Pharmaceuticals for HCV protease
inhibitors and regimens that include protease inhibitors.

ABT-450 is being developed by Abbott for use in combination with Abbott's
other investigational medicines for the treatment of HCV. Abbott is
well-positioned to explore combinations and co-formulations of these

Ritonavir Use in 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 the Important Safety Information and full
Prescribing Information for ritonavir.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery,
development, manufacturing and marketing of pharmaceuticals and medical
products, including nutritionals, devices and diagnostics. The company employs
approximately 91,000 people and markets its products in more than 130

Abbott's news releases and other information are available on the company's
website at


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