Abbott Announces Phase 3 Hepatitis C Program Details
ABBOTT PARK, Illinois, Nov. 13, 2012
- Interferon-free Hepatitis C Regimens will be Studied in Broad Patient
Populations across Multiple Countries
ABBOTT PARK, Illinois, Nov. 13, 2012 /PRNewswire/ -- Abbott (NYSE: ABT) today
released details on its phase 3 hepatitis C registrational program following
promising results from its phase 2b clinical trial, known as Aviator,
presented at the Annual Meeting of the American Association for the Study of
Liver Disease (AASLD) in Boston. The phase 3 clinical trials are designed to
evaluate safety and efficacy of a 12-week regimen of three direct acting
antivirals (DAA), with and without ribavirin, for the treatment of HCV in
genotype 1 (GT1) non-cirrhotic, treatment-naïve and treatment-experienced
patients. An additional phase 3 trial will study triple-DAAs, with ribavirin,
in patients with cirrhosis for 12 or 24 weeks.
The phase 3 program, which is currently open for enrollment, will include more
than 2,000 patients with HCV genotype 1, with trial sites in 29 countries. The
DAAs in the studies include ABT-450/r (protease inhibitor and ritonavir),
ABT-267 (NS5A inhibitor) and ABT-333 (non-nucleoside polymerase inhibitor).
Treatment duration will be 12 weeks in non-cirrhotic patients, and 12 or 24
weeks in cirrhotic patients. All patients will be followed for 48 weeks
post-treatment. Co-formulated tablets of ABT-450/r and ABT-267 will be used in
the phase 3 trials.
More information on the trials is available at www.clinicaltrials.gov .
"Abbott is committed to investigating a short-course HCV therapy without the
use of interferon to achieve high SVR rates," said Scott Brun, M.D.,
divisional vice president, Infectious Disease Development, Abbott. "Our trial
enrollment strives to reflect a broad range of populations, including those
that have been difficult to treat. We have been very encouraged by the data
from the phase 2 studies, and look forward to confirming the findings in our
phase 3 program."
Topline intent-to-treat results from the 12-week, triple-DAA regimens with
ribavirin presented at the AASLD meeting this week found that 97.5 percent (77
of 79) of treatment-naïve GT1 patients and 93.3 percent (42 of 45) in GT1 null
responder patients achieved SVR12.
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.
Of the six main genotypes of hepatitis C, genotypes 1, 2 and 3 are the most
widespread. Genotype 1 is the most common genotype in the U.S. and the most
difficult to treat with interferon based therapies. Patients with genotypes 2
and 3 are more likely than individuals with genotype 1 to respond to therapy
with peg-interferon or the combination of peg-interferon and ribavirin.
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 (non-therapeutic) 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 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
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 www.abbott.com .
Contact: Media, Tracy Sorrentino, +1-847-937-8712 or Roseanne Durril,
+1-847-938-6114, or Financial, Larry Peepo, +1-847-935-6722 or Liz Shea,
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