- 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
these medicines.
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 countries.
Abbott's news releases and other information are available on
the company's website at www.abbott.com.