AbbVie's Investigational HCV Regimen Receives Breakthrough Therapy Designation
from the U.S. Food and Drug Administration
NORTH CHICAGO, Illinois, May 6, 2013
- Interferon-free, direct-acting antiviral combination therapy currently in
Phase 3 development
NORTH CHICAGO, Illinois, May 6, 2013 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced that its investigational direct-acting antiviral (DAA) combination
with and without ribavirin for the treatment of genotype 1 (GT1) hepatitis C
virus (HCV) infection has been designated as a Breakthrough Therapy by the
U.S. Food and Drug Administration (FDA).
The designation is based, in part, on positive data from AbbVie's clinical
development program, including the Phase 2b clinical trial M11-652, known as
"Aviator." The Aviator study was conducted in 571 patients infected with HCV
GT1. Results from the treatment arms evaluating ABT-450/r + ABT-267 + ABT-333
with and without ribavirin demonstrated that the regimen provided high
sustained viral response rates (SVR) with 12 weeks of therapy in patients who
had not been previously treated (treatment naive) and in those who had failed
prior therapy with pegylated interferon and ribavirin (null responders),
regardless of sex, HCV subtype, stage of fibrosis, viral load or IL28B
According to the FDA, Breakthrough Therapy designation is intended to expedite
the development and review of drugs for serious or life-threatening
conditions. The criteria for Breakthrough Therapy designation includes
preliminary clinical evidence demonstrating a drug may have substantial
improvement on at least one clinically significant endpoint compared to
available therapy. A Breakthrough Therapy designation conveys all of the fast
track program features, as well as more intensive FDA guidance on an efficient
drug development program.(1)
"AbbVie is pleased that the FDA has granted Breakthrough Therapy designation
to our 3-DAA combination with and without ribavirin. We feel it reflects the
potential of this regimen to be important in the treatment of HCV," said John
M. Leonard, M.D., senior vice president and chief scientific officer, AbbVie.
"Our HCV program is one part of our advancing pipeline which is focused on
delivering innovative therapies to address pressing areas of unmet clinical
New results from Aviator were recently presented at the 2013 International
Liver Congress® in Amsterdam. These results continued to demonstrate high SVR
rates against GT1 HCV with the 12-week, triple-DAA regimen with ribavirin,
across patient types. Specifically,
*99 percent of treatment-naive patients (n=79) achieved SVR12, 96 percent
achieved SVR24 in an intent-to-treat analysis
*93 percent of prior null responders (n=45) achieved SVR12 and SVR24
*A single relapse with this regimen occurred at post-treatment week two
*Of the 247 patients treated for 12 and 24 weeks with triple DAA with
ribavirin, four patients(1.6 percent) discontinued the study because of
drug-related adverse events. Serious adverse events were noted in four
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.
AbbVie's all-oral, triple-DAA combination is currently being studied in Phase
3 clinical trials. The Phase 3 program includes 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 durations under
investigation are 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 are being used in the Phase 3
About the Hepatitis C Virus
Across the world, about 160 million people are chronically infected with
hepatitis C.(2) Hepatitis C is an inflammation of the liver caused by an
infection with the hepatitis C virus (HCV).(3) HCV is transmitted when an
infected person's blood enters the bloodstream of another person.(4)
For the hepatitis C virus, there are six major HCV genotypes (GT1-6).(5)
Presently, there is no vaccine for the hepatitis C virus (HCV) infection.(5)
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.(5) If treatment is needed, a hepatitis C
infection is typically treated with a combination of antivirals.(5)
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
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
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 .
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 www.abbvie.com . Follow @abbvie on Twitter or view careers on our
Facebook or LinkedIn page.
1.U.S. Food and Drug Administration. Frequently Asked Questions:
Breakthrough Therapies. 2013.
. Accessed April 19, 2013.
2.Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol
Infect. 2011; 17(2):107-15.
3.World Health Organization. Global Alert and Response (GAR): Hepatitis C.
Accessed April 9, 2013.
4.World Health Organization. Hepatitis C Fact Sheet 2012.
http://www.who.int/mediacentre/factsheets/fs164/en/ Accessed April 9,
5.European Association for the Study of the Liver. Clinical Practice
Guidelines: Management of hepatitis C virus infection. Journal of
Hepatology. 2011; 55: 245-264.
Contact: Media, Tracy Sorrentino, +1-847-937-8712, or Roseanne Durril,
+1-847-938-6114, or Investors, Larry Peepo, +1-847-935-6722, or Liz Shea,
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