AbbVie To Present Investigational Data From Phase II Hepatitis C Program At
The Liver Meeting
NORTH CHICAGO, Illinois, Oct. 1, 2013
-- PHASE III TOP-LINE RESULTS EXPECTED BEGINNING LATER IN 2013
NORTH CHICAGO, Illinois, Oct. 1, 2013 /PRNewswire/ -- AbbVie (NYSE: ABBV)
announced that new data from its phase II hepatitis C clinical development
program will be presented at The Liver Meeting, the Annual Meeting of the
American Association for the Study of Liver Diseases (AASLD) in Washington,
D.C., November 1-5, 2013. In total, eight abstracts will be presented, four of
which include additional analyses from the phase IIb AVIATOR study. The data
examine sustained virologic response (SVR) concordance, patient adherence to
the regimen, patient reported outcomes and the impact of ribavirin dose
The Liver Meeting will precede AbbVie's reporting of initial results from the
pivotal phase III clinical trials of the safety and efficacy of AbbVie's
investigational triple direct-acting antiviral (DAA) regimen for the treatment
of hepatitis C. Reporting of those results is expected to begin later this
"At AbbVie, we are committed to researching new therapies that maximize
sustained virologic response with the hope of providing much needed new
options for people with hepatitis C," said Barry Bernstein, M.D., vice
president, infectious disease development, AbbVie. "We are very encouraged as
we await top-line results from our phase III program, which we will share
later this year."
Additionally, the oral presentation at AASLD will provide results from the
PEARL-I study evaluating an interferon- and ribavirin-free, two-DAA
investigational regimen in genotype 1b treatment-naïve patients and prior null
responders. AbbVie is also investigating drug combinations for additional
genotypes and next generations of DAAs as part of their ongoing commitment to
the HCV community.
A brief summary of AbbVie's abstract titles is presented below.
About AbbVie's HCV Development Program The AbbVie HCV clinical development
program is intended to advance scientific knowledge by investigating an
interferon-free, all-oral DAA regimen with the goal of producing high SVR
rates in as many patients as possible, including those typically most
difficult to cure. The large, multinational HCV program includes more than
2,200 patients from 30 countries.
AbbVie's hepatitis C portfolio includes investigational medicines with three
different mechanisms of action targeting areas of the viral replication
process including boosted protease inhibitor (ABT-450), polymerase (ABT-333)
inhibitor and NS5A (ABT-267) inhibitor, currently being studied in clinical
trials. ABT-450/r is co-formulated with ABT-267.
Details of AbbVie's phase III clinical programs are as follows:
Study Patients (n) Treatment Regimen Duration
SAPPHIRE I GT1, treatment-naïve (600*) • ABT450/r +ABT267**• 12 weeks
SAPPHIRE GT1, • ABT450/r +ABT267**• 12 weeks
II treatment-experienced(400*) ABT333• Ribavirin
PEARL II GT1b, • ABT450/r +ABT267**• 12 weeks
treatment-experienced(210*) ABT333• Ribavirin
•ABT450/r +ABT267**ABT333 12 weeks
PEARL III GT1b, treatment-naïve(400*) • ABT450/r +ABT267**• 12 weeks
• ABT450/r +ABT267**• 12 weeks
PEARL IV GT1a, treatment-naive(300*) • ABT450/r 12 weeks
• ABT450/r 12 weeks
TURQUOISE GT1, treatment-naïve and •ABT450/r 12 weeks
II treatment-experienced (with +ABT267**•ABT333•Ribavirin
compensated •ABT450/r 24 weeks
*projected study population **ABT-267 is co-formulated with ABT-450/r
In May of 2013, AbbVie's investigational DAA regimen with and without
ribavirin for HCV genotype 1 was designated as a Breakthrough Therapy by the
U.S. Food and Drug Administration (FDA). This designation is intended to help
expedite the development of drugs for serious or life-threatening conditions
and is based in part on preliminary clinical evidence demonstrating a drug or
regimen may have substantial improvement on at least one clinically
significant endpoint compared to available therapy.
AbbVie Hepatitis C Data at AASLD 2013
*Trends in Liver-Related Healthcare Resource Utilization for HCV-Infected
Individuals in the US: 2002-2010 Poster #367 November 2nd, 2:00PM ET;
Poster Hall This study analyzed years 2002-2010 of the National Inpatient
Sample (NIS) data set of hospital admissions from the Healthcare Cost and
Utilization Project (HCUP) to determine the number of adult (age 20+
years) liver-related hospital admissions occurring in HCV-infected
patients (identified by ICD-9 codes).
*Interferon- and Ribavirin-free Regimen of ABT-450/r + ABT-267 in HCV
Genotype 1b-infected Treatment-Naïve Patients and Prior Null Responders
Oral Presentation: Parallel Session 75 November 3rd, 5:15PM ET; Hall E
This oral presentation includes data from the phase IIb PEARL-I study,
which examines an interferon-free, ribavirin-free investigational regimen
of ABT-450/r plus ABT-267 in 82 patients with HCV genotype 1b.
*Low Relapse Rate Leads to High Concordance of SVR4 and SVR12 with SVR24
After Treatment with ABT-450/r, ABT-267, ABT-333 + Ribavirin in Patients
with Chronic HCV Genotype 1 Infection in the AVIATOR Study Poster #1089
November 3rd, 8:00AM ET; Poster Hall This study evaluated the concordance
of SVR24 with rapid virologic response (RVR), SVR4 and SVR12 in treatment
groups from the phase IIb AVIATOR study in 247 patients.
*High Medication Adherence in HCV-Infected Patients Taking a Triple-DAA
Regimen for 12 Weeks Poster #1096 November 3rd, 8:00AM ET; Poster Hall
This study presents medication adherence data based on electronic
compilation of drug dosing history among 327 patients receiving the
investigational triple-DAA regimen plus ribavirin for 8, 12 or 24 weeks.
*Health-Related Quality of Life (HRQoL), Health State, Function and
Wellbeing of Chronic HCV Patients Treated with Interferon-Free, Oral DAA
Regimens: Patient Reported Outcome (PRO) Results from the AVIATOR Study
Poster #1113 November 3rd, 8:00AM ET; Poster Hall This intent-to-treat
analysis from the phase IIb AVIATOR study includes patient reported
outcomes (PRO) in patients receiving 12-week, ribavirin-containing
investigational triple-DAA regimen.
*Safety of Ribavirin-containing Regimens of ABT-450/r, ABT-333, and ABT-267
for the Treatment of HCV Genotype 1 Infection and Efficacy in Subjects
with Ribavirin Dose Reductions Poster #1118 November 3rd, 8:00AM ET;
Poster Hall This study examined the safety of a ribavirin-containing,
investigational triple-DAA, interferon-free regimen and the effects of
ribavirin dose reductions on treatment response.
*HCV RNA "Target Detected" after "Target Not Detected" During IFN-Free
Treatment: Time to Worry or Not? Poster #1125 November 3rd, 8:00AM ET;
Poster Hall This study examined the frequency of TDANs (Target Detected
After Not Detected) and the likelihood of subsequent virologic failure in
subjects from the phase IIb AVIATOR study treated with ABT- 450/r plus
ABT-267 plus ABT-333 plus ribavirin for 12 or 24 weeks in treatment naïve
and null responders.
*Adherence to Interferon-containing Therapy Among Veteran Affairs Hepatitis
C Patients Poster #1909 November 5th, 8:00AM ET; Poster Hall Data from the
United States Veterans Health Administration (VHA) Medical SAS Dataset
(years 2008 to 2011) were used in this analysis.
The list of accepted abstracts for The Liver Meeting can be accessed on
ABT-450 was discovered during the course of the ongoing 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
About the Hepatitis C Virus Across the world, about 160 million people are
chronically infected with hepatitis C. Hepatitis C is an inflammation of
the liver caused by an infection with the hepatitis C virus (HCV). HCV is
transmitted when an infected person's blood enters the bloodstream of another
For the hepatitis C virus, there are six major HCV genotypes (GT1-6).
Presently, there is no vaccine for the hepatitis C virus (HCV) infection.
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. If treatment is needed, a hepatitis C
infection is typically treated with a combination of antivirals.
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 Facebook or LinkedIn page.
1.Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol
Infect . 2011; 17(2):107-15.
2.World Health Organization. Global Alert and Response (GAR): Hepatitis C.
.Accessed April 9, 2013.
3.World Health Organization. Hepatitis C Fact Sheet 2012.
http://www.who.int/mediacentre/factsheets/fs164/en/ Accessed April 9,
4.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: Elizabeth Hoff, +1-847-935-4236; Javier Boix, +1-847-937-6113;
Or Investor Relations: Elizabeth Shea, +1-847-935-2211
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