AMSTERDAM, April 21, 2017 /PRNewswire/ -- AbbVie (NYSE:
ABBV), a global biopharmaceutical company, today announced high
SVR12 rates were achieved with 8 weeks of treatment with
its investigational, once-daily, ribavirin-free, pan-genotypic
regimen of glecaprevir/pibrentasvir (G/P) in patients with
challenging to treat genotype 3 (GT3) chronic hepatitis C virus
(HCV) infection. In results from the Phase 3 ENDURANCE-3 study, 95
percent (n=149/157) of GT3 chronic HCV infected patients without
cirrhosis and who are new to treatment achieved sustained virologic
response at 12 weeks post-treatment (SVR12) following 8
weeks of treatment with G/P.1 These new data will be
featured as an oral presentation today at The International Liver
Congress™ (ILC) 2017 in Amsterdam, The
Netherlands.
As well as evaluating 8 weeks of treatment with G/P, the
ENDURANCE-3 study was designed to evaluate whether 12 weeks of G/P
is non-inferior to 12 weeks of sofosbuvir plus daclatasvir
(SOF+DCV), a current standard of care for GT3 chronic HCV infected
patients.1 SVR12 rates of 95 percent
were seen in both 8 weeks (n=149/157) and 12 weeks (n=222/233) of
treatment with G/P.1 Additionally, 12 weeks of treatment
with G/P was demonstrated to be non-inferior to 12 weeks of
treatment with SOF+DCV (97 percent, n=111/115).1
Full results from ENDURANCE-3 are the latest to be released from
registrational studies in AbbVie's G/P clinical development
program, designed to investigate a faster path to virologic cure*
for all major HCV genotypes (GT1-6) and with the goal of addressing
areas of continued unmet need.
GT3 is the second most common genotype globally, accounting for
18 percent of patients worldwide and 26 percent of patients in
Europe.2 Patients with
GT3 HCV have more rapid disease progression, with the highest rates
of associated fibrosis, steatosis (fatty liver), and hepatocellular
carcinoma (HCC).3 Treatment guidelines with current
standards of care recommend 12 weeks of treatment in GT3 patients
without cirrhosis and who are new to treatment.4
"GT3 is widely recognized as the most challenging to treat
genotype, with limited treatment options for newly diagnosed
patients," said Edward Gane, M.D.,
professor of medicine at University of Auckland, New Zealand. "When looked at in parallel with
a current standard of care, the ENDURANCE-3 study results explore
the potential of G/P as an 8 week treatment in these patients
without cirrhosis."
"These results, along with a number of other ILC presentations
from our G/P clinical development program, investigate the
potential of our regimen in patients with specific treatment
challenges and explore an 8 week virologic cure for the majority of
patients across all major genotypes," said Michael Severino, M.D., executive vice
president, research and development and chief scientific officer,
AbbVie. "The evidence gathered from the ENDURANCE-3 study is
therefore a key part of our G/P clinical development program,
underscoring our commitment to the HCV community by investigating a
pan-genotypic treatment option."
In the ENDURANCE-3 study, no patients who received 8 weeks of
G/P discontinued treatment due to adverse events (AEs).1
AEs were mostly mild (71 percent) in patients receiving both 8 and
12 weeks of G/P. The most common AEs (≥10 percent) in patients
receiving 8 weeks and 12 weeks of G/P were headache (20 and 26
percent), fatigue (13 and 19 percent) and nausea (12 and 14
percent), respectively and with patients receiving 12 weeks of
SOF+DCV treatment (headache 20 percent, fatigue 14 percent and
nausea 13 percent).1
Authorization applications for G/P are currently under review by
regulatory authorities around the world. G/P has been granted
accelerated assessment by the European Medicines Agency (EMA), and
priority review designations by the U.S. Food and Drug
Administration (FDA) and Japanese Ministry of Health, Labour
and Welfare (MHLW). G/P is an investigational regimen and its
safety and efficacy have not been established.
The ENDURANCE-3 study will be featured in the official
ILC press conference on Friday,
April 21 from 11:30 a.m. - 12:30 p.m. local
time.
About the ENDURANCE-3 Study
ENDURANCE-3 is a Phase 3,
open-label, active-controlled study evaluating patients who are new
to treatment with HCV GT3 infection without cirrhosis. The study
included 505 patients who were randomized to receive either 12
weeks of G/P (Arm A, n=233) or 12 weeks of SOF+DCV (Arm B, n=115),
with subsequently enrolled patients receiving 8 weeks of G/P (Arm
C, n=157). The primary endpoint was the percentage of patients
achieving SVR12. The rate of virologic failure was 1.7
percent (n=4/233) in Arm A, 0.8 percent (n=1/115) in Arm B and 3.8
percent (n=6/157) in Arm C.
Additional information on the clinical trials for G/P is
available at http://www.clinicaltrials.gov.
About AbbVie's HCV Clinical Development
Program
AbbVie's glecaprevir/pibrentasvir (G/P) clinical
development program was designed to investigate a faster path to
virologic cure* for all major HCV genotypes (GT1-6) and with the
goal of addressing treatment areas of continued unmet need.
G/P is an investigational, pan-genotypic regimen being evaluated
as a potential cure in 8 weeks for HCV patients without cirrhosis
and who are new to treatment with direct-acting antivirals (DAA)**,
who make up the majority of HCV patients. AbbVie is also studying
G/P in patients with specific treatment challenges, such as
genotype 3, patients who were not cured with previous DAA treatment
and those with CKD, including patients on dialysis.
G/P is a once-daily regimen that combines two distinct antiviral
agents. G/P is a fixed-dose combination of glecaprevir (300mg), an
NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A
inhibitor, dosed once-daily as three oral tablets.
Glecaprevir (GLE) was discovered during the ongoing
collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ:
ENTA) for HCV protease inhibitors and regimens that include
protease inhibitors.
*Patients who achieve a sustained virologic response at 12
weeks post treatment (SVR12) are considered cured of
hepatitis C.
**Patients who are
treatment-naive or had prior treatment experience with IFN-based
treatments ([peg]IFN +/- RBV or SOF/RBV +/- pegIFN).
About AbbVie
AbbVie is a global, research-based
biopharmaceutical company formed in 2013 following separation from
Abbott Laboratories. 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. Together with its wholly-owned
subsidiary, Pharmacyclics, AbbVie employs approximately 29,000
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.
Forward-Looking Statements
Some
statements in this news release may be forward-looking statements
for purposes of the Private Securities Litigation Reform Act of
1995. The words "believe," "expect," "anticipate," "project" and
similar expressions, among others, generally identify
forward-looking statements. AbbVie cautions that these
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those
indicated in the forward-looking statements. Such risks and
uncertainties include, but are not limited to, challenges to
intellectual property, competition from other products,
difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry.
Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2015 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
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1 Foster,
GR et al. ENDURANCE-3: safety and efficacy of
glecaprevir/pibrentasvir compared to sofosbuvir plus daclatasvir in
treatment-naïve HCV genotype 3-infected patients without cirrhosis.
Presented at The International Liver Congress™ (ILC) in Amsterdam,
The Netherlands, April 19-23, 2017.
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2
Petruzziello, A. et al. Global epidemiology of hepatitis C virus
infection: An up-date of the distribution and circulation of
hepatitis C virus genotypes. World J Gastroenterol. 2016; 22(34):
7824-7840.
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3 Asselah
T, Thompson AJ, Flisiak R, Romero-Gomez M, Messinger D, Bakalos G,
et al. (2016) A Predictive Model for Selecting Patients with HCV
Genotype 3 Chronic Infection with a High Probability of Sustained
Virological Response to Peginterferon Alfa-2a/Ribavirin. PLoS ONE
11(3): e0150569. doi:10.1371/journal.pone.
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4 EASL
Recommendations on Treatment of Hepatitis C 2016. J Hepatol (2016),
http://dx.doi.org/10.1016/j.jhep.2016.09.001.
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