AMSTERDAM, April 20, 2017 /PRNewswire/ -- AbbVie (NYSE:
ABBV), a global biopharmaceutical company, today announced that 99
percent (n=145/146) of chronic hepatitis C virus (HCV) infected
patients with genotype 1, 2, 4, 5 or 6 and compensated cirrhosis
(Child-Pugh A) achieved sustained virologic response at 12 weeks
post-treatment (SVR12) with its investigational,
pan-genotypic regimen of glecaprevir/pibrentasvir (G/P). These high
SVR12 rates were seen following 12 weeks of G/P
treatment without ribavirin. Patients with specific virus strains
associated with resistance or with a high quantity of the virus in
their bloodstream before treatment initiation were not excluded
from the study. These new data, from the Phase 3 EXPEDITION-1
study, will be featured as an oral presentation today at The
International Liver Congress™ (ILC) 2017 in Amsterdam, The Netherlands.
"We have already seen great progress in the treatment of HCV
patients with compensated cirrhosis. However, treatment challenges
remain related to the use of ribavirin," said Xavier Forns, M.D., head of hepatitis unit,
Hospital Clinic de Barcelona,
Spain. "The positive findings from the EXPEDITION-1 study,
along with previously reported data, show that G/P has the
potential to become a ribavirin-free treatment for patients with
compensated cirrhosis across these genotypes."
In the EXPEDITION-1 study, the majority of adverse events (AEs)
were mild and no patients discontinued treatment due to an AE. The
most common AEs (≥10 percent) were fatigue and headache.
"With our G/P clinical development program, our goal is to
provide a cure for as many patients living with HCV as possible,
across all genotypes and regardless of whether their disease has
progressed to compensated cirrhosis," said Michael Severino, M.D., executive vice
president, research and development and chief scientific officer,
AbbVie. "The EXPEDITION-1 study results, along with a number of
other ILC presentations from our G/P clinical development program,
explore the potential of our regimen in patients with specific
treatment challenges."
Approximately 130 to 150 million people worldwide are living
with chronic HCV, for whom the risk of cirrhosis of the liver is
between 15-30 percent within 20 years.2 Treatment
guidelines around the world recommend that all patients with
cirrhosis should be considered for treatment, yet the treatment of
specific patients with HCV and compensated cirrhosis is still
challenging.3,4
AbbVie is presenting additional data at ILC in patients with
specific treatment challenges, including in those with chronic
kidney disease (SAT-273), HIV-1 co-infection (LBP-522), post liver and renal transplant
patients (LBO-03) and in patients who did not achieve
SVR12 with previous direct-acting antiviral (DAA)
treatment (PS-156). Additional information on the clinical trials
for G/P is available at http://www.clinicaltrials.gov.
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.
About the EXPEDITION-1 Study
EXPEDITION-1 is a single
arm, multicenter, open-label study evaluating the efficacy and
safety of 12 weeks of G/P in adults with GT1, 2, 4, 5 or 6 chronic
HCV infection and compensated cirrhosis (Child-Pugh A). The study
enrolled 146 patients, including those new to treatment or had
prior treatment experience with IFN-based treatments (IFN/pegIFN ±
RBV, or sofosbuvir + RBV ± pegIFN). The primary endpoint was the
percentage of patients achieving SVR12. SVR12
was achieved by 145/146 (99 percent) patients, with one
GT1a-infected patient experiencing relapse.
No patients experienced ALT elevations equal to or above Grade
3. Of the 11 patients (7.5 percent) who experienced serious AEs,
none were considered treatment-related.
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.
1 Forns, X et al. EXPEDITION-1: Efficacy and Safety
of Glecaprevir/Pibrentasvir in Adults with Chronic Hepatitis C
Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis.
Presented at The International Liver Congress™ (ILC) in
Amsterdam, The Netherlands,
April 19-23, 2017.
2 Hepatitis C. World Health Organization. World Health
Organization, July 2016. Web.
http://www.who.int/mediacentre/factsheets/fs164/en/.
3 EASL Recommendations on Treatment of Hepatitis C 2016.
J Hepatol (2016), http://dx.doi.org/10.1016/j.jhep.2016.09.001.
4 Spach D, Scott J. Treatment of Hepatitis C in Patients
with Cirrhosis. Hepatitis C Online.
http://cdn.hepatitisc.uw.edu/pdf/special-populations-situations/treatment-cirrhosis/core-concept/all Published
2015. Accessed April 03, 2017.
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