-- 100 percent SVR(12) rate achieved with VIEKIRAX®
(ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir
tablets) without ribavirin(1)
NORTH CHICAGO, Illinois,
June 24, 2015 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a global biopharmaceutical company, today announced
TURQUOISE-III study results demonstrating 100 percent (n=60/60)
sustained virologic response at 12 weeks post-treatment
(SVR12) in genotype 1b (GT1b) chronic hepatitis C virus
(HCV) infected adult patients with compensated liver
cirrhosis.1 Patients received 12 weeks of VIEKIRAX®
(ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir
tablets) without ribavirin (RBV). These new results from AbbVie's
Phase 3b study will be presented at the 15th Annual
International Symposium on Viral Hepatitis and Liver Diseases in
Berlin, Germany.
Approximately 160 million people worldwide are infected with
HCV.2 Genotype 1 is the most common type of HCV
genotype, accounting for 60 percent of cases worldwide3
and in Europe, the most prevalent
genotype is 1b (47 percent).4 Over time, chronic HCV may
lead to liver complications, including compensated cirrhosis, in
about 10-20 percent of people infected.2
"Genotype 1b represents a large portion of HCV patients
globally, as it is the most prevalent sub-genotype, and there is a
need to continue to explore additional treatment regimens," said
Jordan J. Feld, M.D., MPH, research
director and clinician scientist, Toronto Center for Liver Disease,
Toronto, Canada. "The results of
TURQUOISE-III are promising, demonstrating that genotype 1b HCV
patients with compensated liver cirrhosis have the potential to
achieve high response rates with an interferon and ribavirin-free
treatment in 12 weeks."
Patients in TURQUOISE-III were either treatment-naïve or
treatment-experienced (failed previous therapy with pegylated
interferon and RBV). No patients discontinued treatment due to
adverse events.1 The most commonly reported adverse
events (>10 percent) were fatigue (22 percent), diarrhea (20
percent) and headache (18 percent).1
"In the TURQUOISE-III study, GT1b patients with compensated
liver cirrhosis achieved a 100 percent cure rate with VIEKIRAX +
EXVIERA without ribavirin," said Scott
Brun, M.D., vice president, pharmaceutical development,
AbbVie. "TURQUOISE-III is part of our Phase 3b program, which aims
to further enhance our understanding of AbbVie's regimen in HCV
populations seen in clinical practice, and supports our commitment
to continued investigation in this field."
About TURQUOISE-III Study
TURQUOISE-III is a multi-center, open-label Phase 3b study to
evaluate the safety and efficacy of 12 weeks of treatment with
VIEKIRAX® + EXVIERA® without ribavirin (RBV) in adult patients
(n=60) with genotype 1b chronic hepatitis C virus infection and
compensated liver cirrhosis who were treatment-naïve or
treatment-experienced (failed previous therapy with pegylated
interferon and RBV). The primary endpoint is the rate of sustained
virologic response 12 weeks after treatment
(SVR12).1
No patients experienced virologic failure during treatment and
no patients experienced virologic relapse following the end of
treatment.1
About VIEKIRAX® + EXVIERA®
VIEKIRAX + EXVIERA is
approved in the European Union for the treatment of genotype 1
(GT1) chronic hepatitis C virus (HCV) infection, including patients
with compensated cirrhosis. VIEKIRAX is approved in the European
Union for the treatment of genotype 4 (GT4) chronic HCV
infection.
VIEKIRAX tablets consist of the fixed-dose combination of
paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg
with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA
tablets consist of dasabuvir 250mg (non-nucleoside NS5B polymerase
inhibitor) dosed twice daily. VIEKIRAX + EXVIERA are taken with or
without ribavirin (RBV), dosed twice daily based on patient type.
VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV,
except in genotype 1a and GT4 patients with compensated cirrhosis,
who should take it for 24 weeks with RBV.
Paritaprevir was discovered during the ongoing collaboration
between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for
hepatitis C protease inhibitors and regimens that include protease
inhibitors. Paritaprevir has been developed by AbbVie for use in
combination with AbbVie's other investigational medicines for the
treatment of chronic hepatitis C.
Additional information about AbbVie's hepatitis C development
program can be found on www.clinicaltrials.gov.
About AbbVie's HCV Clinical Development Program
The
AbbVie HCV clinical development program is intended to advance
scientific knowledge and clinical care by investigating
interferon-free, all-oral treatments with or without ribavirin with
the goal of achieving high sustained virologic response rates in as
many patients as possible. AbbVie's global Phase 3b program plans
to include more than 2,800 genotype 1 patients in over 200 study
centers worldwide, including the
U.S., Canada, Europe, Russia and Brazil.
Additional information about AbbVie's hepatitis C development
program can be found on www.clinicaltrials.gov.
VIEKIRAX® + EXVIERA® EU Indication
VIEKIRAX
is indicated in combination with other medicinal products for the
treatment of chronic hepatitis C (CHC) in adults. EXVIERA is
indicated in combination with other medicinal products for the
treatment of chronic hepatitis C (CHC) in adults.
Important EU Safety Information
Contraindications:
VIEKIRAX + EXVIERA are contraindicated in
patients with severe hepatic impairment (Child-Pugh C). Patients
taking ethinyl estradiol-containing medicinal products must
discontinue them and switch to an alternative method of
contraception prior to initiating VIEKIRAX + EXVIERA. Do not give
VIEKIRAX with certain drugs that are sensitive CYP3A substrates or
strong inhibitors of CYP3A. Do not give VIEKIRAX and EXVIERA with
strong or moderate enzyme inducers. Do not give EXVIERA with
certain drugs that are strong inhibitors of CYP2C8.
Special warnings and precautions for use:
VIEKIRAX and
EXVIERA are not recommended as monotherapy and should be used in
combination with other medicinal products for the treatment of
hepatitis C infection.
Pregnancy and concomitant use with ribavirin
When
VIEKIRAX + EXVIERA are used in combination with ribavirin, women of
childbearing potential or their male partners must use an effective
form of contraception during the treatment and 6 months after the
treatment. Refer to the Summary of Product Characteristics for
ribavirin for additional information.
ALT elevations
Transient elevations of ALT to >5x
ULN without concomitant elevations of bilirubin occurred in
clinical trials with VIEKIRAX + EXVIERA and were more frequent in a
subgroup who were using ethinyl estradiol-containing
contraceptives.
Use with concomitant medicinal products
Use caution
when administering VIEKIRAX with fluticasone or other
glucocorticoids that are metabolized by CYP3A4. A reduction in
colchicine dosage or interruption in colchicine is recommended in
patients with normal renal or hepatic function. VIEKIRAX with or
without EXVIERA is expected to increase exposure of statins so
certain statins need to be discontinued or dosages reduced. Low
dose ritonavir, which is part of VIEKIRAX, may select for PI
resistance in HIV co-infected patients without ongoing
antiretroviral therapy. HIV co-infected patients without
suppressive antiretroviral therapy should not be treated with
VIEKIRAX.
Adverse Reactions
Most common (>20 percent) adverse
reactions for VIEKIRAX + EXVIERA with RBV were fatigue and
nausea.
Full summary of product characteristics is available
at www.ema.europa.eu
Globally, prescribing information varies; refer to the
individual country product label for
complete information.
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 more than 28,000 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," in
AbbVie's 2014 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 Feld J, et al. TURQUOISE-III: Safety and Efficacy
of 12-week Ribavirin-free Treatment for Patients with HCV Genotype
1b and Cirrhosis. Presented at the 15th Annual International
Symposium on Viral Hepatitis and Liver Diseases (ISVHLD) in
Berlin, Germany, June 26-28, 2015
2 Lavanchy D. Evolving epidemiology of hepatitis C
virus. Clin Microbiol Infect. 2011; 17(2):107-15
3 Global Alert and Response (GAR): Hepatitis C. World
Health Organisation Web site.
http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index2.html#HCV.
Published 2003. Accessed November, 2013
4 O'Leary JG, Davis GL. Hepatitis C. In: Feldman M,
Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran's
Gastrointestinal and Liver Disease:
Pathophysiology/Diagnosis/Management. 9th ed, Vol 1. Philadelphia, PA: Saunders Elsevier.
2010:1313-1335