NORTH CHICAGO, Ill.,
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 (SVR
12) 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 15
th 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 worldwide
3 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 (SVR
12).
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 ProgramThe
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 IndicationVIEKIRAX
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 ribavirinWhen
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 elevationsTransient
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 productsUse
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 ReactionsMost 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.
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
For
further information: Media, Javier Boix, +1 (847) 937-6113,
javier.boix@abbvie.com, or Carlos Taveras, +33 1 41 73 92 64,
carlos.taveras@abbvie.com, or Investor Relations, Liz Shea, +1 (847)
935-2211, liz.shea@abbvie.com