NORTH CHICAGO, Ill.,
Sept. 23, 2016 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a global biopharmaceutical company, today announced
new data showing high response rates with just eight weeks of
VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA®
(dasabuvir tablets) treatment. In the Phase 3b GARNET study, 98
percent (n=160/163) of previously untreated patients with genotype
1b (GT1b) chronic hepatitis C virus (HCV) infection without
cirrhosis achieved sustained virologic response rates at 12 weeks
post-treatment (SVR12).1 These data were
presented today at the 2016 EASL Special Conference: New
Perspectives in Hepatitis C Virus Infection – The Roadmap for
Cure, in Paris, France and
included in the newly published 'EASL Recommendations on Treatment
of Hepatitis C.' VIEKIRAX + EXVIERA is currently approved in the
European Union for GT1b patients without cirrhosis or with
compensated cirrhosis for 12 weeks.
"VIEKIRAX + EXVIERA has already achieved high cure rates with 12
weeks of treatment," said Stefan
Zeuzem, M.D., study author and Chief of the Department of
Medicine at the J.W. Goethe University
Hospital in Frankfurt, Germany.
"These results now show the potential for cure in just eight weeks
with VIEKIRAX + EXVIERA in HCV genotype 1b infected patients
without liver cirrhosis. The efficacy in this population is
particularly important as GT1b is the most common subtype of
hepatitis C virus globally."
Approximately 160 million people worldwide are infected with
HCV.5 Genotype 1 is the most prevalent of the six major
HCV genotypes, affecting an estimated 83 million people
worldwide.6 In Europe,
GT1b is the most predominant subtype accounting for 47 percent of
the nine million people infected with chronic
HCV.3,4,6
"AbbVie remains focused on continuing to explore and understand
the expectations of HCV care, including a shorter treatment
duration with VIEKIRAX + EXVIERA in GT1b patients," said
Rob Scott, M.D., Vice President,
Development and Chief Medical Officer, AbbVie.
In the GARNET study, the most commonly reported adverse events
(≥5 percent) were headache (21 percent), fatigue (17 percent),
nasopharyngitis (8 percent), pruritus (8 percent), nausea (6
percent) and asthenia (5 percent). These adverse events were mostly
mild, with one patient discontinuing treatment due to adverse
events.1
About the GARNET Study1
The Phase 3b GARNET
study is a multicenter, open-label, single-arm study, investigating
the safety and efficacy of eight weeks of treatment with VIEKIRAX +
EXVIERA without ribavirin in treatment-naïve patients with GT1b
chronic HCV infection without cirrhosis.1 The study
enrolled 166 patients across 20 sites around the world. Of the 166
patients enrolled, 163 patients had GT1b chronic HCV infection
without cirrhosis and three patients with other HCV genotypes were
excluded from the efficacy analysis. The primary endpoint is the
percentage of patients who achieved a sustained virologic response
12 weeks after treatment (SVR12).
Two patients experienced post-treatment relapse and one subject
discontinued due to noncompliance. Less than one percent of
patients experienced serious adverse events or clinically
significant (Grade ≥3) laboratory abnormalities. One patient
discontinued treatment on Day 45 due to an adverse event but
achieved SVR12.
Additional information about the GARNET study can be found on
www.clinicaltrials.gov.
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 patients with compensated cirrhosis
(Child-Pugh A), 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.
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 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.
Risk of Hepatic Decompensation and Hepatic Failure in
Patients with Cirrhosis
VIEKIRAX and EXVIERA are not
recommended in patients with moderate hepatic impairment
(Child-Pugh B). Patients with cirrhosis should be monitored for
signs and symptoms of hepatic decompensation, including hepatic
laboratory testing at baseline and during treatment.
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.
Pregnancy and concomitant use with ribavirin
Extreme
caution must be taken to avoid pregnancy in female patients and
female partners of male patients when VIEKIRAX with or without
EXVIERA is taken in combination with ribavirin, see section 4.6 and
refer to the Summary of Product Characteristics for ribavirin for
additional information.
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.
1 Welzel, T. et al. GARNET: High SVR Rates Following
Eight-Week Treatment with Ombitasvir/Paritaprevir/Ritonavir +
Dasabuvir for Patients with HCV Genotype 1b Infection. Presented at
the European Association for the Study of the Liver Special
Conference: New Perspectives in Hepatitis C Virus Infection – The
Roadmap for Cure, Paris, France on
September 23-24, 2016.
2 Gower E. et al. Global epidemiology and genotype
distribution of the hepatitis C virus infection. Journal of
Hepatology Update: Hepatitis C, 2014; 61: S45-S57.
3 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.
4 Hatzakis A. et al. The state of hepatitis B and C in
Europe: report from the hepatitis
B and C summit conference. Journal of Viral Hepatitis, 2011; 18
(Suppl. 1): 1-16.
5 Lavanchy D. Evolving epidemiology of hepatitis C
virus. Clin Microbiol Infect. 2011; 17(2):107-15.
6 Messina, J. et al. Global distribution and
prevalence of hepatitis C virus genotypes. Hepatology 2015; 61:
77-87.
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