NORTH CHICAGO, Ill.,
Feb. 27, 2017 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a global biopharmaceutical company, announced today
that the European Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) has granted a
positive opinion for a shorter, eight-week treatment of VIEKIRAX®
(ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir
tablets) as an option for previously untreated adult patients with
genotype 1b (GT1b) chronic hepatitis C virus (HCV) and minimal to
moderate fibrosis*.
VIEKIRAX + EXVIERA is currently approved in the European Union
for use as a 12-week treatment for GT1b chronic HCV-infected
patients without cirrhosis or with compensated cirrhosis.
"AbbVie continuously strives to expand the utility of our HCV
treatments, including investigating a shorter path to virologic
cure for people living with HCV," said Michael Severino, M.D., executive vice
president, research and development and chief scientific officer,
AbbVie. "With this positive CHMP opinion, we will bring an
eight-week treatment option for the many HCV patients with
GT1b."
Approximately 160 million people worldwide are infected with
HCV, with GT1b being the most common subtype
globally.2,5 In Europe, this subtype accounts for 47 percent
of the nine million people infected with chronic HCV across the
continent.3,4
"Nearly half of the people living with chronic hepatitis C in
Europe are infected with genotype
1b," said Dr. Tania Mara Welzel,
M.H.Sc., study author and Medical Lead of the Clinical Study Center
at the Department of Medicine at J.W. Goethe
University in Frankfurt, Germany. "VIEKIRAX + EXVIERA has demonstrated
high cure rates with only eight weeks of treatment in GT1b patients
with minimal to moderate fibrosis."
The CHMP positive opinion is supported by data from the
dedicated Phase 3b GARNET study. Results showed that with eight
weeks of treatment with VIEKIRAX + EXVIERA, 98 percent (n=160/163)
of previously untreated GT1b chronic HCV infected patients without
cirrhosis achieved sustained virologic response at 12 weeks
post-treatment (SVR12).1 The most commonly
reported adverse events, occurring at rate equal to or greater than
5 percent, were headache (21 percent), fatigue (17 percent),
nasopharyngitis (8 percent), pruritus (8 percent), nausea (6
percent) and asthenia (5 percent).
* When assessing severity of liver disease using non-invasive
methods, additional blood tests improve accuracy and should be
undertaken prior to 8-week treatment in all patients with moderate
fibrosis.
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 SVR12.
Two patients experienced post-treatment relapse and one
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 is 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.
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