NORTH CHICAGO, Ill.,
July 25, 2016 /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 has granted a
positive opinion for the use of 12 weeks of VIEKIRAX®
(ombitasvir/paritaprevir/ritonavir tablets) with ribavirin (RBV) in
genotype 4 (GT4) chronic hepatitis C virus (HCV) infected adult
patients with compensated cirrhosis (Child-Pugh A). VIEKIRAX with
RBV is currently approved in the European Union for GT4 patients
with compensated cirrhosis for 24 weeks.
"Through optimizing the use of VIEKIRAX, AbbVie strives to meet
the needs of patients and physicians, including a shortened
treatment duration," said Michael
Severino, M.D., executive vice president, research and
development and chief scientific officer, AbbVie. "This milestone
is progress toward an approval that would allow us to provide the
opportunity for a cure with just 12 weeks of our regimen to
genotype 4 patients with or without compensated cirrhosis in
Europe."
Chronic HCV affects more than 160 million people
worldwide,4 with 34 million people living with GT4 HCV
infection.3 In Europe,
where nine million people are infected with HCV,2 GT4 is
becoming increasingly prevalent in several countries including
Italy, France, Greece and Spain, where prevalence rates from 10 to 24
percent have been reported.3
The CHMP positive opinion is supported by data from a dedicated
Phase 3 AGATE-I study of GT4 HCV infected patients with compensated
cirrhosis. The randomized, open-label study evaluated the safety
and efficacy of VIEKIRAX and RBV for 12 and 16 weeks. Results from
the study showed that with 12 weeks of treatment with VIEKIRAX and
RBV, 97 percent (n=57/59) of patients achieved sustained virologic
response at 12 weeks post-treatment (SVR12
).1
"Until recently people living with genotype 4 chronic hepatitis
C had limited treatment options," said Tarik Asselah, M.D., lead study author and
professor at Université Paris Diderot. "If approved, this 12-week
treatment would mark another step forward in the cure for GT4
patients, allowing difficult-to-cure patients with compensated
cirrhosis to be treated in half the time with VIEKIRAX,
representing a significant benefit for both them and their
physicians."
Results from the AGATE-I study also showed that patients treated
with 16 weeks of VIEKIRAX and RBV achieved 98 percent (n=60/61)
SVR12 rates. The most commonly reported adverse events
(≥20 percent) in the 12-week arm were asthenia, fatigue and
headache (18 percent, 17 percent and 23 percent respectively); and
for the 16 week arm were fatigue, asthenia, headache, anemia,
nausea, and pruritus (33 percent, 32 percent, 23 percent, 23
percent and 20 percent respectively).1 One patient in
the 12-week group experienced virologic breakthrough and one
discontinued prematurely after the first day of treatment. One
patient missed the post-treatment week 12 visit in the 16-week
group.1 The full study results were published online in
The Lancet in June 2016.
About VIEKIRAX®
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.
Currently, in GT4 HCV infected patients VIEKIRAX with RBV is
taken for 12 weeks, except in patients with compensated cirrhosis
(Child-Pugh A), who should take it for 24 weeks.
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.
Important EU Safety Information
Contraindications:
VIEKIRAX is 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. Do not give VIEKIRAX with certain drugs that
are sensitive CYP3A4 substrates or strong inhibitors of CYP3A4. Do
not give VIEKIRAX with strong or moderate enzyme inducers.
Special warnings and precautions for use:
VIEKIRAX is 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 is 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 >x5
ULN without concomitant elevations of bilirubin occurred in
clinical trials with VIEKIRAX and dasabuvir with or without
ribavirin and 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 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 dasabuvir 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%) adverse reactions for VIEKIRAX and
dasabuvir 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 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 Asselah T, Hezode C, Qaqish R. et al. Ombitasvir,
paritaprevir, and ritonavir plus ribavirin in adults with hepatitis
C virus genotype 4 infection and cirrhosis (AGATE-I): a
multicentre, phase 3, randomised open-label trial. The Lancet
Online. Accessed 22 June 2016;
http://www.thelancet.com/pdfs/journals/langas/PIIS2468-1253(16)30001-2.pdf.
2 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.
3 Khattab MA, et al. Management of hepatitis C virus
genotype 4: Recommendations of an International Expert Panel. J
Hepatol. 2011; 54: 1250–1262.
4 Lavanchy D. Evolving epidemiology of hepatitis C
virus. Clin Microbiol Infect. 2011; 17(2):107-15.
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