- In Phase 3 clinical trials, VIEKIRAX + EXVIERA cured
95-100 percent of genotype 1 chronic hepatitis C patients, with
less than 2 percent of patients experiencing virologic
failure[1],[2]
- Tolerability profile shows more than 98 percent of
patients completed a full course of therapy[3]
- All-oral, interferon-free regimen also approved for
HCV/HIV-1 co-infection, patients on opioid substitution therapy and
patients who have undergone a liver transplant[1],[2]
- VIEKIRAX + EXVIERA are the first products to be approved as
a combination treatment of three direct-acting antivirals with
distinct mechanisms of action targeting hepatitis C at multiple
steps in the viral lifecycle[1],[2]
NORTH CHICAGO, Illinois,
Jan. 16, 2015 /PRNewswire/
-- AbbVie (NYSE: ABBV) announced that the European Commission
has granted marketing authorizations for its all-oral,
short-course, interferon-free treatment of VIEKIRAX®
(ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA®
(dasabuvir tablets).1,2 The treatment has been approved
with or without ribavirin (RBV) for patients with genotype 1 (GT1)
chronic hepatitis C virus (HCV) infection, including those with
compensated liver cirrhosis, HIV-1 co-infection, patients on opioid
substitution therapy and liver transplant recipients.1,2
Additionally, VIEKIRAX has been approved for use with RBV in
genotype 4 (GT4) chronic hepatitis C patients.1
"The approval of AbbVie's hepatitis C treatment in the European
Union, following the recent approvals in the U.S. and Canada, offers patients across Europe a new and effective treatment to cure
this serious disease," said Richard
Gonzalez, chairman of the board and chief executive officer,
AbbVie. "We are committed to working with local governments and
healthcare systems to support broad access to VIEKIRAX +
EXVIERA."
The approvals follow a review under accelerated assessment by
the European Medicines Agency, designated to new medicines of major
public health interest. Approximately nine million people in
Europe are infected with chronic
hepatitis C, a major cause of liver cancer and liver
transplantation.4 Genotype 1 is the most prevalent
form of hepatitis C in Europe,
accounting for 60 percent of cases worldwide.5 In
Europe, the most prevalent sub-genotype is 1b (47
percent).6 Genotype 4, most common in the Middle East, sub-Saharan Africa and
Egypt, is becoming increasingly
prevalent in several European countries, including Italy, France, Greece and Spain.7 AbbVie's treatment is now
licensed for use in all 28 member countries of the European Union,
as well as in the U.S., Canada,
Switzerland, Iceland, Liechtenstein and Norway.
"Hepatitis C is a complex disease, with multiple genotypes and
special patient populations that need to be considered when
determining the right treatment for an individual patient," said
Stefan Zeuzem, M.D., professor of
medicine and chief of the department of medicine I, J.W.
Goethe University Hospital,
Frankfurt, Germany. "In clinical
trials, AbbVie's treatment achieved high cure rates with low rates
of discontinuation across a variety of patient populations, making
it an important addition to the class of therapies that is changing
the way hepatitis C is being treated."
Treating hepatitis C is complex because the virus mutates and
replicates rapidly. VIEKIRAX + EXVIERA are the first products to be
approved as a combination treatment of three direct-acting
antivirals with distinct mechanisms of action and non-overlapping
resistance profiles to target hepatitis C at multiple steps in the
viral lifecycle.1,2
"With the approval of VIEKIRAX + EXVIERA in the European Union,
we are offering a treatment that achieved high cure rates for
people living with GT1 and GT4 chronic hepatitis C," said
Michael Severino, M.D., executive
vice president, research and development and chief scientific
officer, AbbVie. "This is an important part of our ongoing
commitment to advancing public health by applying innovative
science to the development of promising medicines."
Robust Clinical Development Program
The approval of
VIEKIRAX + EXVIERA is supported by a robust clinical development
program designed to study the safety and efficacy of the regimen in
more than 2,300 enrolled patients across 25
countries.1,2 The program consisted of six pivotal Phase
3 studies, which demonstrated that VIEKIRAX + EXVIERA cured 95-100
percent of hepatitis C patients with GT1 HCV infection who received
the recommended regimen, with less than 2 percent of patients
experiencing virologic failure.1,2 Additionally, more
than 98 percent (n=2,011/2,053) of patients in clinical trials
completed a full course of therapy.3 Most common
(>20 percent) adverse reactions for VIEKIRAX + EXVIERA with RBV
were fatigue and nausea.1,2
The approval of VIEKIRAX + EXVIERA is also based on the results
from Phase 2 clinical trials in GT1 chronic HCV infected patients,
which showed that VIEKIRAX + EXVIERA cured 97 percent (n=33/34) of
liver transplant recipients, 92 percent (n=58/63) of patients
co-infected with HIV-1 and 97 percent (n=37/38) of patients on
opioid substitution therapy.1,2 Patients who achieve a
sustained virologic response (SVR12) are considered
cured of hepatitis C.
Approval of VIEKIRAX in GT4 chronic hepatitis C was based on a
Phase 2 study in which patients treated with VIEKIRAX with RBV
achieved 100 percent SVR12.1
About VIEKIRAX® +
EXVIERA®
VIEKIRAX + EXVIERA is approved for the
treatment of genotype 1 chronic hepatitis C virus infection,
including patients with compensated cirrhosis. VIEKIRAX consists of
the fixed-dose combination of paritaprevir 150mg (NS3/4A protease
inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A
inhibitor), dosed once daily, and EXVIERA consists of dasabuvir
250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily
taken with or without ribavirin, dosed twice daily. VIEKIRAX +
EXVIERA is taken for 12 weeks with or without RBV, except in GT1a
patients with cirrhosis, who should take it for 24 weeks.
For the treatment of genotype 4 chronic hepatitis C patients,
AbbVie's treatment consists of VIEKIRAX dosed once daily taken with
RBV, dosed twice daily.
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 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. AbbVie employs
approximately 25,000 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 2013 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. VIEKIRAX™ tablets (ombitasvir/paritaprevir/ritonavir) Summary
of product characteristics. Maidenhead,
UK. AbbVie, Ltd.
2. EXVIERA™ tablets (dasabuvir) Summary of product characteristics.
Maidenhead, UK. AbbVie, Ltd.
3. Data on file
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. 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 December
2014
6. 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
7. Khattab MA, et al. Management of hepatitis C virus genotype 4:
Recommendations of an International Expert Panel. J Hepatol. 2011;
54: 1250-1262