BARCELONA, Spain, April 15, 2016 /PRNewswire/ -- AbbVie (NYSE:
ABBV), a global biopharmaceutical company, today announced new
real-world data showing 96 percent of genotype 1 (GT1) patients
(n=486/505 assessable for analysis) and 100 percent (n=53/53) of
genotype 4 (GT4) patients achieved sustained virologic response at
12 weeks post-treatment (SVR12).1 These data
support results seen in Phase 3 clinical trials for chronic GT1 or
GT4 hepatitis C virus (HCV) infected patients treated with
VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) and EXVIERA®
(dasabuvir tablets) with or without ribavirin (RBV).
The analysis also reports safety outcomes from 1,017 people with
GT1 or GT4 chronic HCV enrolled in the German Hepatitis C-Registry
(DHC-R) who have initiated treatment, representing a diverse group
of patients seen in real-world settings being treated with VIEKIRAX
and EXVIERA. The results will be presented orally today at The
International Liver Congress™ (ILC) 2016 in Barcelona, Spain.
"Real-world studies complement randomized controlled trials and
help to further enhance our knowledge of VIEKIRAX and EXVIERA in
everyday clinical practice," said Heiner
Wedemeyer, M.D., research group leader, department of
gastroenterology, hepatology and endocrinology at Hannover Medical
School in Germany. "The
effectiveness and safety results shown across a broad cross-section
of patients in this particular study provide helpful insight into
treatment of real-world patients."
The safety study population (n=1,017) was reflective of a
diversity of patients seen in routine clinical practice, including
patients with cirrhosis (22 percent) and those previously treated
for HCV (59 percent).1 More than half of patients (59
percent) were taking medicines for other medical
conditions.1
"These results provide additional insights that complement the
Phase 3 clinical trial data for VIEKIRAX and EXVIERA," said
Rob Scott, M.D., vice president,
development and chief medical officer, AbbVie. "We believe further
ongoing real-world studies across multiple countries will enrich
our understanding of HCV treatment."
Among the patients included in the safety analysis (n=1,017),
the rate of discontinuation due to adverse events (AEs) was low
(1.5 percent).1 The most common AEs (≥ 5 percent) were
fatigue (24 percent), pruritus (10 percent), headache (9 percent),
insomnia (6 percent) and nausea (5 percent).1 Serious
AEs were reported in 1 percent (n=5/480) of patients receiving
VIEKIRAX and EXVIERA without RBV and in 3 percent (n=16/537) of
patients receiving VIEKIRAX and EXVIERA with RBV.1
Fifteen patients discontinued treatment due to AEs, while two
patients died due to myocardial infarction or stroke, respectively.
Both cases were assessed as not related to study
treatment.1
About the German Hepatitis C-Registry (DHC-R)*
The
DHC-R is a non-interventional, prospective cohort study enrolling
more than 9,000 patients receiving treatment for chronic HCV at 254
study sites throughout Germany.1 The German Hepatitis
C-Registry (Deutsches Hepatitis C-Register) is a project of the
German Liver Foundation (Deutsche Leberstiftung) managed by
Leberstiftungs-GmbH Deutschland in cooperation with the Association
of German Gastroenterologists (BNG).
This ongoing study included 1,017 registry patients who received
VIEKIRAX and EXVIERA with or without RBV between February 2014 and December
2015.1 Patients included 261 (26 percent) with
genotype 1a (GT1a), 614 (60 percent) with genotype 1b (GT1b, the
most prevalent genotype in Europe)
and 125 (12 percent) with GT4.1,2 A further
17 patients (2 percent) had an unspecified, mixed or alternative
GT1-subgenotype infection.1
*The registry was funded by AbbVie, other companies, the
German Liver Foundation, and the German Center for Infection
Research (DZIF).
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.
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 Hinrichsen H, et al. Real-world Safety and
Effectiveness of Ombitasvir/Paritaprevir/r with Dasabuvir and/or
Ribavirin in the German Hepatitis C Registry. Oral presentation
#GS07; presented at the International Liver CongressTM
(ILC), the Annual Meeting of the European Association for the Study
of the Liver (EASL) in Barcelona,
April 13-17, 2016.
2 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.
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