NORTH CHICAGO, Ill.,
March 30, 2016 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a global biopharmaceutical company, today
announced that 25 abstracts have been accepted for presentation at
The International Liver Congress™ (ILC) 2016 in Barcelona, Spain, April
13-17, including real-world data that support clinical trial
results seen in AbbVie's development program with
VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets)
and EXVIERA® (dasabuvir tablets). Abstracts presented
will further expand scientific knowledge of VIEKIRAX and EXVIERA in
genotype 1 (GT1) and genotype 4 (GT4) chronic hepatitis C virus
(HCV) infected patients, including those with compensated cirrhosis
(Child-Pugh A).
Additionally, data will be presented from AbbVie's HCV pipeline
program, investigating its pan-genotypic, once-daily,
ribavirin-free regimen of ABT-493 and ABT-530 in patients with
genotypes 1-6 (GT1-6) chronic HCV infection, including data on
treatment durations of as short as eight weeks in genotypes 1-3
(GT1-3) treatment-naïve patients without cirrhosis.
"We are pleased to present encouraging results which further
investigate the potential of a pan-genotypic treatment that could
reach even more people with HCV and reflect AbbVie's continued
commitment to people living with this disease," said Michael Severino, M.D., executive vice president
of research and development and chief scientific officer, AbbVie.
"We are also further expanding our understanding of VIEKIRAX and
EXVIERA with the new real-world evidence and clinical data we are
generating."
Real-World Evidence Abstracts Evaluating VIEKIRAX and
EXVIERA
- Real-World Safety and Effectiveness of
Ombitasvir/Paritaprevir/r With Dasabuvir and/or Ribavirin in the
German Hepatitis C Registry; Hinrichsen, H et al. Oral
Presentation, General Session 2 and Awards 1: Friday, April 15 at 08:30am–08:45am CEST;
#GS07
- Real-World Data on the Use of Ribavirin With
Ombitasvir/Paritaprevir/r With or Without Dasabuvir in HCV Genotype
1 or 4-Infected Patients From the German Hepatitis C Registry;
Welzel, T M et al. Poster Presentation, Viral hepatitis: Hepatitis
C – clinical (therapy): Saturday, April
16 at 08:00am–18:00pm CEST; #SAT-276
- Late-Breaking Abstract: Analysis of the
Real-World Effectiveness of Direct Acting Antiviral Treatments for
Hepatitis C in a Large Population; McCombs, JS et al. Late
breaker posters: Thursday, April 14
at 08:00am-Saturday, April 16 at 18:00pm CEST; #LBP510
Clinical Trial Data Abstracts for VIEKIRAX and
EXVIERA
- Late-Breaking Abstract: Effect of Baseline
Resistance-Associated Variants on SVR With the 3D Regimen With and
Without RBV in GT1a and GT1b-infected Patients; Sarrazin, C et
al. Late breaker posters: Thursday,
April 14 at 08:00am-Saturday, April
16 at 18:00pm CEST;
#LBP503
- Efficacy and Safety of Ombitasvir, Paritaprevir/Ritonavir,
and Dasabuvir Without Ribavirin in Patients With HCV Genotype 1b
With or Without Compensated Cirrhosis: Pooled Analysis Across 5
Clinical Trials; Welzel, T M et al. Poster Presentation, Viral
hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST;
#SAT-273
- A Double-Blind, Placebo-Controlled Study to Evaluate the
Safety and Efficacy of Paritaprevir/Ritonavir/Ombitasvir and
Dasabuvir in Non-Cirrhotic Adult Asians With HCV Genotype 1b; Lou,
Y et al. Poster Presentation, Clinical trials in progress:
Thursday, April 14 at 08:00am-18:00pm CEST; #THU-489
- High SVR Rates in Patients With Genotype 4 Chronic Hepatitis
C Infection and Compensated Cirrhosis With
Ombitasvir/Paritaprevir/Ritonavir Co-Administered With Ribavirin
(AGATE-I); Asselah, T et al. Poster Presentation, Viral hepatitis:
Hepatitis C – clinical (therapy): Saturday,
April 16 at 08:00am–18:00pm CEST; #SAT-278
- Improvement in Markers of Liver Fibrosis and Function in HCV
Genotype 4-infected Patients With Compensated Cirrhosis Receiving
Ombitasvir/Paritaprevir/Ritonavir With Ribavirin (AGATE-I);
Hassanein, T I et al. Poster Presentation, Viral hepatitis:
Hepatitis C – clinical (therapy): Saturday,
April 16 at 08:00am–18:00pm CEST; #SAT-277
- Ombitasvir/Paritaprevir/Ritonavir With Ribavirin Achieves
High Sustained Virologic Response (SVR) Rates in Egyptian Adults
With Chronic HCV Genotype 4 Infection (AGATE-II); Waked, I et al.
Poster Presentation, Viral hepatitis: Hepatitis C – clinical
(therapy): Saturday, April 16 at
08:00am–18:00pm CEST; #SAT-166
- Ombitasvir/Paritaprevir/r, Dasabuvir, and Sofosbuvir
Treatment of Patients With HCV Genotype 1-Infection Who Failed a
Prior Course of DAA Therapy: The QUARTZ-I Study; Poordad, F et al.
Poster Presentation, Viral hepatitis: Hepatitis C – clinical
(therapy): Saturday, April 16 at
08:00am–18:00pm CEST; #SAT-156
- Reductions in Lifetime Risks of Liver-Related Morbidity and
Mortality Associated With Novel Direct-Acting Antiviral Regimens
Recommended for Treating Genotype 4 Non-Cirrhotic Hepatitis C
Patients in the United States;
Saab, S et al. Poster Presentation, Viral hepatitis: Hepatitis C –
clinical (therapy): Saturday, April
16 at 08:00am–18:00pm CEST; #SAT-108
- Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and
Dasabuvir, With or Without Ribavirin, in Adults Treated With the
Regimen Approved in Australia,
Canada, New Zealand, and Switzerland; Gane, E et al. Poster
Presentation, Viral hepatitis: Hepatitis C – clinical (therapy):
Saturday, April 16 at 08:00am–18:00pm
CEST; #SAT-136
- Sustained Virologic Response Predicts Fibrosis Regression
Measured by FibroTest in HCV-infected Patients; Forns, X et al.
Poster Presentation, Viral hepatitis: Hepatitis C – clinical
(therapy): Saturday, April 16 at
08:00am–18:00pm CEST; #SAT-283
HCV Pipeline Abstracts for ABT-493 and ABT-530
- High Efficacy of ABT-493 and ABT-530 in HCV Genotype 1
Infected Patients Who Have Failed Direct-Acting
Antiviral-Containing Regimens: The MAGELLAN-I Study; Poordad, F et
al. Oral Presentation, General Session 2 and Awards 1:
Friday, April 15 at 10:00am–10:15am
CEST; #GS11
- Late-Breaking Abstract: 100% SVR4 With ABT-493
and ABT-530 With or Without Ribavirin in Treatment-Naïve HCV
Genotype 3-Infected Patients With Cirrhosis. Oral
Presentation, Late-breaker session: Saturday, April 16 at 16:00pm-16:15pm CEST; #LB01
- High SVR Rates With the Combination of ABT-493 + ABT-530 for
8 Weeks in Non-Cirrhotic Patients With HCV Genotype 1 or 2
Infection; Poordad, F et al. Poster Presentation, Viral
hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST;
#SAT-157
- High SVR Rates With ABT-493 + ABT-530 Co-Administered for 8
Weeks in Non-Cirrhotic Patients With HCV Genotype 3 Infection;
Muir, A et al. Oral Presentation, Viral Hepatitis C 2
Session: Saturday, April 16 at
11:45am–12:00pm CEST; #PS098
- High Efficacy and Favorable Safety of ABT-493
and ABT-530 Co-Administration for 12 Weeks in HCV Genotype
1-Infected Patients With Cirrhosis (SURVEYOR-I); Gane, E et al.
Poster Presentation, Viral hepatitis: Hepatitis C – clinical
(therapy): Saturday, April 16 at
08:00am–18:00pm CEST; #SAT-135
- 100% SVR4 and Favorable Safety of ABT-493 +
ABT-530 Administered for 12 Weeks in Non-Cirrhotic Patients With
Genotypes 4, 5, or 6 Infection (SURVEYOR-I); Gane, E et al.
Poster Presentation, Viral hepatitis: Hepatitis C – clinical
(therapy): Saturday, April 16 at
08:00am–18:00pm CEST; #SAT-137
- Safety of ABT-493 and ABT-530 Co-Administered in Patients
with HCV Genotype 1 – 6 Infection: Results From the SURVEYOR-I and
SURVEYOR-II Studies; Kwo, P et al. Poster Presentation,
Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST;
#SAT-239
- ENDURANCE-3: A Phase 3, Randomized, Open-Label,
Active-Controlled Study to Compare Efficacy and Safety of
ABT-493/ABT-530 to Sofosbuvir Co-Administered With Daclatasvir in
Adults With HCV Genotype 3 Infection; Foster, G et al. Poster
Presentation, Clinical trials in progress: Thursday, April 14 at 08:00am-18:00pm CEST; #THU-482
- Pharmacokinetics, Safety, and Tolerability of Next
Generation Direct Acting Antivirals ABT-493 and ABT-530 in Subjects
With Hepatic Impairment; Kosloski, M P. Poster Presentation,
Viral hepatitis: Hepatitis C – clinical (new compounds,
resistance): Thursday, April 14 at
08:00am-18:00pm CEST;
#THU-230
- Pharmacokinetics, Safety, and Tolerability of Next
Generation Direct-Acting Antivirals ABT-493 and ABT-530 in Subjects
With Hepatic Impairment; Kosloski, M P. Poster Presentation,
Viral hepatitis: Hepatitis C – clinical (new compounds,
resistance): Thursday, April 14 at
08:00am-18:00pm CEST;
#THU-231
- Analysis of HCV Genotype 2 and 3 Variants in Patients
Treated With Combination Therapy of Next Generation HCV
Direct-Acting Antiviral Agents ABT-493 and ABT-530; Ng, T.
Poster Presentation, Viral hepatitis: Hepatitis C – clinical
(new compounds, resistance): Thursday, April
14 at 08:00am-18:00pm CEST;
#THU-240
- ABT-493 and ABT-530 Combination Demonstrated Minimal
Potential for CYP-Mediated Drug-Drug Interactions; Kosloski, M
P. Poster Presentation, Viral hepatitis: Hepatitis C –
clinical (new compounds, resistance): Thursday, April 14 at 08:00am-18:00pm CEST; #THU-229
The full ILC 2016 scientific program can be found
at http://ilc-congress.eu/.
About AbbVie's HCV Clinical Development Program
AbbVie's HCV clinical development program is intended to advance
scientific knowledge and the clinical care of people with chronic
HCV infection by investigating pan-genotypic (genotypes 1-6),
all-oral, ribavirin-free, once-daily treatment for 12 weeks. An
eight-week treatment duration with ABT-493 and ABT-530 will be
investigated across all genotypes in our comprehensive Phase
2/Phase 3 clinical trial program, which focuses on areas of ongoing
need in HCV.
AbbVie's investigational regimen includes 300 mg ABT-493, an
NS3/4A protease inhibitor, and 120 mg ABT-530, an NS5A
inhibitor.
ABT-493 was discovered during the ongoing collaboration between
AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease
inhibitors and regimens that include protease inhibitors.
About VIEKIRAX and 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.
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