- RUBY-I evaluates treatment-naïve, non-cirrhotic, genotype 1
chronic hepatitis C patients with severe renal impairment
- In preliminary data from RUBY-I, patients receiving
VIEKIRAX + EXVIERA with or without ribavirin who reached
post-treatment week four (n=10 of 20 enrolled) achieved 100 percent
sustained virologic response at four weeks post-treatment
(SVR4)1
- AbbVie's Phase 3b studies explore VIEKIRAX + EXVIERA in
additional patient populations seen in clinical practice and across
multiple countries around the world
VIENNA, April 25, 2015 /PRNewswire/ -- AbbVie (NYSE:
ABBV) today announced new, preliminary safety and efficacy data
from the first cohort of its ongoing, Phase 3b RUBY-I study. RUBY-I
is evaluating VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets)
+ EXVIERA® (dasabuvir tablets) with or without ribavirin (RBV) in
treatment-naïve, non-cirrhotic, genotype 1 (GT1) chronic hepatitis
C patients with severe renal impairment (stage 4 or 5), including
those on hemodialysis. The primary endpoint of the study is the
percentage of patients achieving sustained virologic response at 12
weeks post-treatment (SVR12). Patients who reached
post-treatment week four to date (n=10 of 20 enrolled) achieved 100
percent SVR4 (n=10/10).1 RUBY-I was presented
as a late-breaker today at The International Liver Congress™ (ILC)
2015, the 50th annual meeting of the European
Association for the Study of the Liver (EASL) in Vienna, Austria.
"Treating hepatitis C patients with severe renal impairment may
be a concern, particularly in those patients on hemodialysis," said
Paul J. Pockros, M.D., director of
Liver Disease Center Scripps Clinic and director of clinical
research at Scripps Translational Science Institute in La Jolla, California. "With limited data
currently available on the safety and efficacy of interferon-free
treatments for patients with renal impairment, the preliminary
results seen in RUBY-I show promising initial SVR rates with the
VIEKIRAX + EXVIERA regimen in a dedicated study for this often
difficult-to-treat patient population."
Additionally, RUBY-I data showed no virologic failures to
date.1 Preliminary safety analyses reported that
patients experienced mainly mild or moderate adverse events when
receiving VIEKIRAX + EXVIERA with or without RBV, most commonly
(>20 percent) anemia, fatigue, diarrhea, nausea, dizziness and
headache.1 To date, eight of 13 genotype 1a (GT1a)
patients had a RBV dose interruption.1
"RUBY-I is part of AbbVie's broader Phase 3b program and
demonstrates our continued focus on people living with hepatitis C
that have specific needs," said Scott
Brun, M.D., vice president, pharmaceutical development,
AbbVie. "Studies in our Phase 3b program will help to further
expand our knowledge of the utility of VIEKIRAX + EXVIERA in
special populations encountered in clinical practice."
Additional Phase 3b studies from AbbVie presented at ILC 2015
included MALACHITE-I and MALACHITE-II data, and the TOPAZ-I and
TOPAZ-II study design. The MALACHITE studies evaluate adult
patients with GT1 chronic HCV infection without cirrhosis receiving
VIEKIRAX + EXVIERA with or without RBV compared to treatment with
telaprevir with pegylated-interferon and RBV, which remains the
standard of care in many regions of the world.2,3 The
TOPAZ studies will evaluate the effect of SVR12 on
long-term outcomes, five years following treatment with VIEKIRAX +
EXVIERA with or without RBV in adults with GT1 chronic HCV
infection.4
About RUBY-I Study
RUBY-I is an ongoing, multi-center, open-label Phase 3b study with
two cohorts that evaluates the safety and efficacy of 12 or 24
weeks of treatment with VIEKIRAX® + EXVIERA® with or without
ribavirin, based on sub-genotype in treatment-naïve, adult patients
with genotype 1 (GT1) chronic hepatitis C virus infection who have
severe renal impairment (pre-dialysis; stage 4 chronic kidney
disease) or end-stage renal disease (on hemodialysis; stage 5
chronic kidney disease) with or without compensated
cirrhosis.1 Cohort 1 consists of 20 patients without
cirrhosis and cohort 2 will evaluate approximately 20 patients with
or without compensated cirrhosis. Ribavirin was started at 200mg
once daily for all genotype 1a (GT1a)- infected patients and dosed
four hours prior to the start of GT1a patients on hemodialysis.
Additional study results, including cohort 2, will be disclosed at
future scientific congresses.
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 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 (RBV),
dosed twice daily based on patient type. VIEKIRAX + EXVIERA is
taken for 12 weeks with or without RBV, except in GT1a 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.
About AbbVie's HCV Clinical Development Program
The AbbVie HCV clinical development program is intended to advance
scientific knowledge and clinical care by investigating
interferon-free, all-oral treatments with or without ribavirin with
the goal of achieving high sustained virologic response rates in as
many patients as possible. AbbVie's global Phase 3b program plans
to include more than 2,800 genotype 1 patients in over 200 study
centers worldwide, including the U.S., Canada, Europe, Russia and Brazil. Data in patients with severe renal
impairment, including patients on hemodialysis, will be presented
at ILC. Additionally, AbbVie's Phase 3b HCV program includes
studies in patients with decompensated and compensated cirrhosis.
Data from these studies will be presented at future scientific
congresses.
Additional information about AbbVie's hepatitis C development
program can be found on www.clinicaltrials.gov.
VIEKIRAX® + EXVIERA® 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 more than 26,000 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 2014 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.
References:
1 Pockros P, et al. Safety Of
Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir For Treating HCV
GT1 Infection In Patients With Severe Renal Impairment Or End-stage
Renal Disease: The RUBY-I Study. Presented at the 50th
International Liver Congress (ILC); April
22-26; Vienna, Austria
2 Conway B, et al. MALACHITE-I: Phase 3b Trial Of
Ombitasvir/Paritaprevir/R And Dasabuvir +/-Ribavirin Or Telaprevir
+ Peginterferon/Ribavirin In Treatment-naïve Adults With HCV
Genotype 1. Abstract presented at the 50th International Liver
Congress (ILC); April 22-26;
Vienna, Austria
3 Dore G, et al. MALACHITE-II: Phase 3b Trial Of
Ombitasvir/Paritaprevir/R And Dasabuvir + Ribavirin Or Telaprevir +
Peginterferon/Ribavirin In Peginterferon/Ribavirin
Treatment-experienced Adults With HCV Genotype 1. Abstract
presented at the 50th International Liver Congress (ILC);
April 22-26; Vienna, Austria
4 Dumas E, et al. Phase 3b Studies To Assess Long-term
Clinical Outcomes In HCV GT1-infected Patients Treated With
Ombitasvir/Paritaprevir/Ritonavir And Dasabuvir With Or Without
Ribavirin. Abstract presented at the 50th International Liver
Congress (ILC); April 22-26;
Vienna, Austria.