NORTH CHICAGO, Ill.,
Oct. 1, 2014 /PRNewswire/ -- AbbVie
(NYSE: ABBV) announced that data from its ongoing Phase 1 through
Phase 3 hepatitis C clinical development programs will be presented
at The Liver Meeting®, the Annual Meeting of the American
Association for the Study of Liver Diseases (AASLD) in Boston, November 7-11,
2014.
Abstracts will be presented highlighting results from AbbVie's
investigational treatment combining three direct-acting antivirals
(ABT-450/ritonavir, ombitasvir and dasabuvir) with or without
ribavirin (RBV) in patients with genotype 1 (GT1) chronic hepatitis
C virus (HCV) infection. These abstracts include a Phase 2/3 study
in patients co-infected with human immunodeficiency virus type 1
(HIV-1) (TURQUOISE-I) and a Phase 2 study in liver transplant
recipients without cirrhosis (CORAL-I).
Additionally, Phase 2 data will be presented from
investigational studies evaluating the combination of
ABT-450/ritonavir and ombitasvir with or without RBV in genotype 4
(GT4) patients (PEARL-I). AbbVie will also be presenting data from
its two additional pipeline HCV compounds, ABT-493 and ABT-530.
Key AbbVie HCV Data at AASLD 2014 includes:
- TURQUOISE-I: SVR12 data in HCV/HIV-1 Co-infected
Patients Treated with ABT-450/r/Ombitasvir and Dasabuvir and
Ribavirin
Poster # 1939
November 11, 2014, 8:00 a.m. –
12:00 p.m. EST, Poster Hall
This study evaluates a treatment of ABT-450/ritonavir, ombitasvir
and dasabuvir plus RBV in treatment-naïve and
peginterferon/RBV-experienced adults co-infected with GT1 HCV and
HIV-1, with and without cirrhosis (Child-Pugh A).
- Sustained Virologic Response Rates in Liver Transplant
Recipients with Recurrent HCV Genotype 1 Infection Receiving
ABT-450/r/Ombitasvir + Dasabuvir Plus Ribavirin
Oral
Presentation at the Hepatitis Plenary Session
November 11, 2014, 9:15 a.m. – 9:30 a.m.
EST
This ongoing Phase 2 study examines safety and efficacy of
ABT-450/ritonavir, ombitasvir and dasabuvir plus RBV in
non-cirrhotic HCV treatment-naïve since liver transplant recipients
with recurrent GT1 HCV infection.
- Interferon-Free Regimens of Ombitasvir and ABT-450/r with or
without Ribavirin in Patients with HCV Genotype 4 Infection:
PEARL-I Study Results
Poster # 1928
November 11, 2014, 8:00 a.m. –
12:00 p.m. EST, Poster Hall
The PEARL-I study assesses safety and efficacy of an all-oral
regimen of ABT-450/ritonavir and ombitasvir with or without RBV in
treatment-naïve and peginterferon/RBV-experienced non-cirrhotic
patients with GT1b and GT4 HCV infection.
Additional HCV Data Highlights
- Antiviral Activity of ABT-493 and ABT-530 with 3-Day
Monotherapy in Patients with and without Compensated Cirrhosis with
Hepatitis C Virus (HCV) Genotype 1 Infection
Poster #
1956
November 11, 2014, 8:00 a.m. –
12:00 p.m. EST, Poster Hall
This study evaluates antiviral activity, safety, and tolerability
of ABT-493 and ABT-530 administered as monotherapy for three days
in treatment-naive adults with chronic GT1 HCV infection with and
without compensated cirrhosis.
- Pharmacokinetics and Safety of Pan-Genotypic, Direct Acting
Protease Inhibitor, ABT-493, and NS5A Inhibitor, ABT-530, Following
3-Day Monotherapy in HCV Genotype-1 Infected Subjects with or
without Compensated Cirrhosis
Poster # 1986
November 11, 2014, 8:00 a.m. –
12:00 p.m. EST, Poster Hall
This study explores the safety, pharmacokinetics and antiviral
activity of ABT-493 and ABT-530 administered as monotherapy for
three days in GT1 HCV infected patients with or without compensated
cirrhosis.
The full list of accepted abstracts for The Liver Meeting can be
accessed on www.aasld.org.
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 and without ribavirin
with the goal of producing high sustained virologic response rates
in as many patients as possible. AbbVie's multinational Phase 3
program using an investigational treatment combining three
direct-acting antivirals includes more than 2,300 patients in over
25 countries. The program is designed to identify ways to maximize
response rates in a broad spectrum of GT1 patient populations,
including those with compensated cirrhosis, liver transplant
recipients and those with human immunodeficiency virus type 1
co-infection. AbbVie's development programs using all-oral
investigational treatments combining two direct-acting antivirals
are studying additional hepatitis C virus (HCV) genotypes.
AbbVie's pipeline of multiple direct-acting antiviral compounds
for the treatment of hepatitis C aims to investigate
interferon-free treatments that target multiple HCV
genotypes.
ABT-450 was discovered during the ongoing collaboration between
AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease
inhibitors and regimens that include protease inhibitors. ABT-450
is being developed by AbbVie for use in combination with AbbVie's
other investigational medicines for the treatment of hepatitis
C.
Safety Information for Ribavirin and
Ritonavir
Ribavirin and ritonavir are not approved for the
investigational uses discussed above, and no conclusions can or
should be drawn regarding the safety or efficacy of these products
for this use.
There are special safety considerations when prescribing these
drugs in approved populations.
Ritonavir must not be used with certain medications due to
significant drug-drug interactions and in patients with known
hypersensitivity to ritonavir or any of its excipients.
Ribavirin monotherapy is not effective for the treatment of
chronic hepatitis C virus and must not be used alone for this use.
Ribavirin causes significant teratogenic effects and must not be
used in women who are pregnant or breast-feeding and in men whose
female partners are pregnant. Ribavirin must not be used in
patients with a history of severe pre-existing cardiac disease,
severe hepatic dysfunction or decompensated cirrhosis of the liver,
autoimmune hepatitis, hemoglobinopathies, or in combination with
peginterferon alfa-2a in HIV/HCV co-infected patients with
cirrhosis and Child-Pugh score >6.
See approved product labels for more 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/A, 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.
SOURCE AbbVie