LONDON, April 11, 2014 /PRNewswire/ -- AbbVie (NYSE:
ABBV) announced that detailed results from its phase III pivotal
study, SAPPHIRE-I, will be presented today at the International
Liver Congress™ (ILC) 2014 and featured in the ILC
press conference. Results from the pivotal phase III study,
SAPPHIRE-II, were also presented at the congress yesterday.
Additionally, results from both SAPPHIRE-I and SAPPHIRE-II have
been published online in The New England Journal of
Medicine.
In the SAPPHIRE-I (N=631) and SAPPHIRE-II (N=394)
placebo-controlled studies, adult, non-cirrhotic patients with
chronic genotype 1 (GT1) hepatitis C virus (HCV) infection
receiving the investigational AbbVie regimen with ribavirin (RBV)
for 12 weeks achieved sustained virologic response rates 12 weeks
post-treatment (SVR12) of 96.2 percent (n=455/473) and
96.3 percent (n=286/297), respectively.
In SAPPHIRE-II, treatment-experienced sub-populations randomized
to the AbbVie regimen with RBV were prior null responders (49.2
percent), prior relapsers (29.0 percent) and prior partial
responders (21.9 percent) to pegylated interferon and RBV.
"Patients with chronic hepatitis C who have not responded well
to treatment in the past have historically been more difficult to
treat," said Stefan Zeuzem, M.D.,
lead clinical investigator on SAPPHIRE-II and Chief of the
Department of Medicine at the J.W. Goethe
University Hospital in Frankfurt,
Germany. "These data show very promising results in people
who are infected with either subtype of the GT1 hepatitis C virus
and who are either new to therapy or treatment-experienced."
SAPPHIRE-I and SAPPHIRE-II Results
|
SAPPHIRE-I
SVR12
(n=473)
|
SAPPHIRE-II
SVR12
(n=297)
|
All
GT1
|
96.2%
(n=455/473)
|
96.3%
(n=286/297)*
|
GT1a
|
95.3%
(n=307/322)
|
96.0%
(n=166/173)
|
GT1b
|
98.0%
(n=148/151)
|
96.7%
(n=119/123)
|
Treatment-experienced
(GT1a and GT1b)
|
Prior null
responders
|
n/a
|
95.2%
(n=139/146)
|
Prior relapsers
|
n/a
|
95.3%
(n=82/86)
|
Prior partial
responders
|
n/a
|
100.0%
(n=65/65)
|
*Subgenotype could not be determined for one patient
In SAPPHIRE-I, high response rates were seen across patients
with certain variable characteristics, including gender, race, body
mass index, fibrosis stage and baseline HCV viral load, as some of
these patients have historically had a reduced response to
treatment.
"These data provide further evidence that AbbVie's regimen can
achieve high SVR12 rates across a range of GT1 patients
with varying prior treatment experience and response," said
Scott Brun, M.D., Vice President,
Pharmaceutical Development, AbbVie. "We are excited to be able to
share these results at the ILC and as publications in The New
England Journal of Medicine."
Discontinuations due to adverse events were reported in 0.6
percent of patients in both arms in SAPPHIRE-I and in 1.0 percent
of patients receiving the AbbVie regimen in SAPPHIRE-II and no
patients receiving placebo. The most commonly reported
treatment-emergent adverse events (>10 percent in either arm)
for both SAPPHIRE-I and SAPPHIRE-II were fatigue, headache, nausea,
asthenia, insomnia, pruritus and diarrhea. Additional common
adverse events occurring in the studies were rash in SAPPHIRE-I and
dyspnea, cough and myalgia in SAPPHIRE-II. In SAPPHIRE-I, the
adverse events that occurred with a significantly greater frequency
in the treatment arm compared to placebo were pruritus, insomnia,
diarrhea, nausea and asthenia; in SAPPHIRE-II, only pruritus.
About AbbVie's Investigational HCV Regimen
The AbbVie
investigational regimen consists of the fixed-dose combination of
ABT-450/ritonavir (150/100mg) co-formulated with ombitasvir
(ABT-267) 25mg, dosed once daily, and dasabuvir (ABT-333) 250mg
with or without RBV (weight-based), dosed twice daily. The
combination of three different mechanisms of action interrupts the
HCV replication process with the goal of optimizing SVR rates
across different patient populations.
About Study M11-646 (SAPPHIRE-I)
SAPPHIRE-I is a
global, multi-center, randomized, double-blind, placebo-controlled
study to evaluate the efficacy and safety of 12 weeks of treatment
with AbbVie's regimen with RBV in non-cirrhotic, GT1a and GT1b
HCV-infected adult patients new to therapy.
The study population consisted of 631 patients: 473 were
randomized to the AbbVie regimen with RBV for 12 weeks, and 158
patients were randomized to placebo for the initial 12 weeks.
Patients initially randomized to placebo for the first 12 weeks
then received open-label treatment with the AbbVie regimen with RBV
for 12 weeks.
Of the 473 patients randomized to the AbbVie regimen with RBV,
one case (0.2 percent) of on-treatment virologic failure occurred
and seven patients (1.5 percent) experienced post-treatment
relapse. In addition, three patients (0.6 percent) were lost to
follow-up and seven patients (1.5 percent) discontinued the study
prematurely. Patients lost to follow-up were considered treatment
failures.
About Study M13-098 (SAPPHIRE-II)
SAPPHIRE-II is a
global, multi-center, randomized, double-blind, placebo-controlled
study to evaluate the efficacy and safety of 12 weeks of treatment
with AbbVie's regimen with RBV in non-cirrhotic, GT1a and GT1b
HCV-infected, treatment-experienced adult patients who previously
failed treatment with pegylated interferon and RBV.
The study population consisted of 394 patients: 297 were
randomized to the AbbVie regimen with RBV for 12 weeks, and 97
patients were randomized to placebo for the initial 12 weeks.
Patients initially randomized to placebo for the first 12 weeks
then received open-label treatment with the AbbVie regimen with RBV
for 12 weeks.
Of the 297 patients randomized to the AbbVie regimen with RBV,
there were no cases of on-treatment virologic failure and seven
patients (2.4 percent) experienced post-treatment relapse. Of these
patients, six were prior null responders and one was a prior
relapser. Three patients (1.0 percent) prematurely discontinued
therapy due to adverse events and one patient (0.3 percent)
prematurely discontinued the study.
Additional information about AbbVie's phase III studies can be
found on www.clinicaltrials.gov.
AbbVie's HCV Development Program
The AbbVie HCV
clinical development program is intended to advance scientific
knowledge and clinical care by investigating an interferon-free,
all-oral regimen with and without RBV with the goal of producing
high SVR rates in as many patients as possible, including those
that typically do not respond well to treatment, such as previous
non-responders to interferon-based therapy or patients with
advanced liver fibrosis or cirrhosis.
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 HCV.
Safety Information for Ribavirin and
Ritonavir
Ribavirin and ritonavir are not approved for the
investigational use 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, 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