- New data from GIFT-I study presented at the Annual
Meeting of the Japan Society of Hepatology
- Primary endpoint of 95 percent and secondary endpoint of 91
percent SVR12 achieved in genotype 1b hepatitis C virus infected
Japanese patients without and with compensated cirrhosis,
respectively(1)
- 98 percent SVR12 achieved in additional analysis of
patients without cirrhosis receiving double-blind placebo for 12
weeks, followed by open-label therapy with AbbVie's investigational
treatment(1)
- AbbVie's ribavirin-free treatment for genotype 1 hepatitis
C Japanese patients consists of a 12-week, two direct-acting
antiviral, fixed-dosed combination of paritaprevir/ritonavir with
ombitasvir, dosed once daily
NORTH CHICAGO, Illinois,
May 27, 2015 /PRNewswire/ -- AbbVie
(NYSE: ABBV) presented new results from the Phase 3 GIFT-I study of
its investigational, all-oral, interferon (IFN)- and ribavirin
(RBV)-free, two direct-acting antiviral treatment with
ombitasvir/paritaprevir/ritonavir at the Annual Meeting of the
Japan Society of Hepatology in Kumamoto, Japan.1 GIFT-I evaluated genotype
1b (GT1b) chronic hepatitis C virus (HCV) infected Japanese
patients, with and without cirrhosis, who were either
treatment-naïve or IFN (with or without RBV)
treatment-experienced.1 The primary endpoint was
achieved, demonstrating 95 percent (n=106/112) SVR12 in
a sub-group of treatment-naïve, non-cirrhotic, adult GT1b HCV
infected Japanese patients who were eligible for therapy with IFN
and had a high viral load.1 In study results related to
the secondary endpoint, GT1b HCV patients with compensated
cirrhosis achieved 91 percent (n=38/42)
SVR12.1
In an additional intent-to-treat (ITT) analysis,
SVR12 was achieved in 98 percent (n=104/106) of the GT1b
HCV infected patients without cirrhosis (Arm B) who were randomized
to initially receive double-blind placebo for 12 weeks, followed by
open-label treatment with
ombitasvir/paritaprevir/ritonavir.1 The ITT population
included every patient that was randomized to placebo and received
at least one dose of active, open-label study drug.
"It is critical to address the burden of hepatitis C in
Japan, with GT1b being the most
prevalent sub-type of the disease in the country," said Kazuaki
Chayama, M.D., Ph.D, professor and head of the Department of
Gastroenterology and Metabolism, Graduate School of Biomedical and
Health Sciences, Hiroshima
University. "GIFT-I shows the potential of this treatment to
achieve high SVR rates for Japanese patients with GT1b hepatitis C,
including those with compensated cirrhosis."
Across all study arms, three patients (n=3/363) discontinued
treatment due to adverse events.1 The most commonly
reported adverse events (>5 percent in any arm) were
nasopharyngitis, headache, peripheral edema, nausea, pyrexia and
decreased platelet count.1
"We are pleased to present full results from GIFT-I, which
provide further insight into our hepatitis C treatment currently
under priority review by the Japanese health authorities," said
Scott Brun, M.D., vice president,
pharmaceutical development, AbbVie. "We know physicians weigh the
risks and benefits of HCV treatments for their patients as they
look for an option that offers a potential cure. These data will
help guide clinicians in their decision making and support AbbVie's
goal of bringing an interferon- and ribavirin-free treatment to
people living with genotype 1 hepatitis C in Japan."
In Japan, approximately 1.5 to
2 million people are living with HCV.2 Genotype 1 is the
most common HCV genotype in Japan
with 60 to 70 percent of patients infected and, of those, about 95
percent are infected with the GT1b sub-type.3 AbbVie
studied its two direct-acting antiviral treatment regimen without
RBV in Japan due to patient and
viral characteristics specific to the Japanese population,
including high prevalence of GT1b.
AbbVie's investigational, two direct-acting antiviral treatment
consists of ombitasvir/paritaprevir/ritonavir and is currently
under priority review by the Japanese Ministry of Health, Labour
and Welfare.
About GIFT-I Study
GIFT-I comprises 363 patients in two sub-studies. In sub-study 1,
321 genotype 1b (GT1b) patients without cirrhosis, both
treatment-naïve and interferon (IFN) [with or without ribavirin
(RBV)] treatment-experienced, were randomized to receive either
ombitasvir/paritaprevir/ritonavir (Arm A) [OBV/PTV/r] or placebo
(Arm B) [2:1 randomization ratio, stratified by treatment history,
past response, viral load and IFN eligibility]. Patients initially
randomized to placebo (Arm B) then received OBV/PTV/r for an
additional 12 weeks of open-label treatment. Sustained virologic
response was assessed 12 weeks post-treatment (SVR12) as
a primary efficacy endpoint in a sub-group of previously untreated,
non-cirrhotic GT1b patients who were eligible for therapy with IFN
and had a high viral load, defined as an HCV RNA level ≥ 100,000
IU/mL and received at least one dose of the double-blind, active
study drug.1
In sub-study 2, 42 GT1b treatment-naïve and IFN (with our
without RBV) treatment-experienced patients with compensated
cirrhosis received open-label treatment for 12 weeks (Arm C) with
SVR12 and assessed as a secondary efficacy
endpoint.1
One patient from each arm (n=3/363) experienced on-treatment
virologic failure [Arm A, 0.5% (n=1/215); Arm B, 0.9% (n=1/106);
Arm C, 2.4% (n=1/42)].1 Across all arms, eight patients
(n=8/354) experienced post-treatment relapse [Arm A, 2.4%
(n=5/209); Arm B, 1.0% (n=1/105); Arm C, 5.0%
(n=2/40)].1
About AbbVie's Investigational Two Direct-Acting Antiviral
HCV Treatment
For the treatment of genotype 1 chronic hepatitis C virus (HCV)
infection in Japan, AbbVie's
investigational, two direct-acting antiviral treatment consists of
the fixed-dosed combination of paritaprevir/ritonavir (150/100 mg)
with ombitasvir (25 mg), dosed once daily.
AbbVie's chronic HCV treatment combines two direct-acting
antivirals, each with a distinct mechanism of action that targets
and inhibits specific HCV proteins of the viral replication
process.
About AbbVie's HCV Clinical Development Program in
Japan
AbbVie's HCV clinical development program in Japan focuses on our investigational, two
direct-acting antiviral treatment and is designed with the goal of
achieving high SVR rates in chronic HCV infected patients,
including additional genotypes and patients with compensated
cirrhosis.
Paritaprevir was discovered during the ongoing collaboration
between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV
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
hepatitis C.
Ombitasvir/paritaprevir/ritonavir is an investigational product
and its safety and efficacy have not been established in
Japan.
Additional information about AbbVie's clinical development
program in Japan can be found on
www.clinicaltrials.gov.
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.
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.
1 Chayama K, et al. Ombitasvir/paritaprevir/ritonavir
for Treatment of HCV Genotype 1b in Japanese Patients With or
Without Cirrhosis: Results from GIFT-I. Presented at the Annual
Meeting of the Japan Society of Hepatology. May 21-23; Kumamoto, Japan
2 Kohnodai Hospital. National Center for Global Health
and Medicine [cited 20 February
2013]. Available from:
http://www.ncgm.go.jp/center/forpatient_hcv.html
3 Hajarizadeh B et al. Nat Rev Gastroenterol Hepatol
2013; 10: 553-562. Available from:
http://www.nature.com/nrgastro/journal/v10/n9/fig_tab/nrgastro.2013.107_F1.html