– 95 percent SVR12
rate achieved in Japanese patients new to therapy with genotype 1b
chronic hepatitis C virus infection without cirrhosis and with a high
– Regulatory filing in Japan planned for the first quarter of 2015
NORTH CHICAGO, Ill., Jan. 30, 2015 /PRNewswire/
— AbbVie (NYSE: ABBV) released top-line Phase 3 results for its
investigational, all-oral, ribavirin (RBV)-free, two direct-acting
antiviral treatment with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r)
in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV)
infection in Japan. The primary
endpoint of the GIFT-I study was achieved, demonstrating a 95 percent
(n=106/112) sustained virologic response rate at 12 weeks post treatment
(SVR12) in the sub-group of previously
untreated, non-cirrhotic adult GT1b Japanese patients who were eligible
for therapy with interferon (IFN) and had a high viral load.
“AbbVie is committed to advancing HCV care with the goal of
evaluating our treatment in a broad range of patients around the world,”
said Scott Brun, M.D., vice
president, pharmaceutical development, AbbVie. “The GIFT-I results are
encouraging and support moving forward with our Japan development program, with a local regulatory submission anticipated in the first quarter of 2015.”
In Japan, up to two million people are currently living with hepatitis C.1 Genotype 1b is the most common sub-genotype, affecting nearly half of the people infected with HCV.2
In the GIFT-I study, the primary efficacy population comprised a
sub-group of treatment-naive GT1b chronic HCV infected patient
population. This sub-group consisted of treatment-naive patients without
cirrhosis who were eligible for therapy with IFN with or without RBV,
had a high viral load (> 100,000 IU/mL)
and received at least one dose of the double-blind active study drug.
The primary endpoint was assessed at 12 weeks post treatment (SVR12).
In patients without cirrhosis, the most commonly reported adverse
events in the treatment arm were nasopharyngitis (16.7 percent OBV/PTV/r
vs. 13.2 percent placebo), headache (8.8 percent OBV/PTV/r vs. 9.4
percent placebo), and oedema peripheral (5.1 percent OBV/PTV/r vs. 0
percent placebo). Two patients without cirrhosis (0.9 percent)
discontinued treatment due to adverse events.
Within the primary efficacy patient population, there were no
on-treatment virologic failures and 2.8 percent of patients (n=3/109)
AbbVie will disclose detailed GIFT-I study results at future scientific congresses and in publications.
About GIFT-I Study GIFT-I
(M13-004) is a Phase 3, multi-center study designed to evaluate the
efficacy and safety of 12 weeks of treatment with
ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in adult Japanese patients
(n=363) with chronic genotype 1b hepatitis C virus infection. Patients
included those without cirrhosis and with compensated cirrhosis who were
new to therapy (treatment-naive) or had failed previous treatment with
interferon with or without ribavirin (treatment-experienced). The study
consists of two sub-studies. Sub-study one included patients without
cirrhosis randomized to OBV/PTV/r or placebo. Sub-study two included
patients with compensated cirrhosis, who received open-label treatment
Additional information about AbbVie’s GIFT-I study can be found on www.clinicaltrials.gov.
About AbbVie’s Investigational Two Direct-Acting Antiviral HCV TreatmentFor the treatment of genotype 1b 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
will focus on our investigational, two direct-acting antiviral
treatment and is designed with the goal of achieving high sustained
virologic response 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.
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.
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.
1 Kohnodai Hospital. National Center for Global Health and Medicine [cited 20 February 2013]. Available from: http://www.ncgm.go.jp/center/forpatient_hcv.html
2 Hajarizadeh B et al. Nat Rev Gastroenterol Hepatol 2013; 10: 553-562. http://www.nature.com/nrgastro/journal/v10/n9/fig_tab/nrgastro.2013.107_F1.html. Accessed December 2014