NORTH CHICAGO, Ill.
, Feb. 11, 2015
-- AbbVie (NYSE: ABBV) submitted a New Drug Application (NDA) to the
Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval
for the company's investigational, all-oral, ribavirin (RBV) and
interferon (IFN)-free, 12-week, two direct-acting antiviral treatment of
ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), dosed once daily. The
submission is for the treatment of patients with genotype 1 (GT1)
chronic hepatitis C virus (HCV) infection.
The NDA is supported by the Phase 3 GIFT-I study, which met its
primary endpoint, achieving 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 genotype
1b (GT1b)-infected Japanese patients who were eligible for therapy with
IFN and had a high viral load (≥ 100,000 IU/mL). Additionally, two
patients without cirrhosis (0.9 percent) discontinued treatment due to
adverse events. GIFT-I included a placebo-controlled arm and studied
patients with and without compensated cirrhosis, who were new to therapy
or treatment-experienced (with IFN and with or without RBV).
"We are pleased to announce the regulatory submission of our two direct-acting hepatitis C antiviral treatment in Japan
, which follows on quickly from recent approvals of our three direct-acting antiviral treatment in the U.S., Canada
and the European Union," said Scott Brun
M.D., vice president, pharmaceutical development, AbbVie. "This
submission is based on a large Phase 3 study in multiple patient types
and brings us closer to offering the possibility of cure for patients
with chronic genotype 1b hepatitis C infection, the most common form of
the disease in the country."
AbbVie studied a two direct-acting antiviral regimen without RBV in Japan
due to patient and viral characteristics specific to the Japanese population, including high prevalence of GT1b. In Japan
, approximately 1.5 to 2 million people are living with HCV.1
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.2
About the GIFT-I Study
(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-naïve) 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 with OBV/PTV/r.
Within the primary efficacy patient population, there were no
on-treatment virologic failures and 2.8 percent of patients (n=3/109)
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
Additional information about AbbVie's GIFT-I study can be found on www.clinicaltrials.gov
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-dose 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 its 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
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