- AbbVie's investigational, interferon and ribavirin-free treatment in Japan consists of a 12-week, two direct-acting antiviral, fixed-dosed combination of paritaprevir/ritonavir with ombitasvir, dosed once daily
- New Drug Application, based on the Phase 3 GIFT-I study results in Japanese patients with genotype 1b hepatitis C virus (HCV) infection, was submitted in February 2015
- GIFT-I met its primary endpoint, achieving 95 percent sustained virologic response rate at 12 weeks post-treatment (SVR12); two patients (0.9 percent) discontinued treatment due to adverse events
- Approximately 1.5 to 2 million people are living with hepatitis C in Japan(1); genotype 1 is most common, accounting for 60 to 70 percent of all patients infected with HCV(2)
NORTH CHICAGO, Ill., April 15, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted priority review for its investigational, two direct-acting antiviral treatment of ombitasvir/paritaprevir/ritonavir. This all-oral treatment is interferon (IFN) and ribavirin (RBV)-free and will be dosed once daily. The MHLW grants priority review to certain medicines on the basis of clinical usefulness and severity of the disease, including diseases like hepatitis C, which affects approximately 1.5 to 2 million people in Japan.1 AbbVie's investigational hepatitis C treatment was submitted for marketing approval in Japan in February 2015. The New Drug Application is for the treatment of patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection and is supported by the Phase 3 GIFT-I study in Japanese genotype 1b (GT1b) HCV patients.
"AbbVie is pleased that the Japanese MHLW has granted priority review for our interferon and ribavirin-free, 12-week, two direct-acting antiviral treatment regimen. This marks another important advancement in our HCV clinical development program as we aim to provide our HCV treatment to patients across the world," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "If approved, AbbVie's HCV treatment holds the potential to be a promising new treatment option for patients living with this chronic infection in Japan."
AbbVie studied a 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. In Japan, GT1 is the most common HCV genotype and accounts for 60 to 70 percent of all patients infected with HCV.2 Of those patients, about 95 percent are infected with the GT1b sub-type.2
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 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 its investigational, two direct-acting antiviral treatment and is designed to achieve 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.
SOURCE: AbbVie
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