AbbVie’s investigational once-daily oral therapy for patients with genotype 1 chronic hepatitis C will get a priority review from Japan’s Ministry of Health, Labour and Welfare.
The ribavirin and interferon-free therapy is a fixed-dose combination of paritaprevir/ritonavir and ombitasvir - dosed once daily for 12 weeks - offering two direct-acting antivirals with two different mechanisms of action that target and inhibit specific HCV proteins involved in the viral replication process.
The therapy’s submission in Japan is supported by data from the Phase III GIFT-I trial, which met its primary endpoint by achieving 95% sustained virologic response rate at 12 weeks post-treatment.
AbbVie has recently bagged approvals in Europe, the US and Canada for a three-antiviral combo; the two direct-acting antiviral regimen without RBV is being studied in Japan because of patient and viral characteristics specific to the Japanese population.
Around 1.5 to 2 million people in Japan are affected by HCV, 60%-70% of which have the genotype 1 form.