AbbVie’s chronic hepatitis C therapy for adult patients with genotype 4 forms of the disease has been assigned a priority review by the US Food and Drug Administration, signalling a much shorter review time.
As competition in the HCV field continues to heat up, the company is seeking approval of the first all-oral, interferon-free therapy for this patient subset.
The treatment is a fixed-dose, once-daily combination of paritaprevir/ritonavir (150/100mg) co-formulated with ombitasvir (25mg), administered alongside ribavirin, offering two direct-acting antivirals with two different mechanisms of action that target and inhibit specific HCV proteins involved in the viral replication process.
Priority review, which should shorten the review time down to six months, was partly based on results from the Pearl-I study, showing 100% cure rates for patients (without liver cirrhosis) either previously untreated or who had failed on prior therapy.
Genoype 1 HCV is the most common form of the disease, but around 34 million people around the globe are estimated to have genotype 4 forms.