AbbVie announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for a shorter, eight-week treatment of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) as an option for previously untreated adult patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) and minimal to moderate fibrosis.
VIEKIRAX + EXVIERA is currently approved in the European Union for use as a 12-week treatment for GT1b chronic HCV-infected patients without cirrhosis or with compensated cirrhosis.
"AbbVie continuously strives to expand the utility of our HCV treatments, including investigating a shorter path to virologic cure for people living with HCV," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "With this positive CHMP opinion, we will bring an eight-week treatment option for the many HCV patients with GT1b."
Approximately 160 million people worldwide are infected with HCV, with GT1b being the most common subtype globally.2,5 In Europe, this subtype accounts for 47 percent of the nine million people infected with chronic HCV across the continent.3,4
"Nearly half of the people living with chronic hepatitis C in Europe are infected with genotype 1b," said Dr. Tania Mara Welzel, M.H.Sc., study author and Medical Lead of the Clinical Study Center at the Department of Medicine at J.W. Goethe University in Frankfurt, Germany. "VIEKIRAX + EXVIERA has demonstrated high cure rates with only eight weeks of treatment in GT1b patients with minimal to moderate fibrosis."