AbbVie, a global biopharmaceutical company, has had its Viekirax + Exviera eight-week treatment program has been granted a positive opinion by the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.
The drug treatment plan is for previously untreated adult patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) and minimal to moderate fibrosis.
"AbbVie continuously strives to expand the utility of our HCV treatments, including investigating a shorter path to virologic cure for people living with HCV," Dr. Michael Severino, executive vice president of research and development and chief scientific officer for AbbVie, said in a statement. "With this positive CHMP opinion, we will bring an eight-week treatment option for the many HCV patients with GT1b."
As of now, the Viekirax + Exviera treatment is approved as a 12-week treatment in the European Union for GT1b chronic HCV-infected patients without cirrhosis or with compensated cirrhosis. GT1b is the most common global subtype of HCV, which in total affects roughly 160 million people.
"Nearly half of the people living with chronic hepatitis C in Europe are infected with genotype 1b," study author Dr. Tania Mara Welzel of Frankfurt, Germany, said. "VIEKIRAX + EXVIERA has demonstrated high cure rates with only eight weeks of treatment in GT1b patients with minimal to moderate fibrosis."