EMA panel grants positive opinion for Viekirax-Exviera 8-week treatment

AbbVie received a positive opinion for 8-week treatment of genotype 1b chronic hepatitis C with combination Viekirax plus Exviera from the European Committee for Medicinal Products for Human Use of the European Medicines Agency, according to a press release.

“AbbVie continuously strives to expand the utility of our HCV treatments, including investigating a shorter path to virologic cure for people living with HCV,” Michael Severino, MD, executive vice present of research and development and chief scientific officer of AbbVie, said in the release. “With this positive CHMP opinion, we will bring an 8-week treatment option for the many HCV patients with [genotype 1b].”

Viekirax (ombitasvir/parataprevir/ritonavir tablets) plus Exviera (dasabuvir tablets) combination therapy is currently approved in the European Union as a 12-week regimen. The positive opinion for 8 weeks of treatment is supported by data from a phase 3b Garnet study.

Results of the study showed that with 8 weeks of treatment, 160 out of 163 study participants with chronic HCV genotype 1b without cirrhosis achieved sustained virologic response at 12 weeks follow-up. The most common adverse events included headache (21%), fatigue (17%), nasopharyngitis (8%), pruritus (8%), nausea (6%) and asthenia (5%).

Reference: www.abbvie.com