Positive Opinion Issued on Hepatitis C Drug

European regulators offered promising news last week for patients with hepatitis C virus (HCV).

The European Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion for AbbVie’s clinical trial Viekirax (ombitasvir/paritaprevir/ritonavir tablets) plus Exviera (dasabuvir tablets) without ribavirin (RBV) in chronic HCV genotype 1b (GT1b) patients with compensated cirrhosis (Child-Pugh A).

Globally, there are approximately 160 million people infected with HCV, with genotype 1 being the most common, accounting for 60% of cases. The most common genotype in Europe is 1b (GT1b), which accounts for 47% of 9 million HCV patients.

During the 12 week phase 3b TURQUOISE 3 clinical trial, researchers looked at the safety and efficacy of Viekirax and Exviera without RBV in patients with Child-Pugh A.

The results of the study showed that 100% (n=60/60) of patients suffering from chronic GT1b HCV with Child-Pugh A had a sustained virologic response at 12 weeks after treatment.

The most common adverse events (>10%) were fatigue (22%), diarrhea (20%) and headache (18%), but no patients discontinued their treatments because of this.

"This positive CHMP opinion brings us one step closer to delivering a ribavirin-free treatment option for GT1b patients with compensated cirrhosis that has demonstrated high cure rates with no treatment discontinuations in our clinical trial," said Executive Vice President of AbbVie, Michael Severino, MD. "This milestone reinforces our continued commitment to provide additional treatment options for the HCV community, and we look forward to the final decision by the European Commission."