CHMP positive opinion for Viekirax plus Exviera without Ribavirin for the treatment of HCV in GT1B patients with compensated cirrhosis
The European Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has granted a positive opinion for the use of Viekirax ( Ombitasvir / Paritaprevir / Ritonavir tablets ) plus Exviera ( Dasabuvir tablets ) without Ribavirin in chronic hepatitis C virus ( HCV ) infected genotype 1b ( GT1b ) patients with compensated cirrhosis ( Child-Pugh A ).
Approximately 160 million people worldwide are infected with HCV. Genotype 1 is the most common type of HCV genotype, accounting for 60% of cases worldwide.
In Europe, the most prevalent genotype is 1b, accounting for 47% of the nine million people infected with chronic HCV.
The CHMP opinion of the Type-II variation application for Viekirax + Exviera is supported by data from the phase 3b TURQUOISE-III study, which is part of AbbVie's larger clinical program investigating efficacy and safety in a broad range of GT1 patients.
TURQUOISE-III is a dedicatedpPhase 3 study of Viekirax plus Exviera without Ribavirin for 12 weeks in GT1b patients with compensated cirrhosis.
Results from the TURQUOISE-III study showed 100% ( n=60/60 ) of GT1b chronic HCV infected patients with compensated cirrhosis ( Child-Pugh A ) achieved sustained virologic response at 12 weeks post-treatment ( SVR12 ) with Viekirax + Exviera without Ribavirin for 12 weeks.
No patients discontinued treatment due to adverse events.
The most commonly reported adverse events ( more than 10% ) were fatigue ( 22% ), diarrhea ( 20% ) and headache ( 18% ).
Viekirax plus Exviera is approved in the European Union for the treatment of genotype 1 ( GT1 ) chronic hepatitis C virus infection, including patients with compensated cirrhosis.
Viekirax is approved in the European Union for the treatment of genotype 4 ( GT4 ) chronic HCV infection.
Viekirax tablets consist of the fixed-dose combination of Paritaprevir 150mg ( NS3/4A protease inhibitor ) and Ritonavir 100mg with Ombitasvir 25mg ( NS5A inhibitor ), dosed once daily.
Exviera tablets consist of Dasabuvir 250mg ( non-nucleoside NS5B polymerase inhibitor ) dosed twice daily.
Viekirax plus Exviera are taken with or without Ribavirin, dosed twice daily based on patient type.
Viekirax plus Exviera is taken for 12 weeks with or without Ribavirin, except in genotype 1a and GT4 patients with compensated cirrhosis, who should take it for 24 weeks with Ribavirin. ( Xagena )
Source: Abbvie, 2016