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Hepatitis C Cocktail Succeeds in Phase III Trial
Results from the phase IIIb TURQUOISE-III trial have demonstrated a 100% (n = 60/60) sustained virologic response rate at 12 weeks post-treatment (SVR12) in genotype 1b (GT1b) chronic hepatitis C virus (HCV)-infected adults with compensated liver cirrhosis.
The patients received 12 weeks of treatment with Viekirax (ombitasvir/paritaprevir/ritonavir tablets, AbbVie) plus Exviera (dasabuvir tablets, AbbVie) without ribavirin (RBV).
The new findings will be presented at the 15th Annual International Symposium on Viral Hepatitis and Liver Diseases in Berlin, Germany.
Approximately 160 million people worldwide are infected with HCV. GT1 is the most common type of HCV genotype, accounting for 60% of cases worldwide. Over time, chronic HCV may lead to liver complications, including compensated cirrhosis, in approximately 10% to 20% of infected people.
TURQUOISE-III was an open-label study designed to evaluate the safety and efficacy of 12 weeks of treatment with Viekirax plus Exviera without RBV in 60 adult patients with GT1b chronic HCV infection and compensated liver cirrhosis who were treatment-naïve or treatment-experienced (i.e., they had failed previous therapy with pegylated interferon and RBV). The study’s primary endpoint was the SVR12.
No patients discontinued treatment because of adverse events (AEs). The most common AEs were fatigue (22%), diarrhea (20%), and headache (18%). Moreover, no patients experienced virologic failure during treatment or experienced virologic relapse after the end of treatment.
Viekirax tablets consist of a fixed-dose combination of paritaprevir 150 mg (a nonstructural protein [NS] 3/4A protease inhibitor) and ritonavir 100 mg with ombitasvir 25 mg (an NS5A inhibitor), dosed once daily. Exviera tablets consist of dasabuvir 250 mg (a non-nucleoside NS5B polymerase inhibitor) dosed twice daily. Viekirax and Exviera are taken with or without RBV, dosed twice daily based on patient type. Viekirax and Exviera are taken for 12 weeks with or without RBV, except in GT1a and GT4 patients with compensated cirrhosis, who should take the combination for 24 weeks with RBV.
Viekirax and Exviera are not recommended as monotherapy and should be used in combination with other medicinal products for the treatment of HCV infection.
Source: AbbVie; June 24, 2015.