AbbVie, a global biopharmaceutical company, announced TURQUOISE-III study results demonstrating 100 per cent (n=60/60) sustained virologic response at 12 weeks post-treatment (SVR12) in genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected adult patients with compensated liver cirrhosis.
Patients received 12 weeks of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets) without ribavirin (RBV). These new results from AbbVie's phase 3b study 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. Genotype 1 is the most common type of HCV genotype, accounting for 60 per cent of cases worldwide and in Europe, the most prevalent genotype is 1b (47 per cent). Over time, chronic HCV may lead to liver complications, including compensated cirrhosis, in about 10-20 per cent of people infected.
"Genotype 1b represents a large portion of HCV patients globally, as it is the most prevalent sub-genotype, and there is a need to continue to explore additional treatment regimens," said Jordan J. Feld, M.D., MPH, research director and clinician scientist, Toronto Center for Liver Disease, Toronto, Canada. "The results of TURQUOISE-III are promising, demonstrating that genotype 1b HCV patients with compensated liver cirrhosis have the potential to achieve high response rates with an interferon and ribavirin-free treatment in 12 weeks."
Patients in TURQUOISE-III were either treatment-naïve or treatment-experienced (failed previous therapy with pegylated interferon and RBV). No patients discontinued treatment due to adverse events. The most commonly reported adverse events (>10 per cent) were fatigue (22 per cent), diarrhea (20 per cent) and headache (18 per cent).
"In the TURQUOISE-III study, GT1b patients with compensated liver cirrhosis achieved a 100 per cent cure rate with Viekirax + Exviera without ribavirin," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "TURQUOISE-III is part of our phase 3b programme, which aims to further enhance our understanding of AbbVie's regimen in HCV populations seen in clinical practice, and supports our commitment to continued investigation in this field."
TURQUOISE-III is a multi-center, open-label phase 3b study to evaluate the safety and efficacy of 12 weeks of treatment with Viekirax + Exviera without ribavirin (RBV) in adult patients (n=60) with genotype 1b chronic hepatitis C virus infection and compensated liver cirrhosis who were treatment-naïve or treatment-experienced (failed previous therapy with pegylated interferon and RBV). The primary endpoint is the rate of sustained virologic response 12 weeks after treatment (SVR12).
No patients experienced virologic failure during treatment and no patients experienced virologic relapse following the end of treatment.
Viekirax + Exviera is approved in the European Union for the treatment of genotype 1 (GT1) chronic hepatitis C virus (HCV) 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 + Exviera are taken with or without ribavirin (RBV), dosed twice daily based on patient type. Viekirax + Exviera is taken for 12 weeks with or without RBV, except in genotype 1a and GT4 patients with compensated cirrhosis, who should take it for 24 weeks with RBV.
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.