The most commonly reported adverse events (>10 percent) were fatigue
(22 percent), diarrhea (20 percent) and headache (18 percent).
“In the TURQUOISE-III study, GT1b patients with compensated liver
cirrhosis achieved a 100 percent 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 program, which aims to further
enhance our understanding of AbbVie’s regimen in HCV populations seen in
clinical practice, and supports our commitment to continuedinvestigation in this field.”
About TURQUOISE-III Study TURQUOISE-III is a multi-center, open-label Phase 3b study to eva luate the safety andefficacy 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.
About VIEKIRAX®+EXVIERA®
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 theEuropean Union for the treatment of genotype 4 (GT4) chronic HCVinfection.
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 withoutribavirin (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 (NASDAQ: ENTA) 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.
Additional information about AbbVie’s hepatitis C development program can be found on www.clinicaltrials.gov.
About AbbVie’s HCV Clinical Development ProgramThe
AbbVie HCV clinical development program is intended to advancescientific knowledge and clinical care by investigating interferon-free,all-oral treatments with or without ribavirin with the goal ofachieving high sustained virologic response rates in as many patients aspossible.
AbbVie’s global Phase 3b program plans to include more than2,800 genotype 1 patients in over 200 study centers worldwide, includingthe U.S., Canada, Europe, Russia and Brazil.
Additional information about AbbVie’s hepatitis C development program can be found on www.clinicaltrials.gov.
VIEKIRAX® + EXVIERA® EU IndicationVIEKIRAX is indicated in combination with other medicinal products for th |
