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Abbvie reports positive Phase IIIb results of Viekirax+ Exviera in HCV patients

US-based biopharmaceutical firm AbbVie has reported positive results from its Phase IIIb trial (TURQUOISE-III) of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) plus Exviera (dasabuvir tablets) in genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected adult patients with compensated liver cirrhosis.

In the trial, patients received 12 weeks of Viekirax+ Exviera without ribavirin (RBV) and the results showed 100% sustained virologic response at 12 weeks post-treatment (SVR12) in these adults.

Around 160 million people across the world are infected with HCV, and genotype 1 is the most common type of HCV genotype, accounting for 60% of cases worldwide.

Toronto Center for Liver Disease research director and clinician scientist Jordan Feld said: "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.

"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."

In the trial, patients were either treatment-naïve or treatment-experienced and none discontinued treatment due to adverse events.

The most commonly reported adverse events were fatigue, diarrhea and headache.

AbbVie Pharmaceutical Development vice-president Scott Brun said: "In the TURQUOISE-III study, GT1b patients with compensated liver cirrhosis achieved a 100 percent cure rate with VIEKIRAX + EXVIERA without ribavirin.

"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 continued investigation in this field."