Phase 3 clinical results showed 100% of patients with hepatitis C virus infection genotype 1b with compensated liver cirrhosis reached a sustained virologic response 12 weeks after therapy with Viekirax and Exviera, according to a press release from the drug maker.
“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,” Jordan J. Feld, MD, MPH, research director and clinician scientist, Toronto Center for Liver Disease, Toronto, Canada, said in the release.
The clinical trial included 60 patients who were treatment-naive or treatment-experienced and failed previous therapy with pegylated interferon and ribavirin. Each patient was treated with Viekirax (ombitasvir/paritaprevir/ritonavir, AbbVie) and Exviera (dasabuvir, AbbVie) without ribavirin and reached SVR at 12 weeks post-treatment.
No patients discontinued treatment due to adverse events from treatment, according to the release. Common adverse events observed were fatigue (22%), diarrhea (20%) and headache (18%).
“In the TURQUOISE-III study, genotype 1b patients with compensated liver cirrhosis achieved a 100% cure rate with Viekirax plus Exviera without ribavirin,” Scott Brun, MD, vice president of pharmaceutical development at AbbVie, said in the release. “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.”
The combination regimen is an all-oral, interferon-free regimen consisting of a fixed-dose combination of the protease inhibitor ritonavir, at 100 mg/150 mg, co-formulated with 25 mg ombitasvir, administered once daily, along with 250 mg dasabuvir with or without ribavirin, administered twice daily.
TURQUOISE-II results presented at The International Liver Meeting 2014 showed high SVR rates were achieved with this regimen in treatment-experienced patients with HCV genotype 1 and compensated cirrhosis.
Ombitasvir/paritaprevir/ritonavir in combination with dasabuvir was approved by the European Union in January and is available for the treatment of chronic HCV genotype 1 and 4 infections in the United Kingdom.
Ombitasvir/paritaprevir/ritonavir in combination with dasabuvir, known as Viekira Pak (AbbVie) in the U.S., was approved by the FDA in December 2014 for treating patients with HCV genotype 1 infection and cirrhosis.
Disclosures: Brun is employed by AbbVie. Relevant financial disclosures for Feld were unavailable at time of publication.