Biopharmaceutical firm AbbVie has unveiled the late-breaking and preliminary data of its Phase IIIb Ruby-I study with Viekirax+Exviera in chronic hepatitis c patients with renal impairment.
The data from the first cohort of its study was presented at The International Liver Congress 2015, the 50th annual meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria.
The study is being conducted to assess the Viekirax+Exviera with or without ribavirin (RBV) in treatment-naïve, non-cirrhotic, genotype 1 (GT1) chronic hepatitis C patients with severe renal impairment (stage IV or V) including those on haemodialysis.
Viekirax is the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg(NS5A inhibitor), while Exviera consists of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor).
Ruby-I is an ongoing, multi-centre and open-label Phase IIIb study with two cohorts that assesses the safety and efficacy of 12 or 24 weeks of treatment with Viekirax+Exviera with or without ribavirin.
Cohort 1 includes 20 patients without cirrhosis and cohort 2 will evaluate around 20 patients with or without compensated cirrhosis.AbbVie pharmaceutical development vice-president Dr Scott Brun said: "Ruby-I is part of AbbVie’s broader Phase IIIb programme and demonstrates our continued focus on people living with hepatitis C that have specific needs."
According to the company, the primary endpoint of the study is the percentage of patients achieving sustained virologic response at 12 weeks post-treatment (SVR12).
Patients who passed post-treatment week four to date achieved 100% SVR4 .
AbbVie’s additional Phase IIIb studies presented at ILC 2015 comprised MALACHITE-I and MALACHITE-II data, and the TOPAZ-I and TOPAZ-II study design.
The MALACHITE studies assess adult patients with GT1 chronic HCV infection without cirrhosis receiving Viekirax+Exviera with or without RBV compared to treatment with telaprevir with pegylated-interferon and RBV.
The TOPAZ studies will assess the effect of SVR12 on long-term outcomes, five years following treatment with Viekirax+Exviera with or without RBV in adults with GT1 chronic HCV infection.