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     1966  0 Kommentare AbbVie Presents Late-Breaking, Preliminary Phase 3b Data with VIEKIRAX® + EXVIERA® in Chronic Hepatitis C Patients with Renal Impairment at The International Liver Congress™ 2015

    - RUBY-I evaluates treatment-naïve, non-cirrhotic, genotype 1 chronic hepatitis C patients with severe renal impairment

    - In preliminary data from RUBY-I, patients receiving VIEKIRAX + EXVIERA with or without ribavirin who reached post-treatment week four (n=10 of 20 enrolled) achieved 100 percent sustained virologic response at four weeks post-treatment (SVR4)1

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    - AbbVie's Phase 3b studies explore VIEKIRAX + EXVIERA in additional patient populations seen in clinical practice and across multiple countries around the world

    VIENNA, April 25, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new, preliminary safety and efficacy data from the first cohort of its ongoing, Phase 3b RUBY-I study. RUBY-I is evaluating VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) with or without ribavirin (RBV) in treatment-naïve, non-cirrhotic, genotype 1 (GT1) chronic hepatitis C patients with severe renal impairment (stage 4 or 5), including those on hemodialysis. The primary endpoint of the study is the percentage of patients achieving sustained virologic response at 12 weeks post-treatment (SVR12). Patients who reached post-treatment week four to date (n=10 of 20 enrolled) achieved 100 percent SVR4 (n=10/10).1 RUBY-I was presented as a late-breaker today at The International Liver Congress™ (ILC) 2015, the 50th annual meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria.

    "Treating hepatitis C patients with severe renal impairment may be a concern, particularly in those patients on hemodialysis," said Paul J. Pockros, M.D., director of Liver Disease Center Scripps Clinic and director of clinical research at Scripps Translational Science Institute in La Jolla, California. "With limited data currently available on the safety and efficacy of interferon-free treatments for patients with renal impairment, the preliminary results seen in RUBY-I show promising initial SVR rates with the VIEKIRAX + EXVIERA regimen in a dedicated study for this often difficult-to-treat patient population."

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    AbbVie Presents Late-Breaking, Preliminary Phase 3b Data with VIEKIRAX® + EXVIERA® in Chronic Hepatitis C Patients with Renal Impairment at The International Liver Congress™ 2015 - RUBY-I evaluates treatment-naïve, non-cirrhotic, genotype 1 chronic hepatitis C patients with severe renal impairment - In preliminary data from RUBY-I, patients receiving VIEKIRAX + EXVIERA with or without ribavirin who reached post-treatment …