AbbVie presents preliminary safety and efficacy data from its Phase 3b RUBY-I study

AbbVie announced new, preliminary safety and efficacy data from the first cohort of its ongoing, Phase 3b RUBY-I study at The International Liver Congress™ (ILC) 2015.

RUBY-I is evaluating VIEKIRAX® + EXVIERA® 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 haemodialysis. 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). 

Preliminary results seen in RUBY-I show promising initial SVR rates

“Treating hepatitis C patients with severe renal impairment may be a concern, particularly in those patients on haemodialysis,” said Paul J. Pockros, M.D., director of Liver Disease Centre 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.”

Additionally, RUBY-I data showed no virologic failures to date. Preliminary safety analyses reported that patients experienced mainly mild or moderate adverse events when receiving VIEKIRAX + EXVIERA with or without RBV, most commonly (>20 percent) anaemia, fatigue, diarrhoea, nausea, dizziness and headache. To date, eight of 13 genotype 1a (GT1a) patients had a RBV dose interruption.

“RUBY-I is part of AbbVie’s broader Phase 3b program and demonstrates our continued focus on people living with hepatitis C that have specific needs,” said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. “Studies in our Phase 3b program will help to further expand our knowledge of the utility of VIEKIRAX + EXVIERA in special populations encountered in clinical practice.”

Additional Phase 3b studies from AbbVie presented at ILC 2015 included MALACHITE-I and MALACHITE-II data, and the TOPAZ-I and TOPAZ-II study design. The MALACHITE studies evaluate 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, which remains the standard of care in many regions of the world.  The TOPAZ studies will evaluate 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.