Preliminary Phase III data for Viekirax + Exviera in Hepatitis C- AbbVie

AbbVie has announced new, preliminary safety and efficacy data from the first cohort of its ongoing, Phase IIIb RUBY-I study 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). 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 (less than 20 percent) anemia, fatigue, diarrhea, nausea, dizziness and headache. To date, eight of 13 genotype 1a patients had a RBV dose interruption. RUBY-I was presented as a late-breaker at The International Liver Congress.