Phase II data for once-daily, ribavirin-free, pan-genotypic regimen of ABT-493 and ABT-530 for Hepatitis C genotypes 1-6 in SURVEYOR I and II studies- Abbvie

AbbVie announced that with eight weeks of treatment, 97–98% of genotype 1-3 (GT1-3) chronic hepatitis C virus (HCV) infected patients without cirrhosis treated with AbbVie's investigational, once-daily, ribavirin (RBV)-free, pan-genotypic regimen of ABT-493 and ABT-530 achieved sustained virologic response at 12 weeks post-treatment (SVR12).

Results for GT1 (n=33/34), GT2 (n=53/54) and treatment-naïve GT3 (n=28/29) patients were based on an Intent-to-Treat (ITT) analysis. Additionally, 100% (n=34/34) of genotype 4-6 (GT4-6) chronic HCV infected patients without cirrhosis achieved SVR12 with 12 weeks of treatment. These new data from the Phase II SURVEYOR-I and SURVEYOR-II studies were presented at The International Liver Congress (ILC) 2016 in Barcelona, Spain.

In separate late-breaking data from the SURVEYOR-II study, 100% of GT3 chronic HCV infected patients with compensated cirrhosis (Child-Pugh A) new to therapy achieved SVR12 with 12 weeks of treatment both with and without RBV (n=24/24 in each arm). No patients discontinued treatment due to adverse events.

In a pooled analysis of 531 patients across both SURVEYOR studies, of five treatment regimens of ABT-493 and ABT-530 evaluated, the most commonly reported adverse events were fatigue (18%), headache (17%), nausea (13%) and diarrhoea (10%). Three patients across all study arms evaluated to date, two of whom received RBV, discontinued study drugs early due to adverse events.