AbbVie Inc (NYSE:ABBV) declared on Saturday that its eight weeks of treatment, 97% to 98% of genotype 1-3 (GT1-3) chronic hepatitis C virus (HCV) infected patients with no cirrhosis treated with AbbVie’s examinational, ribavirin (RBV)-free, once-daily, pan-genotypic regimen of ABT-493 and ABT-530 achieved sustained virologic response at 12 weeks post-treatment (SVR12). The 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 attained SVR12 with 12 weeks of treatment. These new data from the Phase 2 SURVEYOR-1 and SURVEYOR-2 studies will be presented at The International Liver Congress (ILC) 2016 in Barcelona, Spain.
The VP, development and chief medical officer, AbbVie, Rob Scott stated that these results move them closer to their ultimate goal of providing a treatment option for as many hepatitis C patients as possible. They will continue to examine their examinational, pan-genotypic regimen through their dedicated clinical trial program, comprising eight-week duration across all genotypes.
In separate late-breaking data from SURVEYOR-2 study, 100% of GT3 chronic HCV infected persons with compensated cirrhosis new to therapy attained SVR12 with 12 weeks of treatment both with and without RBV. No patients discontinued treatment because of adverse events. The data in GT3 chronic HCV infected patients with and without cirrhosis were featured in official ILC 2016 press program.
The professor of medicine at the Indiana University School of Medicine, Paul Kwo stated that the recent evolution in hepatitis C treatment has resulted in high cure rates for many patients by means of specific genotypes, other than there remain distinct areas of unmet need. These new data show them possible of ABT-493 and ABT-530 in genotype 3 patients new to therapy even with added complication of compensated cirrhosis.
The ongoing Phase 2SURVEYOR-2 is four-part study intended to evaluate safety and efficacy of ABT-493 and ABT-530, with or without RBV, in adult patients with genotypes 2, 3, 4, 5 or 6 chronic HCV infection who were new to therapy or had failed previous treatment with pegylated interferon (pegIFN)/RBV. Safety and efficacy data for Part 1 of studies were presented at The Liver Meeting 2015, the Yearly Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco.