EASL 2014: Abstract O55. Successful retreatment with sofosbuvir of HCV Genotype-1 Infected patients who failed prior therapy with peginterferon+ribavirin plus 1 or 2 additional direct-acting antiviral agents.
S. Pol1, M. Sulkowski2, T. Hassanein3, E. Gane4, N. Liyun5, H. Ho5, B. Kanwar5, D. Brainard5, M. Subramanian5, W.T. Symonds5, J.G. McHutchison5, M. Bennett6, I.M. Jacobson7
1University of Paris, Paris, France, 2Johns Hopkins University School of Medicine, Baltimore, MD, 3Southern California Liver Centers, Coronado, CA, United States, 4Auckland City Hospital, Aukland, New Zealand,5Gilead Sciences, Foster City, 6Medical Associates Research Group, San Diego, CA, 7Weill Cornell Medical College, New York, NY, United States
Background and Aims: GT1 patients who failed prior treatment with peginterferon (PEG-IFN) + ribavirin (RBV) + a protease inhibitor (PI) have no available treatment options. The aim of this study was to evaluate the efficacy of the 12-week sofosbuvir (SOF) + PEG/RBV regimen in patients who had failed prior 3- and 4-drug regimens.
Results: A total of 57 GT1 prior treatment failure patients entered the study. All patients failed prior therapy with PEG/RBV in combination with a PI with or without an NS5a polymerase inhibitor (ledipasvir) or a non-nucleoside NS5b polymerase inhibitor (tegobuvir). The average duration of prior therapy was 202 days (SD +/- 144 days). Sixteen patients (30%) received more than 1-course of prior therapy. The majority were male (72%), genotype 1a (93%) and IL28B non-CC (95%). To date, SVR4 rates are 96% (22/23) for the patients who have reached the 4-week post treatment visit (see table).
Conclusions: The 12-week regimen of SOF+PEG+RBV results in high SVR4 rates in previously treated HCV GT1- infected patients despite single or multiple baseline resistant mutations and other unfavorable baseline characteristics.