Sa2074 The mutational architecture of oesophageal adenocarcinoma

Abstract

randomize 90 patients per cohort, stratified by IL28B status and GT1 subtype (1a vs non– 1a), in a 2:1:2:1 fashion to 1 of 4 arms: simeprevir 150 mg once daily (QD) plus sofosbuvir 400 mg QD for 24 weeks with or without RBV, or simeprevir 150 mg QD plus sofosbuvir 400 mg QD for 12 weeks with or without RBV. For cohort 1, a safety and efficacy interim analysis was conductedwhen approximately 20% of the planned randomized patients reached the end of treatment (EOT) or permanently discontinued treatment early.Results: At the time of this interim analysis, 80 patients in cohort 1 have been randomized and treated; 19 patients have reached EOT and have post-treatment follow-up data available. Duration of treatment exposure ranges from 3 to 171 days; median is 63 days. One patient discontinued study drugs due to an adverse event (AE). Two patients discontinued treatment early for non-safety reasons. RBV dose was reduced in 4/51 patients due to decline in hemoglobin. No serious AEs were attributed to study drugs. Baseline characteristics and efficacy results are summarized. At the time of the presentation, results of an additional interim analysis will be presented, including SVR data in approximately 50 patients.Conclusions: Once-daily simeprevir + sofosbuvir with or without RBV for 12 or 24 weeks was generally well tolerated and resulted in high SVR4 rates in this initial group of study patients with null response to prior PegIFN/RBV therapy.