Tu2038 All Oral Fixed-dose Combination Sofosbuvir/Ledipasvir With or Without Ribavirin for 12 or 24 Weeks in Treatment-Naive Genotype 1 HCV-Infected Patients: The Phase 3 ION-1 Study

2 of ascending colon (AC) emptying and bowel functions (analysis of variance, ANOVA, on ranks). Dunnett’s test compared each dose with placebo. A per protocol analysis (PPA) of time to first BM was assessed using a proportional hazards model. Results: There were 57 participants (56 female, 1 male; mean age 42.8±1.3y; mean BMI 25.3±0.5kg/m2) with baseline GE T1/2 of 125.0±4.3min (SEM) and GC24 of 1.83±0.05 respectively; 55 patients completed the study. YKP10811 was associated with accelerated GI transit (CF6), AC T1/ 2, and colonic transit at 4, 24, and 48h. PPA also showed overall acceleration of GE T1/2. YKP10811 was associated with accelerated time to pass BM after first dosing, and increased stool consistency over the 8-day treatment period. There were no deaths and no serious adverse events. Two subjects discontinued prematurely (1 on placebo, 1 on 20mg YKP10811). Conclusion: YKP10811 enhances GI and colonic transit and improves bowel functions, particularly stool consistency and time to first BM, during an 8-day treatment trial. Funding: Supported by a grant from SK Life Science.