ITX5061 plasma concentrations before and after
LT were measured with liquid chromatography/mass spectrometry. Clinicaltrials. gov NCT01292824.The majority of recipients were infected with HCV G1 (13/23). All patients survived 1 month after LT. ITX5061 treatment was well tolerated with no difference in the nature or frequency of adverse events between treated and untreated subjects. Oral absorption of ITX5061 was demonstrated with measurable plasma concentrations before and daily for one week after LT. HCV RNA declined during the first 24 hours but remained detectable for all patients during treatment and follow-up. Compared with values measured during the anhepatic phase of surgery, the median reduction in HCV RNA was greater for treated patients at all time-points Pexidartinib solubility dmso (approximately 1log10 difference during treatment). The maximal decline in HCV RNA was greater than 2log10 in Afatinib solubility dmso 8/10 treated patients compared to 6/13 untreated patients (Figure). In G1 patients (n=6) 7 days treatment was associated with a sustained reduction in HCV RNA (all greater than 2log10) compared with the control group (n=7), none of whom achieved a 2log10 reduction at any time. Following treatment withdrawal HCV RNA increased in all patients. Treatment with ITX5061, an inhibitor of HCV entry, is safe and well tolerated in LT. ITX5061 influences HCV RNA kinetics and a significant reduction in HCV RNA
titres during treatment was observed. These findings support further investigation into the efficacy of ITX5061 in HCV infected patients undergoing LT. Disclosures: Matthew J. Armstrong – Grant/Research Support: novo nordisk Jeff McKelvy – Employment: iTherX Pharma Inc Flossie Wong-Staal – Board Membership: United Biomedicals, Inc.; Management Position: iTherX Pharma, Inc. David J. Mutimer – Advisory Committees or Review Panels: BMS, Janssen, MSD, Gilead The following people have nothing
to disclose: Ian A. Rowe, Richard Parker, Kathy Guo, Darren Barton, Gene D. Morse, David H. Idoxuridine Adams, Jane A. McKeating