Sofosbuvir/Ledipasvir for Hep C Rx in HIV/HCV Pre and Post Liver Transplant Subjects

Clinical Center

Investigators

Abstract

This multi-center U01 grant study was funded by the Division for AIDS, National Institutes of Health in January 2015 at which time the study underwent scientific review and regulatory review. We filed and received an Investigational New Drug (IND) exemption from the Food and Drug Administration (FDA) for the use of the combination sofosbuvir and ledipasvir (SOF/LDV). The protocol underwent IRB review at all enrolling sites. The clinical trials agreement was with the sponsor (Gilead) and UCSF and was completed in April 2016. Updated site agreements with all enrolling sites was completed in November 2016. The NIH site has undergone IRB Review, initial site monitoring review and received site activation. We currently have drug on site. There have been a number of barriers to accrual for this study: 1) Harvoni became FDA approved 2) By 2016, it became easier to obtain insurance authorization for Harvoni 3) Most previously potential candidates for the study have already been treated 4) Standard of care treatment with Harvoni (off study) doesnt require many visits to the primary provided for bloodwork, whereas this study required many study visits, requires travel to NIH CC for some patients, and requires collection of research samples. The Grant was to end 12/31/2017 and we have requested and received approval for a no-cost extension with a new end data of 12/31/2018. This extension requires many changes to the current protocol, including: 1) Changing referring centers to enrolling centers 2) Changing NIH to a collaborative site (no longer enrolling subjects) 3) Adding a retrospective arm to the study