HCC recurrence in HCV patients after liver transplantation: SiLVER Study reveals benefits of sirolimus in combination with CNIs.Werner, J. M., et al.
Transpl Int . 2020 [record in progress]
To examine whether the immunosuppressive protocols would benefit a subgroup of patients
Sirolimus-free versus a sirolimus-based immonosuppressive protocol with calcineurin inhibitors (CNIs).
161 adult, hepatitis C positive liver transplant recipients.
hepatocellular carcinoma (HCC) recurrence-free survival. Overall survival was a secondary outcome.
This is a post-hoc analysis of the SiLVER-Study, which is a multicentre, randomised controlled trial comparing an mTORi-free versus sirolimus based immunosuppressive protocol in 525 adult liver transplant recipients. The outcomes of the main trial showed that sirolimus did not improve long-term hepatocellular carcinoma recurrence-free survival. The post-hoc analysis focussed on a subgroup of 161 hepatitis C positive patients and compared sirolimus-free immunosuppression (n=88) with sirolimus-based immunosuppression for more (n=44) or less (n=34) than 50% of visits. Recurrence-free survival was improved for patients receiving sirolimus-based immunosuppression in combination with calcineurin inhibitors for more than 50% of visits compared to the other two groups. The authors discuss possible reasons for these differences in the paper. See also https://www.transplantlibrary.com/article/26555945 for a commentary written by Sir Peter Morris regarding the main trial results.
Clinical trials.gov - NCT00355862