Transplant Trial Watch

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.

5-8 years

CET Conclusions
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 for a commentary written by Sir Peter Morris regarding the main trial results.

Trial registration
Clinical - NCT00355862

Funding source
Industry & non-industry funded