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Switch to sirolimus improved outcomes in liver transplantation

Changing from calcineurin inhibitor-based therapy to sirolimus-based therapy yielded improved survival in a cohort of patients undergoing liver transplantation, according to recent findings.

The researchers suggested that there is uncertainty about the use of sirolimus-based immune suppression in patients undergoing liver transplantation, specifically among those with hepatitis C virus. They noted data demonstrating the ability of sirolimus to slow hepatic fibrosis, spare renal function and prevent hepatocellular carcinoma recurrence. However, many transplant centers do not use the drug due to evidence of hepatic artery thrombosis, graft loss and mortality.

The aim of the current investigation was to assess the effect of sirolimus monotherapy on liver recipients with HCV. Outcome measures included survival, graft loss and hepatic fibrosis.

The single-center analysis included 190 patients. Findings were accrued during a 15-year period.

A change from calcineurin inhibitor-based therapy to low-dose sirolimus monotherapy was reported in 113 patients. This switch occurred at a median of 15 months after transplantation. The reason for transplant was HCV-related fibrosis in 72% of cases, renal impairment in 14% and high-risk HCC in 5%.

Improved survival was reported among patients who changed to sirolimus-based therapy (P<.001), as was slower progression to cirrhosis (P=.001).

Duration of sirolimus therapy — as opposed to strategy of sirolimus use — independently predicted survival among 91 patients with HCC (P=.001). Duration also extended time to HCC recurrence in these patients, 33 months vs. 16 months.

Serum creatinine levels improved from 140 mcmol/L to 108 mcmol/L in patients who switched to sirolimus for renal dysfunction (P=.001).

Post-transplant diabetes risk increased among patients who remained on calcineurin inhibitor-based therapy (P=.03).

“These data suggest selective switching to low-dose sirolimus monotherapy in HCV-positive liver recipients improves clinical outcome,” the researchers concluded.

Disclosure: Two researchers report financial associations with Wyeth Pharmaceuticals.