By Cheryl Lathrop
BOSTON -- November 5, 2009 -- The outcome for patients undergoing a liver transplant for hepatitis C virus (HCV)-related liver disease is not affected by the calcineurin inhibitor chosen for treatment, according to a study presented here at the Liver Meeting 2009, the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).
Victoria Aguilera, Hepatogastroenterology Service, Hospital Universitario La Fe, Valencia, Spain, and colleagues reported findings from their prospective, randomised study on October 31.
In one-third of liver transplants, recurrent hepatitis C is aggressive. Immunosuppression influences the natural history of this infection. In HCV-infected transplant recipients, an association exists between the state of the patient's immunosuppression and the outcome after transplantation. However, data are conflicted in regard to the potential effect of calcineurin inhibitors on the outcome.
This study aimed to determine whether the choice of calcineurin inhibitor makes a difference in survival and histologic outcome after transplantation. Results from 310 patients who underwent liver transplantation between 2001 and 2007 and were given tacrolimus (TAC) or cyclosporine (CSA) for immunosuppression. Exclusion criteria were hepatitis B coinfection, HIV, negative HCV-RNA post transplantation, combined liver-kidney or lung transplantation, or retransplantation; 55 patients were excluded. Patient demographics were similar in the 2 arms: roughly 75% men, mean age 56 years, 40% with hepatocellular carcinoma, and about 25% alcohol users.
The primary endpoint was progression to severe disease, ie, bridging fibrosis, cirrhosis, cholestatic hepatitis, or death due to recurrent hepatitis C, within the first 2 years. Secondary endpoints were progression to fibrosis >1 determined by the first-year liver biopsy, the percentage of patients developing cholestatic hepatitis, no fibrosis in the first-year liver biopsy, and graft/patient survival. Liver biopsies were performed at 1- or 2-year intervals, and the antiviral treatment was chosen based on the results of the first-year biopsy.
The histologic outcome was similar for both groups: 29% of CSA and 23% of TAC patients had bridging fibrosis or cirrhosis, 6% of both groups had cholestatic hepatitis, 44% of CSA and 30% of TAC patients had fibrosis >1 the first year after transplantation, and 21% of CSA and 28% of TAC patients had no fibrosis 1 year after transplantation. Patient survival was also similar in the groups (P = .4).
Based on the results, the researchers concluded that post-transplantation outcome was not related to the choice of calcineurin inhibitor used.
[Presentation title: Calcineurin Inhibitors and Outcome of Liver Transplantation in HCV-Positive Recipients: Final Results of a Prospective Randomized Study. Abstract 511]
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