Background: We report the update of the Tor Vergata immunosuppression (IS) weaning protocol in stable hepatitis C virus (HCV) liver transplant (LT) recipients.
Methods: The weaning off IS was attempted in 34 patients who had received a LT 63.5+/-20.1 month earlier, for HCV-related end stage liver disease. Patients were observed over a period of 6.5 years. During this time, yearly protocol liver biopsies were performed. Primary endpoints were determined as the feasibility of weaning off IS and its impact on the long term disease progression. Secondary endpoints were defined as the impact on patient morbidity and quality of life.
Results: Of the 8 originally tolerant patients, 7 remain alive and in good condition, while 1 died of severe HCV recurrence 10 years post-LT and 6 years after complete removal of IS. Four out of 26 intolerant individuals died of HCV recurrence (2x), lung carcinoma (1x) and acute myocardial infarction (1x), after a mean follow up period from LT of 115 (range 100-124). The 10-year survival from LT was comparable (89% vs. 87.5%). Liver graft pathology showed no significant differences between the two groups in terms of staging, fibrosis progression rate, and grading. Quantitative HCV RNA assay showed a significant non-logarithmic difference between the two groups (p = 0.03). The two groups were comparable in terms of liver function tests and lipid profile, whereas they differed with regards to glycaemia. While all tolerant individuals were euglicemic, 11 intolerant individuals developed new onset diabetes that required specific treatment (p = 0.03). Finally, significantly more intolerant patients are suffering from either cardiovascular (14/22 vs. 0/7, p = 0.01) or infectious diseases (13/22 vs. 0/7, p = 0.01).
Conclusions: After a 6.5-year follow up, the complete withdrawal of IS in HCV LT recipient remains safe and beneficial to patients, because it reduces the IS-related morbidity and increases the quality of life. The impact on HCV disease recurrence is less marked than after 3.5 years.