Transplant Trial Watch

Results of live donor liver transplantation in patients with hepatitic C virus infection: the HCV 3 trial experience.

Sher L, Jennings L, et al.

Clinical Transplantation, 26(3): 502-509, 2012.


Aims
To evaluate the effect of live donor liver transplantation on hepatitis C recurrence in patients with hepatitic C virus infection who were controlled for immunosuppressive regimens.

Interventions
Patients were randomized to receive tacrolimus plus steroids versus tacrolimus plus mycophenolate mofetil and steroids versus tacrolimus plus mycophenolate mofetil and daclizumab according to donor type.

Participants
295 patients undergoing transplantation for hepatitis C.

Outcomes
The primary efficacy endpoint was the proportion of patients who were free of a biopsy-proven rejection episode, recurrent hepatitis C, and treatment failure within 12 months. Secondary variables included time to rejection, number of rejections, time to histological recurrence of hepatitis C, severity of hepatitis, viral load, biochemical hepatitis, and patient and graft survival.

Follow-up
24 months

CET Conclusions
In this study rising from the large multicentre randomised trial directed at the evaluation of the three different immunosuppressive protocols in HCV+ transplant recipients, the recurrence of HCV as determined by protocol biopsies was evaluated in deceased donor recipients and living donor recipients of a liver transplant. Outcomes were very similar in the two groups and recurrent HCV did not account for more deaths or more graft losses in the live donor recipients than in the deceased donor recipients. However the live donor group is quite small (n=35).

Jadad score
3

Data analysis
Available case analysis

Allocation concealment
Yes

Quality notes
This is a subgroup analysis of a previous publication of the same RCT: Klintmalm GB, Washburn WK, Rudich SM et al. Corticosteroid-free immunosuppression with daclizumab in HCV(+) liver transplant recipients: 1-year interim results of the HCV-3 study. Liver Transplantation, 2007: 13: 1521. The methodological quality assessment was based on the previous publication.

Trial registration
Not reported

Funding source
Industry funded