Sustained Virological Response to Antiviral Therapy in a Randomized Trial of Cyclosporine versus Tacrolimus in Liver Transplant Patients with Recurrent Hepatitis C Infection.
Duvoux C, Villamil F, et al.Annals of Transplantation 2015; 20: 25-35.
Aims
To determine whether patients treated with Cyclosporine versus tacrolimus would have a higher sustained virological response (SVR) after the end of a 48-week course of antiviral therapy.
Interventions
Patients randomized to the Cyclosporine (CsA) group received CsA at an initial dose of 5 mg/kg, adjusted to target C2 blood levels of 800ng/mL to month 12, and 600 thereafter, or C0 blood levels of 175ng/mL to month 12, and 125ng/mL thereafter. In the tacrolimus group, C0 level was maintained within the range of 5–10 ng/mL.
Participants
92 liver transplant patients aged 18-70 with recurrent HCV infection
Outcomes
The primary outcome measured was SVR at 24±12 weeks after the end of antiviral therapy. Secondary outcomes measured were rate of rapid virological response, rate of early virological response, end-of-treatment response, non-responder rate, relapse rate, fibrosis progression, biopsy-proven acute rejection, death or graft loss, adverse events, laboratory measurements, and vital signs.
Follow-up
80 weeks
CET Conclusions
In this multicentre study, liver transplant recipients with Hepatitis C infection were randomised to either cyclosporine or tacrolimus in conjunction with pegylated interferon and ribavirin. On the basis of previous studies, the authors hypothesised that the sustained virological response to treatment would be superior in the cyclosporine arm. Unfortunately, the study struggled to recruit, and of the 276 patients planned, only 92 were randomised and 43 included in the primary endpoint analysis (16%). This leaves the study underpowered and unable to detect any difference in outcomes. A number of possible reasons for the failure to recruit are discussed – perhaps reinforcing the idea of a pilot or feasibility study when recruitment difficulties are predicted.
Data analysis
Modified intention-to-treat analysis
Trial registration
NCT00938860