Utility of a monitoring strategy for human herpes viruses 6 and 7 viremia after liver transplantation: a randomized clinical trial.
Fernandez-Ruiz M, Kumar D, Husain S, et al.Transplantation [record in progress].
Aims
To investigate strategies based on the monitoring of human herpes viruses (HHV)-6 and HHV-7 by monitoring real-time polymerase chain reactions or usual care without monitoring.
Interventions
Patients were randomised to a monitoring or no monitoring arm. In the monitoring arm patients were tested for HHV-6 and HHV-7 viral loads by quantitative real-time PCR at baseline and at weekly intervals until the twelfth week after transplantation. Patients in the no-monitoring arm received standard care.
Participants
129 liver transplant recipients.
Outcomes
The primary outcome included post-transplant adverse events such as; symptomatic disease due to HHV-6 or HHV-7, cytomegalovirus (CMV) disease, other non-CMV opportunistic infections, invasive fungal infection, post-transplant lymphoproliferative disease, severe post-transplant hepatitis c virus recurrence, biopsy proven acute rejection, re-transplantation or death from any cause.
Follow-up
1-5 years.
CET Conclusions
129 liver transplant recipients had been randomised to either be monitored using PCR at weekly intervals from 0 to 12 weeks for the detection of HHV-6 and HHV-7 viraemia or not monitored and receiving usual care. If a positive PCR was found, intervention did include reduction of immunosuppression and pre-emptive antiviral therapy at the discretion of the attending team. In the monitored group viraemia with HHV-6 and HHV-7 occurred in 36% and 33% of patients respectively. There were no symptomatic cases of disease. No difference was found in the primary outcome of the monitored group and the non-monitored group at one year or at five years after transplantation. Thus no benefit could be demonstrated from routine monitoring of HHV-6 and HHV-7 viraemia in graft or patient outcome after liver transplantation.
Data analysis
Available case analysis
Trial registration
ClinicalTrials.gov – NCT00242099