Contemporary management of cytomegalovirus infection in transplant recipients: guidelines from an IHMF workshop, 2007.

Publication Type:

Journal Article

Source:

Herpes : the journal of the IHMF, Volume 15, Issue 1, p.4-12 (2008)

Keywords:

2008, Antiviral Agents, Center-Authored Paper, Clinical Research Division, Clinical Trials as Topic, Cytomegalovirus Infections, Evidence-Based Medicine, Humans, Opportunistic Infections, Organ Transplantation, Stem Cell Transplantation, Vaccine and Infectious Disease Institute, Viral Load

Abstract:

An international workshop reviewed the evidence base for deploying antiviral drugs to prevent cytomegalovirus (CMV) end-organ diseases (EOD) as well as the indirect effects of CMV in transplant recipients. Published studies demonstrate that both prophylaxis and pre-emptive therapy can be effective strategies for preventing EOD. However, the optimal drug, dosage and duration of treatment have not been defined for either prophylaxis or pre-emptive therapy and vary by transplant population. Each of these strategies presents practical challenges, including ensuring compliance with the planned management protocol. Furthermore, there is no evidence that either strategy is superior to the other. Non-randomized clinical trials suggest that late-onset disease and antiviral resistance are more problematic with prophylaxis than pre-emptive therapy, while prophylaxis more clearly controls some of the indirect effects of CMV than does pre-emptive therapy. Because of the medical importance of these indirect effects, especially graft rejection, future studies should be powered to directly address their control. Because pre-emptive therapy for CMV disease is used widely in clinical practice, the ability of newer drugs administered prophylactically to reduce the need for pre-emptive therapy is an appropriate primary endpoint for the conduct of randomized controlled trials. International agreement is required on the standard comparator drug(s) against which new drugs should be compared. For debate, we suggest that baseline pre-emptive therapy with oral valganciclovir should be the comparator for new drug evaluation because it is widely used in clinical practice in many groups of transplant patients.