Treatment of cytomegalovirus disease in solid organ transplant recipients: Markers of inflammation as predictors of outcome.
Rollag H, Asber A, et al.Transplantation 2012; 94 (10): 1060-1065.
Aims
This is a subgroup analysis of the VICTOR trial which compared oral valganciclovir and intravenous ganciclovir for the eradication of cytomegalovirus disease (CMV) in solid organ transplant recipients. The study uses VICTOR trial data to evaluate the association between inflammatory markers and the clinical and virologic outcome of treatment for CMV.
Interventions
Patients received oral valganciclovir (900 mg twice daily) or intravenous ganciclovir (5mg/kg twice daily) for 21 days, followed by maintenance treatment with valganciclovir (900 mg once daily) in all patients up to day 49.
Participants
248 patient samples were taken from adult solid organ transplantation recipients with virologic and clinical evidence of CMV disease.
Outcomes
The primary outcome was the treatment success; plasma DNAemia below level of detection at day 21. The secondary outcome measures included the clinical outcome at day 21, clinical recurrence and virologic recurrence.
Follow-up
1 year.
CET Conclusions
In this post hoc analysis of the VICTOR trial a number of inflammatory markers were measured before treatment and their possible association with the outcome of prophylaxis for a CMV infection was evaluated. The results suggest that there may well be a link between CMV infection and inflammation that may influence the outcome of anti CMV therapy. However as the VICTOR trial was not of particular good quality, this post hoc analysis can be no more than suggestive.
Data analysis
Modified intention-to-treat analysis
Quality notes
Score based on Asberg A, Humar A, et al. Oral valganciclovir is noninferior to intravenous ganciclovir for the treatment of cytomegalovirus disease in solid organ transplant recipients. American Journal of Transplantation 2007; 7:2106.
Trial registration
ClinicalTrials.gov - NCT00431353 (VICTOR trial)