Immunglobuline in der transplantationsmedizin: Prävention und therapie von cytomegalievirus-infektionen ein assessment

Background: Cytomegalovirus (CMV) infections are one of the most common infection complications of transplant recipients. In immune competent persons CMV infections are usually asymptomatic but in immune compromised patients there can be fatal consequences. CMV infections are linked to graft dysfunction and graft loss. The most favourable prophylactic treatment/therapy regime and the starting point of the intervention are under long lasting discussion. Aim and Methods: The aim of this health technology assessment (HTA) was to analyse the clinical effectiveness of immunoglobulins (IG) for prevention/therapy of CMV infections in transplant recipients and to compare IG with other prevention/therapy regimes (virustatica, e.g. Ganciclovir) with regard to clinical effectiveness and cost efficiency. This assessment is based on a systematic review and a meta analysis. Additionally basic knowledge on CMV infection, frequency of transplantations and cost issues are analysed. Results: With IG there is a significant reduction of CMV infections and diseases in comparison with placebo or no prophylactic treatment/therapy. A comparison of effectiveness based on a systematic review and meta analysis gives no evidence that IG are more effective than virustatica. There is also no evidence for additional effects of IG in antiviral therapy. A review of cost-efficiency/clinical effectiveness studies shows that virustatica are the most cost efficient option for prophylactic treatment/therapy of CMV infections. Conclusion: Before clinical symptoms appear, the active CMV infection can already be diagnosed by laboratory tests. This allows for a combined CMV management consisting of risk adapted prophylactic treatment in high risk groups and the start of preemptive therapy. For risk evaluation the most important criteria are: CMV antibody constellation between donor and recipient, the type of immune suppressive therapy and the transplanted organ itself. Despite lower toxicity of IG this added value is only marginal because of the many times higher price and the similar, inclining lower clinical effectiveness in comparison to virustatica (e.g. Ganciclovir). From the clinical and economical point of view systematic decisions in the CMV management are necessary: analysis of the actual situation, compilation of working papers for concrete internal standards founded on evidence based guidelines with documentation, including patients in well designed, multicentric studies and considering the establishment of a CMV coordinator.