Comparison of universal prophylaxis and preemptive treatment with valganciclovir in management of cytomegalovirus infection in heart transplant recipients

Abstract

Background: Cytomegalovirus (CMV) is a major cause of infection in the early period after heart transplantation (HTx). There are limited data comparing universal prophylaxis with preemptive treatment of CMV infection in HTx recipients. Therefore, the goal of this study was to evaluate efficacy and safety of both strategies. Methods: A total of 17 HTx recipients were prospectively enrolled in the universal prophylaxis group. This study cohort was matched with 18 HTx recipients who had the same immunosuppressive regimen and received preemptive therapy for CMV infection. All patients were CMV-seropositive. The study group received oral valganciclovir in a dose of 900 mg daily for 100 days. The second group was treated in case of CMV viraemia higher than 500 copies/ml. The incidence of CMV infection, other opportunistic infections and acute graft rejection and adverse events were evaluated at 3 th , 6 th and 12 th months post-transplant. Results: Universal prophylaxis was well tolerated in 87.5% of the patients for a period of 100 days. Leukopenia was the most frequent side-effect that appeared in 25% of this group. This strategy decreased the rate of asymptomatic CMV infection during the first three months after HTx (11.7% vs 55.6%, p = 0.006) compared with preemptive therapy. This positive effect was associated with lower incidence of acute graft rejection at 12 months of follow up (6.3% vs 41.2%, p = 0.015). Conclusion:Universal prophylaxis with valganciclovir in CMV-seropositive HTx recipients was acceptably safe and compared with preemptive therapy of CMV infection reduced the incidence of asymptomatic CMV infection and of acute graft rejection. SOUHRNKontext: Cytomegalovirus (CMV) je jedním z hlavních původců infekce v časném pooperačním období po transplantaci srdce (OTS). V současnosti existují pouze omezená data srovnávající univerzální profylaxi s preemptivní terapií CMV infekce u pacientů po OTS. Cílem naší prospektivní studie bylo posoudit účinnost a bezpečnost obou metod. Metody: Do skupiny s univerzální profylaxí bylo zařazeno celkem 17 příjemců OTS. Kontrolní skupinu tvořilo 18 pacientů, kterým byla podána preemptivní terapie. Všichni pacienti měli zavedenou stejnou imunosupresivní léčbu a byli CMV sérologicky pozitivní. Za účelem univerzální profylaxe byl podán perorální valganciclovir v dávce 900 mg denně po dobu 100 dnů. Ve skupině s preemptivní terapií byla zahájena léčba

Bone marrow suppression and associated consequences in patients after heart transplantation: A 6-year retrospective review

“…First, addition of VGC to therapy is likely to decrease the incidence of CMV infections that have been associated with indirect adverse effects such as increased incidence of acute graft rejections [26][27][28] . Second, although it is generally known that both MMF and VGC are eliminated by renal excretion, no convincing data are available on potential pharmacokinetic interaction between both drugs.…”