Original clinical science
Cytomegalovirus Prevention in High-risk Lung Transplant Recipients: Comparison of 3- vs 12-Month Valganciclovir Therapy

https://doi.org/10.1016/j.healun.2009.03.012Get rights and content

Background

Cytomegalovirus (CMV) infections are common after lung transplantation (LuTx) and have an influence on acute rejection rates and chronic organ dysfunction. The objective of this study was to determine the incidence of CMV infections by comparing a prolonged valganciclovir prophylaxis with a standard regimen in high-risk LuTx recipients.

Methods

A retrospective, single-center study was performed comparing two different CMV prophylactic regimens in high-risk LuTx recipients (D+/R). The study population received either 3 months (Group A, 15 patients) or 12 months (Group B, 17 patients) of oral valganciclovir 900 mg/day in combination with CMV hyperimmune globulin in four doses (Days 1, 7, 14 and 21 post-transplant).

Results

CMV viremia was noted in 11 of 15 patients in Group A (75%) and 5 of 17 in Group B (33%) (p < 0.05) at 6 months after valganciclovir cessation. The incidence of symptomatic CMV disease/syndrome was 6 of 15 (44%) in Group A and 2 of 17 in Group B (13%) (p < 0.05). Histologically proven acute rejection episodes of ISHLT Grade ≥A2 were found in 4 patients in Group A and in 1 patient in Group B within the first year (p = 0.14).

Conclusions

A 12-month CMV prophylaxis with oral valganciclovir is effective in significantly reducing CMV viremia and CMV disease/syndrome in high-risk lung transplant recipients. In addition, a reduction in acute and recurrent rejection episodes was observed, possibly due to less CMV viremia and subsequent immunomodulatory effects.

Section snippets

Study Design

Between October 2002 and November 2004, all at-risk lung transplant recipients received a combined prophylaxis with IV ganciclovir for 2 weeks and four doses (Days 1, 7, 14 and 21 post-transplant) of CMV IVIg (Cytotect; Biotest GmbH, Vienna, Austria), followed by valganciclovir for 3 months. After December 2004, all high-risk patients (D+/R) were treated with valganciclovir for 12 months, again starting with IV ganciclovir for 2 weeks and four doses of CMV IVIg. All patients received

Results

A total of 32 patients were included in the study. Fifteen patients received 3-month CMV prophylaxis (Group A) and 17 patients had 12-month (Group B) CMV prophylaxis with valganciclovir. Mean age was 44.8 ± 16.9 years in Group A and 46.1 ± 12.5 years in Group B (p = not statistically significant [NS]). Table 1 presents data for the two groups. Follow-up was complete for all patients in both groups (mean follow-up period 996 ± 365 days).

Table 2, Table 3 and Figure 1, Figure 2 display results of

Discussion

The aim of the study was to compare the efficacy of two different prophylactic strategies in high-risk lung transplant recipients with CMV serostatus D+/R. Both groups received CMV hyperimmunoglobulin four times: Group A received a 3-month valganciclovir prophylaxis and Group B received a 12-month prophylaxis.

Both regimens achieved good viral suppression while on therapy, with just one detectable CMV viremia in each arm. After cessation of valganciclovir prophylaxis, CMV viremia and disease

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