ABSTRACT
OBJECTIVES: Cytomegalovirus (CMV) infection is responsible for significant morbidity and mortality among solid organ transplant recipients. Prophylaxis using valganciclovir (VGCV) in orthotopic liver transplant (OLT) recipients is not approved by the Food and Drug Administration and its use is controversial. This study aimed to evaluate the effectiveness of VGCV in CMV prophylaxis in OLT recipients. METHODS: We carried out a retrospective, single-centre study including all OLT procedures performed during 2005-2008. Patients with early death (at ≤ 30 days), without CMV serology or prophylaxis, or with follow-up of <1 year were excluded. RESULTS: The overall incidence of CMV disease was 6% (n= 9). The ganciclovir (GCV) and VGCV groups had similar incidences of CMV disease (4.6% vs. 7.0%; P= 0.4) and similar distributions of disease presentation (CMV syndrome vs. tissue-invasive CMV; P= 0.4). Incidences of CMV infection, as well as disease presentation, were similar between the high-risk (CMV D+/R-) and non-high-risk groups (P= 0.16). Although acute cellular rejection occurred more frequently in patients who developed CMV disease (P= 0.005), overall survival in these patients did not differ from that in patients who did not develop CMV infection (P= 0.5). CONCLUSIONS: Valganciclovir is an effective antiviral for the prevention of CMV disease in liver transplant recipients. Our data support its use in high-risk OLT patients.
Subject(s)
Antiviral Agents/administration & dosage , Cytomegalovirus Infections/prevention & control , Ganciclovir/analogs & derivatives , Liver Transplantation , Acute Disease , Adult , Aged , Analysis of Variance , Baltimore , Chi-Square Distribution , Cytomegalovirus Infections/epidemiology , Cytomegalovirus Infections/mortality , Cytomegalovirus Infections/virology , Drug Administration Schedule , Female , Ganciclovir/administration & dosage , Graft Rejection/prevention & control , Graft Rejection/virology , Humans , Immunosuppressive Agents/adverse effects , Incidence , Kaplan-Meier Estimate , Liver Transplantation/adverse effects , Liver Transplantation/mortality , Male , Middle Aged , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , Valganciclovir , Young AdultABSTRACT
BACKGROUND: This study assessed the incidence of reported gastrointestinal (GI) complications in patients treated with enteric-coated mycophenolate sodium (EC-MPS) versus mycophenolate mofetil (MMF) and to examine the impact of dose manipulations on biopsy-proven acute rejection (BPAR). METHODS: A retrospective study was conducted in 379 renal transplant recipients initiated on EC-MPS or MMF through 3-months posttransplant between the years of 2001 to 2007. Descriptive univariate analyses were used for comparisons of baseline characteristics and outcome measures between the cohorts. A Cox proportional hazards model was used to evaluate the time to a first BPAR event. RESULTS: GI complications occurred at an incidence of 52.8% and 48.9% in the EC-MPS and MMF cohorts, respectively (NS). Patients requiring dose manipulations due to GI complications were 19.7% with EC-MPS and 25.3% with MMF (NS). The mean equimolar dose reduction below 2000 mg was 930+/-292.13 mg with EC-MPS and 933+/-173.95 mg with MMF (NS). Patients treated with EC-MPS experienced significantly fewer BPAR episodes than those treated with MMF (14% EC-MPS vs. 23.1% MMF; P =0.0221). CONCLUSIONS: In this study, EC-MPS had a similar incidence of GI complications and dose manipulations compared with MMF. Despite similar GI complication rates and dose manipulations, treatment with EC-MPS seemed to result in a lower incidence of BPAR. Based on these observations, more studies need to be conducted to evaluate risks for BPAR relating to mycophenolic acid product.
