Efficacy and Safety of Low‐Dose Valganciclovir for Prevention of Cytomegalovirus Disease in Renal Transplant Recipients: A Single‐Center, Retrospective Analysis
Abstract:A high rate of CMV disease was noted among the D+/R- population. Administration of ATG as an induction agent also increased the frequency of CMV disease. Despite the low dosage of valganciclovir, hematologic adverse events were common. However, valganciclovir, administered at 450 mg/day for 6 months, was effective and relatively safe for prophylaxis of CMV disease in renal transplant recipients.
“…Sun et al (28,32,38,(40)(41)(42)(43)(44)46,47,52,56 (28,31,32,35,37,38,40,(42)(43)(44)(45)(46)(47)50,51,56 (28,38,43,44).…”
Section: Risk Of CMV Disease With Prophylaxis a Total Of 2094 Patientmentioning
confidence: 99%
“…In the 10 studies that considered ganciclovir-resistance, five assessed if resistant virus existed by clinical observation and none was documented (35,45,48,52,53 (42). In the remaining three studies (36,54,55), patients were assessed for ganciclovir-resistant CMV as clinical indicated and one patient had documented resistant virus (54).…”
Section: The Duration From Transplantation To Development Of Late-onsmentioning
The precise impact of valganciclovir as preventive therapy for cytomegalovirus (CMV) in solid organ transplant (SOT) recipients is not fully defined. Data from studies using valganciclovir as preemptive therapy or prophylaxis for CMV in SOT recipients were synthesized for descriptive analysis. CMV disease occurred in 2.6% and 9.9% of the patients receiving valganciclovir as preemptive therapy and prophylaxis, respectively. Although the incidence of early-onset (≤90 days posttransplant) CMV disease was only 0.8% and 1.2% in all patients and R-/D+ patients receiving valganciclovir prophylaxis, the incidence of late-onset (>90 days posttransplant) CMV disease rose up to 8.9% and 17.7% in the prophylactic group, respectively. On the contrary, no patients developed late-onset CMV disease in preemptive group. Both approaches with valganciclovir have successfully decreased CMV disease in SOT recipients. Late-onset CMV disease is a complication observed uniquely with valganciclovir prophylaxis, particularly in R-/D+ patients, but not with preemptive therapy.
“…Sun et al (28,32,38,(40)(41)(42)(43)(44)46,47,52,56 (28,31,32,35,37,38,40,(42)(43)(44)(45)(46)(47)50,51,56 (28,38,43,44).…”
Section: Risk Of CMV Disease With Prophylaxis a Total Of 2094 Patientmentioning
confidence: 99%
“…In the 10 studies that considered ganciclovir-resistance, five assessed if resistant virus existed by clinical observation and none was documented (35,45,48,52,53 (42). In the remaining three studies (36,54,55), patients were assessed for ganciclovir-resistant CMV as clinical indicated and one patient had documented resistant virus (54).…”
Section: The Duration From Transplantation To Development Of Late-onsmentioning
The precise impact of valganciclovir as preventive therapy for cytomegalovirus (CMV) in solid organ transplant (SOT) recipients is not fully defined. Data from studies using valganciclovir as preemptive therapy or prophylaxis for CMV in SOT recipients were synthesized for descriptive analysis. CMV disease occurred in 2.6% and 9.9% of the patients receiving valganciclovir as preemptive therapy and prophylaxis, respectively. Although the incidence of early-onset (≤90 days posttransplant) CMV disease was only 0.8% and 1.2% in all patients and R-/D+ patients receiving valganciclovir prophylaxis, the incidence of late-onset (>90 days posttransplant) CMV disease rose up to 8.9% and 17.7% in the prophylactic group, respectively. On the contrary, no patients developed late-onset CMV disease in preemptive group. Both approaches with valganciclovir have successfully decreased CMV disease in SOT recipients. Late-onset CMV disease is a complication observed uniquely with valganciclovir prophylaxis, particularly in R-/D+ patients, but not with preemptive therapy.
“…Furthermore, literature evidence says incidence of thrombocytopenia with low-dose valganciclovir as prophylaxis for CMV infections in post-transplant patients was 24% and almost 20% of patients discontinued valganciclovir due to thrombocytopenia [8].…”
Triple immunosuppression is very pivotal in maintaining the graft in case of renal transplantation. But because of severe immunosuppression, always there is chance of severe adverse effects. Hematological toxicity is usually very common but dreaded in case of renal transplant patients. Here, we report a case of valganciclovir-induced drop in platelet counts in a postrenal transplant patient.
“…41 Gabardi and associates also concentrated on intermediate-risk patients (>80%) and concluded that valganciclovir administered at 450 mg/d for 6 months was effective and relatively safe for prophylaxis of CMV disease in kidney transplant recipients. 42 Emergence of CMV resistance is a major concern with low-dose valganciclovir, especially for high-risk patients. 18 Our study included intermediate-risk patients who had lower incidence of CMV infections and did not report any CMV resistance.…”
Objectives: Prophylaxis for cytomegalovirus infection is highly recommended for kidney transplant recipients. The use of daily 900 mg valganciclovir is the usual prophylactic dose, whereas 450 mg daily is under investigation. We evaluated the outcome of using 2 different doses of valganciclovir prophylaxis for cytomegalovirus infection after kidney transplant. Materials and Methods: We randomized kidney transplant recipients (1:1) to receive 450 mg daily valganciclovir (group 1) or 900 mg daily valganciclovir (group 2) for the first 6 months after kidney transplant. Serologically, all patients were at moderate risk for cytomegalovirus infection. Patients were studied for incidence of cytomegalovirus disease, leukopenia attacks, rejection episodes, and graft outcomes for 1 year. Results: Demographic features of group 1 (98 patients) and group 2 (98 patients) were comparable. More than 50% of patients received thymoglobulin induction therapy without difference between the groups. There were more leukopenia attacks in group 2 (P = .03) requiring higher doses of granulocyte colonystimulating factor (P = .03). Group 2 patients received lower doses of mycophenolate mofetil (P= .04) and required reduced doses of valganciclovir (P = .045). Compared with group 1, the high-dose group developed numerically more rejection episodes (P = .057) and more cytomegalovirus infections requiring full treatment (P = .17). Graft and patient outcomes were satisfactory in both groups.
Conclusion:Six months of low-dose valganciclovir prophylaxis for intermediate-risk kidney transplant recipients was as effective as high-dose valganciclovir with a better safety profile.
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