Oral valganciclovir as pre-emptive therapy has similar efficacy on cytomegalovirus DNA load reduction as intravenous ganciclovir in allogeneic stem cell transplantation recipients

Abstract

The efficacy and safety of oral valganciclovir was compared to ganciclovir i.v. in pre-emptive treatment of cytomegalovirus (CMV) in T-cell-depleted allogeneic stem cell transplant (allo-SCT) recipients. A therapeutic guideline was developed to allow the safe application of valganciclovir in allo-SCT recipients requiring CMV therapy. In total, 107 consecutive transplant recipients were evaluated. Cytomegalovirus DNA load in plasma was monitored longitudinally; details on antiviral therapy and treatment responses were analyzed retrospectively. Fifty-seven CMV treatment episodes were recorded in 34 patients: 20 with valganciclovir (900 mg twice-daily) and 37 with ganciclovir (5 mg/kg twice-daily). Median CMV DNA load reduction was 0.079 and 0.069 log 10 copies/ml/ day in the ganciclovir and valganciclovir group, respectively. Good response on CMV DNA load (reduction below 3.0 log 10 copies/ml) was observed in 75.7% of ganciclovir and 80.0% of valganciclovir treatment episodes. Severe adverse effects were not observed and CMV-related disease did not occur. However, the percentage of patients receiving erythrocyte transfusion was higher in the group of patients receiving ganciclovir as compared to valganciclovir (41 versus 20%, P ¼ 0.116). In conclusion, pre-emptive treatment with valganciclovir and ganciclovir, led to similar reduction of CMV DNA load. Oral valganciclovir is an attractive and safe alternative for pre-emptive CMV treatment in T-cell-depleted allo-SCT recipients.

Oral Valganciclovir Is Noninferior to Intravenous Ganciclovir for the Treatment of Cytomegalovirus Disease in Solid Organ Transplant Recipients

“…Reasons for these differences may include sample size, the frequency of viral load measurements, and differences in immunologic parameters, such as CMV specific T-cell responses in different populations (19). However, the viral load reductions of 1.06% and 1.07% copies/mL/day for the valganciclovir and ganciclovir groups, respectively, are similar to those achieved in allogenic stem cell transplantation (20). A median initial lag phase of approximately 6 days was commonly observed before a sustained reduction in viral load was achieved, especially in patients with high initial viral loads.…”

Prevention and Treatment of Cancer-Related Infections

“…160,161 Oral valganciclovir used as preemptive anti-CMV therapy was shown to have acceptable oral bioavailability and was safe and effective in controlling CMV infection in allogeneic HSCT recipients, including in patients with grades I and II gastrointestinal GVHD. 160,[162][163][164] Thus, valganciclovir is a highly acceptable oral option for preemptive therapy for CMV in the absence of substantial gastrointestinal GVHD.…”

Monitoring of Trough Plasma Ganciclovir Levels and Peripheral Blood Cytomegalovirus (CMV)-Specific CD8 + T Cells To Predict CMV DNAemia Clearance in Preemptively Treated Allogeneic Stem Cell Transplant Recipients

“…These two drugs display similar efficacies in CMV DNA clearance (2), despite the fact that V-GCV leads to higher exposure than does GCV (3). Since intracellular GCV triphosphate is the active form of this compound, the plasma GCV concentration is simply a surrogate of the drug's antiviral activity (1,2).…”

“…These two drugs display similar efficacies in CMV DNA clearance (2), despite the fact that V-GCV leads to higher exposure than does GCV (3). Since intracellular GCV triphosphate is the active form of this compound, the plasma GCV concentration is simply a surrogate of the drug's antiviral activity (1,2). Monitoring trough plasma GCV levels in AIDS patients receiving oral GCV as maintenance therapy for CMV retinitis was shown to be clinically useful in predicting therapy failure and disease progression (4,5).…”