PMID- 26354293 OWN - NLM STAT- MEDLINE DCOM- 20161102 LR - 20181202 IS - 1399-3062 (Electronic) IS - 1398-2273 (Linking) VI - 17 IP - 6 DP - 2015 Dec TI - Occurrence of adverse events caused by valganciclovir as pre-emptive therapy for cytomegalovirus infection after allogeneic stem cell transplantation is reduced by low-dose administration. PG - 810-5 LID - 10.1111/tid.12456 [doi] AB - BACKGROUND: Pre-emptive therapy with valganciclovir (VGCV) has become the standard therapy for preventing cytomegalovirus (CMV) infection after allogeneic hematopoietic stem cell transplantation (HSCT). The effectiveness of low-dose VGCV (900 mg per day) has been shown to be equal to that of standard-dose VGCV (900 mg twice daily); however, individualized optimal dosing and toxicity of VGCV have not been reported. METHODS: We conducted a retrospective study to evaluate the optimal dose of VGCV as pre-emptive therapy for preventing CMV infection by comparing the frequency of adverse events (AEs) and clinical efficacy in a low-dose VGCV group with those in a standard-dose VGCV group. Thirty-eight patients who were administered VGCV because of CMV antigenemia after HSCT were analyzed. RESULTS: Neutropenia (standard-dose group: 33%, low-dose group: 15%, P = 0.26) and thrombocytopenia (standard-dose group: 39%, low-dose group: 15%, P = 0.14) were frequent AEs of VGCV, and a significantly higher frequency of overall AEs was detected in the standard-dose group than in the low-dose group (P < 0.01). In comparison of dosage based on weight, dosage of VGCV >27 mg/kg was closely related to onset of AEs (P = 0.04). CONCLUSIONS: Low-dose VGCV was not inferior in clinical efficacy, including clearance rate of CMV antigenemia and incidence of consequent CMV disease, to standard-dose VGCV as was previously reported. Initial low-dose VGCV for pre-emptive CMV therapy markedly reduces hematologic toxicity and has clinical efficacy equivalent to that of standard-dose VGCV. It is therefore reasonable for patients, except for noticeably overweight patients, to be given initial low-dose VGCV. CI - (c) 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. FAU - Takahata, M AU - Takahata M AD - Department of Hematology, Sapporo Hokuyu Hospital, Sapporo, Japan. FAU - Hashino, S AU - Hashino S AD - Health Care Center, Hokkaido University, Sapporo, Japan. FAU - Nishio, M AU - Nishio M AD - Department of Hematology, NTT Higashinihon Sapporo Hospital, Sapporo, Japan. FAU - Sugita, J AU - Sugita J AD - Department of Hematology, Hokkaido University Hospital, Sapporo, Japan. FAU - Shigematsu, A AU - Shigematsu A AD - Department of Hematology, Sapporo Hokuyu Hospital, Sapporo, Japan. FAU - Onozawa, M AU - Onozawa M AD - Department of Hematology, Hokkaido University Hospital, Sapporo, Japan. FAU - Fujimoto, K AU - Fujimoto K AD - Department of Hematology, Hokkaido University Hospital, Sapporo, Japan. FAU - Endo, T AU - Endo T AD - Department of Hematology, Hokkaido University Hospital, Sapporo, Japan. FAU - Kondo, T AU - Kondo T AD - Department of Hematology, Hokkaido University Hospital, Sapporo, Japan. FAU - Tanaka, J AU - Tanaka J AD - Department of Hematology, Tokyo Women's Medical University Hospital, Tokyo, Japan. FAU - Imamura, M AU - Imamura M AD - Department of Hematology, Sapporo Hokuyu Hospital, Sapporo, Japan. FAU - Teshima, T AU - Teshima T AD - Department of Hematology, Hokkaido University Hospital, Sapporo, Japan. LA - eng PT - Journal Article DEP - 20151105 PL - Denmark TA - Transpl Infect Dis JT - Transplant infectious disease : an official journal of the Transplantation Society JID - 100883688 RN - 0 (Antiviral Agents) RN - GCU97FKN3R (Valganciclovir) RN - P9G3CKZ4P5 (Ganciclovir) SB - IM MH - Antiviral Agents/administration & dosage/*adverse effects/therapeutic use MH - Cytomegalovirus Infections/*drug therapy MH - Dose-Response Relationship, Drug MH - Ganciclovir/administration & dosage/adverse effects/*analogs & derivatives/therapeutic use MH - Humans MH - Neutropenia/chemically induced MH - Stem Cell Transplantation/*adverse effects MH - Thrombocytopenia/chemically induced MH - Valganciclovir OTO - NOTNLM OT - CMV OT - VGCV OT - adverse events OT - low-dose administration OT - pre-emptive therapy EDAT- 2015/09/12 06:00 MHDA- 2016/11/03 06:00 CRDT- 2015/09/11 06:00 PHST- 2015/06/29 00:00 [received] PHST- 2015/08/09 00:00 [revised] PHST- 2015/08/18 00:00 [accepted] PHST- 2015/09/11 06:00 [entrez] PHST- 2015/09/12 06:00 [pubmed] PHST- 2016/11/03 06:00 [medline] AID - 10.1111/tid.12456 [doi] PST - ppublish SO - Transpl Infect Dis. 2015 Dec;17(6):810-5. doi: 10.1111/tid.12456. Epub 2015 Nov 5.