Results of a phase I/II British Society of Bone Marrow Transplantation study on PCR-based pre-emptive therapy with valganciclovir or ganciclovir for active CMV infection following alemtuzumab-based reduced intensity allogeneic stem cell transplantation.
This multi-centre randomized study assessed the bioavailability of ganciclovir in patients undergoing alemtuzumab-based reduced intensity conditioning (RIC) haematopoietic stem cell transplantation (HSCT) after oral administration of valganciclovir. Patients were randomized to 2 groups receiving either oral valganciclovir (900 mg twice daily) or intravenous ganciclovir (5mg/kg twice daily) for 14 days. Twenty-seven patients were recruited and 18 patients (67%) completed allocated treatment resulting in clearance of cytomegolovirus (CMV) DNA load at a median of 14 days. The bioavailability of ganciclovir from valganciclovir was 73% (95% CI: 34-112%). The average exposure in the valganciclovir group (36.9+/-14.9 microg h/ml) was higher than the ganciclovir cohort (27.9+/-7.5 microg h/ml). When compared with intravenous ganciclovir, oral valganciclovir had high bioavailability in patients undergoing alemtuzumab-based RIC HSCT.
Lim
Z Y
ZY
Department of Haematological Medicine, Kings College Hospital, London, UK.
Cook
G
G
Johnson
P R
PR
Parker
Anne
A
Zuckerman
M
M
Marks
D
D
Wiltshire
H
H
Mufti
G J
GJ
Pagliuca
A
A
D000328:Adult; D000368:Aged; D000074323:Alemtuzumab; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm / Q000008:administration & dosage*; D003586:Cytomegalovirus Infections / Q000188:drug therapy* / Q000517:prevention & control; D004279:DNA, Viral / Q000187:drug effects; D015774:Ganciclovir / Q000008:administration & dosage* / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D016133:Polymerase Chain Reaction; D011292:Premedication / Q000379:methods*; D019172:Transplantation Conditioning / Q000379:methods; D014184:Transplantation, Homologous; D000077562:Valganciclovir; D019562:Viral Load
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm; D004279:DNA, Viral; D000074323:Alemtuzumab; D000077562:Valganciclovir; D015774:Ganciclovir