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Blood, 15 April 2002, Vol. 99, No. 8, pp. 3050-3056
TRANSPLANTATION
Randomized study of valacyclovir as prophylaxis against
cytomegalovirus reactivation in recipients of allogeneic bone
marrow transplants
Per Ljungman,
Rafael de la Camara,
Noel Milpied,
Liisa Volin,
Charlotte A. Russell,
Adam Crisp,
Alison Webster, and
the Valacyclovir
International Bone Marrow Transplant Study Group
From the Department of Haematology, Huddinge University
Hospital, Stockholm, Sweden; the Department of Haematology, Hospital de
la Princesa, Madrid, Spain; the Department of Haematology, Hotel Dieu,
Nantes, France; the Department of Medicine, Helsinki University Central
Hospital, Finland; the Department of Haematology, Rigshopsitalet,
Copenhagen, Denmark; and Glaxo SmithKline Research and Development,
Greenford, United Kingdom.
Oral valacyclovir for cytomegalovirus (CMV) prophylaxis in bone
marrow transplantation (BMT) was investigated in a randomized, double-blind, acyclovir-controlled, multicenter clinical trial in
recipients of allogeneic BMT who were CMV seropositive (or donor
positive) before transplantation and were aged 13 years or older.
Patients were randomized before BMT. All initially received intravenous
acyclovir (500 mg/m2) 3 times daily until day 28 after transplantation or after discharge, then oral valacyclovir (2 g)
or acyclovir (800 mg) 4 times daily until week 18 after
transplantation. Evidence of CMV infection, CMV disease, and death were
documented for 22 weeks. Primary end points were time to CMV infection
(detection of CMV in blood, broncho-alveolar lavage) or CMV disease and
survival. Preemptive CMV therapy was permitted. Seven hundred
twenty-seven patients were evaluable for efficacy. After the
administration of intravenous acyclovir, valacyclovir was significantly
more effective than oral acyclovir in reducing the incidence of CMV
infection. CMV infection or disease developed in 102 (28%)
valacyclovir patients, compared with 143 (40%) acyclovir patients (HR,
0.59; 95% CI, 0.46-0.76; P < .0001). Survival did not
differ between treatments (76% and 75% in the valacyclovir and
acyclovir groups, respectively). The safety of oral valacyclovir was
similar to that of high-dose oral acyclovir. Valacyclovir was more
effective than acyclovir in preventing CMV reactivation in BMT
recipients and showed a similar safety profile. CMV disease incidence
was low, and no differences were observed between oral valacyclovir and
acyclovir. Survival was similar in each group. Valacyclovir prophylaxis
provides a clinically valuable intervention but must be part of an
overall strategy for CMV prevention in BMT.
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