Acyclovir (ACV) is the first effective antiviral agent for the prevention of cytomegalovirus (CMV) reactivation in stem cell transplanted patients. Herein, we compared two groups of patients receiving iv ACV from day -7 to day +20 after transplant followed by low-dose oral ACV (200 mg x 4/day) (group A) or high-dose oral ACV (800 mg x 4/day) (group B) for a period of 6 months after transplant. Aim of the study was to evaluate differences in CMV infection (detected by pp65 antigenemia), CMV disease, other herpes virus diseases, adverse events, probability of survival and transplant-related mortality (TRM) between the two groups. We analyzed 116 patients managed between January 1999 and November 2006. The first 60 patients received low-dose oral ACV; from March 2004, we prospectively administered in 56 patients high-dose oral ACV. The two groups were comparable for age, sex, disease, disease phase at transplant, CMV serology combination between donor and recipient at transplant, HLA compatibility, conditioning regimens and supportive therapy. No differences were observed between the two groups considering the rate of engraftment and acute and chronic GVHD. The cumulative incidence of CMV infection was 70% in group A and 54% in group B. This difference was statistically significant (p=0.03). We observed CMV disease in 2 patients in group A and in 1 patient in group B. Herpes virus disease was not observed in both groups during the first 6 months after transplant. Observed adverse events that were possibly related to treatment were nausea and vomiting (55% group A vs 66% group B) and creatinine increase (45% group A vs 56% group B). The 1- yr cumulative incidence of TRM was 17% and 21% for groups A and B, respectively (p=ns). The 1-yr probability of survival was 78% in both groups. In conclusion, we showed the efficacy of ACV prophylaxis to control herpes virus infection other than CMV in both groups of patients. The group receiving high-dose oral ACV showed a statistically significant lower incidence of CMV infection; however, no differences were observed between the two groups in the incidence of CMV disease, nor in survival or TRM after transplant. As expected, we observed a higher incidence of adverse events in the group of patients treated with highdose oral ACV. Randomized studies are required to confirm these results.
High dose acyclovir for cytomegalovirus infection prophylaxis after allogeneic stem cell transplantation / Iannella, E; Iori, Ap; Torelli, Gf; Milano, F; Capobianchi, A; Lucarelli, B; Malandruccolo, L; Valle, V; Arleo, E; Martino, P; Foà, R; Gentile, G. - In: HAEMATOLOGICA. - ISSN 0390-6078. - 92:(2007), pp. 103-103. (Intervento presentato al convegno 41st Congress of the Italian-Society-of-Hematology Location tenutosi a Bologna, ITALY).
High dose acyclovir for cytomegalovirus infection prophylaxis after allogeneic stem cell transplantation
Iannella,E;Milano, F;Capobianchi, A;Malandruccolo, L;Valle, V;Arleo, E;Martino, P;Foà, R;Gentile, G
2007
Abstract
Acyclovir (ACV) is the first effective antiviral agent for the prevention of cytomegalovirus (CMV) reactivation in stem cell transplanted patients. Herein, we compared two groups of patients receiving iv ACV from day -7 to day +20 after transplant followed by low-dose oral ACV (200 mg x 4/day) (group A) or high-dose oral ACV (800 mg x 4/day) (group B) for a period of 6 months after transplant. Aim of the study was to evaluate differences in CMV infection (detected by pp65 antigenemia), CMV disease, other herpes virus diseases, adverse events, probability of survival and transplant-related mortality (TRM) between the two groups. We analyzed 116 patients managed between January 1999 and November 2006. The first 60 patients received low-dose oral ACV; from March 2004, we prospectively administered in 56 patients high-dose oral ACV. The two groups were comparable for age, sex, disease, disease phase at transplant, CMV serology combination between donor and recipient at transplant, HLA compatibility, conditioning regimens and supportive therapy. No differences were observed between the two groups considering the rate of engraftment and acute and chronic GVHD. The cumulative incidence of CMV infection was 70% in group A and 54% in group B. This difference was statistically significant (p=0.03). We observed CMV disease in 2 patients in group A and in 1 patient in group B. Herpes virus disease was not observed in both groups during the first 6 months after transplant. Observed adverse events that were possibly related to treatment were nausea and vomiting (55% group A vs 66% group B) and creatinine increase (45% group A vs 56% group B). The 1- yr cumulative incidence of TRM was 17% and 21% for groups A and B, respectively (p=ns). The 1-yr probability of survival was 78% in both groups. In conclusion, we showed the efficacy of ACV prophylaxis to control herpes virus infection other than CMV in both groups of patients. The group receiving high-dose oral ACV showed a statistically significant lower incidence of CMV infection; however, no differences were observed between the two groups in the incidence of CMV disease, nor in survival or TRM after transplant. As expected, we observed a higher incidence of adverse events in the group of patients treated with highdose oral ACV. Randomized studies are required to confirm these results.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
