Valganciclovir as treatment for cytomegalovirus disease in solid organ transplant recipients.
BACKGROUND
Cytomegalovirus (CMV) infection causes morbidity in solid organ transplant (SOT) recipients, either by direct injury or in association with chronic allograft rejection or other opportunistic infections. Ganciclovir is the treatment of choice, but this agent requires intravenous administration, which affects its feasibility for long-term use. Valganciclovir, which has an oral bioavailability of 60%, has proven to be useful for prophylaxis of CMV infection in high-risk SOT recipients and for treating retinitis in persons with acquired immunodeficiency syndrome.


OBJECTIVE
To compare the efficacy of valganciclovir (alone or as sequential therapy after a regimen of intravenous ganciclovir) with intravenous ganciclovir alone for preemptive therapy or treatment of CMV disease (viral syndrome or focal disease) in SOT recipients and to determine the incidence of adverse effects and relapses.


METHODS
In this 2-year prospective, comparative cohort study, 376 episodes of preemptive therapy or treatment of CMV disease were recorded among 334 of 3467 SOT recipients included in the Spanish Network for Research on Infection in Transplantation (RESITRA) database. Intravenous ganciclovir was the first-line treatment in 170 episodes; valganciclovir followed by intravenous ganciclovir was administered in 82 episodes, and valganciclovir alone was administered in 112 episodes.


RESULTS
Valganciclovir was used as preemptive therapy or treatment for CMV disease in 84 and 28 episodes, respectively. Duration of treatment was longer in valganciclovir recipients than in ganciclovir recipients for both preemptive therapy (21 vs. 15 days; P < .001) or viral syndrome treatment (21 vs. 18 days; P < .01). In the valganciclovir arm, 94 (83.9%) of 112 episodes were treated successfully, with no statistical difference in the success rates versus the ganciclovir arm (85.8%) or ganciclovir-valganciclovir arm (95.1%). Eighteen episodes (16.1%) treated with valganciclovir were considered to have resulted in treatment failure (because of persistent antigenemia in 4 [3.6%], on the basis of clinical decision in 7 [6.2%], and because of recurrent disease in 7 [6.2%]). There were no incidents in which valganciclovir treatment was withdrawn because of toxicity.


CONCLUSIONS
Valganciclovir is safe and useful for preemptive therapy and treatment of CMV disease.
Len
Oscar
O
Spanish Network for Research on Infection in Transplantation, Spain. olen@ir.vhebron.net
Gavaldà
Joan
J
Aguado
José María
JM
Borrell
Núria
N
Cervera
Carlos
C
Cisneros
José Miguel
JM
Cuervas-Mons
Valentín
V
Gurguí
Mercè
M
Martin-Dávila
Pilar
P
Montejo
Miguel
M
Muñoz
Patricia
P
Bou
Germán
G
Carratalà
Jordi
J
Torre-Cisneros
Julián
J
Pahissa
Albert
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D019072:Antibiotic Prophylaxis; D000998:Antiviral Agents / Q000627:therapeutic use*; D015331:Cohort Studies; D003586:Cytomegalovirus Infections / Q000188:drug therapy* / Q000517:prevention & control*; D004359:Drug Therapy, Combination; D005260:Female; D015774:Ganciclovir / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D016867:Immunocompromised Host; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control* / Q000821:virology; D011446:Prospective Studies; D014180:Transplantation; D014181:Transplantation Immunology; D000077562:Valganciclovir
D000998:Antiviral Agents; D000077562:Valganciclovir; D015774:Ganciclovir