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Randomized controlled trial of oral ganciclovir versus oral acyclovir after induction with intravenous ganciclovir for long-term prophylaxis of cytomegalovirus disease in cytomegalovirus-seropositive liver transplant recipients.
Transplantation. 2003 Jan 27; 75(2):229-33.T

Abstract

BACKGROUND

Without effective antiviral prophylaxis, cytomegalovirus (CMV) disease is a common cause of morbidity and mortality after liver transplantation. In this randomized, controlled trial, we compared the efficacy and safety of oral ganciclovir with oral acyclovir after induction with intravenous (IV) ganciclovir for long-term prophylaxis of CMV disease in CMV-seropositive liver transplant recipients.

METHODS

Patients were initially administered IV ganciclovir at a dose of 6 mg/kg per day from day 1 to day 14 after transplantation followed by either oral ganciclovir (1 g every 8 hr) or oral acyclovir (800 mg every 6 hr) from day 15 to day 100 after transplantation.

RESULTS

CMV disease occurred in only 1 of 110 patients (0.9%) receiving ganciclovir compared with 8 of 109 patients (7.3%) receiving acyclovir within the first year after transplantation (P =0.019). There was one case of CMV colitis in the ganciclovir group, whereas four cases of CMV syndrome, three cases of CMV pneumonia, and one case of CMV hepatitis developed in the acyclovir group. The only death from CMV disease occurred in an acyclovir-treated patient with CMV pneumonia. Both oral ganciclovir and oral acyclovir were generally well tolerated. Reversible leukopenia (decline in white blood cell count to <3.0 x 10(9)/L) was more common with oral ganciclovir (38/110 patients, 35%) than with oral acyclovir (20/109 patients, 18%) (P =0.009). The emergence of ganciclovir-resistant strains of CMV was not found during the study.

CONCLUSIONS

A prophylactic regimen of 2 weeks of IV ganciclovir followed by an additional 12 weeks of oral ganciclovir is superior to a similar regimen of IV ganciclovir followed by oral acyclovir and almost completely eliminates CMV disease after liver transplantation. This superior protection against CMV disease extends up to 1 year after transplantation and is not associated with ganciclovir resistance.

Authors+Show Affiliations

Division of Hematology-Oncology, Department of Medicine, and the Dumont-UCLA Transplant Center, Department of Surgery, UCLA Medical Center, Los Angeles, CA 90095, USA.No affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12548129

Citation

Winston, Drew J., and Ronald W. Busuttil. "Randomized Controlled Trial of Oral Ganciclovir Versus Oral Acyclovir After Induction With Intravenous Ganciclovir for Long-term Prophylaxis of Cytomegalovirus Disease in Cytomegalovirus-seropositive Liver Transplant Recipients." Transplantation, vol. 75, no. 2, 2003, pp. 229-33.
Winston DJ, Busuttil RW. Randomized controlled trial of oral ganciclovir versus oral acyclovir after induction with intravenous ganciclovir for long-term prophylaxis of cytomegalovirus disease in cytomegalovirus-seropositive liver transplant recipients. Transplantation. 2003;75(2):229-33.
Winston, D. J., & Busuttil, R. W. (2003). Randomized controlled trial of oral ganciclovir versus oral acyclovir after induction with intravenous ganciclovir for long-term prophylaxis of cytomegalovirus disease in cytomegalovirus-seropositive liver transplant recipients. Transplantation, 75(2), 229-33.
Winston DJ, Busuttil RW. Randomized Controlled Trial of Oral Ganciclovir Versus Oral Acyclovir After Induction With Intravenous Ganciclovir for Long-term Prophylaxis of Cytomegalovirus Disease in Cytomegalovirus-seropositive Liver Transplant Recipients. Transplantation. 2003 Jan 27;75(2):229-33. PubMed PMID: 12548129.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized controlled trial of oral ganciclovir versus oral acyclovir after induction with intravenous ganciclovir for long-term prophylaxis of cytomegalovirus disease in cytomegalovirus-seropositive liver transplant recipients. AU - Winston,Drew J, AU - Busuttil,Ronald W, PY - 2003/1/28/pubmed PY - 2003/2/14/medline PY - 2003/1/28/entrez SP - 229 EP - 33 JF - Transplantation JO - Transplantation VL - 75 IS - 2 N2 - BACKGROUND: Without effective antiviral prophylaxis, cytomegalovirus (CMV) disease is a common cause of morbidity and mortality after liver transplantation. In this randomized, controlled trial, we compared the efficacy and safety of oral ganciclovir with oral acyclovir after induction with intravenous (IV) ganciclovir for long-term prophylaxis of CMV disease in CMV-seropositive liver transplant recipients. METHODS: Patients were initially administered IV ganciclovir at a dose of 6 mg/kg per day from day 1 to day 14 after transplantation followed by either oral ganciclovir (1 g every 8 hr) or oral acyclovir (800 mg every 6 hr) from day 15 to day 100 after transplantation. RESULTS: CMV disease occurred in only 1 of 110 patients (0.9%) receiving ganciclovir compared with 8 of 109 patients (7.3%) receiving acyclovir within the first year after transplantation (P =0.019). There was one case of CMV colitis in the ganciclovir group, whereas four cases of CMV syndrome, three cases of CMV pneumonia, and one case of CMV hepatitis developed in the acyclovir group. The only death from CMV disease occurred in an acyclovir-treated patient with CMV pneumonia. Both oral ganciclovir and oral acyclovir were generally well tolerated. Reversible leukopenia (decline in white blood cell count to <3.0 x 10(9)/L) was more common with oral ganciclovir (38/110 patients, 35%) than with oral acyclovir (20/109 patients, 18%) (P =0.009). The emergence of ganciclovir-resistant strains of CMV was not found during the study. CONCLUSIONS: A prophylactic regimen of 2 weeks of IV ganciclovir followed by an additional 12 weeks of oral ganciclovir is superior to a similar regimen of IV ganciclovir followed by oral acyclovir and almost completely eliminates CMV disease after liver transplantation. This superior protection against CMV disease extends up to 1 year after transplantation and is not associated with ganciclovir resistance. SN - 0041-1337 UR - https://www.unboundmedicine.com/medline/citation/12548129/Randomized_controlled_trial_of_oral_ganciclovir_versus_oral_acyclovir_after_induction_with_intravenous_ganciclovir_for_long_term_prophylaxis_of_cytomegalovirus_disease_in_cytomegalovirus_seropositive_liver_transplant_recipients_ L2 - https://doi.org/10.1097/01.TP.0000040601.60276.96 DB - PRIME DP - Unbound Medicine ER -