Prophylaxis of cytomegalovirus infection in liver transplantation

A randomized trial comparing a combination of ganciclovir and acyclovir to acyclovir

Andrew David Badley, Eric C. Seaberg, Michael K. Porayko, Russell H. Wiesner, Michael R. Keating, Mark P. Wilhelm, Randall C. Walker, Robin Patel, William F. Marshall, Michael Debernardi, Rowen Zetterman, Jeffrey L. Steers, Carlos V. Paya

Research output: Contribution to journalArticle

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Abstract

Background. The optimal prophylactic regimen to prevent cytomegalovirus (CMV) infection and disease in orthotopic liver-transplant patients remains to be established. We tested whether a combination of intravenous ganciclovir (GCV) followed by high dosages of oral acyclovir (ACV) for 4 months provided a higher degree of protection from CMV than oral ACV alone. Methods. One hundred sixty-seven liver-transplant recipients were randomized to receive 120 days of antiviral treatment starting at the time of transplantation consisting of either ACV 800 mg orally four times daily (n=84) or 14 days of GCV 5 mg/kg intravenously every 12 hr followed by oral ACV 800 mg four times daily (n=83). Prospective laboratory and clinical surveillance was performed to determine primary endpoints (onset of CMV infection and CMV disease) and secondary endpoints (rates of fungal and bacterial infection, allograft rejection, and survival after transplantation). One-year event rates are presented as cumulative percentages. Results. During the first year after transplantation, CMV infection developed in 57% of patients treated with ACV and in 37% of patients treated with GCV + ACV (P=0.001). CMV disease developed in 23% of patients treated with ACV and in 11% of patients treated with GCV + ACV (P=0.03). In seronegative recipients of allografts from CMV- seropositive donors (D+/R-), CMV disease developed in 58% of patients treated with ACV and in 25% of patients treated with GCV + ACV (P=0.04). In the D+/R- group, 54% of patients treated with ACV and 17% of patients treated with GCV + ACV developed infection with Candida albicans (P=0.05). Conclusions. Prophylaxis of CMV infection in liver-transplant patients with 14 days of intravenous GCV followed by high-dosage oral ACV is more effective than high- dosage oral ACV alone at reducing CMV infection and disease, even for patients in the D+/R- CMV serological group.

Original languageEnglish (US)
Pages (from-to)66-73
Number of pages8
JournalTransplantation
Volume64
Issue number1
DOIs
StatePublished - Jul 15 1997

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Ganciclovir
Acyclovir
Cytomegalovirus Infections
Liver Transplantation
Cytomegalovirus
Transplantation
Allografts
Liver
Transplants
Mycoses
Candida albicans
Bacterial Infections
Antiviral Agents

ASJC Scopus subject areas

  • Transplantation
  • Immunology

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Prophylaxis of cytomegalovirus infection in liver transplantation : A randomized trial comparing a combination of ganciclovir and acyclovir to acyclovir. / Badley, Andrew David; Seaberg, Eric C.; Porayko, Michael K.; Wiesner, Russell H.; Keating, Michael R.; Wilhelm, Mark P.; Walker, Randall C.; Patel, Robin; Marshall, William F.; Debernardi, Michael; Zetterman, Rowen; Steers, Jeffrey L.; Paya, Carlos V.

In: Transplantation, Vol. 64, No. 1, 15.07.1997, p. 66-73.

Research output: Contribution to journalArticle

Badley, AD, Seaberg, EC, Porayko, MK, Wiesner, RH, Keating, MR, Wilhelm, MP, Walker, RC, Patel, R, Marshall, WF, Debernardi, M, Zetterman, R, Steers, JL & Paya, CV 1997, 'Prophylaxis of cytomegalovirus infection in liver transplantation: A randomized trial comparing a combination of ganciclovir and acyclovir to acyclovir', Transplantation, vol. 64, no. 1, pp. 66-73. https://doi.org/10.1097/00007890-199707150-00013
Badley, Andrew David ; Seaberg, Eric C. ; Porayko, Michael K. ; Wiesner, Russell H. ; Keating, Michael R. ; Wilhelm, Mark P. ; Walker, Randall C. ; Patel, Robin ; Marshall, William F. ; Debernardi, Michael ; Zetterman, Rowen ; Steers, Jeffrey L. ; Paya, Carlos V. / Prophylaxis of cytomegalovirus infection in liver transplantation : A randomized trial comparing a combination of ganciclovir and acyclovir to acyclovir. In: Transplantation. 1997 ; Vol. 64, No. 1. pp. 66-73.
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abstract = "Background. The optimal prophylactic regimen to prevent cytomegalovirus (CMV) infection and disease in orthotopic liver-transplant patients remains to be established. We tested whether a combination of intravenous ganciclovir (GCV) followed by high dosages of oral acyclovir (ACV) for 4 months provided a higher degree of protection from CMV than oral ACV alone. Methods. One hundred sixty-seven liver-transplant recipients were randomized to receive 120 days of antiviral treatment starting at the time of transplantation consisting of either ACV 800 mg orally four times daily (n=84) or 14 days of GCV 5 mg/kg intravenously every 12 hr followed by oral ACV 800 mg four times daily (n=83). Prospective laboratory and clinical surveillance was performed to determine primary endpoints (onset of CMV infection and CMV disease) and secondary endpoints (rates of fungal and bacterial infection, allograft rejection, and survival after transplantation). One-year event rates are presented as cumulative percentages. Results. During the first year after transplantation, CMV infection developed in 57{\%} of patients treated with ACV and in 37{\%} of patients treated with GCV + ACV (P=0.001). CMV disease developed in 23{\%} of patients treated with ACV and in 11{\%} of patients treated with GCV + ACV (P=0.03). In seronegative recipients of allografts from CMV- seropositive donors (D+/R-), CMV disease developed in 58{\%} of patients treated with ACV and in 25{\%} of patients treated with GCV + ACV (P=0.04). In the D+/R- group, 54{\%} of patients treated with ACV and 17{\%} of patients treated with GCV + ACV developed infection with Candida albicans (P=0.05). Conclusions. Prophylaxis of CMV infection in liver-transplant patients with 14 days of intravenous GCV followed by high-dosage oral ACV is more effective than high- dosage oral ACV alone at reducing CMV infection and disease, even for patients in the D+/R- CMV serological group.",
author = "Badley, {Andrew David} and Seaberg, {Eric C.} and Porayko, {Michael K.} and Wiesner, {Russell H.} and Keating, {Michael R.} and Wilhelm, {Mark P.} and Walker, {Randall C.} and Robin Patel and Marshall, {William F.} and Michael Debernardi and Rowen Zetterman and Steers, {Jeffrey L.} and Paya, {Carlos V.}",
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T1 - Prophylaxis of cytomegalovirus infection in liver transplantation

T2 - A randomized trial comparing a combination of ganciclovir and acyclovir to acyclovir

AU - Badley, Andrew David

AU - Seaberg, Eric C.

AU - Porayko, Michael K.

AU - Wiesner, Russell H.

AU - Keating, Michael R.

AU - Wilhelm, Mark P.

AU - Walker, Randall C.

AU - Patel, Robin

AU - Marshall, William F.

AU - Debernardi, Michael

AU - Zetterman, Rowen

AU - Steers, Jeffrey L.

AU - Paya, Carlos V.

PY - 1997/7/15

Y1 - 1997/7/15

N2 - Background. The optimal prophylactic regimen to prevent cytomegalovirus (CMV) infection and disease in orthotopic liver-transplant patients remains to be established. We tested whether a combination of intravenous ganciclovir (GCV) followed by high dosages of oral acyclovir (ACV) for 4 months provided a higher degree of protection from CMV than oral ACV alone. Methods. One hundred sixty-seven liver-transplant recipients were randomized to receive 120 days of antiviral treatment starting at the time of transplantation consisting of either ACV 800 mg orally four times daily (n=84) or 14 days of GCV 5 mg/kg intravenously every 12 hr followed by oral ACV 800 mg four times daily (n=83). Prospective laboratory and clinical surveillance was performed to determine primary endpoints (onset of CMV infection and CMV disease) and secondary endpoints (rates of fungal and bacterial infection, allograft rejection, and survival after transplantation). One-year event rates are presented as cumulative percentages. Results. During the first year after transplantation, CMV infection developed in 57% of patients treated with ACV and in 37% of patients treated with GCV + ACV (P=0.001). CMV disease developed in 23% of patients treated with ACV and in 11% of patients treated with GCV + ACV (P=0.03). In seronegative recipients of allografts from CMV- seropositive donors (D+/R-), CMV disease developed in 58% of patients treated with ACV and in 25% of patients treated with GCV + ACV (P=0.04). In the D+/R- group, 54% of patients treated with ACV and 17% of patients treated with GCV + ACV developed infection with Candida albicans (P=0.05). Conclusions. Prophylaxis of CMV infection in liver-transplant patients with 14 days of intravenous GCV followed by high-dosage oral ACV is more effective than high- dosage oral ACV alone at reducing CMV infection and disease, even for patients in the D+/R- CMV serological group.

AB - Background. The optimal prophylactic regimen to prevent cytomegalovirus (CMV) infection and disease in orthotopic liver-transplant patients remains to be established. We tested whether a combination of intravenous ganciclovir (GCV) followed by high dosages of oral acyclovir (ACV) for 4 months provided a higher degree of protection from CMV than oral ACV alone. Methods. One hundred sixty-seven liver-transplant recipients were randomized to receive 120 days of antiviral treatment starting at the time of transplantation consisting of either ACV 800 mg orally four times daily (n=84) or 14 days of GCV 5 mg/kg intravenously every 12 hr followed by oral ACV 800 mg four times daily (n=83). Prospective laboratory and clinical surveillance was performed to determine primary endpoints (onset of CMV infection and CMV disease) and secondary endpoints (rates of fungal and bacterial infection, allograft rejection, and survival after transplantation). One-year event rates are presented as cumulative percentages. Results. During the first year after transplantation, CMV infection developed in 57% of patients treated with ACV and in 37% of patients treated with GCV + ACV (P=0.001). CMV disease developed in 23% of patients treated with ACV and in 11% of patients treated with GCV + ACV (P=0.03). In seronegative recipients of allografts from CMV- seropositive donors (D+/R-), CMV disease developed in 58% of patients treated with ACV and in 25% of patients treated with GCV + ACV (P=0.04). In the D+/R- group, 54% of patients treated with ACV and 17% of patients treated with GCV + ACV developed infection with Candida albicans (P=0.05). Conclusions. Prophylaxis of CMV infection in liver-transplant patients with 14 days of intravenous GCV followed by high-dosage oral ACV is more effective than high- dosage oral ACV alone at reducing CMV infection and disease, even for patients in the D+/R- CMV serological group.

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