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Prevention of primary cytomegalovirus disease in organ transplant recipients with oral ganciclovir or oral acyclovir prophylaxis.
Transpl Infect Dis. 2000 Sep; 2(3):112-7.TI

Abstract

BACKGROUND

Optimal prophylaxis against cytomegalovirus (CMV) disease for organ transplant patients at risk for primary infection (donor seropositive, recipient seronegative, D+R-) remains to be determined. We hypothesized that prolonged oral ganciclovir therapy following intravenous therapy would provide increased protection.

METHODS

A total of 155 evaluable D+R- organ transplant recipients from 13 transplant centers were entered into the study: all received intravenous ganciclovir (5 mg/kg/day) for 5-10 days and then either oral acyclovir (400 mg tid) or oral ganciclovir (1 g tid) for an additional 12 weeks. Patients were assigned to their treatment groups at a central randomization site, with a separate randomization scheme for each of the organs transplanted (kidney, heart, or liver). In the case of kidney transplants, the patients were stratified according to source of the kidney (living related vs. cadaveric donor). The primary endpoint was the incidence of CMV disease in the first six months post-transplant.

RESULTS

Treatment with oral ganciclovir was associated with a significant decrease in the incidence of symptomatic disease or viremia when compared with the oral acyclovir group (32% vs. 50%, P<0.05). This difference was most marked in terms of tissue invasive disease: only 3 of 15 symptomatic patients in the ganciclovir group vs. 10 of 21 in the acyclovir group developed tissue-invasive infection (P<0.05). There was a significant difference in the time to CMV disease or viremia in the two groups: mean time 212+/-17 days post-transplant for the acyclovir group vs. 291+/-13 days for the ganciclovir group (P<0.001). The incidence of allograft rejection was 34% in the ganciclovir group and 46% in the acyclovir group (P=NS). Leukopenia was more common in the ganciclovir group (P<0.05), but in no case did it require drug discontinuation. Ganciclovir resistance did not develop in this study.

CONCLUSION

Prophylaxis with oral ganciclovir following a brief course of intravenous ganciclovir provides useful protection against primary CMV disease.

Authors+Show Affiliations

Infectious Disease Unit, Massachusetts General Hospital, Boston, Massachusetts 02114-2696, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

11429021

Citation

Rubin, R H., et al. "Prevention of Primary Cytomegalovirus Disease in Organ Transplant Recipients With Oral Ganciclovir or Oral Acyclovir Prophylaxis." Transplant Infectious Disease : an Official Journal of the Transplantation Society, vol. 2, no. 3, 2000, pp. 112-7.
Rubin RH, Kemmerly SA, Conti D, et al. Prevention of primary cytomegalovirus disease in organ transplant recipients with oral ganciclovir or oral acyclovir prophylaxis. Transpl Infect Dis. 2000;2(3):112-7.
Rubin, R. H., Kemmerly, S. A., Conti, D., Doran, M., Murray, B. M., Neylan, J. F., Pappas, C., Pitts, D., Avery, R., Pavlakis, M., Del Busto, R., DeNofrio, D., Blumberg, E. A., Schoenfeld, D. A., Donohue, T., Fisher, S. A., & Fishman, J. A. (2000). Prevention of primary cytomegalovirus disease in organ transplant recipients with oral ganciclovir or oral acyclovir prophylaxis. Transplant Infectious Disease : an Official Journal of the Transplantation Society, 2(3), 112-7.
Rubin RH, et al. Prevention of Primary Cytomegalovirus Disease in Organ Transplant Recipients With Oral Ganciclovir or Oral Acyclovir Prophylaxis. Transpl Infect Dis. 2000;2(3):112-7. PubMed PMID: 11429021.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prevention of primary cytomegalovirus disease in organ transplant recipients with oral ganciclovir or oral acyclovir prophylaxis. AU - Rubin,R H, AU - Kemmerly,S A, AU - Conti,D, AU - Doran,M, AU - Murray,B M, AU - Neylan,J F, AU - Pappas,C, AU - Pitts,D, AU - Avery,R, AU - Pavlakis,M, AU - Del Busto,R, AU - DeNofrio,D, AU - Blumberg,E A, AU - Schoenfeld,D A, AU - Donohue,T, AU - Fisher,S A, AU - Fishman,J A, PY - 2001/6/29/pubmed PY - 2001/10/26/medline PY - 2001/6/29/entrez SP - 112 EP - 7 JF - Transplant infectious disease : an official journal of the Transplantation Society JO - Transpl Infect Dis VL - 2 IS - 3 N2 - BACKGROUND: Optimal prophylaxis against cytomegalovirus (CMV) disease for organ transplant patients at risk for primary infection (donor seropositive, recipient seronegative, D+R-) remains to be determined. We hypothesized that prolonged oral ganciclovir therapy following intravenous therapy would provide increased protection. METHODS: A total of 155 evaluable D+R- organ transplant recipients from 13 transplant centers were entered into the study: all received intravenous ganciclovir (5 mg/kg/day) for 5-10 days and then either oral acyclovir (400 mg tid) or oral ganciclovir (1 g tid) for an additional 12 weeks. Patients were assigned to their treatment groups at a central randomization site, with a separate randomization scheme for each of the organs transplanted (kidney, heart, or liver). In the case of kidney transplants, the patients were stratified according to source of the kidney (living related vs. cadaveric donor). The primary endpoint was the incidence of CMV disease in the first six months post-transplant. RESULTS: Treatment with oral ganciclovir was associated with a significant decrease in the incidence of symptomatic disease or viremia when compared with the oral acyclovir group (32% vs. 50%, P<0.05). This difference was most marked in terms of tissue invasive disease: only 3 of 15 symptomatic patients in the ganciclovir group vs. 10 of 21 in the acyclovir group developed tissue-invasive infection (P<0.05). There was a significant difference in the time to CMV disease or viremia in the two groups: mean time 212+/-17 days post-transplant for the acyclovir group vs. 291+/-13 days for the ganciclovir group (P<0.001). The incidence of allograft rejection was 34% in the ganciclovir group and 46% in the acyclovir group (P=NS). Leukopenia was more common in the ganciclovir group (P<0.05), but in no case did it require drug discontinuation. Ganciclovir resistance did not develop in this study. CONCLUSION: Prophylaxis with oral ganciclovir following a brief course of intravenous ganciclovir provides useful protection against primary CMV disease. SN - 1398-2273 UR - https://www.unboundmedicine.com/medline/citation/11429021/Prevention_of_primary_cytomegalovirus_disease_in_organ_transplant_recipients_with_oral_ganciclovir_or_oral_acyclovir_prophylaxis_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&amp;sid=nlm:pubmed&amp;issn=1398-2273&amp;date=2000&amp;volume=2&amp;issue=3&amp;spage=112 DB - PRIME DP - Unbound Medicine ER -