Comparison of standard versus low‐dose valganciclovir regimens for cytomegalovirus prophylaxis in high‐risk liver transplant recipients
dc.contributor.author | Bixby, Alexandra L. | |
dc.contributor.author | Fitzgerald, Linda | |
dc.contributor.author | Park, Jeong M. | |
dc.contributor.author | Kaul, Daniel | |
dc.contributor.author | Tischer, Sarah | |
dc.date.accessioned | 2021-11-02T00:48:00Z | |
dc.date.available | 2022-11-01 20:47:59 | en |
dc.date.available | 2021-11-02T00:48:00Z | |
dc.date.issued | 2021-10 | |
dc.identifier.citation | Bixby, Alexandra L.; Fitzgerald, Linda; Park, Jeong M.; Kaul, Daniel; Tischer, Sarah (2021). "Comparison of standard versus low‐dose valganciclovir regimens for cytomegalovirus prophylaxis in high‐risk liver transplant recipients." Transplant Infectious Disease 23(5): n/a-n/a. | |
dc.identifier.issn | 1398-2273 | |
dc.identifier.issn | 1399-3062 | |
dc.identifier.uri | https://hdl.handle.net/2027.42/170889 | |
dc.description.abstract | PurposeThe purpose of this study was to compare the safety and efficacy of two valganciclovir (VGCV) institutional dosing protocols for cytomegalovirus (CMV) prophylaxis in liver transplant (LT) recipients with CMV serotype donor +/recipient‐ (D+/R−).MethodsThis was a single‐center review of CMV D+/R− adult LT recipients who received VGCV 450 mg/day for 90 days (low‐dose) or VGCV 900 mg/day for 180 days (standard‐dose). The primary outcome was incidence of CMV disease at 1 year. Secondary outcomes included rates of CMV syndrome, end‐organ disease, breakthrough infection, and resistance. Neutropenia, early discontinuation of VGCV, growth colony stimulating factors use (G‐CSF), biopsy‐proven rejection (BPAR), graft loss, and death at 1 year were analyzed.ResultsNinety‐six CMV D+/R− LT recipients were included. Although no difference in CMV disease was observed (low‐dose 26% vs. standard‐dose 23%, p = 0.71), 75% of CMV infections in the low‐dose group presented with end‐organ disease. Ganciclovir (GCV) resistance was observed only in the low‐dose group (n = 2). Significantly more patients in the standard‐dose group developed neutropenia (low‐dose 10% vs 60% standard‐dose, p < 0.001). In the standard‐dose group, 29% required early discontinuation of VGCV (vs. 5% in the low‐dose group, p < 0.001), and 20% were treated with G‐CSF. Both cohorts had similar rates of BPAR, graft loss, and death at 1 year.ConclusionsVGCV 900 mg/day for 180 days had higher rates of hematologic adverse effects resulting in frequent treatment interruptions. However, the occurrence of two cases of GCV‐resistant CMV disease raises concerns about routinely using low‐dose VGCV prophylaxis. | |
dc.publisher | Wiley Periodicals, Inc. | |
dc.subject.other | cytomegalovirus | |
dc.subject.other | liver transplantation | |
dc.subject.other | neutropenia | |
dc.subject.other | valganciclovir | |
dc.title | Comparison of standard versus low‐dose valganciclovir regimens for cytomegalovirus prophylaxis in high‐risk liver transplant recipients | |
dc.type | Article | |
dc.rights.robots | IndexNoFollow | |
dc.subject.hlbsecondlevel | Microbiology and Immunology | |
dc.subject.hlbsecondlevel | Medicine (General) | |
dc.subject.hlbtoplevel | Health Sciences | |
dc.description.peerreviewed | Peer Reviewed | |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/170889/1/tid13713.pdf | |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/170889/2/tid13713_am.pdf | |
dc.identifier.doi | 10.1111/tid.13713 | |
dc.identifier.source | Transplant Infectious Disease | |
dc.identifier.citedreference | Montejo M, Montejo E, Gastaca M, et al. Prophylactic therapy with valgancyclovir in high‐risk (cytomegalovirus D+/R−) liver transplant recipients: a single‐center experience. Transplant Proc. 2009; 41 ( 6 ): 2189 – 2191. | |
dc.identifier.citedreference | Razonable RR, Humar A. Cytomegalovirus in solid organ transplant recipients– guidelines of the American Sociery of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019; 33 ( 9 ): e13512. | |
dc.identifier.citedreference | Kotton CN, Kumar D, Caliendo AM, et al. The third international consensus guidelines on the management of cytomegalovirus in solid organ transplantation. Transplantation. 2018; 102 ( 6 ): 900 – 931. | |
dc.identifier.citedreference | Fishman JA. Infection in organ transplantation. Am J Transplant. 2017; 17 ( 4 ): 856 – 879. | |
dc.identifier.citedreference | Kotton CN, Huprikar S, Kumar D. Transplant infectious diseases: a review of the scientific registry of transplant recipients published data. Am J Transplant. 2017; 17 ( 6 ): 1439 – 1446. | |
dc.identifier.citedreference | Highlights of prescribing information. Hoffmann‐La Roche Limited. Product Monograph Valcyte. 2010. http://www.gene.com/gene/products/information/valcyte/pdf/pi.pdf. Accessed July 6, 2019. | |
dc.identifier.citedreference | Paya C, Humar A, Dominguez E, et al. Efficacy and safety of valganciclovir vs. oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant. 2004; 4 ( 4 ): 611 – 620. | |
dc.identifier.citedreference | Pescovitz MD, Rabkin J, Merion RM, et al. Valganiclovir results in improved oral absorption of ganciclovir in liver transplant patients. Antimicrob Agents Chemother. 2000; 44 ( 10 ): 2811 – 2815. | |
dc.identifier.citedreference | Park JM, Lake KD, Arenas JD, Fontana RJ. Efficacy and safety of low‐dose valganciclovir in the prevention of cytomegalovirus disease in adult liver transplant recipients. Michigan MEdicine Transplant Center. 2006; 12 ( 1 ): 112 – 116. | |
dc.identifier.citedreference | Tischer S, Park J, Stuckey L, Kaul D, Sonnenday CFR. Incidence of CMV disease in high‐risk liver transplant recipients on low dose. Am J Transplant. 2013 ( 13 ). https://atcmeetingabstracts.com/abstract/incidence-of-cmv-disease-in-high-risk-liver-transplant-recipients-on-low-dose-valganciclovir-prophylaxis/. | |
dc.identifier.citedreference | Ljungman P, Boeckh M, Hirsch HH, et al. Definitions of cytomegalovirus infection and disease in transplant patients for use in clinical trials. Clin Infect Dis. 2017; 64 ( 1 ): 87 – 91. | |
dc.identifier.citedreference | Brady RL, Green K, Frei C, Maxwell P. Oral ganciclovir versus valganciclovir for cytomegalovirus prophylaxis in high‐risk liver transplant recipients. Transpl Infect Dis. 2009; 11 ( 2 ): 106 – 111. | |
dc.identifier.citedreference | Dupuis R, Harris M, Gillis K, et al. Experience with low‐dose valganciclovir prophylaxis in adult liver transplant recipients. Transplant Proc. 2007; 39 ( 10 ): 3266 – 3270. | |
dc.identifier.citedreference | Kalil AC, Mindru C, Botha JF, et al. Risk of cytomegalovirus disease in high‐risk liver transplant recipients on valganciclovir prophylaxis: a systematic review and meta‐analysis. Liver Transplant. 2012; 18 ( 12 ): 1440 – 1447. | |
dc.identifier.citedreference | Jain A, Orloff M, Kashyap R, et al. Does valganciclovir hydrochloride (Valcyte) provide effective prophylaxis against cytomegalovirus infection in liver transplant recipients?. Transplant Proc. 2005; 37 ( 7 ): 3182 – 3186. | |
dc.identifier.citedreference | Donnelly C, Kennedy F, Keane C, Schaffer K, McCormick PA. Late‐onset CMV disease following CMV prophylaxis. Ir J Med Sci. 2009; 178 ( 3 ): 333 – 336. | |
dc.identifier.citedreference | Arthurs SK, Eid AJ, Pedersen RA, et al. Delayed‐onset primary cytomegalovirus disease after liver transplantation. Liver Transplant. 2007; 13 ( 12 ): 1703 – 1709. | |
dc.identifier.citedreference | Shiley KT, Gasink LB, Barton TD, Pfeiffenberger P, Olthoff KM, Blumberg EA. Increased incidence of cytomegalovirus infection in high‐risk liver transplant recipients receiving valganciclovir prophylaxis versus ganciclovir prophylaxis. Liver Transplant. 2009; 15 ( 8 ): 963 – 967. | |
dc.identifier.citedreference | Avery RK, Arav‐Boger R, Marr KA, et al. Outcomes in transplant recipients treated with foscarnet for ganciclovir‐resistant or refractory cytomegalovirus infection. Transplantation. 2016; 100 ( 10 ): e74 – e80. | |
dc.identifier.citedreference | Humar A, Limaye AP, Blumberg EA, et al. Extended valganciclovir prophylaxis in D+/R− kidney transplant recipients is associated with long‐term reduction in cytomegalovirus disease: two‐year results of the impact study. Transplantation. 2010; 90 ( 12 ): 1427 – 1431. | |
dc.identifier.citedreference | Humar A, Lebranchu Y, Vincenti F, et al. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high‐risk kidney transplant recipients. Am J Transplant. 2010; 10 ( 5 ): 1228 – 1237. | |
dc.identifier.citedreference | Åsberg A, Humar A, Rollag H, et al. Oral valganciclovir is noninferior to intravenous ganciclovir for the treatment of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant. 2007; 7 ( 9 ): 2106 – 2113. | |
dc.identifier.citedreference | Mavrakanas TA, Fournier MA, Clairoux S, et al. Neutropenia in kidney and liver transplant recipients: risk factors and outcomes. Clin Transplant. 2017; 31 ( 10 ): e13058. | |
dc.identifier.citedreference | Sign N, Winston DJ, Razonable RR, et al. Effect of premptive therapy vs antiviral prophylaxis on cytomegalovirus disease in seronegative liver transplant recipients with seropositive donors. JAMA. 2020; 232 ( 14 ): 1378 – 1387. | |
dc.working.doi | NO | en |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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