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. 2025 Jan 14;1(1):CD005133.
doi: 10.1002/14651858.CD005133.pub4.

Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients

Affiliations

Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients

Robin Wm Vernooij et al. Cochrane Database Syst Rev. .

Abstract

Background: Cytomegalovirus (CMV) is a significant cause of morbidity and death in solid organ transplant recipients. Pre-emptive treatment of patients with CMV viraemia using antiviral agents has been suggested as an alternative to routine prophylaxis to prevent CMV disease. This is an update of a Cochrane review first published in 2006 and updated in 2013.

Objectives: To determine the benefits and harms of pre-emptive treatment of CMV viraemia to prevent CMV disease and death (any cause) and the indirect effects of CMV infection (acute rejection, graft loss, opportunistic infections) in solid organ transplant recipients.

Search methods: The Cochrane Kidney and Transplant Register of Studies was searched up to 17 December 2024 using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal, and ClinicalTrials.gov.

Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs comparing pre-emptive treatment with placebo, no specific treatment, or antiviral prophylaxis in solid organ transplant recipients.

Data collection and analysis: Two authors independently assessed the eligibility of the identified studies, assessed the risk of bias, and extracted all data. Results were expressed as risk ratio (RR) and 95% confidence intervals (CI) for dichotomous outcomes. Statistical analyses were performed using a random-effects model. The certainty of evidence was assessed per outcome using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach.

Main results: In this update, we have included seven new studies, bringing the total number of included studies to 22 (1883 participants). Of these, seven investigated pre-emptive treatment versus placebo or standard care, 12 looked at pre-emptive treatment versus antiviral prophylaxis, one study investigated oral versus intravenous pre-emptive treatment, one investigated pre-emptive valganciclovir versus pre-emptive ganciclovir, and one investigated letermovir 40 mg twice/day versus 80 mg once/day. Studies were conducted in Australia, Brazil, the Czech Republic, Germany, Italy, Japan, Norway, Spain, South Korea, and the USA. Organ transplant recipients included kidney, liver, heart, lung, and kidney-pancreas. Thirteen studies were single-centre studies, six were multicentre, and three were unknown. The number of participants ranged from 12 to 296. Overall, selection bias was unclear (55%); performance, detection and attrition bias were high (91%, 63% and 95%, respectively), and reporting bias was low (55%). Compared with placebo or standard care, pre-emptive treatment probably reduces the risk of CMV disease (7 studies, 315 participants: RR 0.29, 95% CI 0.11 to 0.80; I2 = 54%; moderate-certainty evidence) but may result in little or no difference in death (any cause) (3 studies, 176 participants: RR 1.23, 95% CI 0.35 to 4.30; I2 = 0%; low-certainty evidence). Pre-emptive treatment may result in little or no difference in CMV organ involvement, CMV-associated symptoms, acute rejection, graft loss, other infections or leucopenia. Compared to prophylaxis, pre-emptive treatment may make little or no difference to the risk of developing CMV disease (11 studies, 1322 participants: RR 0.97, 95% CI 0.47 to 2.01; I2 = 54%; low-certainty evidence) and probably makes little or no difference to death (any cause) (9 studies, 1098 participants: RR 0.95, 95% CI 0.60 to 1.52; I2 = 0%; moderate-certainty evidence). Pre-emptive treatment may increase the risk of CMV infection (8 studies, 867 participants: RR 1.97, 95% CI 1.48 to 2.61; I2 = 66%; low-certainty evidence). The risk of leucopenia (7 studies, 869 participants: RR 0.57, 95% CI 0.38 to 0.87; I2 = 33%; moderate-certainty evidence) and neutropenia (5 studies, 859 participants: RR 0.63, 95% CI 0.44 to 0.90; I2 = 0% moderate certainty evidence) probably decreases with pre-emptive therapy. There may be little or no difference in the risks of acute rejection, graft loss, and infections other than CMV. Single studies were identified for comparisons between different pre-emptive treatments: 1) oral ganciclovir versus IV ganciclovir; 2) valganciclovir versus ganciclovir; 3) 40 mg twice/day versus 80 mg once/day. No differences between these treatment modalities in terms of CMV disease, death (any cause), or adverse events were identified.

Authors' conclusions: In this review, we have included seven new studies, yet the available evidence is overall of low certainty and the conclusions remain similar to the previous version of this review. Pre-emptive treatment probably reduces the risk of CMV disease compared with placebo or standard care. There were no clear differences between pre-emptive treatment and prophylaxis to prevent CMV disease or reduce the risk of death (any cause). The risk of CMV infection may be higher for patients receiving pre-emptive therapy, but the risk of adverse events, such as leucopenia, is probably lower.

Trial registration: ClinicalTrials.gov NCT02550639 NCT00374686 NCT00373165 NCT01552369 NCT00372229 NCT01509404 NCT00947141 NCT00294515 NCT01753167 NCT00497796 NCT00566072 NCT01446445 NCT00227370 NCT00431353 NCT03699254 NCT05708508 NCT00966836.

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Conflict of interest statement

  1. Robin Vernooij: no relevant interests were disclosed

  2. Julia Colombijn: no relevant interests were disclosed

  3. Mini Micheal: Novo Nordisk Inc (Independent Contractor ‐ Other)

  4. Daniel Owers: no relevant interests were disclosed

  5. Angela C. Webster: no relevant interests were disclosed

  6. Giovanni FM Strippoli: no relevant interests were disclosed

  7. Elisabeth M Hodson: no relevant interests were disclosed

Update of

References

References to studies included in this review

Brennan 1997a Kidney {published data only}
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Koetz 2001 Kidney/liver {published data only}
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Queiroga 2003 Kidney {published data only}
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Sagedal 2003 Kidney {published data only}
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Scott 2011 Liver {published data only}12610000787088
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Singh 1994 Liver {published data only}
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Singh 2000 Liver {published data only}
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Stoelben 2014 Kidney/pancreas {published data only}2006–006148–69
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Togashi 2011 Liver {published data only}C000000295
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Witzke 2012 Kidney {published data only}
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References to studies excluded from this review

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Cohen 1993 Liver {published data only}
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Conti 1995 Kidney {published data only}
    1. Conti DJ, Freed BM, Singh TP, Gallichio M, Gruber SA, Lempert N, et al. Preemptive ganciclovir therapy in cytomegalovirus-seropositive renal transplants recipients. Archives of Surgery 1995;130(11):1217-22. [MEDLINE: ] - PubMed
Dickinson 1996 {published data only}
    1. Dickinson BI, Gora-Harper ML, McCraney SA, Gosland M. Studies evaluating high-dose acyclovir, intravenous immune globulin, and cytomegalovirus hyperimmunoglobulin for prophylaxis against cytomegalovirus in kidney transplant recipients. Annals of Pharmacotherapy 1996;30(12):1452-64. [MEDLINE: ] - PubMed
Duncan 1994 Lung {published data only}
    1. Duncan SR, Grgurich WF, Iacono AT, Burckart GJ, Yousem SA, Paradis IL, et al. A comparison of ganciclovir and acyclovir to prevent cytomegalovirus after lung transplantation. American Journal of Respiratory & Critical Care Medicine 1994;150(1):146-52. [MEDLINE: ] - PubMed
Egan 2002 Heart {published data only}
    1. Egan JJ, Carroll KB, Yonan N, Woodcock A, Crisp A. Valacyclovir prevention of cytomegalovirus reactivation after heart transplantation: a randomized trial. Journal of Heart & Lung Transplantation 2002;21(4):460-6. [MEDLINE: ] - PubMed
Falagas 1997 {published data only}
    1. Falagas ME, Snydman DR, Ruthazer R, Griffith J, Werner BG, Freeman R, et al. Cytomegalovirus immune globulin (CMVIG) prophylaxis is associated with increased survival after orthotopic liver transplantation. The Boston Center for Liver Transplantation CMVIG Study Group. Clinical Transplantation 1997;11(5 Pt 1):432-7. [MEDLINE: ] - PubMed
    1. Falagas ME, Snydman DR, Werner B, Griffith J, Ruthazer R, Rohrer R, et al. Cytomegalovirus immune globulin (CMVIG) prophylaxis is associated with increased survival after orthotopic liver transplantation [abstract no: 254]. In: 16th Annual Meeting. American Society of Transplant Physicians (ASTP); 1997 May 10-14; Chicago (IL). 1997:148. - PubMed
Fehir 1989 {published data only}
    1. Fehir KM, Decker WA, Samo T, Young JB, Lederer E, Lawrence EC. Immune globulin (GAMMAGARD) prophylaxis of CMV infections in patients undergoing organ transplantation and allogeneic bone marrow transplantation. Transplantation Proceedings 1989;21(1 Pt 3):3107-9. [MEDLINE: ] - PubMed
Ferreira 2004 {published data only}
    1. Ferreira A, Felipe CR, Motegi SA, Hosaka BA, Tamura MK, Kamura LA, et al. Relationship between immunosuppression and subsequent development of CMV disease [abstract no: P77]. In: 3rd International Congress on Immunosuppression; 2004 Dec 8-11; San Diego, (CA). 2004.
First 1993a {published data only}
    1. First MR, Blum MR, Brennan P, Connors J, Drummer S, Lee I, et al. Pharmacokinetics of 256U87, an acyclovir prodrug in renal transplant patients [abstract]. In: 12th International Congress of Nephrology; 1993 Jun 13-18; Jerusalem, Israel. 1993:168. [CENTRAL: CN-01657470]
Fishman 2000 {published data only}
    1. Fishman JA, Doran MT, Volpicelli SA, Cosimi AB, Flood JG, Rubin RH. Dosing of intravenous ganciclovir for the prophylaxis and treatment of cytomegalovirus infection in solid organ transplant recipients. Transplantation 2000;69(3):389-94. [MEDLINE: ] - PubMed
Flechner 1998 Kidney {published data only}
    1. Flechner SM, Avery RK, Fisher R, Mastroianni BA, Papajcik DA, O'Malley KJ, et al. A randomized prospective controlled trial of oral acyclovir versus oral, ganciclovir for cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Transplantation 1998;66(12):1682-8. [MEDLINE: ] - PubMed
    1. Flechner SM, O'Malley K, Fisher R, Mastroianni B, Papajcik D, Avery R, et al. A randomized prospective trial of oral acyclovir vs oral ganciclovir for CMV prophylaxis in high risk kidney transplant recipients [abstract no: 739]. Transplantation 1998;65(12):S187. [CENTRAL: CN-00644223] - PubMed
Fleming 2017 {published data only}
    1. Fleming JN, Taber DJ, Weimert NA, Nadig S, McGillicuddy JW, Bratton CF, et al. Valganciclovir (VGCV) followed by cytomegalovirus (CMV) hyperimmune globulin compared to VGCV for 200 days in abdominal organ transplant recipients at high risk for CMV infection: A prospective, randomized pilot study. Transplant Infectious Disease 2017;19:6. [MEDLINE: ] - PubMed
Gane 1997 Liver {published data only}
    1. Gane E, Saliba F, Valdecasas GJ, O'Grady J, Pescovitz MD, Lyman S, et al. Randomised trial of efficacy and safety of oral ganciclovir in the prevention of cytomegalovirus disease in liver-transplant recipients. The Oral Ganciclovir International Transplantation Study Group. Lancet 1997;350(9093):1729-33. [MEDLINE: ] - PubMed
    1. Pescovitz MD, Pruett TL, Brook B, McGory R, Jung D. Pharmacokinetics of oral ganciclovir in liver transplant recipients [abstract]. In: 15th Annual Meeting. American Society of Transplant Physicians (ASTP); 1996 May 10-14; Chicago (ILL). 1996. [CENTRAL: CN-01657982]
    1. Saliba F, Bismuth H, Gane E, Valdecasas G, O'Grady J, Behrend M, et al. A randomized double blind versus placebo multicenter study of efficacy and tolerance of oral ganciclovir in the prevention of cytomegalovirus disease in hepatic transplanted patients. Gastroenterologie Clinique et Biologique 1997;21(2 bis):A157. [CENTRAL: CN-00583127]
Gavalda 1997 Liver {published data only}
    1. Gavalda J, De Otero J, Murio E, Vargas V, Rossello J, Calico I, et al. Two grams daily of oral acyclovir reduces the incidence of cytomegalovirus disease in CMV-seropositive liver transplant recipients. Transplant International 1997;10(6):462-5. [MEDLINE: ] - PubMed
Gerna 2003 {published data only}
    1. Gerna G, Baldanti F, Lilleri D, Parea M, Torsellini M, Castiglioni B, et al. Human cytomegalovirus pp67 mRNAemia versus pp65 antigenemia for guiding preemptive therapy in heart and lung transplant recipients: a prospective, randomized, controlled, open-label trial. Transplantation 2003;75(7):1012-9. [MEDLINE: ] - PubMed
Gerna 2007 {published data only}
    1. Gerna G, Baldanti F, Torsellini M, Minoli L, Vigano M, Oggionnis T, et al. Evaluation of cytomegalovirus DNAaemia versus pp65-antigenaemia cutoff for guiding preemptive therapy in transplant recipients: a randomized study. Antiviral Therapy 2007;12(1):63-72. [MEDLINE: ] - PubMed
Green 1997 Liver {published data only}
    1. Green M, Kaufmann M, Wilson J, Reyes J. Comparison of intravenous ganciclovir followed by oral acyclovir with intravenous ganciclovir alone for prevention of cytomegalovirus and Epstein- Barr virus disease after liver transplantation in children. Clinical Infectious Diseases 1997;25(6):1344-9. [MEDLINE: ] - PubMed
    1. Green M, Reyes J, Nour B, Beatty D, Kaufman M, Wilson J, et al. Randomized trial of ganciclovir followed by high-dose oral acyclovir vs ganciclovir alone in the prevention of cytomegalovirus disease in pediatric liver transplant recipients: preliminary analysis. Transplantation Proceedings 1994;26(1):173-4. [PMID: ] - PubMed
Greger 1988 {published data only}
    1. Greger B, Schareck WD, Busing M, Mellert J, Muller GH, Hopt UT, et al. Are the risks of viral infections increased in kidney transplant patients receiving triple-drug therapy? Transplantation Proceedings 1988;20(1 Suppl 1):466-8. [EMBASE: CN-00583354]
Griffiths 2016 {published data only}
    1. Griffiths PD, Rothwell E, Raza M, Wilmore S, Doyle T, Harber M, et al. Randomized controlled trials to define viral load thresholds for cytomegalovirus pre-emptive therapy. PLoS ONE [Electronic Resource] 2016;11(9):e0163722. [MEDLINE: ] - PMC - PubMed
Halim 2016 {published data only}
    1. Abdel-Halim M, Al-Otaibi T, Gheith O, Adel H, Mosaad A, Abo-Atya H, et al. Efficacy and safety of low dose versus full dose valganciclovir for prevention of cytomegalovirus disease in kidney transplant recipients [abstract no: BO71]. Transplant International 2015;28(Suppl 4):155. [EMBASE: 72111670]
    1. Gheith O, Al-Otaibi T, Halim A, Adel H, Mosaad A, Atteya H, et al. Successful cost effective prevention of cytomegalovirus disease in kidney transplant [abstract no: O02]. Transplant International 2015;28(Suppl 4):1. [EMBASE: 72111247]
    1. Gheith O, Al-Otaibi T, Halim MA, Mansour H, Attia H, Elsayed Z, et al. Successful cost effective prevention of cytomegalovirus disease in kidney transplant recipients using low dose valganciclovir [abstract no: MP687]. Nephrology Dialysis Transplantation 2016;31(Suppl 1):i568. [EMBASE: 72327538] - PubMed
    1. Gheith O, Halim MA, Al-Otaibi T, Mansour H, Mosaad A, Atteya HA, et al. Successful cost-effective prevention of cytomegalovirus disease in kidney transplant recipients using low-dose valganciclovir. Experimental & Clinical Transplantation 2017;15(Suppl 1):156-63. [MEDLINE: ] - PubMed
    1. Gheith O, Halim MA, Alotaibi T, Nair P, Said T, Nampoory N. Low dose valganciclovir prophylaxis among renal transplants: cost benefit analysis [abstract no: SP790]. Nephrology Dialysis Transplantation 2017;32(Suppl 3):iii410. [EMBASE: 617291198]
Hertz 1988 Heart/Lung {published data only}
    1. Hertz MI, Jordan C, Savik SK, Fox JM, Park S, Bolman RM 3rd, et al. Randomized trial of daily versus three-times-weekly prophylactic ganciclovir after lung and heart-lung transplantation. Journal of Heart & Lung Transplantation 1988;17(9):913-20. [MEDLINE: ] - PubMed
Hibberd 1995 Kidney {published data only}
    1. Hibberd PL, Tolkoff-Rubin NE, Conti D, Stuart F, Thistlethwaite JR, Neylan JF, et al. Preemptive ganciclovir therapy to prevent cytomegalovirus disease, in cytomegalovirus antibody-positive renal transplant recipients. A randomized controlled trial. Annals of Internal Medicine 1995;123(1):18-26. [MEDLINE: ] - PubMed
IMPACT 2010 Kidney {published data only}
    1. Blumberg E, Hauser I, Gahlemann CG, Berenson KL, Jardine A, Humar A. Cost-effectiveness model to evaluate 200-day vs 100-day valganciclovir (Valcyte®) prophylaxis to reduce CMV disease incidence post-transplant [abstract no: 290]. American Journal of Transplantation 2010;10(Suppl 4):126. [EMBASE: 70463651]
    1. Boivin G, Goyette N, Farhan M, Ives J, Elston R. Incidence of cytomegalovirus UL97 and UL54 amino acid substitutions detected after 100 or 200 days of valganciclovir prophylaxis. Journal of Clinical Virology 2012;53(3):208-13. [MEDLINE: ] - PubMed
    1. Chou S, Marousek G, Boivin G, Goyette N, Farhan M, Ives JA, et al. Recombinant phenotyping of cytomegalovirus sequence variants detected after 200 or 100 days of valganciclovir prophylaxis. Transplantation 2010;90(12):1409-13. [MEDLINE: ] - PubMed
    1. Chou S, Marousek G, Wong V, Boivin G, Goyette N, Farhan M, et al. The IMPACT study: phenotypic analysis of previously uncharacterized cytomegalovirus UL54 and UL97 amino acid substitutions detected in virus from patients receiving 200 or 100 days of valganciclovir (Valcyte) prophylaxis [abstract no: 1099]. Transplantation 2010;90(Suppl 1):24. [EMBASE: 71531149]
    1. Elston R, Bovin G, Goyette N, Voulgari A, Ives J, Farhan M. The IMPACT Study: genotypic analysis of cytomegalovirus UL54 and UL97 genes derived from patients receiving 100 or 200 days of valganciclovir (Valcyte®) prophylaxis [abstract no: 580]. American Journal of Transplantation 2010;10(Suppl 4):208. [CENTRAL: 70463941]
Ishida 2017 {published data only}
    1. Deng R, Wang Y, Maia M, Burgess T, McBride JM, Liao XC, et al. Pharmacokinetics and exposure-response analysis of RG7667, a combination of two anticytomegalovirus monoclonal antibodies, in a phase 2a randomized trial to prevent cytomegalovirus infection in high-risk kidney transplant recipients. Antimicrobial Agents & Chemotherapy 2018;62(2):e01108-17. [MEDLINE: ] - PMC - PubMed
    1. Ishida JH, Patel A, Mehta AK, Gatault P, McBride JM, Burgess T, et al. Phase 2 randomized, double-blind, placebo-controlled trial of RG7667, a combination monoclonal antibody, for prevention of cytomegalovirus infection in high-risk kidney transplant recipients. Antimicrobial Agents & Chemotherapy 2017;61(2):e01794-16. [MEDLINE: ] - PMC - PubMed
King 1999 {published data only}
    1. King SM. Immune globulin versus antivirals versus combination for prevention of cytomegalovirus disease in transplant recipients. Antiviral Research 1999;40(3):115-37. [MEDLINE: ] - PubMed
Kiser 2012 {published data only}
    1. Kiser TH, Fish DN, Zamora MR. Evaluation of valganciclovir pharmacokinetics in lung transplant recipients. Journal of Heart & Lung Transplantation 2012;31(2):159-66. [MEDLINE: ] - PubMed
Kletzmayr 1996 Kidney {published data only}
    1. Kletzmayr J, Kotzmann H, Popow-Kraupp T, Kovarik J, Klauser R. Impact of high-dose oral acyclovir prophylaxis on cytomegalovirus (CMV) disease in CMV high-risk renal transplant recipients. Journal of the American Society of Nephrology 1996;7(2):325-30. [MEDLINE: ] - PubMed
    1. Kletzmayr J, Kotzmann H, Popow-Kraupp T, Kovarik J, Klauser R. Oral acyclovir in prevention of CMV disease in high-risk renal transplant recipients [abstract]. In: ISN XIII International Congress of Nephrology; 1995 Jul 2-6; Madrid, Spain. 1995:375. [CENTRAL: CN-00509282]
Leray 1995 Kidney {published data only}
    1. Leray H, Mourad G, Chong G, Segondy M, Mion C. Prophylactic treatment of cytomegalovirus primary infection with ganciclovir in renal transplant recipients. Transplantation Proceedings 1995;27(4):2448. [MEDLINE: ] - PubMed
Limaye 2022 {published data only}
    1. Limaye AP, Budde K, Humar A, Garcia-Diaz J, Carroll RP, Murata Y, et al. Safety and efficacy of letermovir (LET) versus valganciclovir (VGCV) for prevention of cytomegalovirus (CMV) disease in kidney transplant recipients (KTRs): a phase 3 randomized study [abstract no: LB2307]. Open Forum Infectious Diseases 2022;9(Suppl 2):S936. [DOI: 10.1093/ofid/ofac492.1897] [EMBASE: 640022298] - DOI
Lowance 1998 Kidney {published data only}
    1. Legendre CM, Norman DJ, Keating MR, Maclaine GD, Grant DM. Valaciclovir prophylaxis of cytomegalovirus infection and disease in renal transplantation: an economic evaluation. Transplantation 2000;70(10):1463-8. [MEDLINE: ] - PubMed
    1. Lowance D, Legendre C, Neumayer H, Norman D, Coggon G, Lee I, et al. Valaciclovir reduces the incidence of cytomegalovirus disease and acute graft rejection in CMV-seronegative recipients of a seropositive cadaveric renal allograft [abstract no: 61]. Transplantation 1998;65(12):S18. [CENTRAL: CN-00776893]
    1. Lowance D, Neumayer HH, Legendre CM, Squifflet JP, Kovarik J, Brennan PJ, et al. Valacyclovir for the prevention of cytomegalovirus disease after renal transplantation. International Valacyclovir Cytomegalovirus Prophylaxis Transplantation Study Group. New England Journal of Medicine 1998;340(19):1462-70. [MEDLINE: ] - PubMed
    1. Squifflet J, Mendez R. Valaciclovir reduces the incidence of cytomegalovirus disease in CMV-seropositive renal allograft recipients [abstract]. In: 16th Annual Meeting. American Society of Transplant Physicians (ASTP); 1997 May 10-14; Chicago (IL). 1997:87. [CENTRAL: CN-00509489]
MacDonald 1991 {published data only}
    1. MacDonald AS, Belitsky P, Cohen A, Lee S. Cytomegalovirus disease prophylaxis in seronegative recipients of kidneys from seropositive donors by combination of cytomegalovirus-hyperimmune globulin and low-dose acyclovir. Transplantation Proceedings 1991;23(1 Pt 2):1355-6. [MEDLINE: ] - PubMed
Macdonald 1995 Heart {published data only}
    1. Macdonald PS, Keogh AM, Marshman D, Richens D, Harvison A, Kaan AM, et al. A double-blind placebo-controlled trial of low-dose ganciclovir to prevent cytomegalovirus disease after heart transplantation. Journal of Heart & Lung Transplantation 1995;14(1):32-8. [MEDLINE: ] - PubMed
Marker 1980 {published data only}
    1. Marker SC, Howard RJ, Groth KE. A trial of vidarabine for cytomegalovirus infection in renal transplant patients. Archives of Internal Medicine 1980;140(11):1441-4. [MEDLINE: ] - PubMed
Mattes 2004 {published data only}
    1. Mattes FM, Hainsworth EG, Geretti AM, Nebbia G, Prentice G, Potter M, et al. A randomized, controlled trial comparing ganciclovir to ganciclovir plus foscarnet (each at half dose) for preemptive therapy of cytomegalovirus infection in transplant recipients. Journal of Infectious Diseases 2004;189(8):1355-61. [MEDLINE: ] - PubMed
Merigan 1992 Heart {published data only}
    1. Merigan TC, Renlund DG, Keay S, Bristow MR, Starnes V, O'Connell JB, et al. A controlled trial of ganciclovir to prevent cytomegalovirus disease after heart transplantation. New England Journal of Medicine 1992;326(18):1182-6. [MEDLINE: ] - PubMed
    1. Valantine HA, Gao SZ, Menon SG, Renlund DG, Hunt SA, Oyer P, et al. Impact of prophylactic immediate posttransplant ganciclovir on development of transplant atherosclerosis: a post hoc analysis of a randomized, placebo-controlled study. Circulation 1999;100(1):61-6. [MEDLINE: ] - PubMed
    1. Wagner JA, Ross H, Hunt S, Gamberg P, Valantine H, Merigan T, et al. Prophylactic ganciclovir treatment reduces cytomegalovirus and fungal infections in orthotopic heart transplant recipients [abstract]. In: 14th Annual Meeting. American Society of Transplant Physicians (ASTP); 1995 May 14-17; Chicago (ILL). 1995.
    1. Wagner JA, Ross H, Hunt S, Gamberg P, Valantine H, Merigan TC, et al. Prophylactic ganciclovir treatment reduces fungal as well as cytomegalovirus infections after heart transplantation. Transplantation 1995;60(12):1473-7. [PMID: ] - PubMed
Murray 1997 {published data only}
    1. Murray B, Venuto R, Stephan R, Blas S, Myers J, Amsterdam D. A randomized trial of preemptive therapy versus conventional prophylaxis and treatment of cytomegalovirus (CMV) infection [abstract]. In: 15th Annual Meeting. American Society of Transplant Physicians (ASTP); 1996 May 10-14; Chicago (ILL). 1996. [CENTRAL: CN-01657987]
    1. Murray BM, Blas S. Cost comparison of two approaches to the management of CMV infection in renal transplant recipients [abstract]. Journal of the American Society of Nephrology 1997;8(Program & Abstracts):695A. [CENTRAL: CN-00446876]
Nakazato 1993 Liver {published data only}
    1. Nakazato PZ, Burns W, Moore P, Garcia-Kennedy R, Cox K, Esquivel C. Viral prophylaxis in hepatic transplantation: Preliminary report of a randomized trial of acyclovir and ganciclovir. Transplantation Proceedings 1993;25(2):1935-7. [MEDLINE: ] - PubMed
NCT00497796 {unpublished data only}
    1. NCT00497796. Maribavir versus oral ganciclovir for the prevention of cytomegalovirus (CMV) disease in liver transplant recipients. http://clinicaltrials.gov/ct2/show/NCT00497796 (first received 9 July 2007).
NCT00566072 {published data only}
    1. NCT00566072. The influence of intensive education and coaching on compliance for oral ganciclovir in the prophylaxis of CMCV: an open randomised trial. http://clinicaltrials.gov/ct2/show/NCT00566072 (first received 10 January 2013).
Padulles 2016 {published data only}2010‐021433‐32
    1. Padulles A, Colom H, Bestard O, Cruzado JM, Melilli E, Sabe N, et al. Contribution of population pharmacokinetics to dose optimization of ganciclovir/ valganciclovir in solid organ transplant patients [abstract no: O267]. Transplant International 2015;28(Suppl 4):99. [EMBASE: 72111509] - PMC - PubMed
    1. Padulles A, Colom H, Bestard O, Melilli E, Sabe N, Rigo R, et al. Contribution of population pharmacokinetics to dose optimization of ganciclovir-valganciclovir in solid-organ transplant patients. Antimicrobial Agents & Chemotherapy 2016;60(4):1992-2002. [MEDLINE: ] - PMC - PubMed
    1. Padulles A, Colom H, Bestard O, Torras J, Cerezo G, Rigo R, et al. Contribution of population pharmacokinetics to guide ganciclovir/valganciclovir dosage in kidney transplant patients [abstract no: FP812]. Nephrology Dialysis Transplantation 2015;30(Suppl 3):iii348. [EMBASE: 72207229]
    1. Padulles A, Colom H, Caldes A, Cerezo G, Bestard O, Melilli E, et al. Ganciclovir/valganciclovir dose monitoring in solid organ transplanted patients using Bayesian prediction [abstract no: D2362]. Transplantation 2014;98(Suppl 1):762-3. [EMBASE: 71546141]
Palmer 2010 Lung {published data only}
    1. Finlen Copeland CA, Davis WA, Snyder LD, Banks M, Avery R, Davis RD, et al. Long-term efficacy and safety of 12 months of valganciclovir prophylaxis compared with 3 months after lung transplantation: a single-center, long-term follow-up analysis from a randomized, controlled cytomegalovirus prevention trial. Journal of Heart & Lung Transplantation 2011;30(9):990-6. [MEDLINE: ] - PubMed
    1. Finlen Copeland CA, Davis WA, Snyder LD, Banks M, Avery R, Palmer SM. Reduced lifetime incidence of cytomegalovirus with extended prophylaxis: Long-term follow up from a randomized controlled trial [abstract no: 104]. Journal of Heart & Lung Transplantation 2011;30(4 Suppl 1):S42. [EMBASE: 70383484] - PubMed
    1. Palmer SM, Limaye AP, Banks M, Gallup D, Chapman J, Lawrence EC, et al. Extended valganciclovir prophylaxis to prevent cytomegalovirus after lung transplantation: a randomized, controlled trial. Annals of Internal Medicine 2010;152(12):761-9. [MEDLINE: ] - PubMed
Paya 2004 All {published data only}
    1. Boivin G, Goyette N, Gilbert C, Roberts N, Macey K, Paya C, et al. Absence of cytomegalovirus-resistance mutations after valganciclovir prophylaxis, in a prospective multicenter study of solid-organ transplant recipients. Journal of Infectious Diseases 2004;189(9):1615-8. [MEDLINE: ] - PubMed
    1. Freeman RB, Macey K, Paya C, Pescovitz MD, Humar A, Dominquez E, et al. Risk factors for cytomegalovirus (CMV) disease: results from a multicenter randomized trial of valganciclovir (VGC) [abstract no: 932]. American Journal of Transplantation 2003;3(Suppl 5):391. [CENTRAL: CN-00465780]
    1. Humar A, Mazzulli T, Moussa G, Razonable RR, Paya CV, Pescovitz MD, et al. Clinical utility of cytomegalovirus (CMV) serology testing in high-risk CMV D+/R- transplant recipients. American Journal of Transplantation 2005;5(5):1065-70. [MEDLINE: ] - PubMed
    1. Humar A, Paya C, Pescovitz MD, Dominguez E, Washburn K, Blumberg E, et al. Clinical utility of cytomegalovirus (CMV) viral load testing for predicting CMV disease in high risk D+/R- solid organ transplant recipients [abstract no: 1054]. American Journal of Transplantation 2003;3(Suppl 5):421. [CENTRAL: CN-01657546] - PubMed
    1. Paya C, Humar A, Dominguez E, Washburn K, Blumberg E, Alexander B, et al. Efficacy and safety of valganciclovir vs. oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients. American Journal of Transplantation 2004;4(4):611-20. [MEDLINE: ] - PubMed
Pescovitz 2009 {published data only}
    1. Pescovitz MD, Bloom R, Pirsch J, Johnson J, Gelone S, Villano S. Pharmacokinetics (PK) and safety of maribavir (MBV) in combination with tacrolimus (TAC) in stable renal transplant recipients [abstract no: 200]. American Journal of Transplantation 2009;9(Suppl 2):248. [EMBASE: 70010073] - PubMed
    1. Pescovitz MD, Bloom R, Pirsch J, Johnson J, Gelone S, Villano SA. A randomized, double-blind, pharmacokinetic study of oral maribavir with tacrolimus in stable renal transplant recipients. American Journal of Transplantation 2009;9(10):2324-30. [MEDLINE: ] - PubMed
Pouteil 1991 {published data only}
    1. Pouteil-Noble C, Betuel H, Raffaele P, Megri K, Louvier C, Lefrancois N, et al. Influence of HLA compatibility on cytomegalovirus infection in kidney transplantation. Presse Medicale 1991;20(40):2022-4. [MEDLINE: ] - PubMed
Pouteil‐Noble 1996 Kidney {published data only}
    1. Pouteil-Noble C, Megas F, Chapuis F, Bosshard S, Colin C, Hadj-Aissa A, et al. Cytomegalovirus prophylaxis by ganciclovir followed by high-dose acyclovir in renal transplantation: a randomized, controlled trial. Transplantation Proceedings 1996;28(5):2811. [MEDLINE: ] - PubMed
    1. Pouteil-Noble C, Megas F, Chapuis F, Colul C, Bosshard S, Hadj-Aissa A, et al. Is CMV prophylaxis by ganciclovir-high dose acyclovir worthwhile in renal transplantation? A randomized, controlled, clinical and economical trial [abstract]. In: ISN XIII International Congress of Nephrology; 1995 Jul 2-6; Madrid, Spain. 1995:343. [PMID: ]
Prabakaran 2020 {published data only}2018/06/014356
    1. Prabakaran MR, Gupta KL, Sharma A, Kohli HS, Ramachandran R. Low-dose valganciclovir is as effective as the standard dose prophylaxis for cytomegalovirus in renal transplant recipients [abstract no: SUN-293]. Kidney International Reports 2020;5(3 Suppl):S320-1. [EMBASE: 2005255506]
Reischig 2002 Kidney {published data only}100600090
    1. Kielberger L, Bouda M, Jindra P, Reischig T. Pharmacoeconomic impact of different regimens to prevent cytomegalovirus infection in renal transplant recipients. Kidney & Blood Pressure Research 2012;35(6):407-16. [MEDLINE: ] - PubMed
    1. Reischig T, Bouda M, Opatrny K Jr, Treska V, Jindra P, Svecova M. Oral ganciclovir versus valacyclovir for prophylaxis of cytomegalovirus disease in renal transplant recipients [abstract no: O355]. In: XIXth International Congress of the Transplantation Society; 2002 Aug 25-30; Miami (FL). 2002. [CENTRAL: CN-00416525] - PubMed
    1. Reischig T, Jindra P, Mares J, Cechura M, Svecova M, Hes O, et al. Valacyclovir for cytomegalovirus prophylaxis reduces the risk of acute renal allograft rejection. Transplantation 2005;79(3):317-24. [MEDLINE: ] - PubMed
    1. Reischig T, Jindra P, Mares J, Cechura M, Svecova M, Opatrny K Jr, et al. Valacyclovir for cytomegalovirus prophylaxis reduces the risk of acute renal allograft rejection: a randomized comparison with oral ganciclovir and deferred therapy [abstract no: P805]. Transplantation 2004;78(2 Suppl):483. - PubMed
    1. Reischig T, Jindra P, Mares J, Opatrny K Jr, Treska V, et al. Valacyclovir for cytomegalovirus prophylaxis reduces the risk of acute renal allograft rejection: a randomized comparison of oral ganciclovir and valacyclovir [abstract no: 1225]. American Journal of Transplantation 2004;4(Suppl 8):493. [CENTRAL: CN-00509102] - PubMed
Rondeau 1993 Kidney {published data only}
    1. Rondeau E, Bourgeon B, Peraldi MN, Lang P, Buisson C, Schulte KM, et al. Effect of prophylactic ganciclovir on cytomegalovirus infection in renal transplant recipients. Nephrology Dialysis Transplantation 1993;8(9):858-62. [MEDLINE: ] - PubMed
    1. Rondeau E, Bourgeon B, Peraldi MN, Lang P, Buisson C, Schulte KM, et al. Prophylaxis of CMV disease by ganciclovir (DHPG) in seronegative recipients of renal allograft from seropositive donors. Transplant International 1992;5(Suppl 1):S30-1. [MEDLINE: ] - PubMed
    1. Rondeau E, Bourgeon B, Peraldi MN, Lang P, Buisson C, Schulte KM, et al. Prophylaxis of cytomegalovirus infections with ganciclovir in kidney transplant recipients. Presse Medicale 1992;21(41):1979-80. [MEDLINE: ] - PubMed
Rostaing 1994 Kidney {published data only}
    1. Rostaing L, Crespin A, Icart J, Lloveras JJ, Durand D, Martinet O, et al. Cytomegalovirus (CMV) prophylaxis by acyclovir in pre-transplant CMV-positive renal transplant recipients. Transplant International 1994;7 Suppl 1:331-5. [MEDLINE: ] - PubMed
Rubin 2000 All {published data only}
    1. Rubin RH, Kemmerly SA, Conti D, Doran M, Murray BM, Neylan JF, et al. Prevention of primary cytomegalovirus disease in organ transplant recipients with oral ganciclovir or oral acyclovir prophylaxis. Transplant Infectious Disease 2000;2(3):112-7. [MEDLINE: ] - PubMed
Saliba 1993 Liver {published data only}
    1. Saliba F, Eyraud D, Samuel D, David MF, Arulnaden JL, Dussaix E, et al. Randomized controlled trial of acyclovir for the prevention of cytomegalovirus infection and disease in liver transplant recipients. Transplantation Proceedings 1993;25(1 Pt 2):1444-5. [MEDLINE: ] - PubMed
Singh 2002 {published data only}
    1. Singh N. Delayed occurrence of cytomegalovirus disease in organ transplant recipients receiving antiviral prophylaxis: are we winning the battle only to lose the war? European Journal of Clinical Microbiology & Infectious Diseases 2002;21(9):643-6. [MEDLINE: ] - PubMed
Tong 2000 {published data only}
    1. Tong CY, Bakran A, Peiris JS, Muir P, Herrington CS. The association of viral infection and chronic allograft nephropathy with graft dysfunction after renal transplantation. Transplantation 2002;74(4):576-8. [MEDLINE: ] - PubMed
    1. Tong CY, Bakran A, Williams H, Cheung CY, Peiris JS. Association of human herpesvirus 7 with cytomegalovirus disease in renal transplant recipients. Transplantation 2000;70(1):213-6. [MEDLINE: ] - PubMed
Viana 2023 {published data only}
    1. Viana LA, Cristelli MP, Basso G, Santos DW, Dantas MT, Dreige YC, et al. Conversion to mTOR inhibitor to reduce the incidence of cytomegalovirus recurrence in kidney transplant recipients receiving preemptive treatment: a prospective, randomized trial. Transplantation 2023;107(8):1835-45. [DOI: 10.1097/TP.0000000000004559] [PMID: ] - DOI - PubMed
VICTOR 2007 {published data only}
    1. Asberg A, Humar A, Jardine AG, Rollag H, Pescovitz MD, Mouas H, et al. Long-term outcomes of CMV disease treatment with valganciclovir versus IV ganciclovir in solid organ transplant recipients. American Journal of Transplantation 2009;9(5):1205-13. [MEDLINE: ] - PubMed
    1. Asberg A, Humar A, Rollag H, Jardine AG, Kumar D, Aukrust P, et al. Lessons learned from a randomized study of oral valganciclovir versus parenteral ganciclovir treatment of cytomegalovirus disease in solid organ transplant recipients: the VICTOR Trial. Clinical Infectious Diseases 2016;62(9):1154-60. [MEDLINE: ] - PubMed
    1. Asberg A, Humar A, Rollag H, Jardine AG, Mouas H, Pescovitz MD, et al. Oral valganciclovir is noninferior to intravenous ganciclovir for the treatment of cytomegalovirus disease in solid organ transplant recipients. American Journal of Transplantation 2007;7(9):2106-13. [MEDLINE: ] - PubMed
    1. Asberg A, Jardine AG, Bignamini AA, Rollag H, Pescovitz MD, Gahlemann CC, et al. Effects of the intensity of immunosuppressive therapy on outcome of treatment for CMV disease in organ transplant recipients. American Journal of Transplantation 2010;10(8):1881-8. [MEDLINE: ] - PubMed
    1. Asberg A, Pescovitz MD, Humar A, Jardine AG, Rollag H, Mouas H, et al. Oral valganciclovir and intravenous ganciclovir results in comparable long-term outcomes in transplant recipients with CMV disease: the VICTOR study [abstract no: 634]. Transplantation 2008;86(2S):222. [CENTRAL: CN-00740534]
Winston 1995 Liver {published data only}
    1. Jurim O, Martin P, Winston DJ, Shackleton C, Holt C, Feller J, et al. Failure of ganciclovir prophylaxis to prevent allograft reinfection following orthotopic liver transplantation for chronic hepatitis B infection. Liver Transplantation & Surgery 1996;2(5):370-4. [MEDLINE: ] - PubMed
    1. Winston DJ, Wirin D, Shaked A, Busuttil RW. Randomised comparison of ganciclovir and high-dose acyclovir for long-term cytomegalovirus prophylaxis in liver-transplant recipients. Lancet 1995;346(8967):69-74. [MEDLINE: ] - PubMed
Winston 2003 Liver {published data only}
    1. 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. [MEDLINE: ] - PubMed
Winston 2004 Liver {published data only}
    1. Winston DJ, Busuttil RW. Randomized controlled trial of sequential intravenous and oral ganciclovir versus prolonged intravenous ganciclovir for long-term prophylaxis of cytomegalovirus disease in high-risk cytomegalovirus-seronegative liver transplant recipients with cytomegalovirus-seropositive donors. Transplantation 2004;77(2):305-8. [MEDLINE: ] - PubMed
Winston 2012 {published data only}
    1. Winston DJ, Saliba F, Blumberg E, Abouljoud M, Garcia-Diaz JB, Goss JA, et al. Efficacy and safety of maribavir dosed at 100 mg orally twice daily for the prevention of cytomegalovirus disease in liver transplant recipients: a randomized, double-blind, multicenter controlled trial [Erratum in: Am J Transplant. 2013 Feb;13(2):529]. American Journal of Transplantation 2012;12(11):3021-30. [MEDLINE: ] - PubMed
Yang 1999 {published data only}
    1. Yang HC, Holman MJ, Langhoff E, Dellock CA, Gupta M, Ulsh PJ, et al. A comparative study of 500 mg BID and 250 mg BID of prophylactic oral ganciclovir in post-kidney transplant 'CMV at risk' recipients. Transplantation Proceedings 1999;31(1-2):1125-6. [MEDLINE: ] - PubMed

References to ongoing studies

CYTOCOR 2019 {published data only}2018‐003300‐39
    1. Paez-Vega A, Cantisan S, Vaquero JM, Vidal E, Luque-Pineda A, Lobo-Acosta MA, et al. Efficacy and safety of the combination of reduced duration prophylaxis followed by immuno-guided prophylaxis to prevent cytomegalovirus disease in lung transplant recipients (CYTOCOR STUDY): an open-label, randomised, non-inferiority clinical trial. BMJ Open 2019;9(8):e030648. [MEDLINE: ] - PMC - PubMed
NCT05708508 {published data only}
    1. Effectiveness of an immune-guided cytomegalovirus infection preventive strategy compared to a universal prophylactic strategy in renal transplant patients (CYTOPREV). https://clinicaltrials.gov/study/NCT05708508 (first received 01 February 2023).
PROTECT 2015 {unpublished data only}
    1. Grigioni F, Perciaccante B, Chiereghin A, Lazzarotto T, Potena L, Masetti M, et al. Efficacy and tolerability of strategies to reduce cytomegalovirus infection onset: Insights from the randomized study PROTECT [abstract no: BO408]. Transplant International 2015;28(Suppl 4):266-7. [EMBASE: 72111999]

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References to other published versions of this review

Owers 2013
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Strippoli 2006a
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Strippoli 2006b
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