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Meta-Analysis
. 2024 May 3;5(5):CD003774.
doi: 10.1002/14651858.CD003774.pub5.

Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients

Robin Wm Vernooij  1 , Mini Michael  2 , Maleeka Ladhani  3 , Angela C Webster  4   5   6   7 , Giovanni Fm Strippoli  4   8 , Jonathan C Craig  8   9 , Elisabeth M Hodson  4   8
Affiliations
Meta-Analysis

Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients

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

Abstract

Background: The risk of cytomegalovirus (CMV) infection in solid organ transplant recipients has resulted in the frequent use of prophylaxis to prevent the clinical syndrome associated with CMV infection. This is an update of a review first published in 2005 and updated in 2008 and 2013.

Objectives: To determine the benefits and harms of antiviral medications to prevent CMV disease and all-cause death in solid organ transplant recipients.

Search methods: We contacted the information specialist and searched the Cochrane Kidney and Transplant Register of Studies up to 5 February 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 antiviral medications with placebo or no treatment, comparing different antiviral medications or different regimens of the same antiviral medications for CMV prophylaxis in recipients of any solid organ transplant. Studies examining pre-emptive therapy for CMV infection are studied in a separate review and were excluded from this review.

Data collection and analysis: Two authors independently assessed study eligibility, risk of bias and extracted data. Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes and mean difference (MD) and 95% CI for continuous outcomes. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Main results: This 2024 update found four new studies, bringing the total number of included studies to 41 (5054 participants). The risk of bias was high or unclear across most studies, with a low risk of bias for sequence generation (12), allocation concealment (12), blinding (11) and selective outcome reporting (9) in fewer studies. There is high-certainty evidence that prophylaxis with aciclovir, ganciclovir or valaciclovir compared with placebo or no treatment is more effective in preventing CMV disease (19 studies: RR 0.42, 95% CI 0.34 to 0.52), all-cause death (17 studies: RR 0.63, 95% CI 0.43 to 0.92), and CMV infection (17 studies: RR 0.61, 95% CI 0.48 to 0.77). There is moderate-certainty evidence that prophylaxis probably reduces death from CMV disease (7 studies: RR 0.26, 95% CI 0.08 to 0.78). Prophylaxis reduces the risk of herpes simplex and herpes zoster disease, bacterial and protozoal infections but probably makes little to no difference to fungal infection, acute rejection or graft loss. No apparent differences in adverse events with aciclovir, ganciclovir or valaciclovir compared with placebo or no treatment were found. There is high certainty evidence that ganciclovir, when compared with aciclovir, is more effective in preventing CMV disease (7 studies: RR 0.37, 95% CI 0.23 to 0.60). There may be little to no difference in any outcome between valganciclovir and IV ganciclovir compared with oral ganciclovir (low certainty evidence). The efficacy and adverse effects of valganciclovir or ganciclovir were probably no different to valaciclovir in three studies (moderate certainty evidence). There is moderate certainty evidence that extended duration prophylaxis probably reduces the risk of CMV disease compared with three months of therapy (2 studies: RR 0.20, 95% CI 0.12 to 0.35), with probably little to no difference in rates of adverse events. Low certainty evidence suggests that 450 mg/day valganciclovir compared with 900 mg/day valganciclovir results in little to no difference in all-cause death, CMV infection, acute rejection, and graft loss (no information on adverse events). Maribavir may increase CMV infection compared with ganciclovir (1 study: RR 1.34, 95% CI: 1.10 to 1.65; moderate certainty evidence); however, little to no difference between the two treatments were found for CMV disease, all-cause death, acute rejection, and adverse events at six months (low certainty evidence).

Authors' conclusions: Prophylaxis with antiviral medications reduces CMV disease and CMV-associated death, compared with placebo or no treatment, in solid organ transplant recipients. These data support the continued routine use of antiviral prophylaxis in CMV-positive recipients and CMV-negative recipients of CMV-positive organ transplants.

Trial registration: ClinicalTrials.gov NCT00294515 NCT00227370 NCT00497796 NCT03699254 NCT00947141 NCT01753167 NCT02550639 NCT00374686 NCT00373165 NCT00566072 NCT01446445 NCT01611974 NCT00966836 NCT01552369 NCT00431353 NCT00372229 NCT03443869 NCT01329185 NCT04225923.

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Conflict of interest statement

  1. Robin Vernooij: no relevant interests were disclosed

  2. Mini Michael: no relevant interests were disclosed

  3. Maleeka Ladhani: no relevant interests were disclosed

  4. Angela Webster: no relevant interests were disclosed

  5. Giovanni Strippoli: no relevant interests were disclosed

  6. Jonathan Craig: no relevant interests were disclosed

  7. Elisabeth Hodson: no relevant interests were disclosed

Figures

1
1
Flow diagram show study selection
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
4
4
Funnel plot of 19 trials comparing antiviral medications with placebo or no treatment
5
5
CMV disease: cumulative meta‐analysis showing change over time
6
6
All‐cause death cumulative meta‐analysis showing change over time
1.1
1.1. Analysis
Comparison 1: Antiviral prophylaxis versus placebo or no treatment, Outcome 1: CMV disease
1.2
1.2. Analysis
Comparison 1: Antiviral prophylaxis versus placebo or no treatment, Outcome 2: All symptomatic CMV disease stratified by antibody status
1.3
1.3. Analysis
Comparison 1: Antiviral prophylaxis versus placebo or no treatment, Outcome 3: CMV disease in all patients by antiviral medication
1.4
1.4. Analysis
Comparison 1: Antiviral prophylaxis versus placebo or no treatment, Outcome 4: CMV disease for different organ transplants
1.5
1.5. Analysis
Comparison 1: Antiviral prophylaxis versus placebo or no treatment, Outcome 5: CMV disease and ganciclovir duration
1.6
1.6. Analysis
Comparison 1: Antiviral prophylaxis versus placebo or no treatment, Outcome 6: CMV disease and ATG therapy and antiviral efficacy
1.7
1.7. Analysis
Comparison 1: Antiviral prophylaxis versus placebo or no treatment, Outcome 7: CMV disease and immunosuppression without ATG induction and antiviral efficacy
1.8
1.8. Analysis
Comparison 1: Antiviral prophylaxis versus placebo or no treatment, Outcome 8: All‐cause death according to antiviral medication
1.9
1.9. Analysis
Comparison 1: Antiviral prophylaxis versus placebo or no treatment, Outcome 9: All‐cause death according to CMV status
1.10
1.10. Analysis
Comparison 1: Antiviral prophylaxis versus placebo or no treatment, Outcome 10: All‐cause death for different organ transplants
1.11
1.11. Analysis
Comparison 1: Antiviral prophylaxis versus placebo or no treatment, Outcome 11: All‐cause death and ganciclovir duration
1.12
1.12. Analysis
Comparison 1: Antiviral prophylaxis versus placebo or no treatment, Outcome 12: All‐cause death with or without ATG therapy and antiviral efficacy
1.13
1.13. Analysis
Comparison 1: Antiviral prophylaxis versus placebo or no treatment, Outcome 13: CMV infection
1.14
1.14. Analysis
Comparison 1: Antiviral prophylaxis versus placebo or no treatment, Outcome 14: Death due to CMV disease or other causes
1.15
1.15. Analysis
Comparison 1: Antiviral prophylaxis versus placebo or no treatment, Outcome 15: Additional outcomes: all medications
1.16
1.16. Analysis
Comparison 1: Antiviral prophylaxis versus placebo or no treatment, Outcome 16: Acute rejection according to method of diagnosis
1.17
1.17. Analysis
Comparison 1: Antiviral prophylaxis versus placebo or no treatment, Outcome 17: Valaciclovir: additional outcomes
1.18
1.18. Analysis
Comparison 1: Antiviral prophylaxis versus placebo or no treatment, Outcome 18: Adverse effects
2.1
2.1. Analysis
Comparison 2: Effect of methodological quality on CMV disease in studies of prophylaxis versus placebo or no treatment, Outcome 1: Allocation concealment
2.2
2.2. Analysis
Comparison 2: Effect of methodological quality on CMV disease in studies of prophylaxis versus placebo or no treatment, Outcome 2: Blinding of participants/investigators
2.3
2.3. Analysis
Comparison 2: Effect of methodological quality on CMV disease in studies of prophylaxis versus placebo or no treatment, Outcome 3: Intention‐to‐treat analysis (ITT)
2.4
2.4. Analysis
Comparison 2: Effect of methodological quality on CMV disease in studies of prophylaxis versus placebo or no treatment, Outcome 4: CMV disease by time of outcome assessment
2.5
2.5. Analysis
Comparison 2: Effect of methodological quality on CMV disease in studies of prophylaxis versus placebo or no treatment, Outcome 5: CMV disease by trial publication date
3.1
3.1. Analysis
Comparison 3: Effect of methodological quality on all‐cause death in studies of prophylaxis versus placebo or no treatment, Outcome 1: Allocation concealment
3.2
3.2. Analysis
Comparison 3: Effect of methodological quality on all‐cause death in studies of prophylaxis versus placebo or no treatment, Outcome 2: Blinding of participants and investigators
3.3
3.3. Analysis
Comparison 3: Effect of methodological quality on all‐cause death in studies of prophylaxis versus placebo or no treatment, Outcome 3: Intention‐to‐treat analysis (ITT)
3.4
3.4. Analysis
Comparison 3: Effect of methodological quality on all‐cause death in studies of prophylaxis versus placebo or no treatment, Outcome 4: All‐cause death and time of outcome assessment or trial publication date
3.5
3.5. Analysis
Comparison 3: Effect of methodological quality on all‐cause death in studies of prophylaxis versus placebo or no treatment, Outcome 5: All‐cause death and trial publication date
4.1
4.1. Analysis
Comparison 4: Ganciclovir versus aciclovir, Outcome 1: CMV disease in all treated patients
4.2
4.2. Analysis
Comparison 4: Ganciclovir versus aciclovir, Outcome 2: CMV disease by antibody +ve recipients
4.3
4.3. Analysis
Comparison 4: Ganciclovir versus aciclovir, Outcome 3: CMV disease by +ve donors / CMV ‐ve recipients
4.4
4.4. Analysis
Comparison 4: Ganciclovir versus aciclovir, Outcome 4: CMV ‐ve donor / CMV ‐ve recipient
4.5
4.5. Analysis
Comparison 4: Ganciclovir versus aciclovir, Outcome 5: CMV disease and effect of prophylaxis for different transplanted organs
4.6
4.6. Analysis
Comparison 4: Ganciclovir versus aciclovir, Outcome 6: Death
4.7
4.7. Analysis
Comparison 4: Ganciclovir versus aciclovir, Outcome 7: CMV infection
4.8
4.8. Analysis
Comparison 4: Ganciclovir versus aciclovir, Outcome 8: CMV infection by antibody +ve recipients
4.9
4.9. Analysis
Comparison 4: Ganciclovir versus aciclovir, Outcome 9: CMV infection by +ve donors / CMV ‐ve recipients
4.10
4.10. Analysis
Comparison 4: Ganciclovir versus aciclovir, Outcome 10: CMV infection and effect of prophylaxis for different transplanted organs
4.11
4.11. Analysis
Comparison 4: Ganciclovir versus aciclovir, Outcome 11: Additional outcomes
5.1
5.1. Analysis
Comparison 5: Ganciclovir then aciclovir versus ganciclovir, Outcome 1: CMV disease in all treated patients
5.2
5.2. Analysis
Comparison 5: Ganciclovir then aciclovir versus ganciclovir, Outcome 2: Death
5.3
5.3. Analysis
Comparison 5: Ganciclovir then aciclovir versus ganciclovir, Outcome 3: CMV infection in all treated patients
5.4
5.4. Analysis
Comparison 5: Ganciclovir then aciclovir versus ganciclovir, Outcome 4: Additional outcomes
6.1
6.1. Analysis
Comparison 6: Valganciclovir versus ganciclovir, Outcome 1: CMV disease in CMV donor +ve / recipient ‐ve
6.2
6.2. Analysis
Comparison 6: Valganciclovir versus ganciclovir, Outcome 2: Death
6.3
6.3. Analysis
Comparison 6: Valganciclovir versus ganciclovir, Outcome 3: CMV infection in CMV donor +ve / recipient ‐ve
6.4
6.4. Analysis
Comparison 6: Valganciclovir versus ganciclovir, Outcome 4: Additional outcomes
7.1
7.1. Analysis
Comparison 7: Valaciclovir versus ganciclovir or valganciclovir, Outcome 1: CMV disease in all treated patients
7.2
7.2. Analysis
Comparison 7: Valaciclovir versus ganciclovir or valganciclovir, Outcome 2: Death
7.3
7.3. Analysis
Comparison 7: Valaciclovir versus ganciclovir or valganciclovir, Outcome 3: CMV infection
7.4
7.4. Analysis
Comparison 7: Valaciclovir versus ganciclovir or valganciclovir, Outcome 4: Additional outcomes
7.5
7.5. Analysis
Comparison 7: Valaciclovir versus ganciclovir or valganciclovir, Outcome 5: Kidney function at end of study
8.1
8.1. Analysis
Comparison 8: Different ganciclovir regimens, Outcome 1: IV doses given at different frequencies
8.2
8.2. Analysis
Comparison 8: Different ganciclovir regimens, Outcome 2: Oral versus IV ganciclovir
9.1
9.1. Analysis
Comparison 9: Extended versus short‐duration valganciclovir, Outcome 1: CMV disease
9.2
9.2. Analysis
Comparison 9: Extended versus short‐duration valganciclovir, Outcome 2: CMV syndrome
9.3
9.3. Analysis
Comparison 9: Extended versus short‐duration valganciclovir, Outcome 3: CMV invasive disease
9.4
9.4. Analysis
Comparison 9: Extended versus short‐duration valganciclovir, Outcome 4: All‐cause death
9.5
9.5. Analysis
Comparison 9: Extended versus short‐duration valganciclovir, Outcome 5: CMV infection
9.6
9.6. Analysis
Comparison 9: Extended versus short‐duration valganciclovir, Outcome 6: Graft loss
9.7
9.7. Analysis
Comparison 9: Extended versus short‐duration valganciclovir, Outcome 7: Acute rejection
9.8
9.8. Analysis
Comparison 9: Extended versus short‐duration valganciclovir, Outcome 8: Other outcomes
9.9
9.9. Analysis
Comparison 9: Extended versus short‐duration valganciclovir, Outcome 9: Adverse effects
10.1
10.1. Analysis
Comparison 10: Different valganciclovir regimens, Outcome 1: All‐cause death
10.2
10.2. Analysis
Comparison 10: Different valganciclovir regimens, Outcome 2: CMV infection
10.3
10.3. Analysis
Comparison 10: Different valganciclovir regimens, Outcome 3: Acute rejection
10.4
10.4. Analysis
Comparison 10: Different valganciclovir regimens, Outcome 4: Graft loss
11.1
11.1. Analysis
Comparison 11: Maribavir versus ganciclovir, Outcome 1: CMV disease
11.2
11.2. Analysis
Comparison 11: Maribavir versus ganciclovir, Outcome 2: All‐cause death
11.3
11.3. Analysis
Comparison 11: Maribavir versus ganciclovir, Outcome 3: CMV infection
11.4
11.4. Analysis
Comparison 11: Maribavir versus ganciclovir, Outcome 4: Acute rejection
11.5
11.5. Analysis
Comparison 11: Maribavir versus ganciclovir, Outcome 5: Adverse events
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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    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 1998;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. [EMBASE: 70463941]
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
Lowance 1999 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 (ILL). 1997:87. [CENTRAL: CN-00509489]
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 Pt 1):32-8. [MEDLINE: ] - PubMed
Martin 1994 Liver {published data only}
    1. Martin M, Manez R, Linden P, Estores D, Torre-Cisneros J, Kusne S, et al. A prospective randomized trial comparing sequential ganciclovir-high dose acyclovir to high dose acyclovir for prevention of cytomegalovirus disease in adult liver transplant recipients. Transplantation 1994;58(7):779-85. [MEDLINE: ] - PMC - 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. [MEDLINE: ] - PubMed
Nafar 2005 Kidney {published data only}
    1. Nafar M, Pezeshki ML, Farrokhi F, Einollahi B, Pour-Reza-Gholi F, Firouzan A, et al. A randomized prospective trial of oral versus intravenous ganciclovir for prophylaxis of cytomegalovirus infection and disease in high-risk kidney recipients. Transplantation Proceedings 2005;37(7):3053-5. [MEDLINE: ] - PubMed
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 gancyclovir. Transplantation Proceedings 1993;25(2):1935-7. [MEDLINE: ] - PubMed
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
Pavlopoulou 2005 Kidney {published data only}
    1. Pavlopoulou ID, Syriopoulou VP, Chelioti H, Daikos GL, Stamatiades D, Kostakis A, et al. A comparative randomised study of valacyclovir vs. oral ganciclovir for cytomegalovirus prophylaxis in renal transplant recipients. Clinical Microbiology & Infection 2005;11(9):736-43. [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
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. [CENTRAL: CN-00509426]
Prabakaran 2020 Kidney {published data only}
    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 2005 Kidney {published and unpublished data}
    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 KJ, Treska V, Jindra P, Svecova M. Oral ganciclovir versus valacyclovir for prophylaxis of cytomegalovirus disease in renal transplant recipients [abstract no: 0355]. 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, Opatrny KJ, 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):483-4. - PubMed
    1. Reischig T, Jindra P, Mares J, Opatrny K, Cechura M, Svecova M, 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, Opatrny K Jr, Treska V, Cechura M, 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. - 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. [PMID: ] - 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 [Prophylaxie des infections a cytomegalovirus par le ganciclovir chez les receveurs de greffe de rein]. 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:S331-5. [MEDLINE: ] - PubMed
Rubin 2002 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
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 Liver {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

References to studies excluded from this review

Basic‐Jukic 2019 {published data only}
    1. Basic-Jukic N, Furic-Cunko V, Hudolin T, Zimak Z, Kirincich J, Kastelan Z. A comparison of different valgancyclovir formulations in the universal 6-month prophylaxis against cmv infection in renal transplant recipients: a randomized single-centre study. Prilozi Makedonska Akademija Na Naukite I Umetnostite Oddelenie Za Medicinski Nauki 2019;40(3):47-55. [MEDLINE: ] - PubMed
    1. Basic-Jukic N, Furic-Cunko V, Hudolin T, Zimak Z, Zeljko K. Comparison of different valgancyclovir formulations in universal 6-months prophylaxis of CMV infection in renal transplant recipients: a randomized single centre study [abstract no: BOS174]. Transplant International 2019;32(Suppl 2):195. [EMBASE: 632117254] - PubMed
Brennan 1997a Kidney {published data only}
    1. Brennan DC, Burton KG, Lippmann BJ, Buller RS, Keener-Gaudreault M, Lowell JA, et al. Control of cytomegalovirus associated morbidity and costs in renal transplant patients using intensive monitoring and preemptive or deferred therapy [abstract]. In: 15th Annual Meeting. American Society of Transplant Physicians (ASTP); 1996 May 10-14; Chicago (ILL). 1996.
    1. Brennan DC, Garlock KA, Lippmann BA, Buller RS, Gaudreault-Keener M, Lowell JA, et al. Control of cytomegalovirus-associated morbidity in renal transplant patients using intensive monitoring and either preemptive or deferred therapy. Journal of the American Society of Nephrology 1997;8(1):118-25. [MEDLINE: ] - PubMed
    1. Brennan DC, Garlock KA, Lippmann BJ, Buller RS, Gaudreault-Keener M, Lowell JA, et al. Polymerase chain reaction-triggered preemptive or deferred therapy to control cytomegalovirus-associated morbidity and costs in renal transplant patients. Transplantation Proceedings 1997;29(1-2):809-11. [MEDLINE: ] - PubMed
    1. Brennan DC, Storch GA, Singer GG, Lee L, Rueda J, Schnitzler MA. The prevalence of human herpesvirus-7 in renal transplant recipients is unaffected by oral or intravenous ganciclovir. Journal of Infectious Diseases 2000;181(5):1557-61. [MEDLINE: ] - PubMed
    1. Schnitzler MA, Metheney TG, Rueda JF, Woodward RS, Lowell JA, Singer GG, et al. A 3-year follow-up of pre-emptive vs deferred treatment of cytomegalovirus disease in renal transplantation. Clinical Drug Investigation 2000;19(5):367-74. [EMBASE: 30330291]
CYTOCOR 2019 {published data only}
    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
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]
Gerna 2008 Liver {published data only}
    1. Gerna G, Lilleri D, Callegaro A, Goglio A, Cortese S, Stroppa P, et al. Prophylaxis followed by preemptive therapy versus preemptive therapy for prevention of human cytomegalovirus disease in pediatric patients undergoing liver transplantation. Transplantation 2008;86(1):163-6. [MEDLINE: ] - PubMed
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
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. [MEDLINE: ] - PMC - PubMed
Jarque 2020 {published data only}
    1. Jarque M, Crespo E, Melilli E, Gutierrez A, Moreso F, Guirado L, et al. Cellular immunity to predict the risk of cytomegalovirus infection in kidney transplantation: a prospective, interventional, multicenter clinical trial. Clinical Infectious Diseases 2020;71(9):2375-85. [MEDLINE: ] - PubMed
    1. Jarque M, Melilli E, Gutierez A, Moreso F, Guirado L, Manonelles A, et al. Prospective randomized trial for predicting CMV infection according to baseline CMV-specific T-cell immunity in kidney transplant patients [abstract no: 27]. American Journal of Transplantation 2017;17(Suppl 3):216. [EMBASE: 615705134]
Jung 2001 Kidney {published data only}
    1. Jung C, Engelmann E, Borner K, Offermann G. Preemptive oral ganciclovir therapy versus prophylaxis to prevent symptomatic cytomegalovirus infection after kidney transplantation. Transplantation Proceedings 2001;33(8):3621-3. [MEDLINE: ] - PubMed
    1. Offermann G, Jung C. Preemptive oral ganciclovir therapy versus prophylaxis to prevent symptomatic cytomegalovirus infection after kidney transplantation [abstract no: 1094]. In: A Transplant Odyssey; 2001 Aug 20-23; Istanbul, Turkey. 2001. - PubMed
Khoury 2006 Kidney {published data only}
    1. Brennan DC, Hardinger KL, Bohl DL, Lockwood M, Torrence S, Schuessler R, et al. Preemptive vs prophylactic valganciclovir for CMV in renal transplantation: early results from a randomized, prospective trial [abstract no: SA-FC009]. Journal of the American Society of Nephrology 2004;15(Oct):23A. [CENTRAL: CN-00583150]
    1. Khoury JA, Storch GA, Bohl DL, Schuessler RM, Torrence SM, Lockwood M, et al. Prophylactic versus preemptive oral valganciclovir for the management of cytomegalovirus infection in adult renal transplant recipients. American Journal of Transplantation 2006;6(9):2134-43. [MEDLINE: ] - PubMed
    1. Spinner ML, Saab G, Casabar E, Bowman LJ, Storch GA, Brennan DC. Impact of prophylactic versus preemptive valganciclovir on long-term renal allograft outcomes. Transplantation 2010;90(4):412-8. [MEDLINE: ] - PMC - 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
Kliem 2008 Kidney {published data only}
    1. Kliem V, Fricke L, Wollbrink T, Burg M, Radermacher J, Rohde F. Improvement in long-term renal graft survival due to CMV prophylaxis with oral ganciclovir: results of a randomized clinical trial. American Journal of Transplantation 2008;8(5):975-83. [MEDLINE: ] - PubMed
    1. Radermacher J, Fricke L, Burg M, Mischak H, Rohde F, Kliem V. Influence of prophylactic compared with early ganciclovir treatment on graft survival in renal allograft recipients [abstract no: TH-PO025]. Journal of the American Society of Nephrology 2006;17(Abstracts):111A. [CENTRAL: CN-00653761]
Koetz 2001 kidney/Liver {published data only}
    1. Koetz AC, Delbruch R, Furtwangler A, Hufert FT, Neumann-Haefelin D, Kirste G, et al. Cytomegalovirus pp65 antigen-guided preemptive therapy with ganciclovir in solid organ transplant recipients: a prospective double-blind, placebo-controlled study. Transplantation 2001;72(7):1325-7. [MEDLINE: ] - PubMed
Marker 1980 {published data only}
    1. Marker SC, Howard RJ, Groth KE, Mastri AR, Simmons RL, Balfour HH Jr. 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
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 no: A3235]. Journal of the American Society of Nephrology 1997;8(Program & Abstracts):695A. [CENTRAL: CN-00446876]
NCT00566072 {published data only}
    1. Devolder I. The influence of intensive education and coaching on compliance for oral ganciclovir in the prophylaxis of CMV: an open randomised trial. www.clinicaltrials.gov/ct2/show/NCT00566072 (first received 3 December 2007).
Padulles 2016 {published data only}
    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]
Papanicolaou 2018 {published data only}
    1. Chou S, Wu J, Song K, Bo T. Novel UL97 drug resistance mutations identified at baseline in a clinical trial of maribavir for resistant or refractory cytomegalovirus infection. Antiviral Research 2019;172:104616. [MEDLINE: ] - PMC - PubMed
    1. Papanicolaou GA, Silveira FP, Langston A, Pereira MR, Avery R, Wijatyk A, et al. Maribavir for treatment of cytomegalovirus (CMV) infections resistant or refractory to ganciclovir or foscarnet in hematopoietic stem cell transplant (SCT) or solid organ transplant (SOT) recipients: a randomized, dose-ranging, double-blind, phase 2 study [abstract no: 78]. Open forum Infectious Diseases 2016;1(Suppl 1). [EMBASE: 627784044]
    1. Papanicolaou GA, Silveira FP, Langston AA, Pereira MR, Avery RK, Uknis M, et al. Maribavir for refractory or resistant cytomegalovirus infections in hematopoietic-cell or solid-organ transplant recipients: a randomized, dose-ranging, double-blind, phase 2 study. Clinical Infectious Diseases 2019;68(8):1255-64. [MEDLINE: ] - PMC - PubMed
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Paya 2002 Liver {published data only}
    1. Paya CV, Wilson JA, Espy MJ, Sia IG, DeBernardi MJ, Smith TF, et al. Preemptive use of oral ganciclovir to prevent cytomegalovirus infection in liver transplant patients: a randomized, placebo-controlled trial. Journal of Infectious Diseases 2002;185(7):854-60. [MEDLINE: ] - PubMed
    1. Razonable RR, Cruijsen H, Brown RA, Wilson JA, Harmsen WS, Wiesner RH, et al. Dynamics of cytomegalovirus replication during preemptive therapy with oral ganciclovir. Journal of Infectious Diseases 2003;187(11):1801-8. [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
PROTECT 2010 {published 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]
Queiroga 2003 Kidney {published data only}
    1. Quieroga M, Castro MC, Araujo LM, Alves CF, Kakehashi E, Panutti C, et al. A prospective, randomized controlled trial comparing oral ganciclovir with weekly monitored CMV-antigenemia in renal transplant patients with a high-risk for CMV infection [abstract no: 1403]. American Journal of Transplantation 2003;3(Suppl 5):511. [CENTRAL: CN-00447308]
Rayes 2001 Liver {published data only}
    1. Rayes N, Seehofer D, Oettle H, Schmidt CA, Neuhaus R, Steinmuller T, et al. Prospective randomised trial to assess the value of preemptive oral therapy for CMV-infection after OLT [abstract no: PO989]. In: XVIII International Congress of the Transplantation Society; 2000 Aug 27-Sept 1; Rome, Italy. 2000. [CENTRAL: CN-00416522]
    1. Rayes N, Seehofer D, Schmidt CA, Oettle H, Muller AR, Steinmuller T, et al. Prospective randomized trial to assess the value of preemptive oral therapy for CMV infection following liver transplantation. Transplantation 2001;72(5):881-5. [MEDLINE: ] - PubMed
    1. Struecker B, Seehofer D, Andreas A, Neuhaus P, Nada R. Impact of CMV viremia after liver transplantation: 15 year results of a prospective, randomized clinical trial [abstract no: D2399]. Transplantation 2014;98(Suppl 1):773. [EMBASE: 71546178]
Reischig 2008 Kidney {published data only}
    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, Hribova P, Jindra P, Hes O, Bouda M, Treska V, et al. Improved long-term renal allograft survival in preemptive valganciclovir therapy compared to valacyclovir prophylaxis for cytomegalovirus: Results of randomized controlled trial [abstract no: 1464]. American Journal of Transplantation 2011;11(Suppl 2):455. [EMBASE: 70406517]
    1. Reischig T, Hribova P, Jindra P, Hes O, Bouda M, Treska V, et al. Improved long-term renal allograft survival in preemptive valganciclovir therapy compared to valacyclovir prophylaxis for cytomegalovirus: results of randomized controlled trial [abstract no: O-145]. Transplant International 2011;24(Suppl 2):40. [EMBASE: 70527222]
    1. Reischig T, Hribova P, Jindra P, Hes O, Bouda M, Treska V, et al. Long-term outcomes of pre-emptive valganciclovir compared with valacyclovir prophylaxis for prevention of cytomegalovirus in renal transplantation. Journal of the American Society of Nephrology 2012;23(9):1588-97. [MEDLINE: ] - PMC - PubMed
    1. Reischig T, Jindra P, Hes O, Svecova M, Klaboch J, Treska V. Valacyclovir prophylaxis versus preemptive valganciclovir therapy to prevent cytomegalovirus disease after renal transplantation. American Journal of Transplantation 2008;8(1):69-77. [MEDLINE: ] - PubMed
Sagedal 2003 Kidney {published data only}
    1. Sagedal S, Nordal KP, Hartmann A, Midvedt K, Foss A, Asberg A, et al. Pre-emptive therapy of CMVpp65 antigen positive renal transplant recipients with oral ganciclovir: a randomized, comparative study. Nephrology Dialysis Transplantation 2003;18(9):1899-908. [MEDLINE: ] - PubMed
Scott 2011 Liver {published data only}
    1. Scott GM, Naing Z, Pavlovic J, Iwasenko JM, Angus P, Jones R, et al. Viral factors influencing the outcome of human cytomegalovirus infection in liver transplant recipients. Journal of Clinical Virology 2011;51(4):229-33. [MEDLINE: ] - PubMed
    1. Scott GM, Naing Z, Pavlovic J, Waliuzzaman ZM, Iwasenko J, Rismanto N, et al. CMV infection and antiviral resistance in a liver transplant cohort followed longitudinally [abstract o: 1945]. Transplantation 2010;90(Suppl 1):668. [EMBASE: 71532382]
Singh 1994 Liver {published data only}
    1. Sing N, Yu VL, Mieles L, Wagener MM, Miner RC, Gayowsky T. High-dose acyclovir compared with short-course preemptive ganciclovir therapy to prevent cytomegalovirus disease in liver transplant recipients. Annals of Internal Medicine 1994;120(5):375-81. [MEDLINE: ] - PubMed
Singh 2000 Liver {published data only}
    1. Singh N, Paterson DL, Gayowsky T, Wagener MM, Marino IR. Cytomegalovirus antigenemia directed pre-emptive prophylaxis with oral versus iv ganciclovir for the prevention of cytomegalovirus disease in liver transplant recipients. Transplantation 2000;70(5):717-22. [MEDLINE: ] - PubMed
    1. Singh N, Yu VL, Gayowski T, Marino IR. CMV antigenemia directed preemptive prophylaxis with oral ganciclovir for the prevention of CMV disease in liver transplant recipients: a prospective, randomised, controlled trial [abstract no: 442]. Transplantation 1998;65(12):S113. [CENTRAL: CN-00764233] - PubMed
Singh 2019 Liver {published data only}
    1. Singh N, Winston D, Razonable RR, Lyon GM, Silveira FP, Wagener M, et al. Preemptive therapy (PET) vs. prophylaxis for prevention of cytomegalovirus (CMV) disease in high-risk donor seropositive/recipient seronegative (D+R-) liver transplant recipients (LTR): A NIH-sponsored, randomized, controlled, multicenter trial [abstract no: LB21]. Open Forum Infectious Diseases 2018;5(Suppl 1):S766. [EMBASE: 629442710]
    1. Singh N, Winston DJ, Razonable RR, Lyon GM, Silveira FP, Wagener MM, et al. Cost-effectiveness of preemptive therapy versus prophylaxis in a randomized clinical trial for the prevention of CMV disease in seronegative liver transplant recipients with seropositive donors. Clinical Infectious Diseases 2020;73(9):e2739-45. [MEDLINE: ] - PMC - PubMed
    1. Singh N, Winston DJ, Razonable RR, Lyon GM, Silveira FP, Wagener MM, et al. Effect of preemptive therapy vs antiviral prophylaxis on cytomegalovirus disease in seronegative liver transplant recipients with seropositive donors: a randomized clinical trial. JAMA 2020;323(14):1378-87. [MEDLINE: ] - PMC - PubMed
    1. Singh N, Winston DJ, Razonable RR, Lyon GM, Silveira FP, Wagener MM, et al. Risk factors for cytomegalovirus viremia following liver transplantation with a seropositive donor and seronegative recipient receiving antiviral therapy. Journal of Infectious Diseases 2021;223(6):1073-7. [MEDLINE: ] - PMC - PubMed
    1. Wagener MM, Winston DJ, Razonable RR, Lyon GM, Silveira FP, Limaye AP, et al. Preemptive therapy is cost effective when compared to prophylaxis in cytomegalovirus donor positive-recipient negative liver transplant recipients [abstract no: 111). American Journal of Transplantation 2019;1(3):461. [EMBASE: 628454976]
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]
Westall 2018 {published data only}
    1. Westall GP, Cristiano Y, Levvey BJ, Whitford H, Paraskeva MA, Paul E, et al. A randomized study of quantiferon-CMV-directed versus fixed-duration valganciclovir prophylaxis to reduce late CMV following lung transplantation. Transplantation 2019;103(5):1005-13. [MEDLINE: ] - PubMed
Witzke 2012 Kidney {published data only}
    1. Witzke O, Hauser IA, Bartels M, Wolf G, Wolters H, Nitschke M. Valganciclovir prophylaxis versus preemptive therapy in cytomegalovirus-positive renal allograft recipients: 1-year results of a randomized clinical trial. Transplantation 2012;93(1):61-8. [MEDLINE: ] - PubMed
    1. Witzke O, Nitschke M, Bartels M, Ott U, Hauser IA. CMV valganciclovir prophylaxis versus preemptive therapy after renal transplantation: one year results of a randomized clinical trial [abstract no: 3273]. Transplantation 2010;90(Suppl 2):186. [EMBASE: 71531461]
    1. Witzke O, Nitschke M, Bartels M, Wolters H, Wolf G, Reinke P, et al. Valganciclovir prophylaxis versus preemptive therapy in cytomegalovirus-positive renal allograft recipients: long-term results after 7 years of a randomized clinical trial. Transplantation 2018;102(5):876-82. [MEDLINE: ] - PubMed
    1. Witzke O. CMV valganciclovir prophylaxis versus preemptive therapy after renal transplantation: Two year results of a randomized clinical trial [abstract no: LB05]. American Journal of Transplantation 2011;11(Suppl 2):210. [EMBASE: 70405637]
    1. Witzke O. CMV valganciclovir prophylaxis versus preemptive therapy after renal transplantation: two year results of a randomized clinical trial [abstract no: P042]. Transplant International 2011;24(Suppl 3):31-2. [EMBASE: 70537366]
Yang 1998 Kidney {published data only}
    1. Yang CW, An HJ, Kim YO, Shin YS, Chang YS, Bang BK. Indication of ganciclovir treatment during early cytomegalovirus (CMV) viremia in CMV seropositive recipients. a longitudinal study of CMV pp65 antigenemia (Ag) assay [abstract no: A3404]. Journal of the American Society of Nephrology 1996;7(9):1928. [CENTRAL: CN-00775192]
    1. Yang CW, Kim YO, Kin YS, Kin SY, Moon IS, Ahn HJ, et al. Clinical course of cytomegalovirus (CMV) viremia with and without ganciclovir treatment in CMV-seropositive kidney transplant recipients. Longitudinal follow-up of CMV pp65 antigenemia assay. American Journal of Nephrology 1998;18(5):373-8. [MEDLINE: ] - PubMed

References to studies awaiting assessment

Limaye 2023 {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. [EMBASE: 640022298]
    1. Limaye AP, Budde K, Humar A, Vincenti F, Kuypers DR, Carroll RP, et al. Letermovir vs valganciclovir for prophylaxis of cytomegalovirus in high-risk kidney transplant recipients: a randomized clinical trial. JAMA 2023;330(1):33‐42. [PMID: ] - PMC - PubMed
Verghese 2022 {published data only}
    1. Verghese PS, Matas A, Chinnakotla S, Evans M, Balfour H Jr. Post-kidney transplant valacyclovir versus valganciclovir for CMV prophylaxis: a randomized controlled trial [abstract no: 51]. American Journal of Transplantation 2022;22(Suppl 3):354. [EMBASE: 639185621]

References to ongoing studies

NCT04225923 {published data only}
    1. NCT04225923. A study for kidney transplant recipients at high-risk of cytomegalovirus infection [A phase 2, randomized, double-blind, placebo-controlled study of NPC-21 for kidney transplant recipients at high-risk of cytomegalovirus infection]. www.clinicaltrials.gov/study/NCT04225923 (first posted 13 January 2020).

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References to other published versions of this review

Hodson 2005a
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