Valganciclovir for cytomegalovirus prevention in solid organ transplant patients: An evidence-based reassessment of safety and efficacy

PLoS ONE

Volumn 4, Issue 5, 2009, Pages

  Kalil, Andre C ^a   Freifeld, Alison G ^a   Lyden, Elizabeth R ^b   Stoner, Julie A ^c  

^a UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^b UNIVERSITY OF NEBRASKA AT OMAHA   (United States)

^c UNIVERSITY OF OKLAHOMA HEALTH SCIENCES CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACICLOVIR; ANTIVIRUS AGENT; GANCICLOVIR; UNCLASSIFIED DRUG; VALGAN; VALGANCICLOVIR; DRUG DERIVATIVE;

ARTICLE; CLINICAL TRIAL; COST EFFECTIVENESS ANALYSIS; CYTOMEGALOVIRUS INFECTION; DRUG COST; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; EVIDENCE BASED PRACTICE; HUMAN; LIVER TRANSPLANTATION; LOW DRUG DOSE; META ANALYSIS; NEUTROPENIA; ONSET AGE; ORGAN TRANSPLANTATION; RISK FACTOR; RISK REDUCTION; STANDARDIZATION; SYSTEMATIC REVIEW; CASE CONTROL STUDY; COHORT ANALYSIS; CYTOMEGALOVIRUS; DRUG EFFECT; EVIDENCE BASED MEDICINE; FEMALE; MALE; MIDDLE AGED; RANDOMIZED CONTROLLED TRIAL;

CYTOMEGALOVIRUS;

ANTIVIRAL AGENTS; CASE-CONTROL STUDIES; COHORT STUDIES; CYTOMEGALOVIRUS; CYTOMEGALOVIRUS INFECTIONS; EVIDENCE-BASED MEDICINE; FEMALE; GANCICLOVIR; HUMANS; MALE; MIDDLE AGED; ORGAN TRANSPLANTATION; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 65849405940     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0005512     Document Type: Article

References (58)

1. Sia IG, Patel R (2000) New strategies for prevention and therapy of cytomegalovirus infection and disease in solid-organ transplant recipients. Clin Microbiol Rev 13(1): 83-121, table of contents.
2. Kalil AC, Levitsky J, Lyden E, Stoner J, Freifeld AG (2005) Meta-analysis: The efficacy of strategies to prevent organ disease by cytomegalovirus in solid organ transplant recipients. Ann Intern Med 143(12): 870-880.
3. Strippoli GF, Hodson EM, Jones C, Craig JC (2006) Preemptive treatment for cytomegalovirus viremia to prevent cytomegalovirus disease in solid organ transplant recipients. Transplantation 81(2): 139-145.
4. Small LN, Lau J, Snydman DR (2006) Preventing post-organ transplantation cytomegalovirus disease with ganciclovir: A meta-analysis comparing prophylactic and preemptive therapies. Clin Infect Dis 43(7): 869-880.
5. Baliga RS, Kadambi PV, Javaid B, Harland R, Williams JW, et al. (2004) A nationwide survey of cytomegalovirus prophylaxis and treatment in the transplant community. Am J Transplant 4: 495.
6. Levitsky J, Stosor V, Abceassis M, Ison MG (2007) A survey of CMV prevention strategies after liver transplantation. Am J Transplant 7(195 Suppl): 197.
7. Paya C, Humar A, Dominguez E, Washburn K, Blumberg E, et al. (2004) Efficacy and safety of valganciclovir vs. oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant 4(4): 611-620.
8. Lange WR (2003) 2003 safety alert: Valcyte (valganciclovir HCTg tablets). 2007(Apr 30).
9. Khoury JA, Storch GA, Bohl DL, Schuessler RM, Torrence SM, et al. (2006) Prophylactic versus preemptive oral valganciclovir for the management of cytomegalovirus infection in adult renal transplant recipients. Am J Transplant 6(9): 2134-2143.
10. Said T, Nampoory MR, Pacsa AS, Essa S, Madi N, et al. (2007) Oral valgancyclovir versus intravenous gancyclovir for cytomegalovirus prophylaxis in kidney transplant recipients. Transplant Proc 39(4): 997-999.
11. Humar A, Kumar D, Preiksaitis J, Boivin G, Siegal D, et al. (2005) A trial of valganciclovir prophylaxis for cytomegalovirus prevention in lung transplant recipients. Am J Transplant 5(6): 1462-1468.
12. Zamora MR, Nicolls MR, Hodges TN, Marquesen J, Astor T, et al. (2004) Following universal prophylaxis with intravenous ganciclovir and cytomegalovirus immune globulin, valganciclovir is safe and effective for prevention of CMV infection following lung transplantation. Am J Transplant 4(10): 1635-1642.
13. Weng FL, Patel AM, Wanchoo R, Brahmbhatt Y, Ribeiro K, et al. (2007) Oral ganciclovir versus low-dose valganciclovir for prevention of cytomegalovirus disease in recipients of kidney and pancreas transplants. Transplantation 83(3): 290-296.
14. Akalin E, Sehgal V, Ames S, Hossain S, Daly L, et al. (2003) Cytomegalovirus disease in high-risk transplant recipients despite ganciclovir or valganciclovir prophylaxis. Am J Transplant 3(6): 731-735.
15. Keven K, Basu A, Tan HP, Thai N, Khan A, et al. (2004) Cytomegalovirus prophylaxis using oral ganciclovir or valganciclovir in kidney and pancreas-kidney transplantation under antibody preconditioning. Transplant Proc 36(10): 3107-3112.
16. Park JM, Lake KD, Arenas JD, Fontana RJ (2006) Efficacy and safety of low-dose valganciclovir in the prevention of cytomegalovirus disease in adult liver transplant recipients. Liver Transpl 12(1): 112-116.
17. Mattes FM, Hainsworth EG, Hassan-Walker AF, Burroughs AK, Sweny P, et al. (2005) Kinetics of cytomegalovirus load decrease in solid-organ transplant recipients after preemptive therapy with valganciclovir. J Infect Dis 191(1): 89-92.
18. Singh N, Wannstedt C, Keyes L, Gayowski T, Wagener MM, et al. (2005) Efficacy of valganciclovir administered as preemptive therapy for cytomegalovirus disease in liver transplant recipients: Impact on viral load and late-onset cytomegalovirus disease. Transplantation 79(1): 85-90.
19. Aigner C, Jaksch P, Winkler G, Czebe K, Taghavi S, et al. (2005) Initial experience with oral valganciclovir for pre-emptive cytomegalovirus therapy after lung transplantation. Wien Klin Wochenschr 117(13-14): 480-484.
20. Devyatko E, Zuckermann A, Ruzicka M, Bohdjalian A, Wieselthaler G, et al. (2004) Pre-emptive treatment with oral valganciclovir in management of CMV infection after cardiac transplantation. J Heart Lung Transplant 23(11): 1277-1282.
21. Diaz-Pedroche C, Lumbreras C, San Juan R, Folgueira D, Andres A, et al. (2006) Valganciclovir preemptive therapy for the prevention of cytomegalovirus disease in high-risk seropositive solid-organ transplant recipients. Transplantation 82(1): 30-35.
22. Muñoz V, Castellares C, Muñoz P Epidemiology of citomegalovirus (CMV) infection in liver transplant recipients (LTR) in spain: A national survey (abstract # K-1813).
23. Lopau K, Greser A, Wanner C (2007) Efficacy and safety of preemptive anti-CMV therapy with valganciclovir after kidney transplantation. Clin Transplant 21(1): 80-85.
24. Walker JK, Scholz LM, Scheetz MH, Gallon LG, Kaufman DB, et al. (2007) Leukopenia complicates cytomegalovirus prevention after renal transplantation with alemtuzumab induction. Transplantation 83(7): 874-882.
25. National Cancer Institute. Guidelines and tools for protocol development. 2006.
26. Ljungman P, Griffiths P, Paya C (2002) Definitions of cytomegalovirus infection and disease in transplant recipients. Clin Infect Dis 34(8): 1094-1097.
27. Mantel N, Haenszel W (1959) Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 22(4): 719-748.
28. DerSimonian R, Laird N (1986) Meta-analysis in clinical trials. Control Clin Trials 7(3): 177-188.
29. Higgins JP, Thompson SG, Deeks JJ, Altman DG (2003) Measuring inconsistency in meta-analyses. BMJ 327(7414): 557-560.
30. Freeman RB, Paya C, Pescovitz MD, Humar A, Dominguez E, et al. (2004) Risk factors for cytomegalovirus viremia and disease developing after prophylaxis in high-risk solid-organ transplant recipients. Transplantation 78(12): 1765-1773.
31. Ioannidis JP, Evans SJ, Gotzsche PC, O'Neill RT, Altman DG, et al. (2004) Better reporting of harms in randomized trials: An extension of the CONSORT statement. Ann Intern Med 141(10): 781-788.
32. Mulrow CD, Cook D (1998) Systematic reviews : Synthesis of best evidence for health care decisions. PhiladelphiaPa.: American College of Physicians. pp 117.
33. Sterne JA, Gavaghan D, Egger M (2000) Publication and related bias in meta-analysis: Power of statistical tests and prevalence in the literature. J Clin Epidemiol 53(11): 1119-1129.
34. Begg CB, Mazumdar M (1994) Operating characteristics of a rank correlation test for publication bias. Biometrics 50(4): 1088-1101.
35. Gane E, Saliba F, Valdecasas GJ, O'Grady J, Pescovitz MD, et al. (1997) 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 [corrected. Lancet 350(9093): 1729-1733.
36. Limaye AP, Bakthavatsalam R, Kim HW, Kuhr CS, Halldorson JB, et al. (2004) Late-onset cytomegalovirus disease in liver transplant recipients despite antiviral prophylaxis. Transplantation 78(9): 1390-1396.
37. Jain A, Mohanka R, Orloff M, Abt P, Ryan C, et al. (2006) Question of using valganciclovir for cytomegalovirus (CMV) infection prophylaxis in post-liver transplant recipients. Liver Transpl 12(6): 1020-1; author reply 1022-3.
38. Jain A, Orloff M, Kashyap R, Lansing K, Betts R, et al. (2005) Does valganciclovir hydrochloride (valcyte) provide effective prophylaxis against cytomegalovirus infection in liver transplant recipients? Transplant Proc 37(7): 3182-3186.
39. Fiddian P, Sabin CA, Griffiths PD (2002) Valacyclovir provides optimum acyclovir exposure for prevention of cytomegalovirus and related outcomes after organ transplantation. J Infect Dis 186 Suppl 1: S110-5.
40. Couchoud C (2000) Cytomegalovirus prophylaxis with antiviral agents for solid organ transplantation. Cochrane Database Syst Rev (2)(2): CD001320.
41. Merigan TC, Renlund DG, Keay S, Bristow MR, Starnes V, et al. (1992) A controlled trial of ganciclovir to prevent cytomegalovirus disease after heart transplantation. N Engl J Med 326(18): 1182-1186.
42. Brennan DC, Garlock KA, Singer GG, Schnitzler MA, Lippmann BJ, et al. (1997) Prophylactic oral ganciclovir compared with deferred therapy for control of cytomegalovirus in renal transplant recipients. Transplantation 64(12): 1843-1846.
43. Einsele H, Reusser P, Bornhauser M, Kalhs P, Ehninger G, et al. (2006) Oral valganciclovir leads to higher exposure to ganciclovir than intravenous ganciclovir in patients following allogeneic stem cell transplantation. Blood 107(7): 3002-3008.
44. Pescovitz MD (1999) Oral ganciclovir and pharmacokinetics of valganciclovir in liver transplant recipients. Transpl Infect Dis 1 Suppl 1: 31-34.
45. Fleming TR, DeMets DL (1996) Surrogate end points in clinical trials: Are we being misled? Ann Intern Med 125(7): 605-613.
46. Bucher HC, Guyatt GH, Cook DJ, Holbrook A, McAlister FA (1999) Users' guides to the medical literature: XIX. applying clinical trial results. A. how to use an article measuring the effect of an intervention on surrogate end points. evidence-based medicine working group. JAMA 282(8): 771-778.
47. Boivin G, Goyette N, Gilbert C, Roberts N, Macey K, et al. (2004) Absence of cytomegalovirus-resistance mutations after valganciclovir prophylaxis, in a prospective multicenter study of solid-organ transplant recipients. J Infect Dis 189(9): 1615-1618.
48. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ, et al. (2006) Reporting of noninferiority and equivalence randomized trials: An extension of the CONSORT statement. JAMA 295(10): 1152-1160.
49. Pocock SJ (2003) The pros and cons of noninferiority trials. Fundam Clin Pharmacol 17(4): 483-490.
50. Gomberg-Maitland M, Frison L, Halperin JL (2003) Active-control clinical trials to establish equivalence or noninferiority: Methodological and statistical concepts linked to quality. Am Heart J 146(3): 398-403.
51. Temple R, Ellenberg SS (2000) Placebo-controlled trials and active-control trials in the evaluation of new treatments. part 1: Ethical and scientific issues. Ann Intern Med 133(6): 455-463.
52. Sacks H, Chalmers TC, Smith H Jr (1982) Randomized versus historical controls for clinical trials. Am J Med 72(2): 233-240.
53. Kunz R, Oxman AD (1998) The unpredictability paradox: Review of empirical comparisons of randomised and non-randomised clinical trials. BMJ 317(7167): 1185-1190.
54. Benson K, Hartz AJ (2000) A comparison of observational studies and randomized, controlled trials. N Engl J Med 342(25): 1878-1886.
55. Concato J, Shah N, Horwitz RI (2000) Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 342(25): 1887-1892.
56. Singh N (2005) Late-onset cytomegalovirus disease as a significant complication in solid organ transplant recipients receiving antiviral prophylaxis: A call to heed the mounting evidence. Clin Infect Dis 40(5): 704-708.
57. Limaye AP, Bakthavatsalam R, Kim HW, Randolph SE, Halldorson JB, et al. (2006) Impact of cytomegalovirus in organ transplant recipients in the era of antiviral prophylaxis. Transplantation 81(12): 1645-1652.
58. Singh N, Paterson DL, Gayowski T, Wagener MM, Marino IR (2000) Cytomegalovirus antigenemia directed pre-emptive prophylaxis with oral versus I.V. ganciclovir for the prevention of cytomegalovirus disease in liver transplant recipients: A randomized, controlled trial. Transplantation 70(5): 717-722.