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The efficacy and safety of 200 days Valganciclovir Cytomegalovirus prophylaxis in high-risk kidney transplant recipients

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Abstract
Late-onset cytomegalovirus (CMV) disease is a significant problem with a standard 3-month prophylaxis regimen. This multicentre, double-blind, randomized controlled trial compared the efficacy and safety of 200 days' versus 100 days' valganciclovir prophylaxis (900 mg once daily) in 326 high-risk (D+/R-) kidney allograft recipients. Significantly fewer patients in the 200-day group versus the 100-day group developed confirmed CMV disease up to month 12 posttransplant (16.1% vs. 36.8%; p < 0.0001). Confirmed CMV viremia was also significantly lower in the 200-day group (37.4% vs. 50.9%; p = 0.015 at month 12). There was no significant difference in the rate of biopsy-proven acute rejection between the groups (11% vs. 17%, respectively, p = 0.114). Adverse events occurred at similar rates between the groups and the majority were rated mild-to-moderate in intensity and not related to study medication. In conclusion, this study demonstrates that extending valganciclovir prophylaxis (900 mg once daily) to 200 days significantly reduces the incidence of CMV disease and viremia through to 12 months compared with 100 days' prophylaxis, without significant additional safety concerns associated with longer treatment. The number needed to treat to avoid one additional patient with CMV disease up to 12 months posttransplant is approximately 5.
Keywords
valganciclovir, cytomegalovirus (CMV), prophylaxis, PREVENTION, MANAGEMENT, INFECTION, DISEASE, ACUTE REJECTION, RENAL-TRANSPLANTATION, LUNG TRANSPLANTATION, INDEFINITE PROPHYLAXIS, SOLID-ORGAN TRANSPLANTATION, ORAL GANCICLOVIR, Antivirals

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Chicago
Humar, A, Y Lebranchu, F Vincenti, EA Blumberg, JD Punch, AP Limaye, D Abramowicz, et al. 2010. “The Efficacy and Safety of 200 Days Valganciclovir Cytomegalovirus Prophylaxis in High-risk Kidney Transplant Recipients.” American Journal of Transplantation 10 (5): 1228–1237.
APA
Humar, A., Lebranchu, Y., Vincenti, F., Blumberg, E., Punch, J., Limaye, A., Abramowicz, D., et al. (2010). The efficacy and safety of 200 days Valganciclovir Cytomegalovirus prophylaxis in high-risk kidney transplant recipients. AMERICAN JOURNAL OF TRANSPLANTATION, 10(5), 1228–1237.
Vancouver
1.
Humar A, Lebranchu Y, Vincenti F, Blumberg E, Punch J, Limaye A, et al. The efficacy and safety of 200 days Valganciclovir Cytomegalovirus prophylaxis in high-risk kidney transplant recipients. AMERICAN JOURNAL OF TRANSPLANTATION. 2010;10(5):1228–37.
MLA
Humar, A, Y Lebranchu, F Vincenti, et al. “The Efficacy and Safety of 200 Days Valganciclovir Cytomegalovirus Prophylaxis in High-risk Kidney Transplant Recipients.” AMERICAN JOURNAL OF TRANSPLANTATION 10.5 (2010): 1228–1237. Print.
@article{1068661,
  abstract     = {Late-onset cytomegalovirus (CMV) disease is a significant problem with a standard 3-month prophylaxis regimen. This multicentre, double-blind, randomized controlled trial compared the efficacy and safety of 200 days' versus 100 days' valganciclovir prophylaxis (900 mg once daily) in 326 high-risk (D+/R-) kidney allograft recipients. Significantly fewer patients in the 200-day group versus the 100-day group developed confirmed CMV disease up to month 12 posttransplant (16.1\% vs. 36.8\%; p {\textlangle} 0.0001). Confirmed CMV viremia was also significantly lower in the 200-day group (37.4\% vs. 50.9\%; p = 0.015 at month 12). There was no significant difference in the rate of biopsy-proven acute rejection between the groups (11\% vs. 17\%, respectively, p = 0.114). Adverse events occurred at similar rates between the groups and the majority were rated mild-to-moderate in intensity and not related to study medication. In conclusion, this study demonstrates that extending valganciclovir prophylaxis (900 mg once daily) to 200 days significantly reduces the incidence of CMV disease and viremia through to 12 months compared with 100 days' prophylaxis, without significant additional safety concerns associated with longer treatment. The number needed to treat to avoid one additional patient with CMV disease up to 12 months posttransplant is approximately 5.},
  author       = {Humar, A and Lebranchu, Y and Vincenti, F and Blumberg, EA and Punch, JD and Limaye, AP and Abramowicz, D and Jardine, AG and Voulgari, AT and Ives, J and Hauser, IA and Peeters, Patrick},
  issn         = {1600-6135},
  journal      = {AMERICAN JOURNAL OF TRANSPLANTATION},
  keyword      = {valganciclovir,cytomegalovirus (CMV),prophylaxis,PREVENTION,MANAGEMENT,INFECTION,DISEASE,ACUTE REJECTION,RENAL-TRANSPLANTATION,LUNG TRANSPLANTATION,INDEFINITE PROPHYLAXIS,SOLID-ORGAN TRANSPLANTATION,ORAL GANCICLOVIR,Antivirals},
  language     = {eng},
  number       = {5},
  pages        = {1228--1237},
  title        = {The efficacy and safety of 200 days Valganciclovir Cytomegalovirus prophylaxis in high-risk kidney transplant recipients},
  url          = {http://dx.doi.org/10.1111/j.1600-6143.2010.03074.x},
  volume       = {10},
  year         = {2010},
}

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