The full content of Annals is available to subscribers

Subscribe/Learn More  >
Articles |

Cytomegalovirus Immune Globulin Prophylaxis in Liver Transplantation: A Randomized, Double-blind, Placebo-controlled Trial

David R. Snydman, MD; Barbara G. Werner, PhD; Nancy N. Dougherty, RN, MPH; John Griffith, PhD; Robert H. Rubin, MD; Jules L. Dienstag, MD; Richard H. Rohrer, MD; Richard Freeman, MD; Roger Jenkins, MD; W. David Lewis, MD; Scott Hammer, MD; Edward O'Rourke, MD; George F. Grady, MD; Karim Fawaz, MD; Marshall M. Kaplan, MD; Mark A. Hoffman, MD; Andrea T. Katz, BSN, RN; Maureen Doran, RN, MPH, The Boston Center for Liver Transplantation CMVIG Study Group.
[+] Article, Author, and Disclosure Information

From New England Medical Center, Massachusetts General Hospital, New England Deaconess Hospital, Children's Hospital, and Massachusetts State Laboratory Institute, Tufts University School of Medicine, and Harvard Medical School, Boston, Massachusetts. Requests for Reprints: David R. Snydman, MD, Box 238, New England Medical Center, 750 Washington Street, Boston, MA 02111. Acknowledgments: The authors thank Roselia Martinez for preparation of the manuscript and Yvonne Gonzalez, Laurie Gibbons, Fay Gitlin, Karen Chen, and Sandy Monticello for technical assistance. Grant Support: By grant R10 DK31389 from the National Institutes of Health.

Copyright 2004 by the American College of Physicians

Ann Intern Med. 1993;119(10):984-991. doi:10.7326/0003-4819-119-10-199311150-00004
Text Size: A A A

Objective: To study the effect of cytomegalovirus immune globulin (CMVIG) on prevention of cytomegalovirus (CMV) disease and its complications in patients receiving liver transplants.

Design: Randomized, multicenter, placebo-controlled, double-blind trial.

Setting: Four university-affiliated transplant centers in Boston (Boston Center for Liver Transplantation).

Patients: One hundred forty-one liver transplant recipients completed the study.

Intervention: CMVIG or placebo (1% albumin) given in a dose of 150 mg/kg body weight within 72 hours of the transplant, then at weeks 2, 4, 6, and 8, and at 100 mg/kg at weeks 12 and 16.

Measurements: Patients were observed for 1 year after transplantation for the development of CMV infection, disease, pneumonia, as well as for opportunistic fungal infections, graft survival, and mortality. Weekly cultures were taken of urine, buffy coat, and throat wash for CMV for 2 months, then monthly, and at any clinical illness.

Results: Using a Cox proportional-hazards model, CMVIG was shown to reduce severe CMV-associated disease (multi-organ CMV disease, CMV pneumonia, or invasive fungal disease associated with CMV infection) from 26% to 12% (relative risk, 0.39; 95% CI, 0.17 to 0.89). When we controlled for the use of monoclonal antibodies to T cells (OKT3), CMVIG use was still protective (relative risk, 0.39; CI, 0.17 to 0.90). Rates of CMV disease were reduced from 31% to 19% (relative risk, 0.56; CI, 0.3 to 1.1) in CMVIG recipients although no effect on rates of CMV infection, graft survival, or patient survival at 1 year were shown. When we controlled for the urgency of transplantation and OKT3 use, a reduction in CMV disease (relative risk, 0.22; CI, 0.06 to 0.81) was shown for globulin recipients for all serologic groups except for the highest risk group (the CMV-seropositive donor, CMV-seronegative group).

Conclusion: CMVIG reduced the rate of severe CMV-associated disease in patients undergoing orthotopic liver transplantation. No effect of CMVIG on CMV donor-positive, recipient-negative liver transplant recipients was shown, suggesting a need for additional prophylactic strategies.





Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).


Submit a Comment/Letter
Submit a Comment/Letter

Summary for Patients

Clinical Slide Sets

Terms of Use

The In the Clinic® slide sets are owned and copyrighted by the American College of Physicians (ACP). All text, graphics, trademarks, and other intellectual property incorporated into the slide sets remain the sole and exclusive property of the ACP. The slide sets may be used only by the person who downloads or purchases them and only for the purpose of presenting them during not-for-profit educational activities. Users may incorporate the entire slide set or selected individual slides into their own teaching presentations but may not alter the content of the slides in any way or remove the ACP copyright notice. Users may make print copies for use as hand-outs for the audience the user is personally addressing but may not otherwise reproduce or distribute the slides by any means or media, including but not limited to sending them as e-mail attachments, posting them on Internet or Intranet sites, publishing them in meeting proceedings, or making them available for sale or distribution in any unauthorized form, without the express written permission of the ACP. Unauthorized use of the In the Clinic slide sets will constitute copyright infringement.


Buy Now for $32.00

to gain full access to the content and tools.

Want to Subscribe?

Learn more about subscription options

Related Articles
Journal Club
Topic Collections
Forgot your password?
Enter your username and email address. We'll send you a reminder to the email address on record.