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Comparison of ganciclovir- and immune globulin-containing regimens in preventing cytomegalovirus infection in patients with renal transplants

T Walton, B Sankari, and L Wyner
The effectiveness and costs of ganciclovir compared with intravenous immune globulin (IVIG) in the prevention of cytomegalovirus (CMV) disease were studied. A retrospective analysis was conducted of renal transplant patients treated with ganciclovir during the initial hospital stay followed by three months of acyclovir therapy and a historical control group that received IVIG at one, two, four, six, and eight weeks posttransplant and acyclovir at two weeks posttransplant and continued for three months. The average drug cost for each regimen and the average direct cost of treating CMV disease in each group were calculated. The overall frequency of CMV disease was 14% in the IVIG group (n = 42) and 3% in the ganciclovir group (n = 30). CMV disease occurred less frequently in all ganciclovir-treated subgroups, but the difference was significant only in the group in which the recipient was CMV seronegative and the donor CMV seropositive. No ganciclovir-related adverse events were noted. Three IVIG-related infusion reactions were noted. Treatment with ganciclovir decreased drug costs by approximately $2,775 per patient or $83,250 for the study sample. The overall avoided cost in the ganciclovir group was $102,575 ($3,419 per patient). Ganciclovir followed by acyclovir was significantly more effective than IVIG followed by acyclovir in the prevention of CMV disease in CMV-seronegative patients who received renal transplants from CMV-seropositive donors; among all patients studied, ganciclovir did not differ from IVIG in preventing CMV infection but was considerably less expensive.

Human immunoglobulins for intravenous use: comparison of available preparations for group B streptococcal antibody levels, opsonic activity, and efficacy in animal models

LB Givner

Dept of Pediatrics, Bowman Gray School of Medicine, Wake Forest University, Winston-Salem, NC 27103.

Currently available human immunoglobulin preparations for intravenous use(IVIGs) are being used (with antibiotics) by some physicians for therapy of sepsis in newborns. Most neonatal sepsis and/or meningitis in this countryis caused by group B Streptococcus (GBS), and most of these cases are dueto type III GBS (III-GBS). The killing of III-GBS in vitro is dependent onspecific IgG antibody. Adequate serum levels of specific III-GBS antibodyprotect the exposed newborn from the development of invasive disease.Therefore, III-GBS was used as a model to evaluate the activity of threeIVIG preparations available for clinical use. Specific antibody levels, in vitro opsonophagocytic killing, and protective efficacy in animal models revealed differences in activity for III-GBS between the three IVIGpreparations as well as between IVIG lots from the same manufacturer. Furthermore, it was found that the effect of IVIG using one of the assay methods may not reliably predict activity obtained using the other assays. These data document the inability to predict functional activity against a specific pathogen such as GBS on the part of a lot of IVIG chosen at random. In view of these findings and of the limited data evaluating clinical efficacy, IVIG cannot be recommended at this time for use in the therapy of infectious diseases such as neonatal sepsis.





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