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| 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. |
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 country is caused by group B Streptococcus (GBS), and most of these cases are due to type III GBS (III-GBS). The killing of III-GBS in vitro is dependent on specific IgG antibody. Adequate serum levels of specific III-GBS antibody protect the exposed newborn from the development of invasive disease. Therefore, III-GBS was used as a model to evaluate the activity of three IVIG 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 IVIG preparations 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.
1 Research Fellow, Department of Ophthalmology, Harvard Medical
School, Boston, MA
2 Research Fellow, Department of Periodontology, Harvard School of
Dental Medicine
3 Research Fellow, Center for Blistering Diseases, New England
Baptist Hospital, Boston
4 Director, Center for Blistering Diseases, New England Baptist
Hospital
Reprints: Dr. Ahmed, Center for Blistering Diseases, 70 Parker Hill Ave., Boston, MA 02120-3224, fax 617/754-6434, arahmedmd@msn.com
BACKGROUND: Intravenous immunoglobulin (IVIG) is an expensive biologic agent used to treat patients with mucous membrane pemphigoid (MMP) nonresponsive to conventional immunosuppressive therapy (CIST). The high cost of IVIG is of concern to healthcare providers and insurance companies.
OBJECTIVE: To compare the cost of IVIG with that of CIST in treating a cohort of 15 patients with severe and extensive MMP.
METHODS: Fifteen patients with biopsy-proven MMP nonresponsive to CIST were subsequently treated with IVIG and demonstrated a positive clinical response. This was a comparative, retrospective study; the mean total duration of the observation period was 8.4 years. A comparison of the cost of IVIG with that of CIST during the study period and the annual cost was performed. The cost of CIST was defined as the actual cost of the drug plus the cost of management of the multiple adverse effects, including hospitalizations, produced by CIST. In the same patient cohort, no significant adverse effects to IVIG were observed and no hospitalizations were required. Hence, the cost of IVIG therapy is simply the actual cost of the IVIG.
RESULTS: In this cohort of patients, CIST had significant adverse effects, many of which were hazardous and required prolonged and frequent hospitalizations. The mean total cost using IVIG therapy was significantly less than that of CIST during the entire course of the disease (p < 0.001) and on an annual basis (p < 0.05).
CONCLUSIONS: IVIG therapy is a safe, clinically beneficial, and less-expensive alternative treatment in patients with progressive MMP that is nonresponsive to CIST.
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