<i>In vitro</i> evaluation of cytomegalovirus‐specific hyperimmune globulins vs. standard intravenous immunoglobulins

Miescher, Sylvia; Huber, T.; Kuhne, Mirjam; Lieby, Patricia; Snydman, David R.; Vensak, Judith; Berger, Melvin

doi:10.1111/vox.12246

Cited by 18 publications

(18 citation statements)

References 40 publications

(67 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In vitro studies show consistently enhanced functional antibody against CMV compared to regular intravenous immune globulin. 245,246 Monoclonal antibodies are in development and show potential promise for reduction of CMV DNAemia and disease. 247,248…”

Section: Immune Globulinmentioning

confidence: 99%

The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation

et al. 2018

View full text Add to dashboard Cite

Despite recent advances, cytomegalovirus (CMV) infections remain one of the most common complications affecting solid organ transplant recipients, conveying higher risks of complications, graft loss, morbidity, and mortality. Research in the field and development of prior consensus guidelines supported by The Transplantation Society has allowed a more standardized approach to CMV management. An international multidisciplinary panel of experts was convened to expand and revise evidence and expert opinion-based consensus guidelines on CMV management including prevention, treatment, diagnostics, immunology, drug resistance, and pediatric issues. Highlights include advances in molecular and immunologic diagnostics, improved understanding of diagnostic thresholds, optimized methods of prevention, advances in the use of novel antiviral therapies and certain immunosuppressive agents, and more savvy approaches to treatment resistant/refractory disease. The following report summarizes the updated recommendations.

show abstract

Section: Immune Globulinmentioning

confidence: 99%

The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation

et al. 2018

View full text Add to dashboard Cite

show abstract

“…As a result, the effect of CMVIg for the treatment of GR‐CMV is almost always confounded by the concomitant use of antiviral agents. There are no published clinical studies demonstrating the superiority of CMVIg over IVIG, and in vitro evidence is conflicting . In vitro studies use neutralizing titer to determine anti‐CMV activity, and measurements of IgG subclasses, specifically IgG3, as a surrogate marker of neutralizing titer .…”

Section: Discussion and Review Of The Literaturementioning

confidence: 99%

“…24 In a recent industry-funded study, CMVIg demonstrated 4-fold higher neutralizing activity than pooled IVIG, and there was no correlation between IgG3 and neutralizing titer between products. 24 The authors concluded that CMVIg was not less active, as was suggested in a previous study, and IgG3 levels alone do not provide assurance of high anti-CMV titers or neutralizing activity. Overall measurement of anti viral antibody activity found in IVIG products is not standardized and is highly variable.…”

Section: Immune Globulin: Cmvig and Ivigmentioning

confidence: 96%

“…[23][24][25][26] In vitro studies use neutralizing titer to determine anti-CMV activity, and measurements of IgG subclasses, specifically IgG3, as a surrogate marker of neutralizing titer. 24 In a recent industry-funded study, CMVIg demonstrated 4-fold higher neutralizing activity than pooled IVIG, and there was no correlation between IgG3 and neutralizing titer between products. 24 The authors concluded that CMVIg was not less active, as was suggested in a previous study, and IgG3 levels alone do not provide assurance of high anti-CMV titers or neutralizing activity.…”

Section: Immune Globulin: Cmvig and Ivigmentioning

confidence: 99%

See 1 more Smart Citation

Ganciclovir‐Resistant Cytomegalovirus Infection in Abdominal Solid Organ Transplant Recipients: Case Series and Review of the Literature

et al. 2017

View full text Add to dashboard Cite

Ganciclovir-resistant cytomegalovirus (GR-CMV) is emerging as a significant infection in the abdominal transplant population. GR-CMV is difficult to manage, and treatment options are limited. We report a descriptive case series of 15 patients who had documented GR-CMV at our center and review the literature on treatment of GR-CMV. The first case in this series was detected in 2012; the majority of cases occurred after January 1, 2014, with approximately 50% occurring in 2015. UL97 and UL54 viral genome mutations were present in 100% and 40% of CMV-infected patients, respectively. GR-CMV infection occurred ≤ 1 year posttransplantation in 11 patients (73%). All patients experienced dose reduction of valganciclovir (the oral prodrug of ganciclovir) before the development of GR-CMV. Initial treatment for GR-CMV included a variety of regimens, all including reduction in maintenance immunosuppression. Of the 6 patients with detectable GR-CMV by polymerase chain reaction (PCR) who were discharged without GR-CMV treatment and had a length of stay (LOS) less than 14 days, 83% were subsequently readmitted for treatment of GR-CMV within 2 months (60% in < 20 days); none received leflunomide. Of six patients with a LOS ≥ 14 days, 80% had CMV PCR below quantification on hospital discharge, and only one patient was readmitted in less than 20 days; 83% received leflunomide. Following GR-CMV, there was a 50% rejection incidence, 27% graft loss, and 20% mortality. For patients with more than three admissions for GR-CMV treatment, 100% had a major complication: 60% rejection, 20% graft loss, and 40% mortality. Common clinical characteristics of patients with GR-CMV included high-risk serostatus, lymphocyte depletion, and history of valganciclovir dose reduction. Overall, outcomes were poor. It appears that hospital readmission rate was reduced when CMV was treated to negativity with an initial treatment regimen of reduced immunosuppression, foscarnet, intravenous immunoglobulins, and leflunomide.

show abstract

“…Of the remaining candidates, no simple cell culture system is available for EBV, and different neutralization assay formats exist for CMV, with unclear correlation of results with clinical relevance. 25,27,28 HAdV, RSV, and hPIV were thus finally selected for further investigation.…”

Section: Choice Of Alternative Virus Antibody Specificitiesmentioning

confidence: 99%

Immunoglobulins and virus antibody titers: of past needs, current requirements, and future options

Kreil

Farcet

2018

Transfusion

View full text Add to dashboard Cite

BACKGROUND Immunoglobulins (Igs) have been in clinical use for almost 70 years, and early on were also used in conjunction with exposure to the measles virus or polio virus. The US regulations that describe functional Ig lot release thus require the demonstration of minimum antibody titers against these two viruses, although the use of vaccines has now dramatically reduced their incidence. The lower clinical importance of these viruses raises the question of whether other virus antibodies might be more informative for patients with immunodeficiency. STUDY DESIGN AND METHODS A literature survey was conducted to identify viruses of potential clinical concern for people with immunodeficiency. The viruses selected have stable seroepidemiology and associated functional antibody assays. As a result, neutralizing antibody titers to human adenovirus 5 (HAdV5), respiratory syncytial virus (RSV) serotypes A and B, and human parainfluenza virus 3 (hPIV3) were determined in Ig lots produced from plasma collected in either the United States or the European Union. RESULTS The virus antibody titers measured were high and consistent among the Ig lots tested. Use of either US‐ or EU‐derived plasma as starting material resulted in equivalent virus antibody titers, with the exception of RSV serotype B, for which a lower titer was seen in EU plasma–derived Ig lots. CONCLUSION With the significant decline in measles virus and polio virus circulation, and even their potential eradication, measurement of antibody titers against other viruses in Ig products may be more informative for functional lot release testing.

show abstract

In vitro evaluation of cytomegalovirus‐specific hyperimmune globulins vs. standard intravenous immunoglobulins

Cited by 18 publications

References 40 publications

The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation

The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation

Ganciclovir‐Resistant Cytomegalovirus Infection in Abdominal Solid Organ Transplant Recipients: Case Series and Review of the Literature

Immunoglobulins and virus antibody titers: of past needs, current requirements, and future options

Contact Info

Product

Resources

About