Effects of the Intensity of Immunosuppressive Therapy on Outcome of Treatment for CMV Disease in Organ Transplant Recipients

Åsberg, Anders; Jardine, Alan G.; Bignamini, A; Rollag, Halvor; Pescovitz, Mark D.; Gahlemann, C. G.; Humar, Atul; Hartmann, Anders

doi:10.1111/j.1600-6143.2010.03114.x

Cited by 79 publications

(65 citation statements)

References 34 publications

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“…Thus, posttransplant treatment with RG7667 may provide benefits by delaying CMV viremia until a time when immunosuppressant doses are lower and CMV infection may be easier to manage (31,32). Notably, despite this delay, there did not appear to be deleterious effects as levels of RG7667 decreased.…”

Section: Discussionmentioning

confidence: 99%

Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of RG7667, a Combination Monoclonal Antibody, for Prevention of Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients

Ishida

Patel²,

Mehta

et al. 2017

Antimicrob Agents Chemother

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Cytomegalovirus (CMV) infection is a significant complication after kidney transplantation. We examined the ability of RG7667, a combination of two monoclonal antibodies, to prevent CMV infection in high-risk kidney transplant recipients in a randomized, double-blind, placebo-controlled trial. CMV-seronegative recipients of a kidney transplant from a CMV-seropositive donor (DϩRϪ) were randomized to receive RG7667 (n ϭ 60) or placebo (n ϭ 60) at the time of transplant and 1, 4, and 8 weeks posttransplant. Patients were monitored for CMV viremia every 1 to 2 weeks posttransplant for 24 weeks. Patients who had seroconverted (DϩRϩ) or withdrawn before dosing were excluded from the analysis (n ϭ 4). CMV viremia occurred in 27 of 59 (45.8%) patients receiving RG7667 and 35 of 57 (61.4%) patients receiving placebo (stratum-adjusted difference, 15.3%; P ϭ 0.100) within 12 weeks posttransplant and in 30 of 59 (50.8%) patients receiving RG7667 and 40 of 57 (70.2%) patients receiving placebo (stratum-adjusted difference, 19.3%; P ϭ 0.040) within 24 weeks posttransplant. Median time to CMV viremia was 139 days in patients receiving RG7667 compared to 46 days in patients receiving placebo (hazard ratio, 0.53; P ϭ 0.009). CMV disease was less common in the RG7667 than placebo group (3.4% versus 15.8%; P ϭ 0.030). Adverse events were generally balanced between treatment groups. In high-risk kidney transplant recipients, RG7667 was well tolerated, numerically reduced the incidence of CMV infection within 12 and 24 weeks posttransplant, delayed time to CMV viremia, and was associated with less CMV disease than the placebo. (This study has been registered at ClinicalTrials.gov under registration no. NCT01753167.)

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Section: Discussionmentioning

confidence: 99%

Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of RG7667, a Combination Monoclonal Antibody, for Prevention of Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients

Ishida

Patel²,

Mehta

et al. 2017

Antimicrob Agents Chemother

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“…This concept has been clearly demonstrated by a sub-analysis of the VICTOR trial 71 , which showed that dual vs.…”

Section: Management Of Immunosuppressionmentioning

confidence: 92%

Treatment and prevention of cytomegalovirus infection in heart and lung transplantation: an update

Potena¹,

Solidoro

Patrucco

et al. 2016

Expert Opinion on Pharmacotherapy

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“…Additional factors that influence viral decay are a high net state of immunosuppression, thoracic organ transplantation, and gastrointestinal tissueinvasive CMV disease (49,180,181). Knowledge of these risk factors allows for some individualization of therapy but only as a supplement to clinical and virologic monitoring.…”

Section: Treatmentmentioning

confidence: 98%

Updated International Consensus Guidelines on the Management of Cytomegalovirus in Solid-Organ Transplantation

et al. 2013

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Cytomegalovirus (CMV) continues to be one of the most common infections after solid-organ transplantation, resulting in significant morbidity, graft loss, and adverse outcomes. Management of CMV varies considerably among transplant centers but has been become more standardized by publication of consensus guidelines by the Infectious Diseases Section of The Transplantation Society. An international panel of experts was reconvened in October 2012 to revise and expand evidence and expert opinion-based consensus guidelines on CMV management, including diagnostics, immunology, prevention, treatment, drug resistance, and pediatric issues. The following report summarizes the recommendations.

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Effects of the Intensity of Immunosuppressive Therapy on Outcome of Treatment for CMV Disease in Organ Transplant Recipients

Cited by 79 publications

References 34 publications

Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of RG7667, a Combination Monoclonal Antibody, for Prevention of Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients

Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of RG7667, a Combination Monoclonal Antibody, for Prevention of Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients

Treatment and prevention of cytomegalovirus infection in heart and lung transplantation: an update

Updated International Consensus Guidelines on the Management of Cytomegalovirus in Solid-Organ Transplantation

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