An audit of CMV disease in renal transplant recipients transplanted at the Queen Elizabeth Hospital Birmingham Gemma Banham, Shazia Shabir, Richard Borrows.

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Presentation transcript:

An audit of CMV disease in renal transplant recipients transplanted at the Queen Elizabeth Hospital Birmingham Gemma Banham, Shazia Shabir, Richard Borrows

Cytomegalovirus infection Direct effects Viral syndrome Tissue invasive disease Indirect effects Acute and chronic rejection Post transplantation diabetes Opportunistic infections

IMPACT Trial Humar A et al. American Journal of Transplantation 2010; 10: 1228–1237 Humar A et al, Transplantation 2010; 90: 1427–1431

RCT of oral prophylactic ganciclovir vs intravenous pre-emptive therapy FULL ITT population D+/R- D+/R+ D-/R+ Kliem V et al, American Journal of Transplantation 2008; 8: 975–983

British Transplantation Society Guidelines (2011) CMV prophylaxis to seronegative recipients who receive a transplant from a seropositive donor (D+/R-) CMV prophylaxis where either the donor or recipient is seropositive if patient is treated with T-cell depleting antibodies Choice of prophylaxis strategies Audit standards Rate of CMV disease in 1st year in D+/R- patients <8% Rate of CMV disease in 1st year in D+/R+ patients <8% Rate of CMV disease in 1st year in D-/R+ patients <8%

CMV status (Donor/Recipient) Audit Methods Patients transplanted at QEHB between 1st August 2007 and 30th June 2011 Patients identified from Surgery Department’s database Total of 569 patients PICS microbiology tab for CMV PCR results Electronic clinical notes for those with CMV viraemia Heartland’s Hospital Virology Department results database Stoke audit NHS Blood and Transplant CMV status (Donor/Recipient) Number (%) D-/R- 150 (26.4) D-/R+ 121 (21.3) D+/R+ 178 (31.3) D+/R- 116 (20.4) Unknown 4 (0.7)

Audit Questions? Should we offer extended prophylaxis (200 days) to D+/R- recipients? Should we offer prophylaxis to D+/R+ recipients? Should we offer prophylaxis to D-/R+ recipients? £1081.46 for 30 day supply of 900mg once daily dose

CMV Syndrome CMV Disease Number at risk 100 200 300 365 150 137 127 119 111 121 104 96 94 89 116 109 86 75 67 178 128 115 107 105 Number at risk 100 200 300 365 150 140 130 121 113 110 104 102 97 116 98 91 85 178 154 143 136 133

Audit Standards  Rate of CMV disease in the first year post transplantation in D+/R- patients <8% Rate of CMV disease in the first year post transplantation in D+/R+ patients <8% Rate of CMV disease in the first year post transplantation in D-/R+ patients <8%  

Early CMV in D+/R- 3/23 cases CMV syndrome during 1st 100 days Subtherapeutic dose of valganciclovir in 2/3 Creatinine clearance (ml/min) Cockcroft-Gault Formula Recommended valganciclovir prophylaxis >60 900mg once daily 40 - 59 450mg once daily 25 - 39 450mg alternate days 10 - 24 450mg twice weekly <10 Not recommended

Consequences of CMV Syndrome Syndrome cases (%) D-/R- 3/150 (2.0) D-/R+ 12/122 (9.9) D+/R+ 39/178 (21.9) D+/R- 23/116 (19.8) Total 77/569 (13.5) Disease 1 (33.0) 2 (16.7) 5 (12.8) 4 (17.4) 12 (15.6) Histology 0 (0.0) 2 (5.1) 1 (4.3) 5 (6.5) Death during CMV episode 1 (2.6) 2 (2.6) Viraemia level (median, range) 2.2x107, 1.6x106 - 3.1x107 1.1x104, 1025-1.9x105 1.3x104, 504- 1.7x108 3.1x105, 571- 7.7x106 2.2x104, 504- 1.7x108 Requiring treatment* - Total Intravenous 3 (100.0) 2 (66.7) 11 (91.7) 2 (1.7) 37 (94.9) 12 (30.8) 21 (91.3) 8 (34.8) 72 (93.5) 24 (31.2) Patients requiring CMV related hospitalisation - QEHB - Stoke 8 (66.7) 27 (69.2) 23 (59.0) 4 (10.3) 17 (73.9) 14 (60.9) 3 (13.0) 55 (71.4) 48 (62.3) 7 (9.1) Days in QEHB 8, 6-10 21, 2-42 9, 2-48 10.5, 3-26 Total days in QEHB 24 175 343 168 710 *5 additional patients received treatment with no evidence of CMV Syndrome or Disease

Conclusions Meeting targets for CMV ‘Disease’ Large amounts CMV ‘Syndrome’ with significant morbidity and cost Highest burden in D+/R+, followed by D+/R- then D-/R+ Majority D+/R- disease is late Early D+/R- disease may be due to inappropriate dosing of valganciclovir

Acknowledgments Everyone at other transplant units Kerry Tomlinson Caroline Clark Hari Krishnan Husum Osman

Who should receive prophylaxis? Number at risk 200 400 600 730 150 127 110 97 81 121 96 87 74 59 116 86 62 51 40 178 115 102 90 77