an audit of cmv disease in renal transplant recipients transplanted at the queen elizabeth hospital...
TRANSCRIPT
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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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Cytomegalovirus infection
• Direct effects– Viral syndrome– Tissue invasive disease
• Indirect effects– Acute and chronic rejection– Post transplantation diabetes– Opportunistic infections
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IMPACT Trial
Humar A et al. American Journal of Transplantation 2010; 10: 1228–1237Humar A et al, Transplantation 2010; 90: 1427–1431
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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
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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 standards1. Rate of CMV disease in 1st year in D+/R- patients <8%2. Rate of CMV disease in 1st year in D+/R+ patients <8%3. Rate of CMV disease in 1st year in D-/R+ patients <8%
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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
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)
• 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
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Audit Questions?
1. Should we offer extended prophylaxis (200 days) to D+/R- recipients?
2. Should we offer prophylaxis to D+/R+ recipients?
3. Should we offer prophylaxis to D-/R+ recipients?
£1081.46 for 30 day supply of 900mg once daily dose
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CMV Syndrome CMV Disease
Number at risk
0 100 200 300 365
150 137 127 119 111
121 104 96 94 89
116 109 86 75 67
178 128 115 107 105
Number at risk
0 100 200 300 365
150 140 130 121 113
121 110 104 102 97
116 110 98 91 85
178 154 143 136 133
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Audit Standards
1. Rate of CMV disease in the first year post transplantation in D+/R- patients <8%
2. Rate of CMV disease in the first year post transplantation in D+/R+ patients <8%
3. Rate of CMV disease in the first year post transplantation in D-/R+ patients <8%
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Early CMV in D+/R-
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
• 3/23 cases CMV syndrome during 1st 100 days• Subtherapeutic dose of valganciclovir in 2/3
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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 (16.7) 2 (5.1) 1 (4.3) 5 (6.5)
Death during CMV episode 0 (0.0) 0 (0.0) 1 (2.6) 1 (4.3) 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 - Total- QEHB- Stoke
3 (100.0)3 (100.0)
0 (0.0)
8 (66.7)8 (66.7)0 (0.0)
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 (median, range) 8, 6-10 21, 2-42 9, 2-48 10.5, 3-26 9, 2-48Total days in QEHB 24 175 343 168 710
*5 additional patients received treatment with no evidence of CMV Syndrome or Disease
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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
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Acknowledgments
• Everyone at other transplant units • Kerry Tomlinson• Caroline Clark• Hari Krishnan• Husum Osman
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Who should receive prophylaxis?
Number at risk
0 200 400 600 730
150 127 110 97 81
121 96 87 74 59
116 86 62 51 40
178 115 102 90 77