The risk of variant Creutzfeldt‐Jakob disease among UK patients with bleeding disorders,known to have received potentially contaminated plasma products |
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Authors: | S. M. A. ZAMAN F. G. H. HILL B. PALMER C. M. MILLAR A. BONE A. M. MOLESWORTH N. CONNOR C. A. LEE G. DOLAN J. T. WILDE O. N. GILL M. MAKRIS |
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Affiliation: | 1. Health Protection Agency, London;2. The Childrens’ Hospital NHS Foundation Trust, Birmingham;3. Members of Transfusion Transmitted Infection Working Party of UKHCDO;4. National Haemophilia Database, Manchester;5. Department of Haematology, Imperial College, London;6. University of London, London;7. Nottingham University Hospitals NHS Trust, Nottingham;8. University Hospital Birmingham NHS Foundation Trust, Birmingham;9. University of Sheffield, Royal Hallamshire Hospital, Sheffield |
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Abstract: | Summary. The risk of variant Creutzfeldt‐Jakob disease (vCJD) from potentially infected plasma products remains unquantified. This risk has been assessed for 787 UK patients with an inherited bleeding disorder prospectively followed‐up for 10–20 years through the UK Haemophilia Centre Doctors’ Organisation (UKHCDO) Surveillance Study. These patients had been treated with any of 25 ‘implicated’ clotting factor batches from 1987 to 1999, which included in their manufacture, plasma from eight donors who subsequently developed clinical vCJD. Variant CJD infectivity of these batches was estimated using plasma fraction infectivity estimates and batch‐manufacturing data. Total potential vCJD infectivity received by each patient has been estimated by cumulating estimated infectivity from all doses received during their lifetime. Of 787 patients, 604 (77%) were followed‐up for over 13 years following exposure to an implicated batch. For these 604 patients, the estimated vCJD risk is ≥1% for 595, ≥50% for 164 and 100% for 51. This is additional to background UK population risk due to dietary exposure. Of 604 patients, 94 (16%) received implicated batches linked to donors who developed clinical vCJD within 6 months of their donations. One hundred and fifty‐one (25%) had received their first dose when under 10 years of age. By 1st January 2009, none of these patients had developed clinical vCJD. The absence of clinical vCJD cases in this cohort to date suggests that either plasma fraction infectivity estimates are overly precautionary, or the incubation period is longer for this cohort than for implicated cellular blood product recipients. Further follow‐up of this cohort is needed. |
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Keywords: | haemophilia inherited bleeding disorders risk assessment UK plasma products variant Creutzfeldt‐Jakob disease |
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