Transcript Assessment of preventive measures of accidental blood exposure in

HCV - Hemodialysis
순천향 대학병원
신장내과 강혜란
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Between 27 July - 29 September 2005, in Italy
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Of the 50 patients treated in the HD unit
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5 were already anti-HCV positive, 13 became positive during the study period
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all the molecularly characterized incident cases (10/13) were infected with the same viral
variant of one of the prevalent cases
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11 cases : a single event of multi-dose vials heparin contamination
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2 cases : occurred possibly as a result of inappropriate risk management
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More than 30% of all HCV infections in developed countries results from poor application of
standard precautions during percutaneous procedures
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Comprehensive strategy which included
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educational programmes
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periodical auditing on standard precaution
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use of single-dose vials whenever possible
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prospective surveillance for blood-borne infections (including a system of prompt
notification)
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risk assessment/management dedicated staff
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Patients undergoing dialysis are at risk for HCV infection
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HCV may be easily transmitted whenever standard precautions are not strictly applied
• Standard precautions
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Hand hygiene
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Gloves
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Facial protection
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Gown
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Prevention of needle stick and
injuries from other sharp
instruments
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Respiratory hygiene and cough
etiquette
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Environmental cleaning
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Linens
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Waste disposal
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Patient care equipment
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September 2007 - August 2009, in USA
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248 patients received hemodialysis at Facility A
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HCV infection status was determined for 149 (60.1%) patients
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Viral sequencing results suggest that four patients with HCV infection were each the likely
source of infection for one or more patients. The patients in all four of these clusters were
dialyzed on the same schedule and on the same or consecutive shifts
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These temporal and proximal relationships between patients within each cluster suggest
that transmission could have occurred through shared supplies or environmental surfaces,
or could be related to practices performed by shared staff
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48 patients were undergoing HD : 9 (19%) : HCV-infected , 39 (81%) : were not
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Through the six-monthly routine anti-HCV screening programme
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3 HD patients were found to have seroconverted to become anti-HCV antibody positive
between November 2012 and May 2013, in Italy
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During this period they had received HD in the same room, and during the same shifts,
together with a fourth patient with known chronic HCV infection that predated his attendance at
the HD centre
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During site visits, inadequate cleaning and disinfection, were observed
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Gloves were not regularly changed by staff members after touching machines and during vascular
access care
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Hand washing was not regularly performed after contact with different patients, even though all
rooms in the HD unit had provision of dispensers with alcohol based hand rub
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In each dialysis room a clean area for medication storage and preparation was not separated and
clearly identified
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Preparation of medications was performed on a stationary trolley located in the same room close to
the patient treatment area
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Multi-dose saline vials (250 mL) were used in the HD centre. According to interviews with the
nurses, this saline was solely employed to prime the machines; it was not used to flush indwelling
peripheral intravenous cannulas, for which single dose saline vials were used
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Although when interviewed all nurses denied refilling the same syringe more than once from a
multi-dose vial, we observed the presence of open vials at different locations in each
dialysis room, suggesting that refilling was taking place
Kidney International (2016) 89, 988–994
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Chronic HCV infection plays a detrimental role in the survival of patients undergoing regular
dialysis and renal transplant recipients
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Various mechanisms could explain the reduced survival among HCV-infected patients with
CKD
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increased liver-related mortality
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impaired quality of life
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higher cardiovascular risk
The HCV Kidney Disease: Improving Global Outcomes (KDIGO) : recommended the
treatment of those HCV-infected patients, dialysis dependent or not, in the waiting list for renal
transplant
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The antiviral therapy of HCV infected kidney transplant candidates targets
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disease (slowing the progression of hepatitis C)
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infection (avoiding the extrahepatic complications of HCV after transplant)
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The extrahepatic complications due to HCV after renal transplantation
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de novo or recurrent glomerulonephritis
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post-transplant diabetes mellitus
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nephrotoxicity related to excessive exposure to cyclosporine
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greater incidence of humoral rejection
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chronic allograft nephropathy
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An accelerated atherogenesis induced by HCV
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has been suggested in the adult general population
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explain the association between HCV infection and the decline in kidney function in patients
with CKD
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Some data have been established on a link between HCV and an increased
cardiovascular risk in the adult general population and among patients on intermittent
hemodialysis
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Such evidence would lead to the treatment of all anti-HCV–positive patients with CKD,
irrespective of whether they are suitable candidates for renal transplant
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A recent survey from the Dialysis Outcomes and Practice Patterns Study gave emphasis to the
low number of dialysis patients who are currently receiving antiviral therapy for HCV
(<5%); this is in keeping with the unsatisfactory results offered by many interferon (IFN)based clinical trials in terms of efficacy and safety
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Interferon-based regimens (pegylated IFN plus ribavirin)
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provided limited efficacy and safety among CKD patients
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Anemia, infection
advent of the new direct-acting antivirals (launched over the past 5 years)
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given the opportunity to reach sustained virologic response rates(SVR) of 90% for many
patient groups
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Unfortunately, poor information exists regarding the antiviral treatment of hepatitis C in the
CKD population
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CKD stage 4–5 and HCV genotype 1
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grazoprevir (NS3/4A protease inhibitor) + elbasvir (NS5A inhibitor) combination
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excellent efficacy (SVR, 94.3%; 115/122) and safety have been achieved
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sofosbuvir (NS5B inhibitor) + simeprevir (NS3/4A inhibitor)
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viral response of 89%, but the size of the study group (n[38 patients with ESRD) was small
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Some phase 2 and 3 clinical trials based on other antiviral combinations (3D regimen,
sofosbuvir/ledipasvir, or other sofosbuvir-containing approaches) are ongoing
Thus, the antiviral regimens based on direct-acting antivirals promise to play a pivotal
role in the eradication of hepatitis C among kidney disease patients
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Direct-acting antivirals are very expensive
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Adverse drug reactions resulting from concomitantly administered medications are another
ongoing concern for patients undergoing HCV treatment, particularly for CKD patients who
have a heavy burden of comorbidities
DAAs approved in Korea 2015
Asunaprevia
NS3/4A
protease
Daclatasvir
Genotype 1b
NS5A
Sofosbuvir
Ribavirin
Genotype 2
NS5B
polymerase
Sofosbuvir
Ledipasvir
NS5B
polymerase
NS5A
Genotype 1