Prevention, Diagnosis, Evaluation, and Treatment of Hepatitis C in Chronic Kidney Disease
Chapter 1: Detection and evaluation of HCV in CKD
1.1: Screening patients with chronic kidney disease (CKD) for hepatitis C virus (HCV) infection
1.2: Follow-up HCV screening of in-center hemodialysis patients
1.3: Liver testing in patients with CKD and HCV infection
1.4: Other testing of patients with HCV infection
Chapter 2: Treatment of HCV infection in patients with CKD
Figure 1. Direct-acting antiviral (DAA) regimens with evidence of effectiveness for various chronic kidney disease (CKD) populations
Figure 2. Summary of currently available direct-acting antiviral (DAA) treatment targets in hepatitis C virus (HCV) life cycle
Chapter 3: Preventing HCV transmission in hemodialysis units
Table 1. Infection control practices (“hygienic precautions”) particularly relevant for preventing HCV transmission
- Proper hand hygiene and glove changes, especially between patient contacts, before invasive procedures, and after contact with blood and potentially blood-contaminated surfaces/supplies
- Proper injectable medication preparation practices following aseptic techniques and in an appropriate clean area, and proper injectable medication administration practice
- Thorough cleaning and disinfection of surfaces at the dialysis station, especially high-touch surfaces
- Adequate separation of clean supplies from contaminated materials and equipment
Table 3. Factors and lapses in infection control practices associated with transmission of HCV infection in dialysis units
- Preparation of injections in a contaminated environment (including at patient treatment station)
- Reuse of single-dose medication vial for more than 1 patient
- Use of mobile cart to transport supplies or medications to patients
- Inadequate cleaning or disinfection of shared environmental surfaces between patients
- Failure to separate clean and contaminated areas
- Failure to change gloves and perform hand hygiene between tasks or patients
- Hurried change-over processes
- Low staff-to-patient ratio
Table 4. Hygienic precautions for hemodialysis (dialysis machines)
- The ‘transducer protector’ is a filter (normally a hydrophobic 0.2-μm filter) that is fitted between the pressure-monitoring line of the extracorporeal circuit and the pressure-monitoring port of the dialysis machine. The filter allows air to pass freely to the pressure transducer that gives the reading displayed by the machine, but it resists the passage of fluid. This protects the patient from microbiologic contamination (as the pressure-monitoring system is not disinfected) and the machine from ingress of blood or dialysate. An external transducer protector is normally fitted to each pressure-monitoring line in the blood circuit. A back-up filter is located inside the machine. Changing the internal filter is a technical job.•A “single-pass machine” is a machine that pumps the dialysate through the dialyzer and then to waste. In general, such machines do not allow fluid to flow between the drain pathway and the fresh pathway except during disinfection. “Recirculating” machines produce batches of fluid that can be passed through the dialyzer several times.
- External transducer protectors should be fitted to the pressure lines of the extracorporeal circuit.
- Before commencing dialysis, staff should ensure that the connection between the transducer protectors and the pressure-monitoring ports is tight, as leaks can lead to wetting of the filter.
- Transducer protectors should be replaced if the filter becomes wet, as the pressure reading may be affected. Using a syringe to clear the flooded line may damage the filter and increase the possibility of blood passing into the dialysis machine.•If wetting of the filter occurs after the patient has been connected, the line should be inspected carefully to see if any blood has passed through the filter. If any fluid is visible on the machine side, the machine should be taken out of service at the end of the session so that the internal filter can be changed and the housing disinfected.•Some blood tubing sets transmit pressure to the dialysis machine without a blood–air interface, thus eliminating the need for transducer protectors.
- After each session, the exterior of the dialysis machine and all surfaces in the dialysis treatment station should be cleaned with a low-level disinfectant if not visibly contaminated. Pay particular attention to high-touch surfaces that are likely to come into contact with the patient (e.g., arm rests, blood pressure cuff) or staff members’ hands (e.g., machine control panel).•Disinfection of external machine surfaces should not commence until the patient has left the dialysis treatment station. A complete (unit-wide) patient-free interval between shifts might facilitate more thorough cleaning and disinfection of the unit.
- If a blood spillage has occurred, the exterior should be disinfected with a commercially available tuberculocidal germicide or a solution containing at least 500 p.p.m. hypochlorite (a 1:100 dilution of 5% household bleach) if this is not detrimental to the surface of dialysis machines. Advice on suitable disinfectants, and the concentration and contact time required, should be provided by the manufacturer.
- If blood or fluid is thought to have seeped into inaccessible parts of the dialysis machine (e.g., between modules or behind blood pump), the machine should be taken out of service until it can be dismantled and disinfected.
Disinfection of the internal fluid pathways
- It is not necessary for the internal pathways of single-pass dialysis machines to be disinfected between patients, even in the event of a blood leak. Some facilities may still opt to disinfect the dialysate-to-dialyzer (Hansen) connectors before the next patient.
- Machines with recirculating dialysate should always be put through an appropriate disinfection procedure between patients.
Table 5. Steps to initiate concurrently and undertake following identification of a new HCV infection in a hemodialysis patient
- Report the infection to appropriate public health authority.
- Assess risk factors of the affected patient in conjunction with public health.
- Determine HCV infection status of all patients in the hemodialysis unit.
- Test all patients treated in the center for HCV infection (Chapter 1) unless they are already known to have active infection. Follow-up and testing of patients who were treated in the center and those subsequently transferred or discharged may be warranted.
- Conduct a thorough root cause analysis of the infection and address infection control lapses.
- Perform rigorous assessments of staff infection control practices to identify lapses. This should minimally include assessments of hand hygiene and glove change practices; injectable medication preparation, handling, and administration; and environmental cleaning and disinfection practices.
- Share findings with all staff members and take action to address lapses. Staff education and retraining may be necessary.
- Consider hiring a consultant with infection prevention expertise to provide recommendations for improvement of practices and work flow and/or to help implement actions to address identified lapses.
- Conduct regular audits to ensure improved adherence to recommended practice.
- Demonstrations of cleaning adequacy such as use of Glo Germ (Moab, UT) or luminol might be helpful for staff education.
- Communicate openly with patients.
- Inform all patients of the reason for additional HCV testing and the results of their HCV tests.
- If transmission within the center is suspected or confirmed, inform all patients of this. Patients should also be made aware of steps being taken to assess and improve practices.
Table 6. Strategies to support adherence to infection control recommendations in hemodialysis centers
- It is important for the designers of dialysis units to create an environment that makes infection control procedures easy to implement. Adequate hand-washing facilities must be provided, and the machines and shared space should make it easy for staff to visualize individual treatment stations. Certain jurisdictions specify the area around a hemodialysis machine.
- The unit should ensure that there is sufficient time between shifts for effective decontamination of the exterior of the machine and other shared surfaces.
- The unit should locate supplies of gloves at enough strategic points to ensure that staff has no difficulty obtaining gloves in an emergency.
- When selecting new equipment, ease of disinfection should be considered.
- There are indications from the literature that the rate of failure to implement hygienic precautions increases with understaffing. Understaffing has been associated with hepatitis C outbreaks. Certain jurisdictions specify a specific nurse-to-patient ratio (e.g., 1:4 in France). Formal healthcare training of all staff should be required (e.g., in the US, technicians provide most direct hemodialysis care but lack standardized training). Dialysis units that are changing staff-to-patient ratios, or introducing a cohort of new staff, should review the implications on infection control procedures and educational requirements.
- Resource problems should be handled by carrying out a risk assessment and developing local procedures. For example, if blood is suspected to have penetrated the pressure-monitoring system of a machine but the unit has no on-site technical support and no spare machines, an extra transducer protector can be inserted between the blood line and the contaminated system so that the dialysis can continue until a technician can attend to the problem.
- Hand Hygiene in Outpatient and Home-based Care and Long-term Care Facilities: http://apps.who.int/iris/bitstream/handle/10665/78060/9789241503372_eng.pdf (See Figure 9 of document and p. 44-49)
Table 7. Key hygienic precautions for hemodialysis staff (in addition to standard precautions)
- A “dialysis station” is the space and equipment within a dialysis unit that is dedicated to an individual patient. This may take the form of a well-defined cubicle or room, but there is usually no material boundary separating dialysis stations from each other or from the shared areas of the dialysis unit.
- A “potentially contaminated” surface is any item of equipment at the dialysis station that could have been contaminated with blood, or fluid containing blood, since it was last disinfected, even if there is no visual evidence of contamination.
- A program of continuing education covering the mechanisms and prevention of crossinfection should be established for staff caring for hemodialysis patients.
- Staff should demonstrate infection control competency for the tasks they are assigned. Infection control competencies (e.g., use of aseptic technique) should be assessed upon hire and at least yearly thereafter.
- Appropriate information on infection control should also be given to nonclinical staff, patients, caregivers, and visitors. Patients should be encouraged to speak up when they observe an infection control practice that is concerning to them.
- Staff should wash their hands with soap or an antiseptic hand-wash and water, before and after contact with a patient or any equipment at the dialysis station. An alcohol-based hand rub may be used instead when their hands are not visibly contaminated.
- In addition to hand washing, staff should wear disposable gloves when caring for a patient or touching any potentially contaminated surfaces at the dialysis station. Gloves should always be removed when leaving the dialysis station.
- Patients should also clean their hands with soap and water, or use an alcohol-based hand rub or sanitizer, when arriving at and leaving the dialysis station.
- Medication preparation should be done in a designated clean area.
- All vials should be entered with a new needle and a new syringe, which should be discarded at point of use.
- Medications should be administered aseptically, after wearing a disposable glove and disinfecting the injection port with an antiseptic.
- Hand hygiene must be performed before and after administration of injection.
- All single-dose vials must be discarded and multidose vials, if used, should not be stored or handled in the immediate patient care area.
Equipment management (for management of the dialysis machine, see Table 4)
- Single-use items required in the dialysis process should be disposed of after use on 1 patient.
- Nondisposable items should be disinfected after use on 1 patient. Items that cannot be disinfected easily (e.g., adhesive tape and tourniquets) should be dedicated to a single patient and discarded after use.
- The risks associated with use of physiologic monitoring equipment (e.g., blood pressure monitors, weight scales, and access flow monitors) for groups of patients should be assessed and minimized. Blood pressure cuffs should be dedicated to a single patient or made from a light-colored, wipe-clean fabric.
- Medications and other supplies should not be moved between patients (e.g., on carts or by other means). Medications provided in multiple-use vials, and those requiring dilution using a multiple-use diluent vial, should be prepared in a dedicated central area and taken separately to each patient. Items that have been taken to the dialysis station should not be returned to the preparation area.
- After each session, all potentially contaminated surfaces at the dialysis station should be wiped clean with a low-level disinfectant if not visibly contaminated. Surfaces that are visibly contaminated with blood or fluid should be disinfected with a commercially available tuberculocidal germicide or a solution containing at least 500 p.p.m. hypochlorite (a 1:100 dilution of 5% household bleach).
Waste and specimen management
- Needles should be disposed of in closed, unbreakable containers, which should not be overfilled. A “no-touch” technique should be used to drop the needle into the container, as it is likely to have a contaminated surface. If this is difficult due to the design of the container, staff should complete patient care before disposing of needles.
- All blood and other biologic specimen handling should occur away from dedicated clean areas, medications, and clean supplies.
- The used extracorporeal circuit should be sealed as effectively as possible before transporting it from the dialysis station in a fluid-tight waste bag or leak-proof container for disposal. Avoid draining or manipulating the used circuit. If it is necessary to drain the circuit to comply with local regulatory requirements, or to remove any components for reprocessing, this should be done in a dedicated area away from the treatment and preparation areas.
Chapter 4: Management of HCV-infected patients before and after kidney transplantation
4.1: Evaluation and management of kidney transplant candidates regarding HCV infection
4.2: Use of kidneys from HCV-infected donors
4.3: Use of maintenance immunosuppressive regimens
4.4: Management of HCV-related complications in kidney transplant recipients
Figure 3. Proposed management strategy in a hepatitis C virus (HCV)–infected kidney transplant candidate
Chapter 5: Diagnosis and management of kidney diseases associated with HCV infection
Figure 4. Indications for biopsy in patients with hepatitis C virus (HCV) and severe glomerulonephritis
Prevention, Diagnosis, Evaluation, and Treatment of Hepatitis C in Chronic Kidney Disease
November 18, 2022
Country of Publication
The Kidney Disease: Improving Global Outcomes (KDIGO) 2022 Clinical Practice Guideline for the Prevention, Diagnosis, Evaluation, and Treatment of Hepatitis C in Chronic Kidney Disease represents a focused update of the 2018 guideline. This guideline is intended to assist the practitioner caring for patients with hepatitis C virus (HCV) and kidney disease, including those who are on dialysis therapy, and kidney transplant candidates and recipients. Topic areas for which recommendations are updated include: Chapter 2: Treatment of HCV infection in patients with CKD; Chapter 4: Management of HCV-infected patients before and after kidney transplantation; and Chapter 5: Diagnosis and management of kidney diseases associated with HCV infection. Previous chapters on the detection and evaluation of HCV in CKD (Chapter 1) and prevention of HCV transmission in hemodialysis units (Chapter 3) have been deemed current, and their content has therefore remained unchanged. Development of this guideline followed an explicit process of evidence review and appraisal. Treatment approaches and guideline recommendations are based on systematic reviews of relevant studies, and appraisal of the quality of the evidence and the strength of recommendations followed the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Limitations of the evidence are discussed, with areas of future research also presented.
Male, Female, Adolescent, Adult, Older adult
Health Care Settings
Ambulatory, Hospital, Outpatient
Epidemiology infection prevention, nurse, nurse practitioner, physician, physician assistant
Diagnosis, Assessment and screening, Treatment, Management
D006526 - Hepatitis C, D019698 - Hepatitis C, Chronic, D012080 - Chronic Kidney Disease-Mineral and Bone Disorder, D007668 - Kidney
chronic kidney disease, hepatitis C, CKD, hepatitis C virus, HCV