The above table summarizes the interpretation of the three levels of recommendations. Each statement strength is matched with specific wording and with a given basis for the strength. For further clarity, in the lists of statements Strong statements are in bold print, Moderate statements are in regular print, and Weak statements are in italics.
GUIDELINE 1: DETECTION AND EVALUATION OF HCV IN CKD
Guideline 1.1: Determining which CKD patients should be tested for HCV:
1.1.1 It is suggested that CKD patients be tested for HCV. (Weak)
1.1.2 Testing for HCV should be performed in patients on maintenance hemodialysis (CKD Stage 5D) and kidney transplant candidates. (Strong)
Guideline 1.2: HCV testing for patients on maintenance hemodialysis:
1.2.1 Patients on hemodialysis should be tested when they first start hemodialysis or when they transfer from another hemodialysis facility. (Strong)
- In hemodialysis units with a low prevalence of HCV, initial testing with EIA (if positive, followed by NAT) should be considered (see Algorithm 1). (Moderate)
- In hemodialysis units with a high prevalence of HCV, initial testing with NAT should be considered (see Algorithm 1). (Moderate)
1.2.2 For patients on hemodialysis who test negative for HCV, retesting every 6–12 months with EIA should be considered. (Moderate)
1.2.3 Testing for HCV with NAT should be performed for hemodialysis patients with unexplained abnormal aminotransferase(s) levels. (Strong)
1.2.4 If a new HCV infection in a hemodialysis unit is suspected to be nosocomial, testing with NAT should be performed in all patients who may have been exposed. (Strong)
- Repeat testing with NAT is suggested within 2–12 weeks in initially NAT-negative patients. (Weak)
GUIDELINE 2: TREATMENT OF HCV INFECTION IN PATIENTS WITH CKD
Guideline 2.1: Evaluation of HCV-infected CKD patients for antiviral treatment
2.1.1 It is suggested that CKD patients with HCV infection be evaluated for antiviral treatment. (Weak)
2.1.2 It is suggested that the decision to treat be based on the potential benefits and risks of therapy, including life expectancy, candidacy for kidney transplantation, and comorbidities. (Weak)
2.1.3 It is suggested that in CKD patients-except kidney transplant recipients-who develop an acute HCV infection, a waiting period beyond 12 weeks to observe spontaneous clearance (by NAT) is not justified, and that antiviral treatment should be started. (Weak)
2.1.4 It is suggested that HCV-infected patients accepted for kidney transplantation be treated (see Guideline 4). (Weak)
2.1.5 It is suggested that treatment of HCV-infected kidney transplant recipients be considered only when the benefits of treatment clearly outweigh the risk of allograft rejection due to IFN-based therapy (for example, fibrosing cholestatic hepatitis, life-threatening vasculitis). (Weak)
2.1.6 It is suggested that antiviral therapy be considered for patients with HCV-related GN (see Guideline 5.3). (Weak)
Guideline 2.2: Basing HCV treatment on CKD stage
2.2.1 For HCV-infected patients with CKD Stages 1 and 2, combined antiviral treatment using pegylated IFN and ribavirin is suggested, as in the general population. (Weak)
- It is suggested that ribavirin dose be titrated according to patient tolerance. (Weak)
2.2.2 For HCV-infected patients with CKD Stages 3, 4, and 5 not yet on dialysis, monotherapy with pegylated IFN with doses adjusted to the level of kidney function is suggested. (Weak)
2.2.3 For HCV-infected patients with CKD Stage 5D on maintenance hemodialysis, monotherapy with standard IFN that is dose-adjusted for a GFR <15 ml per min per 1.73m2 is suggested. (Weak)
2.2.4 For HCV-infected kidney transplant recipients in whom the benefits of antiviral treatment clearly outweigh the risks (see Guideline 2.1.5), monotherapy with standard IFN is suggested. (Weak)
Guideline 2.3: Monitoring the response to HCV treatment in CKD patients
2.3.1 SVR, defined as HCV RNA clearance 6 months after completion of antiviral treatment, is suggested for assessing response to antiviral treatment. (Weak)
2.3.2 If SVR is achieved, it is suggested that testing with NAT be performed annually to ensure that the patient remains nonviremic. (Weak)
- For patients on maintenance hemodialysis, repeat testing with NAT every 6 months is suggested. (Weak)
2.3.3 All patients with HCV infection, regardless of treatment or treatment response, should be followed for HCVassociated
comorbidities. (Strong)
- Patients who have evidence of clinical or histologic cirrhosis should have follow-up every 6 months. (Strong)
- Annual follow-up for patients without cirrhosis is suggested. (Weak)
GUIDELINE 3: PREVENTING HCV TRANSMISSION IN HEMODIALYSIS UNITS
Guideline 3.1: Hemodialysis units should ensure implementation of, and adherence to, strict infection-control procedures designed to prevent transmission of blood-borne pathogens, including HCV. (Strong)
- Isolation of HCV-infected patients is not recommended as an alternative to strict infection-control procedures for preventing transmission of blood-borne pathogens. (Weak)
- The use of dedicated dialysis machines for HCV infected patients is not recommended. (Moderate)
- Where dialyzer reuse is unavoidable, it is suggested that the dialyzers of HCV-infected patients can be reused provided there is implementation of, and adherence to, strict infection-control procedures. (Weak)
Guideline 3.2: Infection-control procedures should include hygienic precautions (Tables 18 and 19) that effectively prevent the transfer of blood-or fluids contaminated with blood-between patients, either directly or via contaminated equipment or surfaces. (Strong)
- It is suggested to integrate regular observational audits of infection-control procedures in performance reviews of hemodialysis units. (Weak)
GUIDELINE 4: MANAGEMENT OF HCV-INFECTED PATIENTS BEFORE AND AFTER KIDNEY TRANSPLANTATION
Guideline 4.1: Evaluation and management of kidney transplant candidates regarding HCV infection
4.1.1 All kidney transplant candidates should be evaluated for HCV infection (see Algorithm 2). (Strong)
- In low-prevalence settings, initial testing with EIAand follow-up of positive EIA with NAT should be considered. (Moderate)
- In high-prevalence settings, initial testing with NATshould be considered. (Moderate)
4.1.2 HCV infection should not be considered a contraindication for kidney transplantation. (Moderate)
4.1.3 It is suggested that HCV-infected kidney transplant candidates undergo a liver biopsy before transplantation. (Weak)
4.1.4 It is suggested that HCV-infected patients with cirrhosis confirmed by liver biopsy, but clinically compensated liver disease, be considered for kidney transplantation only in an investigational setting. (Weak)
4.1.5 It is suggested that HCV-infected kidney transplant candidates be considered for treatment with standard IFN before transplantation (see Algorithm 2). (Weak)
4.1.6 It is suggested that patients on a kidney transplant waiting list be evaluated for HCV infection (see Algorithm 3). (Weak)
- For patients who have never been tested for HCV, it is suggested that testing be performed with EIA in low-prevalence settings (with follow-up of positive results by NAT) and NAT in high-prevalence settings (see Guideline 1.1.1). (Weak)
- It is suggested that HCV-infected patients not previously known to be viremic be placed on hold status pending full evaluation of the severity of their liver disease. (Weak)
- It is suggested that patients who had received antiviral treatment before listing and had SVR have testing with NAT repeated at least annually (see Guideline 2.3.2) (Weak); if NAT becomes positive, it is suggested that the patient be put on hold status and have full evaluation of their liver disease. (Weak)
- It is suggested that HCV-infected patients who had prior evaluation with liver biopsy, but either failed or refused antiviral treatment, have repeat liver biopsy every 3–5 years while on the transplant waiting list, depending on their histologic stage. (Weak)
Guideline 4.2: Use of kidneys from HCV-infected donors
4.2.1 All kidney donors should be tested for HCV infection. (Strong)
- Testing with both EIA and NAT (if NAT is available) is suggested. (Weak)
4.2.2 It is suggested that transplantation of kidneys from donors infected with HCV be restricted to recipients with positive NAT. (Weak)
Guideline 4.3: Use of maintenance immunosuppressive regimens
4.3 All conventional current maintenance immunosuppressive regimens can be considered for use in HCV-infected kidney transplant recipients. (Weak)
Guideline 4.4: Management of HCV-related complications in kidney transplant recipients
4.4.1 It is suggested that HCV-infected kidney transplant recipients more than 6 months after transplant have their liver disease evaluated at least annually. (Weak)
4.4.2 For HCV-infected kidney transplant recipients in whom the benefits of antiviral treatment clearly outweigh the risks (see Guidelines 2.1.5 and 2.2.4), monotherapy with standard IFN is suggested. (Weak)
4.4.3 It is suggested that HCV-infected kidney transplant recipients be screened for the development of hyperglycemia after transplantation. (Weak)
4.4.4 It is suggested that HCV-infected kidney transplant recipients be tested at least every 3–6 months for proteinuria. (Weak)
- It is suggested that patients who develop new onset proteinuria (either urine protein/creatinine ratio >1 or 24-h urine protein greater than 1 g on two or more occasions) have an allograft biopsy with immunofluorescence and electron microscopy included in the analysis. (Weak)
4.4.5 Because of the risk of rejection, it is suggested that kidney transplant recipients with HCV-associated glomerulopathy not receive IFN-based therapy, unless it is determined that the benefits of therapy outweigh the risks of treatment. (Weak)
GUIDELINE 5: DIAGNOSIS AND MANAGEMENT OF KIDNEY DISEASES ASSOCIATED WITH HCV INFECTION
Guideline 5.1: It is suggested that HCV-infected patients be tested at least annually for proteinuria, hematuria, and estimated GFR to detect possible HCV-associated kidney disease. (Weak)
Guideline 5.2: It is suggested that a kidney biopsy be performed in HCV-infected patients with clinical evidence of GN. (Weak)
Guideline 5.3: It is suggested that for patients with HCV-associated glomerular diseases, particularly MPGN, antiviral treatment as per Guideline 2.2 be considered. (Weak)
- It is suggested that immunosuppressive agents be considered for patients with cryoglobulinemic kidney diseases. (Weak)
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