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Burden, detection and evaluation of HCV in CKD patients

Burden, detection and evaluation of HCV in CKD patients. Dr Pankaj Hans Patna. India: Kidney disease burden. India is the world’s largest democracy with a population of around 1.13 billion and faces tremendous challenges to provide basic healthcare for its masses

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Burden, detection and evaluation of HCV in CKD patients

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  1. Burden, detection and evaluation of HCV in CKD patients Dr Pankaj Hans Patna

  2. India: Kidney disease burden • India is the world’s largest democracy with a population of around 1.13 billion and faces tremendous challenges to provide basic healthcare for its masses • The incidence rates of end-stage renal disease (ESRD) in India • 232 per million population (age adjusted rate) NDT Plus 2010; 3: 203–207

  3. India: Kidney disease burden • The Indian Chronic Kidney Disease (CKD) registry is an initiative by the Indian Society of Nephrology, and out of the latest total of 35 697 CKD patients, • 26 609 (74.5%) amongst the CKD patients were not receiving any form of RRT (renal replacement therapy) and • only 880 (2.5%) received renal transplantation (RT) NDT Plus 2010; 3: 203–207

  4. India: Kidney disease burden • It is estimated that >90% of patients with ESRD in South Asia die within months of diagnosis because they cannot afford treatment NDT Plus 2010; 3: 203–207

  5. CKD Clinical Stages

  6. CKD – A Silent Killer CKD – Increased Death CKD at a glance CKD – A Global Pandemic CKD 1-2 are asymptomatic Third after CVD, Cancer 1 in 10 Indians have CKD 10 million people of CKD Term ‘CRF’ no longer used Dialysis ↑ death rate 100 x Small ↑ in Creat - ↑ ↑ in CV

  7. HCV - CKD

  8. Screening for HCV in hemodialysis

  9. Introduction: HCV in CKD • Hepatitis C virus (HCV) infection in hemodialysis (HD) is a significant problem • Liver disease caused by HCV causes • Significant morbidity and mortality among patients with end stage renal disease (ESRD) treated with HD The Hepatitis C Virus. Indian J Nephrol. 2009 April; 19(2): 62–67.

  10. Burden HCV in CKD • Prevalence of anti- HCV and chronic HCV infection in dialysis units worldwide • Considerable variation • Ranging from • As low as 1% to • As high as 95% Hepatitis Research and Treatment Volume 2010, Article ID 534327,

  11. Burden HCV in CKD • Prevalence Hepatitis C in HD patients in • Middle Eastern countries: 68% • Saudi Arabia: 14.5% to 94.7% • Oman : 26% • Egypt: 80% • Western Europe: 1%–29% • North America: 8%–36% • Australia: 5.9% , and • Far Eastern countries: 44%–60% Hepatitis Research and Treatment Volume 2010, Article ID 534327,

  12. Burden HCV in CKD • With the introduction of routine screening and heightened attention to prevention of spread, • The incidence of HCV infection has declined in dialysis centers in many countries, but • Remained high in others Kidney International, 1997;51(4): 981–99.

  13. Burden HCV in CKD • Currently, third-generation anti-HCV ELISA is largely in use and has shown • Greater sensitivity and specificity in patients receiving HD • Using third-generation ELISA, prevalence of anti-HCV antibodies among dialysis patients was found to be • 42% in France, 75% in Moldavia, and 49% in Syria Indian J Nephrol. 2009 April; 19(2): 62–67.

  14. Burden HCV in CKD • In the US, • The prevalence of hepatitis C in the dialysis population has not changed, and • The incidence of new cases of hepatitis C has remained constant, in the • Range of 1% to 3% per year US Renal Data System: USRDS 2002 Annual Data Report

  15. Burden HCV in CKD • Indian study • Single centre study • A total of 119 hemodialysis patients were tested for HCV RNA • Results: • Thirty three (27.7%) tested positive Indian J Nephrol. 2009 April; 19(2): 62–67.

  16. Burden HCV in CKD • Indian study • Prevalence of HCV RNA in the HD population is 27.7% • Important associations for HCV RNA positivity • Duration of dialysis • Getting dialysis at > 1 center • Elevated transaminase levels, and • Low serum albumin Indian J Nephrol. 2009 April; 19(2): 62–67.

  17. Burden HCV in CKD • The high prevalence of HCV in dialysis patients is of • Great concern in view of studies that suggest that • These patients have a higher mortality than HCV-negative patients Journal of the American Society of Nephrology, 2000; 11(10):1896–1902 Kidney International 1998; 53(5):1374–1381

  18. Hepatitis C in Dialysis • In a multicenter prospective study from Japan, • 1,470 patients (19% positive for anti-HCV) from 16 dialysis centers were followed up for an average of 6 years • Mortality was greater in the anti- HCV-positive group (33%) than in controls (23%) Hepatitis Research and Treatment Volume 2010, Article ID 534327,

  19. Hepatitis C in Dialysis • The excess mortality appeared to be accounted for by deaths from • Cirrhosis (5.5% versus 0%) and • Hepatocellular carcinoma (8.8% versus 0.4%) • The RR for death in anti- HCV-positive patients was 1.57 (95% CI, 1.23 to 2.00). Hepatitis Research and Treatment Volume 2010, Article ID 534327,

  20. Hepatitis C in Dialysis • In a study from the US, • 287 anti-HCV positiveand 286 randomly selected dialysis control patients from 14 transplant centers were assessed, with a median follow up of 7 years • In multivariate analysis, RR for death from all causes in anti-HCV-positive patients was 1.41 (95% CI, 1.01 to 1.97), and for death from liver disease or infection, 2.39 (95% CI, 1.28 to 4.48) Hepatitis Research and Treatment Volume 2010, Article ID 534327,

  21. Hepatitis C in Dialysis • Death from liver disease occurred in • 14% of anti-HCV–positive and only 2% of anti-HCV–negative controls • These data show that • Chronic hepatitis C adversely affects survival in patients with ESRD; • Cirrhosis and liver cancer account for 13% to 14% of deaths Hepatitis Research and Treatment Volume 2010, Article ID 534327,

  22. Hepatitis C in Dialysis • The spectrum of liver disease in HCV positive HD patients • Mild to moderate in most series, and a • High proportion of patients had normal ALT levels Hepatitis Research and Treatment Volume 2010, Article ID 534327,

  23. Hepatitis C in Dialysis • In studies, the frequency of bridging hepatic fibrosis (stage 3) or cirrhosis (stage 4) ranged from • 5% to 32%. • In most studies, there were no associations between ALT or HCV RNA levels and severity of histological changes Hepatitis Research and Treatment Volume 2010, Article ID 534327,

  24. Hepatitis C in Dialysis • Risk factors for spread include a • History of transfusions, • Number of blood products transfused, and • Number of years on hemodialysis • Transmission of HCV, as with HBV, • Depends on the presence of chronically infected patients and potential exposure to blood and blood products Hepatitis Research and Treatment Volume 2010, Article ID 534327,

  25. Hepatitis C in Dialysis • Although HCV transmission through blood product transfusion was a significant source of infection previously, • The current cases are more likely related to nosocomial exposure Hepatitis Research and Treatment Volume 2010, Article ID 534327,

  26. KDIGO guideline • Guideline 1: Detection and evaluation of HCV in CKD • Determining which CKD patients should be tested for HCV • It is suggested that CKD patients be tested for HCV (Weak evidence) • Testing for HCV should be performed in patients on maintenance hemodialysis (CKD Stage 5D) and kidney transplant candidates. (Strong evidence) Kidney International 2008; 73 (Suppl 109), S10–S19

  27. Algorithm CKD Stage 5 HD diagnostic algorithm • In particular, note that after a negative primary NAT, a patient can be considered to be at low probability of HCV infection (unless other factors change) so that subsequent testing by EIA is appropriate • ALT,alanine aminotransferase; AST, aspartataminotransferase; CKD: chronic kidney disease; EIA: enzyme immunoassay; HCV: hepatitis C virus; • NAT: nucleic acid test. Kidney International 2008; 73 (Suppl 109), S10–S19

  28. KDIGO guideline • Guideline 2: HCV testing for patients on maintenance hemodialysis: • Patients on HD should be tested when they first start hemodialysis or when they transfer from another hemodialysis facility. (Strong evidence) Kidney International 2008; 73 (Suppl 109), S10–S19

  29. KDIGO guideline (Contd) • Testing for HCV with NAT should be performed for hemodialysis patients with unexplained abnormal aminotransferase(s) levels. (Strong evidence) • 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 evidence) Kidney International 2008; 73 (Suppl 109), S10–S19

  30. KDIGO guideline (Summary) • These strong recommendations should be applicable worldwide, as • It is rare that a country or individual can afford maintenance hemodialysis yet not afford occasional HCV testing—at least by means of HCV antibody measurement if not NAT Nature clinical practice NEPHROLOGY Published online 23 September 2008 NAT: nucleic acid test

  31. KDIGO guideline (Summary) • These two techniques • HCV antibody testing and NAT • Provide similar epidemiological information, • Although HCV antibody measurement has • Lower accuracy than NAT and • Cannot detect very early infection Nature clinical practice NEPHROLOGY Published online 23 September 2008

  32. KDIGO guideline (Summary) • The weaker recommendations regarding HCV detection are less applicable in many countries • The suggestion that all patients with CKD be tested for HCV is unlikely to be followed since the number of such patients is enormous Nature clinical practice NEPHROLOGY Published online 23 September 2008

  33. KDIGO guideline (Summary) • Other suggestions revolve around the • Frequency of testing and • The use of NAT, • Both of which are subject to local factors

  34. HCV in CKD • In addition to standard universal precautions, additional practices are recommended because exposure to blood is routinely anticipated • These recommendations include • Special dialysis unit precautions • Regular serological testing • Active surveillance, and • Training and education Hepatitis Research and Treatment Volume 2010, Article ID 534327,

  35. HCV in CKD • Recommended precautions include • Routine use of gloves and restriction of use of common supplies, medications, and carts to deliver them • In addition, there should be • Strict attention to cleaning and disinfecting items shared between patients and careful disposal of dialyzers and blood tubing after treatments. Hepatitis Research and Treatment Volume 2010, Article ID 534327,

  36. HCV in CKD • The CDC has not recommended isolation of HCV-infected patients in dialysis units • Baseline testing should include • Serum ALT levels and assays for both • HBV and HCV infection Hepatitis Research and Treatment Volume 2010, Article ID 534327,

  37. HCV in CKD • For anti-HCV-negative patients, recommended monitoring includes • Testing ALT levels monthly and • Anti-HCV every 6 months • Elevations in ALT levels should lead to anti-HCV testing Hepatitis Research and Treatment Volume 2010, Article ID 534327,

  38. HCV in CKD • If ALT levels are persistently abnormal despite the absence of anti-HCV, testing for HCV RNA by • Qualitative assay (such as polymerase chain reaction) should be considered Hepatitis Research and Treatment Volume 2010, Article ID 534327,

  39. Conclusions • CKD population is increasing in India • HCV infection in HD patients is a significant problem • Prevalence of HCV RNA in the HD population is 27.7% (according to Indian study) • Studies suggest higher mortality in HCV positive patients than HCV-negative patients in dialysis setup Slide 1 of 3

  40. Conclusions • Testing for HCV should be performed in patients on maintenance hemodialysis (CKD Stage 5D) and kidney transplant candidates • Patients on HD should be tested when they first start hemodialysis or when they transfer from another hemodialysis facility Slide 2 of 3

  41. Conclusions • Testing for HCV with NAT should be performed for hemodialysis patients with unexplained abnormal aminotransferase(s) levels • HCV antibody testing and NAT • Provide similar epidemiological information, • Although HCV antibody measurement has • Lower accuracy than NAT and • Cannot detect very early infection Slide 3 of 3

  42. Thank You!

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