recomendation for HCV management

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Recommendation for HCV management[/

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1. As part of a comprehensive health evaluation, all persons should be screened for behaviors that place them at high risk for HCV infection. (Class I, level B).

2. Persons who are at risk should be tested for the presence of HCV infection (Table 2) (Class I, level B).

4. Patients suspected of having acute or chronic HCV infection should ﬁrst be tested for anti-HCV (Class I, Level B.)

5. HCV RNA testing should be performed in:
a) Patients with a positive anti-HCV test (Class I, Level B)
b) Patients for whom antiviral treatment is being considered, using a sensitive quantitative assay (Class I, Level A)
c) Patients with unexplained liver disease whose anti-HCV test is negative and who are immunocom-omised or suspected of having acute HCV infection (Class I, Level B).

6. HCV genotyping should be performed in all HCV-infected persons prior to interferon-based treatment in order to plan for the dose and duration of therapy and to estimate the likelihood of response (Class I, Level A)mendatio.

7. A liver biopsy should be considered in patients ith chronic hepatitis C infection if the patient and ealth care provider wish information regarding ﬁrosis stage for prognostic purposes or to make aecision regarding treatment (Class IIa, Level B)

8. Currently available noninvasive tests may be useful in deﬁning the presence or absence of advanced fibrosis in persons with chronic hepatitis C infection,but should not replace the liver biopsy in routine clinical practice (Class IIb, Level C).

9. Treatment decisions should be individualized based on the severity of liver disease, the potential for serious side effects, the likelihood of treatment response, the presence of comorbid conditions, and the patient’s readiness for treatment (Class IIa, Level C).

10. For patients in whom liver histology is available, treatment is indicated in those with bridging ﬁbrosis or compensated cirrhosis provided they do notave contraindications to therapy (Class I, Level B).

11. The optimal therapy for chronic HCV infection is the combination of peginterferon alfa and ribavirin (Class I, Level A).

12. HCV RNA should be tested by a highly sensitive quantitative assay at the initiation of or shortly before treatment and at week 12 of therapy, (Class I, Level A).

Genotypes 1 and 4 HCV Infection

13. Treatment with peginterferon plus ribavirin should be planned for 48 weeks; the dose for peginterferon alfa-2a is 180 g subcutaneously per week together with ribavirin using doses of 1,000 mg for those <75 kg in weight and 1,200 mg for those >75 kg; the dose for peginterferon alfa-2b is 1.5 g/kg subcutaneously per week together with ribavirin using doses of 800 mg for those weighing <65 kg; 1,000 mg for those weighing >65 kg to 85 kg, 1,200 mg for >85 kg to 105 kg, and 1,400 mg for >105 kg (Class I, Level A).

14. Treatment may be discontinued in patients who do not achieve an early virological response (EVR; >2
log reduction in HCV RNA at week 12 of treatment) (Class I, Level A).

15. Patients who do not achieve a complete EVR (undetectable HCV RNA at week 12 of treatment) should be re-tested at week 24, and if HCV RNA remains positive, treatment should be discontinued (Class I, Level A).

16. For patients with genotype 1 infection who have delayed virus clearance (HCV RNA test becomes negative between weeks 12 and 24), consideration should be given to extending therapy to 72 weeks (Class IIa, Level B).

17. Patients with genotype 1 infection whose treatment continues through 48 to 72 weeks and whose measurement of HCV RNA with a highly sensitive assay is negative at the end of treatment should be retested for HCV RNA 24 weeks later to evaluate for a sustained virological response (SVR; HCV RNA negative 24 weeks after cessation of treatment) (Class I, Level A).

Genotype 2 or Genotype 3 HCV Infection

18. Treatment with peginterferon plus ribavirin should be administered for 24 weeks, using a ribavirin dose of 800 mg (Class I, Level A).

19. Patients whose treatment continues through 24 weeks and whose measurement of HCV RNA with a highly sensitive assay is negative should be retested for HCV RNA 24 weeks later to evaluate for an SVR (Class I, Level A).

20. Patients with HCV-related cirrhosis who achieve an SVR, regardless of the genotype, should continue to be monitored at 6 to 12 month intervals for the development of HCC (Class IIa, Level C).

21. Retreatment with peginterferon plus ribavirin in patients who did not achieve an SVR after a prior full course of peginterferon plus ribavirin is not recommended, even if a different type of peginterferon is administered (for relapsers, Class III, Level C; for non-responders, Class III, Level B).

22. Retreatment with peginterferon plus ribavirin can be considered for non-responders or relapsers who have previously been treated with non-pegylated interferon with or without ribavirin, or with peginterferon monotherapy, particularly if they have bridging ﬁbrosis or cirrhosis (Class IIa, Level B).

23. Maintenance therapy is not recommended for patients with bridging ﬁbrosis or cirrhosis who have failed a prior course of peginterferon and ribavirin (Class III, Level B).

24. Regardless of the serum alanine aminotransferase level, the decision to initiate therapy with pegylated interferon and ribavirin should be individualized based on the severity of liver disease by liver biopsy, the potential for serious side effects, the like-lihood of response, and the presence of comorbid conditions (Class I, Level B).

25. The treatment regimen for HCV-infected persons with normal aminotransferase levels should be the same as that used for persons with elevated serum aminotransferase levels (Class I, Level B).

Diagnosis and Treatment of HCV-Infected Children. The exact prevalence of HCV infection among 31.26. The diagnosis and testing of children suspected of being infected with HCV should proceed as for adults (Class I, Level B).

27. Routine testing for anti-HCV at birth of children born to HCV-infected mothers is not recommended because of the high rate of positive
antibody due to passive transfer from the mother. Testing for anti-HCV may be performed at 18 months of age or older (Class I, Level B).

28. Testing for HCV RNA may be considered at 1-2 months of age in infants born to HCV-infected mothers if early diagnosis is desired (Class II, Level B).

29. Children aged 2-17 years who are infected with HCV should be considered appropriate candidates for treatment using the same criteria as that used for adults. (Class IIa, Level B).

30. Children should be treated with pegylated interferon alfa-2b, 60 g/m2 weekly in combination with ribavirin, 15 mg/kg daily for a duration of 48 weeks (Class 1, Level B). Anti-HCV testing should be performed in all HIV-infected persons (Class I, Level B).

32. HCV RNA testing should be performed to conﬁrm HCV infection in HIV-infected persons who are positive for anti-HCV, as well as in those who are negative and have evidence of unexplained liver disease (Class I, Level B).

33. Hepatitis C should be treated in the HIV/HCV co-infected patient in whom the likelihood of serious liver disease and a treatment response are judged to outweigh the risk of morbidity from the adverse effectsof therapy (Class I, Level A).

34. Initial treatment of hepatitis C in most HIV- infected patients should be peginterferon alfa plus ribavirin for 48 weeks at doses recommended for HCV mono-infected patients (see recommendation 13) (Class I, Level A).

35. When possible, patients receiving zidovudine (AZT) and especially didanosine (ddI) should be switched to an equivalent antiretroviral agent before beginning therapy with ribavirin (Class I, Level C).

36. HIV-infected patients with decompensated liver disease (CTP Class B or C) should not be treated with peginterferon alfa and ribavirin and may be candidates for liver transplantation (Class IIa, Level C).

37.All persons with chronic kidney disease awaiting renal replacement therapy, namely hemodialysis or kidney transplantation, should be screened for hepatitis C in order to plan for management and treatment (Class I, Level B).

38. The decision to perform a liver biopsy in patients with kidney disease should be individualized, based upon the clinical assessment for the need for therapy and the need to establish the severity of the liver disease (Class IIa, Level C).

39. Persons with chronic HCV infection and mild kidney disease (GFR >60 mL/minute) can be treated with the same combination antiviral therapy as that sed in persons without kidney disease (Class IIa,level C).

40. Persons with chronic HCV infection and severe kidney disease not undergoing hemodialysis can be reated with reduced doses of both peginterferon (alpha-2a, 135 g/week; alpha-2b, 1 g/kg/week) and ribavirin (200-800 mg/day) with careful monitoring or adverse effects (Class IIa, Level C).

41. Treatment of HCV in patients on dialysis may be considered with either standard interferon (2a or b) in a dose of 3 mU t.i.w. or reduced dose pegylated interferon 2a, 135 ug/week or 2b 1 ug/kg/week. (ClassIIa, level C). Ribavirin can be used in combination with interferon in a markedly reduced daily dose with careful monitoring for anemia and other adverse efects. (Class IIb, level C).

42. Treatment is not recommended for patients with chronic HCV infection who have undergone kidney transplantation, unless they develop ﬁbrosing cholestatic hepatitis (Class III, Level C).

43. Patients with cryoglobulinemia and mild to moderate proteinuria and slowly progressive kidney disease can be treated with either standard interferon or reduced doses of pegylated interferon alfa and ribavirin (Class IIa, Level C).

44. Patients with cryoglobulinemia and marked proteinuria with evidence of progressive kidney disease or an acute ﬂare of cryoglobulinemia can be

45. African Americans infected with HCV who are appropriate treatment candidates should be treated with the current optimal regimen consisting of pegylated interferon and ribavirin (Class I, Level A).

46. African Americans with baseline neutropenia (ANC <1500 mm3) should not be excluded from hepatitis C treatment (Class IIa, Level B).

47. Patients with HCV-related compensated cirrhosis (CTP class A), can be treated with the standard regimen of pegylated interferon and ribavirin but will require close monitoring for adverse events (Class I, Level A).

48. Patients with HCV-related decompensated cirrhosis should be referred for consideration of liver transplantation (Class I, Level B).

49. Interferon-based therapy may be initiated at a lower dose in patients with decompensated cirrhosis (CTP class B and C), as long as treatment is administered by experienced clinicians with vigilant monitoring for adverse events preferably in patients who have already been accepted as candidates for liver transplantation (Class IIb, Level B).

50. Growth factors can be used for treatment-associated anemia and leukopenia to improve quality of life and may limit the need for antiviral dose reduc

51. Treatment of HCV-related disease following liver transplantation should be initiated in appropriate candidates after demonstration of recurrent histologic disease but should be undertaken with caution and under the supervision of a physician experienced in transplantation (Class IIa, Level A).

52. Peginterferon alfa either with or without ribavirin should be the preferred regimen when treating patients with hepatitis C after liver transplantation (Class IIa, Level B).

53. Interferon-based therapy should not be used in recipients of heart, lung, and kidney grafts, except for patients who develop ﬁbrosing cholestatic hepatitis (Class III, Level C).

54. Patients with acute HCV infection should be considered for interferon-based anti-viral therapy (Class I, Level B).

55. Treatment can be delayed for 8 to 12 weeks after acute onset of hepatitis to allow for spontaneous resolution (Class IIa, Level B).

56. Although excellent results were achieved using standard interferon monotherapy, it is appropriate to consider the use of peginterferon because of its greater ease of administration (Class I, Level B).

57. Until more information becomes available, no deﬁnitive recommendation can be made about the optimal duration needed for treatment of acute hepatitis C; however, it is reasonable to treat for at least 12 weeks, and 24 weeks may be considered (Class IIa,level B).

58. No recommendation can be made for or against the addition of ribavirin and the decision will therefore need to be considered on a case-by-case basis (Class IIa, Level C).ns

59. Treatment of HCV infection can be considered for persons even if they currently use illicit drugs or who are on a methadone maintenance program, provided they wish to take HCV treatment and are able and willing to maintain close monitoring and practice contraception (Class IIa, Level C)

60. Persons who use illicit drugs should receive continued support from drug abuse and psychiatric counseling services as an important adjunct to treatment of HCV infection (Class IIa, Level C).

61. Patients with HCV infection and concomitant mental and psychiatric disorders can be considered fortreatment using the currently approved regimens.(Class IIa, Level C).

62. Treatment of hepatitis C infection in patients with psychiatric disorders should be undertaken only with the support of a multi-displinary team that should include psychiatric counseling services (Class IIa, Level C).

63. All persons with chronic HCV infection who lack antibodies to hepatitis A and B should be offered vaccination against these two viral infections (Class IIa, Level C).

64. Persons with chronic HCV infection should be advised to abstain from alcohol consumption (Class IIb, Level C).

65. No recommendation can be made for the use of herbal products. There is no current evidence that herbal products have a role in the treatment of patients with acute or chronic HCV infection, (Class III level C).

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