SPECIAL PATIENT GROUPS FOR HEPATITIS C TREATMENT

1. Treatment of persons with normal serum aminotransferase values [79]
• Management of persons with normal serum aminotransferase values is important because up to 60 percent of HCV-infected first-time blood donors and injection drug users have been reported to have normal values
• A person is considered to have normal ALT levels when there have been two or more determinations identified to be in the normal range of a licensed laboratory over 6 or more months.
• Regardless of the serum aminotransferase levels, the decision to initiate therapy with interferon and ribavirin should be individualized based on the severity of liver disease by liver biopsy, the potential of serious side effects, the likelihood of response, and the presence of co morbid conditions


Treatment of persons with renal disease [79]

• In patients on dialysis, HCV infection is associated with a modest increase in risk of death.
• There is an additional concern that hepatitis C has an adverse effect on long-term patient and graft survival after renal transplantation.
• As a result, current treatment efforts focus on eliminating the virus in dialysis patients who may be candidates for renal transplantation.
• There are several circumstances in which treatment of HCV infection in patients with renal disease might be considered. These include
• Persons with HCV-induced glomerulonephritis not on dialysis (most of whom have associated cryoglobulinemia);
• Persons on hemodialysis who are HCV-infected
• Persons with milder degrees of renal disease who develop superimposed HCV infection
• Persons who are infected peri- or post-renal transplantation.

• Although treatment of persons with cyroglobulinemia-related glomerulonephritis has led to improvement in the renal disease as defined by decreased levels of cryoglobulin, rheumatoid factor, and creatinine
• Relapse is common, even with the use of combination therapy
• Other therapeutic approaches have included the use of corticosteroids, cyclophosphamide, plasmapheresis, and the use of monoclonal antibody to B cells (rituximab)
• Individuals on hemodialysis with significant fibrosis on liver biopsy are less likely to have abnormal ALT values than HCV-infected persons with similar histologic findings who do not have renal disease
• There is a theoretical increased risk of bleeding in patients on hemodialysis who undergo liver biopsy, but studies involving liver biopsy in such patients have rarely reported severe side effects from the procedure
• Accordingly, a liver biopsy may be performed in persons with renal insufficiency for whom treatment is believed to be a high priority.
• Ribavirin is contraindicated in this patient population because the drug is not removed during conventional dialysis and its accumulation causes a dose-dependent hemolytic anemia
• Ribavirin is contraindicated in patients with renal failure, and, if treatment is undertaken, therapy should be with interferon alpha monotherapy.
• Treatment of patients with mild to moderate impairment in renal function (ie, not on dialysis) must be individualized. The closer the renal function to normal, the safer it is to use ribavirin.
• With regard to the use of peg interferon, a dose recommendation for persons on dialysis (135 µg SQ/wk) is available only for peg interferon alfa-2a
Treatment of persons with decompensated cirrhosis [79]
• Patients with clinically decompensated cirrhosis should be referred for consideration of liver transplantation.
• Antiviral therapy may be initiated at a low dose in patients with mild degrees of hepatic compromise, 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 as post transplantation hepitits C infection in infected patients is the rule
• Growth factors can be used for treatment-associated anemia (epoetin) and leukopenia (G-CSF, GM-CSF) and may limit the need for antiviral dose reductions in patients with decompensated cirrhosis
Treatment of patients after solid organ transplantation [79]
• Treatment of HCV-related disease following liver transplantation should be undertaken with caution because of the increased risk of adverse events and should be performed under the supervision of a physician experienced in transplantation
• Antiviral therapy is generally contraindicated in recipients of heart, lung, and kidney grafts
Treatment of active injection drug users [79]

• Treatment of HCV infection should not be withheld from persons who 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
• The decision of whether to treat should be made considering the anticipated risks and benefits for the individual.
• Continued support from drug abuse and psychiatric counseling services is an important adjunct to treatment of HCV infection in persons who use illicit drugs
Acute Hepatitis C [79]
• If patient has acute icteric hepatitis C there is some evidence that high dose alpha and/or beta interferon given during the acute phase will reduce the rate of chronicity to only 10%
• If patient has mild to moderate acute Hepatitis C, specially emphesise on rest and oral hydration
• If patient of Hepatitis C develops severe disease characterized by vomiting, dehydration, or signs of hepatic decompensation (change in conscious level or personality); they should be hospitalized
• Recommending treatment of acute HCV infection, the use of pegylated interferon monotherapy may prevent the development of CHC infection, although the duration of therapy in still unknown.
• Based on available data, most authorities would initiate treatment no later than two to four months after presentation with acute hepatitis and would extend therapy for at least 24 weeks.

• There are insufficient data to recommend the use of ribavirin in the acute setting.
• Therapy should be deferred until 12 weeks after exposure, to allow for spontaneous clearance to occur, thus avoiding therapy.


Patients with Unstable Psychiatric Illness [79]
• Refer patients to a mental health provider for treatment and stabilization. Collaborate with mental health provider to reassess for antiviral treatment eligibility.
• Assessment for antiviral treatment readiness should include an assessment of the patient’s supportive networks, both formal and informal. Family meetings may help clarify expectations for the initiation of antiviral treatment, and promote family support to the patient.
• Patients with unstable psychiatric illness who refuse to engage in psychiatric treatment are not candidates for antiviral treatment.
• Assess stability of psychiatric illness and eligibility for antiviral treatment at periodic intervals.
• Patients not currently undergoing antiviral therapy should be reassessed periodically for eligibility and interest. Providers and patients should actively address substance abuse, psychiatric, and medical co-morbidities in order to prepare for antiviral treatment.
• Ideally, patients should have 3 to 6 months of symptom reduction to a socially stable level for anxiety, depression, and psychotic symptoms.
HCV infection in children [79]

• An estimated 240,000 children in the United States have antibodies to hepatitis C [10]. The seroprevalence is 0.2 percent for children under 12 years of age and 0.4 percent for those 12 to 19 years of age
• Diagnosis and testing (including liver biopsy) of children suspected of having chronic HCV should proceed as with adults (Grade, II-2).
• Because of the high rate of clearance of the HCV virus within the first year of life, and the level of anxiety that may be caused by an early positive test, routine testing for HCV RNA in infants born to HCV-infected mothers is not recommended.
• Testing with anti-HCV may be performed at 18 months or later.
• If an earlier diagnosis is desired, PCR for HCV RNA may be performed at or after the infant's first well-child visit at 1 to 2 months
• Children aged 3 to 17 who are infected with hepatitis C and are considered appropriate candidates for treatment may receive therapy with interferon alfa-2b and ribavirin, administered by those experienced in treating children
• Treatment of children under the age of 3 years is contraindicated