Patient Education and Treatment Strategies Implemented at a Pharmacist-Managed Hepatitis C Virus Clinic

Bonnie Kolor, Pharm.D.


Pharmacotherapy. 2005;25(9):1230-1241. 

In This Article

Initial Assessment of Patients with Hepatitis C Virus Infection

The initial diagnosis of HCV infection is often made by a primary care provider. The provider then sends the patient first to a group education class and then to the liver clinic (Figure 1). Patient education, involving the pharmacist as well as other members of the multidisciplinary team, is provided to facilitate empowerment of patients to participate in decisions relating to their care. Topics covered include measures to take to lessen risk of transmission, lifestyle changes (e.g., alcohol avoidance) to limit disease progression, and treatment of HCV infection.

Evaluation and treatment of patients with hepatitis C virus (HCV) infection at a pharmacist-managed HCV clinic.

At the clinic, physical and psychological patient evaluations are performed by a nurse practitioner to assess if the patient is appropriate for treatment. Patients who indicate unwillingness or inability to adhere to the prescribed treatment duration are not given the therapeutic regimen.

Laboratory tests are performed for HCV genotyping (i.e., determination of HCV viral strain) and serum HCV RNA concentrations, since these factors can determine treatment duration and provide an indication of the likelihood of treatment success. For example, high viral loads (> 2 million copies/ml) and infection with HCV genotype 1 are associated with low probability of achieving a sustained viral response after treatment with combination therapy.[33] Other laboratory tests that may be performed are HIV testing for patients believed to be at risk, and tests to detect previous infection with hepatitis A and B viruses.

After this initial assessment, patients considered candidates for treatment with combination therapy (or monotherapy with peginterferon alfa in those for whom ribavirin is contraindicated) are evaluated by a physician. Evaluation by a physician, usually a gastroenterologist or a hepatologist, with experience in the use of combination therapy has been recommended for all patients diagnosed with HCV infection.[34] The patients then undergo liver biopsy. Those considered ineligible for treatment are either instructed to undergo follow-up care with their primary care provider or sent for evaluation of advanced liver disease.

Liver biopsy is considered the most accurate test for evaluating the histologic status of the liver, although biopsy results have been reported to depend on the technique used to collect the tissue sample.[7,35] Current recommendations for the diagnosis, management, and treatment of HCV from the American Association for the Study of Liver Diseases (AASLD) practice guidelines state that liver biopsy should be performed when the results will guide treatment decisions or when additional information is needed regarding extent of liver damage.[7]

Each tissue sample is characterized by an activity score representing ongoing liver inflammation and a fibrosis score representing past organ damage. The Knodell, Metavir, and Ishak systems for evaluating histologic status of the liver have been used to assess the level of liver activity and fibrosis.[7,8,36] However, predictions of prognosis and decisions regarding treatment are made more frequently on the basis of fibrosis scores. The Metavir and Ishak scoring systems have been used most frequently; a fibrosis score of 0 with either system indicates no fibrosis; scores of 4 and 6, respectively, on the Metavir and Ishak scales indicate cirrhosis.

Patients with HCV infection whose liver fibrosis score is 2 or greater on the Metavir scale or 3 or greater on the Ishak scale, patients manifesting extrahepatic complications of HCV (e.g., cryoglobulinemia), and those with signs of cirrhosis are typically considered good candidates for treatment with combination therapy.[7] In addition, patients who are very likely to respond favorably to combination therapy, such as those infected with HCV genotype 2 or 3, are also good treatment candidates.[6] Those infected with genotype 1, but with no evidence of liver fibrosis or abnormalities in laboratory assessments of liver function, may be considered possible candidates for treatment. Preliminary data indicate that response to combination therapy is similar in patients with HCV infection whose levels of alanine aminotransferase are normal and in those whose levels are elevated.[37] Patients with HCV infection who are more likely to respond to treatment are young (< 40 yrs), have low body weight and viral loads, and have not been infected for a long time. Again, treatment decisions regarding these patients should be made on a case-by-case basis.[7,38]


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