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    Overview of Controversies in the Management of Hepatitis C

    The increased recognition of the serious public health problem that hepatitis C virus (HCV) infection poses for the US and other countries has produced many recent advances in our knowledge of the management of chronic hepatitis C. Despite our increased awareness, many controversies in the treatment and management of hepatitis C still exist. Surrogate markers of hepatitis C have been used in the diagnosis, pretreatment and post-treatment assessment, and follow up in chronic hepatitis. The clinically effective use of histological, biochemical and virological surrogate markers are all used at various times and remain controversial in the treatment and management of hepatitis C.

    Liver biopsy is important for grading and staging disease in HCV infection. The rate of progression to cirrhosis has been shown to be higher in those with initial biopsies with high-grade or high-stage lesions. Liver biopsy is recommended prior to treatment to obtain baseline disease stage and rule out other more concomitant forms of liver disease. However, because this intervention is costly and associated with a certain degree of risk, patient monitoring should involve case history, serial alanine transaminase (ALT) and HCV RNA measurements.

    Alanine transaminase is an important biochemical marker of liver function and is used as a diagnostic test and to monitor patient response during treatment (Figure 1), although ALT levels have not been shown to be accurate prognostic value in predicting treatment response. Patients with hepatitis C and normal ALT levels represent a difficult-to-treat subgroup of patients. These individuals are usually asymptomatic but have detectable HCV-RNA and have histological evidence of mild-to-moderately active chronic hepatitis. Limited data suggest that although response rates are similar to those in patients with elevated ALT levels, serum ALT levels become abnormal in about two-thirds of these patients if followed long enough, and remain abnormal in some after therapy. Clearly more data on the long-term prognosis of these patients are needed.

    Identification of those patients most likely to respond to therapy is an important consideration in the management of chronic hepatitis C. Symptoms related to HCV infection are not predictive of disease activity. Histological liver disease may be present without physical signs. Virologic predictors of sustained response to therapy include HCV genotype and pretreatment viral load, early disappearance of HCV RNA during treatment and negative HCV RNA six months after treatment. Stopping interferon therapy based on serum ALT response misses about 33% of sustained responders at week 12 compared with 7% using HCV RNA. The sensitivity / specificity of week 4 HCV RNA is higher than that of ALT at weeks 4, 8 or 12. Response appears to be affected by genotype (lower rates for genotype 1), race, and previous non-response to interferon therapy. In addition, alcohol intake, presence of cirrhosis and pretherapy viral load are important factors in predicting response, as well as estimating duration, dose and pattern of administration for interferon.

    Therapy for patients with compensated cirrhosis or those who are relapsers and nonresponders also remains controversial. It appears that the combination of interferon and ribavirin may improve our overall ability to treat these conditions. In addition, treatment of the liver transplantation patients with recurrent HCV also remains controversial. In general, the combination of interferon and ribavirin therapy is poorly tolerated in patients with HCV both pretransplantation and post-transplantation.

    Finally, the use of interferon in preventing the development of hepatocellular cancer also remains controversial. Recent data published in Japan suggest that patients who respond or have a partial response to interferon therapy have a reduced incidence of hepatocellular cancer with long-term follow up. These data remain controversial, and further long-term studies will be needed to confirm these results.



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