Medicine Today Internal Medicine Webcast Series

Hepatitis C Management:

Management of Special Groups:
Patients with Persistently Normal
Aminotransferase Levels

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Key Points

  • Treatment of HCV infection in patients whose aminotransferase levels are persistently normal has been controversial, but such patients should be fully assessed and considered for antiviral therapy.

A significant proportion (25% to 30%) of patients with chronic HCV infection have persistently normal aminotransferase levels. Examination of liver biopsy specimens has shown that almost all of these patients have histologic evidence of mild chronic hepatitis, and their prognosis appears to be favorable.131 Studies in which fibrosis is reported in HCV-infected patients with persistently normal ALT levels have not been controlled for comorbidities (eg, alcohol abuse, obesity).

Although most trials of IFN have excluded patients who have persistently normal aminotransferase levels, some data are available regarding the response to therapy in this population. In a review of seven small uncontrolled trials of IFN alfa, Marcellin et al reported that the end-of-treatment and sustained virologic response rates of patients with persistently normal aminotransferase levels were similar to those of patients with abnormal levels.133 However, they also found that the serum ALT level became abnormal during therapy in approximately 50% of these patients; the level remained elevated in some of them even after therapy was discontinued, which suggests that IFN alfa might be harmful in this population.

Preliminary results from a more recent international, multicenter, randomized clinical trial of patients with chronic HCV infection and persistently normal aminotransferase levels also suggested that the efficacy and safety of PEG-IFN alfa-2a and ribavirin combination therapy in these patients was equal to that observed in patients with high aminotransferase levels.134 Additionally, more than a third of the patients in the observation group in this study developed abnormal ALT levels with observation alone.

Current evidence appears to suggest that the indications for anti-HCV therapy are independent of the ALT level, and this panel recommends considering full assessment and potential therapy for patients with normal ALT levels.


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