Watchful Waiting with Periodic Liver Biopsy versus Immediate Empirical Therapy for Histologically Mild Chronic Hepatitis C.
    A Cost Effectiveness Analysis.

   Wong JB, Koff RS New England Medical Center, 750 Washington Street, Box 302, Boston, MA 02111.

Not all patients with histologically mild chronic hepatitis C progress to cirrhosis.

To compare no antiviral treatment, periodic liver biopsy with subsequent antiviral treatment for moderate hepatitis or cirrhosis, and immediate antiviral therapy.

Cost-effectiveness analysis.

Data Sources:
Clinical trial data and published studies.

Target Population:
Hepatitis C virus-infected patients with histologically mild hepatitis.

Time Horizon:


Immediate combination antiviral treatment or biopsy every 3 years plus combination antiviral therapy for moderate hepatitis or cirrhosis.

Outcome Measures:
Life expectancy, quality-adjusted life expectancy, and costs.

Results of Base-Case Analysis:
Over 20 years, biopsy every 3 years with treatment of moderate hepatitis would avoid treatment in 50% of the cohort and would result in an 18% likelihood of cirrhosis compared with 16% for immediate treatment and 27% for no antiviral therapy. Immediate antiviral treatment should increase life expectancy by 1.0 quality-adjusted life-year compared with biopsy management.

Over an average lifetime, biopsy management would lead to six liver biopsies costing $6200; immediate antiviral treatment would cost $5100 less than biopsy management because of savings related to biopsy and prevention of future hepatitis C-related morbidity. Immediate therapy was cost-effective compared with biopsy management and had a cost-effectiveness ratio of $7000 compared with no antiviral therapy.

Results of Sensitivity Analysis:
When age, sex, genotype, and estimates of histologic progression or compliance with follow-up are varied, immediate therapy should result in an increase of at least 0.8 quality-adjusted life-year compared with biopsy management.

For histologically mild chronic hepatitis C, initial combination treatment compared with periodic liver biopsy should reduce the future risk for cirrhosis, prolong life, and be cost-effective.