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.

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

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

Design:
Cost-effectiveness analysis.

Data Sources:
Clinical trial data and published studies.

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

Time Horizon:
Lifetime.

Perspective:
Societal.

Intervention:
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.

Conclusion:
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.