Context Approximately 2.7 million US individuals are chronically infected with
the hepatitis C virus (HCV). As public health campaigns are pursued, a growing
number of treatment candidates are likely to have minimal evidence of liver
Objective To examine the clinical benefits and cost-effectiveness of newer treatments
for chronic hepatitis C infection in a population of asymptomatic, HCV sero-positive
but otherwise healthy individuals.
Design and Setting Cost-effectiveness analysis using a Markov model of the natural history
of HCV infection and impact of treatment. We used an epidemiologic model to
derive a range of natural history parameters that were empirically calibrated
to provide a good fit to observed data on both prevalence of HCV seropositivity
and time trends in outcomes related to HCV infection.
Patients Cohorts of 40-year-old men and women with elevated levels of alanine
aminotransferase, positive results on quantitative HCV RNA assays and serologic
tests for antibody to HCV, and no histological evidence of fibrosis on liver
Interventions Monotherapy with standard or pegylated interferon alfa-2b; combination
therapy with standard or pegylated interferon plus ribavirin.
Main Outcome Measures Lifetime costs, life expectancy, quality-adjusted life-years (QALYs),
and incremental cost-effectiveness ratios.
Results The probability of patients with chronic HCV developing cirrhosis over
a 30-year period ranged from 13% to 46% for men and from 1% to 29% for women.
The incremental cost-effectiveness of combination therapy with pegylated interferon
for men ranged from $26 000 to $64 000 per QALY for genotype 1 and
from $10 000 to $28 000 per QALY for other genotypes; and for women
ranged from $32 000 to $90 000 for genotype 1 and from $12 000
to $42 000 for other genotypes. Because the benefits of treatment were
realized largely in the form of improvements in health-related quality of
life, rather than prolonged survivorship, cost-effectiveness ratios expressed
as dollars per year of life were substantially higher. Results were most sensitive
to assumptions about the gains and decrements in health-related quality of
life associated with treatment.
Conclusions While newer treatment options for hepatitis C appear to be reasonably
cost-effective on average, these results vary widely across different patient
subgroups and depend critically on quality-of-life assumptions. As the pool
of persons eligible for treatment for HCV infection expands to the more general
population, it will be imperative for patients and their physicians to consider
these assumptions in making individual-level treatment decisions.