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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 damage., 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 biopsy., 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 dollars to 64 000 dollars per QALY for genotype 1 and from 10 000 dollars to 28 000 dollars per QALY for other genotypes; and for women ranged from 32 000 dollars to 90 000 dollars for genotype 1 and from 12 000 dollars to 42 000 dollars 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.

Context: Chronic hepatitis C (CHC) infection affects nearly 4 million people in the United States. Treatment with interferon alfa-2b has been limited by its cost and low likelihood of long-term response., Objective: To examine the cost-effectiveness of alternative pretreatment management strategies for patients with CHC., Design: Decision and cost-effectiveness analysis using a Markov model to examine prevalence of genotypes, viral load, and histological characteristics in relation to the sustained response rate with treatment. Data were based on a previously published decision model and a MEDLINE literature search for hepatitis C, biopsy, and liver from 1966 to 1996., Patients: A hypothetical population of patients with CHC infection and elevated serum alanine aminotransferase level., Interventions: Combinations of liver biopsy, genotyping, and quantitative viral load determination prior to a single 6-month course of interferon alfa-2b; empirical interferon treatment; and conservative management., Main Outcome Measures: Proportion of sustained responders, lifetime costs, life expectancy, and quality-adjusted life expectancy., Results: Strategies involving hepatitis C virus (HCV) RNA testing had marginal cost-effectiveness ratios up to $4400 per discounted quality-adjusted life-year gained but would miss up to 36% of sustained responders. Empirical interferon treatment had a marginal cost-effectiveness ratio of $12400 per discounted quality-adjusted life-year gained and reached all potential sustained responders. Strategies involving liver biopsy were more expensive and would miss 6% of sustained responders and yield slightly lower life expectancies., Conclusions: Routine liver biopsy before treatment with interferon increases the cost of managing patients with CHC without improving health outcomes. Using quantitative HCV RNA testing to guide therapy misses some potential sustained responders. Empirical interferon treatment has a marginal cost-effectiveness ratio within the bounds of other commonly accepted therapies and misses none of the sustained responders.

Objectives: To estimate the economic impact of (1) treating pregnant women who are human immunodeficiency virus (HIV)-positive with zidovudine and (2) voluntary screening programs for pregnant women for HIV infection and offering treatment with zidovudine to those found to be HIV-positive., Main Outcome Measures: Number of cases of pediatric HIV infection and costs of screening, zidovudine treatment, and pediatric HIV infection treatment., Design: Health care costs associated with treatment of HIV-positive pregnant women and their newborns are estimated as the costs of zidovudine and its administration and the reduction in costs of treating pediatric HIV infection. The lifetime costs of pediatric HIV infection are derived from the published literature. Estimates of the reduction in maternal-to-fetal transmission rates are taken from the AIDS [acquired immunodeficiency syndrome] Clinical Trials Group (ACTG) Protocol 076. Costs of a voluntary screening program include costs of screening tests and counseling. Sensitivity and threshold analyses are performed to determine the impact of changes in input parameter values including zidovudine treatment costs, efficacy of treatment, costs of pediatric HIV infection, prevalence of HIV infection in pregnant women, screening test sensitivity and specificity, and pregnancy termination rates on the results., Results: Assuming transmission rates are reduced from 25.5% to 8.3% as found in the ACTG 076 trial, treatment costs of $104,502 for 100 HIV-positive pregnant women and their newborns are offset by the reduction of $1,701,333 associated with fewer cases of pediatric HIV infection for a net savings of $1,596,831. The sensitivity and threshold analyses show that overall cost savings from treatment of HIV-positive pregnant women and their newborns are achieved for a wide range of possible maternal treatment costs, efficacy rates, and lifetime pediatric HIV treatment costs. In the base-case analysis for the voluntary screening program, overall cost savings are seen when HIV prevalence rate among pregnant women is greater than 4.6 per 1000. However, this threshold prevalence rate is sensitive to changes In parameter value-especially pediatric HIV treatment costs, counselling costs, efficacy of treatment, and years of additional HIV treatment for the pregnant women., Conclusions: Offering zidovudine treatment to pregnant women known to be HIV-positive will decrease the number of cases of pediatric HIV infection and reduce health care costs. Voluntary screening programs for pregnant women will further decrease the number of cases of pediatric HIV infection. The effect of a screening program on health care costs varies according to HIV prevalence and the costs associated with the screening program.

Objective: To evaluate the cost-effectiveness of a short-course zidovudine program to prevent perinatal transmission of human immunodeficiency virus (HIV) type 1 in sub-Saharan African country settings., Design and Setting: Several clinical trials of short-course zidovudine during pregnancy for prevention of perinatal transmission of HIV are under way in developing countries in sub-Saharan Africa. A decision model was used to examine the cost-effectiveness of zidovudine programs in a hypothetical 1-year birth cohort in a sub-Saharan African setting from the perspective of the health care system and of society. A completed short course of zidovudine was assumed to reduce perinatal HIV transmission from 25% to 16.5%, approximately one half of the effect of the longer-course zidovudine. Estimates of program costs, lifetime HIV-related health care costs, and lost productivity costs were derived from the published literature and from preliminary data available from sites of planned clinical trials. Sensitivity analyses were conducted on all relevant parameters., Main Outcome Measures: Medical costs, lost productivity costs, program costs, cost savings, and incremental cost-effectiveness, expressed as cost per infant HIV infection prevented., Results: The model estimated that a national zidovudine program in a setting with 12.5% HIV seroprevalence would reduce perinatal HIV incidence by 12% (4.9 infections per 1000 births). The costs to the health care system would be $3748 per infant HIV infection prevented. When productivity losses were included in the model, the cost decreases to $1115 per infant HIV infection prevented. The cost to implement a national zidovudine program including the cost of counseling, testing, and drugs, would be $2 million per 100,000 births or $20 per pregnant woman. In the base case, decreases in the cost of counseling and testing and increases in maternal HIV prevalence, zidovudine efficacy, and medical and lost productivity costs improved cost-effectiveness of the zidovudine program., Conclusions: Assuming demonstrable efficacy of short-course zidovudine prevention of perinatal HIV, a national perinatal HIV prevention program with zidovudine in most sub-Saharan African country settings would reduce the incidence of infant HIV infection and, in some settings, provide societal savings; however, substantial initial investment in such programs will be required. Where health care resources are limited, as in these regions, allocation of resources to a perinatal zidovudine program will need to be considered in the context of resources required for other pressing medical care needs.