Title: Clinical and economic impact of population-based screening for hepatitis C: A decision analysis
Abstract: Background: Hepatitis C virus (HCV) infection is common and may progress unrecognized to an untreatable stage.Accurate diagnostic tests exist and available treatments may eliminate HCV in the short term.However, since the impact of virus clearance on the rate of progression to HCV-related complications is unknown, the decision to screen low-risk individuals is controversial.Aim: Use decision analysis to estimate the clinical benefits and cost-effectiveness of HCV screening and treatment in a cohort of 45 yr-old men in the US.Methods: A Markov simulation was developed to estimate the impact of HCV screening on HCV-related mortality and associated direct medical costs.In the base-case analysis, HCV prevalence was assumed to be 1.3%.Screening involved two stages: I) ELISA (sens 93%, spec 93%, $24) was performed initially in all subjects; 2) In ELISA positive subjects (1.8%), PCR was used to confirm infection (sens 100%, spec 100%, $50).PCR-Positive subjects with elevated ALT and no cirrhosis on biopsy (76%) were treated with interferon and ribavirin.Patients with genotype I (66% of infected) were treated for 12 mono (sustained resp.rate (SR) 28%, $14,000), while patients with other genotypes received 6 months of therapy (SR 69%, $7000).In the base case, individuals with viral clearance after therapy were assumed to have similar life expectancy (66 yr) as those without HCV infection.Individuals with persistent infection after therapy had a shortened life expectancy (60.5 yr) and $31,500 in HCV-associated costs.Sensitivity analysis varied HCV prevalence, cost of chronic HCV infection and life expectancy benefit associated with sustained response to therapy.Costs and benefits were discounted at 3%.Results: Assuming short term clearance always led to long term cure, screening yielded 24.5 additional life-yr per 1000 patients screened at an incremental cost of $18 per patient screened ($719 per life-yr saved).The incremental cost-effectiveness of screening varied as the long term impact of HCV clearance was varied, but remained less than $50,000 per life year saved if > 12% life expectancy benefit (>8 months) was achieved.The results were insensitive to HCV prevalence and chronic HCV costs.Conclusions: HCV screening has the potential to produce substantial health benefits at acceptable incremental cost at modest rates of long term effectiveness.Until controlled studies to confirm and quantify this benefit are completed, it might be reasonable to consider screening in certain populations.