? This K01 award will support the Principal Investigator's development as an independent research scientist conducting economic evaluations of the medical complications of injection drug use (IDU). A team of mentors and advisors with expertise in cost-effectiveness evaluation, epidemiology of drug abuse, hepatitis C clinical treatment, infectious disease modeling, and health behavior research will provide the PI with the necessary support and guidance. The purpose of the research proposal is to determine chronic hepatitis C (HCV) treatment preferences among HCV-infected IDUs and to assess the cost-effectiveness of HCV treatment for 3 specific IDU populations: (1) HCV-infected IDUs in methadone maintenance treatment (MMT) and other substance abuse treatment settings; (2) IDUs co-infected with HIV and HCV who have early stage liver disease; and (3) HCV-infected pregnant women with a history of IDU. An estimated 65 to 90% of injection IDUs are infected with HCV and are at risk for sequelae such as cirrhosis, decompensated liver disease, and hepato-cellular carcinoma. Decisions about HCV treatment require complex trade-offs between uncertain benefits and considerable quality-of-life and financial costs. Combination therapy with ribavirin and pegylated interferon is effective in 40-80% of patients, depending on their genotype, but is costly and potentially toxic. Treatment preferences will be assessed by computer-assisted interviews with 200 HCV-infected patients at 3 New York City hospitals before and after treatment. Cost-effectiveness analysis provides a methodology for analyses to inform HCV treatment resource allocation decisions. Computer simulation models to measure cost effectiveness will be developed using the treatment preferences identified, reports from the literature, results of a survey of MMT providers, and data from HIV/HCV co-infected cohorts in 2 urban clinics.
The specific aims are: (1) To assess preferences and perceived barriers to HCV treatment among HCV patients infected by IDU, and to compare preferences before and after HCV treatment; (2) To conduct a cost-effectiveness analysis of treating IDUs with chronic HCV in MMT clinics and other substance abuse treatment settings, and to determine the budgetary costs of these alternatives for government-funded programs such as Medicaid; (3) To conduct a cost-effectiveness analysis of treating chronic HCV in HIV/HCV co-infected patients with persistently normal or moderately elevated ALT levels and/or stage 1 or 2 liver disease, using cohort data from 2 urban clinics; and (4) To conduct a cost-effectiveness analysis of elective Cesarean delivery for HCV-infected women identified with detectable HCV RNA during pregnancy and of HCV RNA screening of pregnant women with a history of IDU. This work will provide insight into important policy questions identified by the NIH Consensus Development Conference on the Management of Hepatitis C in June 2002 and will inform development of treatment and reimbursement guidelines. ? ? ? ?
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