Prior to 1986 risk factors for hepatitis C, or non A, non B hepatitis as it was then called, included transfusions of blood and blood products, needle sharing and intravenous drug abuse, health care employment with frequent exposure to blood, sexual contact with, or household exposure to a person who had hepatitis C, and possibly sexual contact. The overall prevalence of hepatitis C infection ranges from 0.5% for low risk blood donors to 60%-90% for drug users and hemophiliacs who have received multiple blood transfusions. Five to 15% of persons transfused prior to 1986 contracted hepatitis C. In examining these results, it is important to take into account that the majority of reports between 1990 and 1992 pertain to results obtained using first generation type radioimmunoassay tests, which, as noted above, have a poor sensitivity and predictive value. There is very little known of the natural history of HCV infections in childhood. High risk groups include children requiring multiple blood transfusions and/or pooled blood products, as well as those born to Hepatitis C positive mothers. It is postulated that the natural history and risk of progression to liver disease in children will vary depending on the underlying condition for which the blood products were received, but that it is likely that 40% of infected children will develop chronic hepatitis with progression at some time to cirrhosis, and that they will be at increased risk of developing hepatocellular carcinoma. This progression may extend over 30 to 40 years.
The Specific Aims are: 1) to examine the prevalence of Hepatitis C infection in a cohort of very low birthweight young adults. 2) to estimate the risk of hepatitis C infection according to the total volume of blood received, and the number of different donors. 3) among Hepatitis C positive VLBW subjects, to identify the neonatal risk factors and childhood and adolescent health and behavioral risk factors associated with both the development of Hepatitis C liver disease and its severity. 4) to refer the Hepatitis C positive VLBW subjects for the best possible treatment currently available, to prevent the development of disease and/or deterioration of the liver associated with viral infection. 5) to inform the Hepatitis C positive VLBW subjects of the results of their tests, and to counsel them concerning health risk behaviors (such as drinking alcohol) and hepatotoxic medications, and precautions they might need to take to prevent transmission to close intimate partners. Hypotheses: 1) That 10-15% of the very low birthweight subjects who received neonatal blood transfusions will be Hepatitis C positive at 20 years of age. 2) That the probability of testing Hepatitis C positive will depend on the number of transfusions from different donors and the total volume of blood received during the neonatal and behavioral risk factors. We propose, initially, a pilot study to examine the prevalence of Hepatitis C infection among the 20 year-old subjects in our main study born in 1977 who received blood (n=87). If the hypothesized Hepatitis C infection rate of 10-15% is found, we plan to extend the study to examine the prevalence of Hepatitis C infection among the total cohort of 20 year-old very low birthweight subjects who received blood (n=198/156 seen at age 20). All subjects will be screened with the anti-HCV 3.0 enzyme immunoassay. We also plan to test for ALT as an indicator of ongoing hepatitis associated with HCV infection and for other transfusion-transmitted disease associated markers including HbsAg, anti-HBc and HIV. The pilot project will be implemented by initially sending a letter to the subjects who received neonatal blood transfusions informing them that they received blood as infants, that prior to 1986 blood was not screened for Hepatitis C, and that the Center for Disease Control suggests screening all persons who received blood transfusions prior to this time. Blood tests will be free of charge. Since the subjects were seen a year ago, the only additional information which will be required is an update on health and a question as to whether they ever received blood transfusions after the neonatal period. The subjects will be informed of the results, and if positive for Hepatitis C they will be referred for counseling and further testing for potential liver disease. """"""""

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000080-39
Application #
6441909
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
39
Fiscal Year
2001
Total Cost
Indirect Cost
Name
Case Western Reserve University
Department
Type
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
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