Natural History Study of Non-A, Non-B Post-Transfusion Hepatitis (NANB-TAH) - Catalog
Natural History Study of Non-A, Non-B Post-Transfusion Hepatitis (NANB-TAH)
HLB00901212a
NANB-TAH
(TTVS) Transfusion-Transmitted Viruses Study (TTVS)
(VA2-TAH) VA Cooperative Study of the Efficacy of Hepatitis Immune Serum Globulin for the Prevention or Modification of Post-Transfusion Hepatitis (VA2-TAH)
NAN
False
True
True
Coded
False
Epidemiology Study
Open BioLINCC Study
Both
2012-03-06
2012-03-06
2012-03-05
2023-02-07
1988 - 2001
DBDR
Transfusion Medicine
non-HIV
non-COVID
0
0
No
No
No
Yes
Yes
Yes
Use of biospecimens is restricted to studies related to hepatitis.
Blood Transfusion
Hepatitis, Viral, Human
Liver Diseases
This extended follow-up study of 5 major prospective studies of transfusion-associated hepatitis conducted in the US between 1967 and 1980, attempted to address the uncertainty about the frequency progression to clinically symptomatic and debilitating chronic liver disease and the frequency of fatal liver disease. The study, designed to track both mortality and morbidity of transfusion-associated non-A, non-B hepatitis, was a natural history evaluation that began at the time of disease onset. It also included a concurrent control group that could be evaluated, and that the study subjects were monitored for almost 25 years.
Prior to this study, little was known about the long-term consequences of non-A, non-B hepatitis. Most studies examined the short-term prognosis following acute infection which was characterized by mild but persistent inflammation. However, reports of late-onset cirrhosis, liver failure or even hepatocellular carcinoma were accumulating from patients with more than 10 years of follow-up. The frequency, rate of development and contribution to mortality of these sequelae of transfusion-associated non-A, non-B hepatitis were not well established.
Of the total 6438 subjects who entered the original 5 studies, that included the VA Cooperative Study of the Efficacy of Hepatitis Immune Serum Globulin for the Prevention or Modification of Post-Transfusion Hepatitis (VA2-TAH) and the Transfusion-Transmitted Viruses Study (TTVS), 1765 subjects were included in this study including 1552 non-A, non-B cases and controls (568 cases and 984 matched controls) and 213 hepatitis B cases and controls (79 cases and 134 matched controls). Thirty-eight of the non-A, non-B cases had no matched controls and seventy-six had only one control. Eight of the hepatitis B cases had no matched controls and eight had only one control.
A total of 311 subjects in the NANB-TAH study were recruited from the VA2-TAH study of which 308 subjects can be linked to the available dataset. A subset have biospecimens available from the VA2-TAH study period. A total of 501 subjects in the TTVS study subsequently were enrolled and followed in the NANB-TAH study although linkage at the subject level is no longer available.
Researchers traced patients with two control subjects with transfusion related non-A, non –B hepatitis who had been identified in 5 separate studies conducted between 1967 and 1980. Each patient was matched with two control subjects who received transfusions but did not have hepatitis. They were matched based on five categorical variables: the initial treatment center, sex, race (black or non-black), use of hepatitis immunoprophylaxis, and the presence or absence of a history of alcoholism; and three continuous variables: age, the number of units of blood transfused, and the date of transfusion. The mortality rates in the three groups were determined with use of data from National Death Index and Social Security Death Tapes. Cause specific mortality rates were determined by reviewing death certificates.
The data indicated that the frequency of death from all causes among transfusion recipients whom non-A, non-B hepatitis had developed an average of 18 years earlier in virtually identical to that in a carefully matched group of transfusion recipients in whom hepatitis did not develop. There was no increase in the mortality from all causes after transfusion associated non-A, non-B hepatitis, although there was a small, but statistically significant increase in the number of deaths related to liver disease. With an additional 7 years of follow-up, the liver-related mortality rate attributable to chronic hepatitis C increased among the cases compared to the controls. Additional follow-up of subjects, restricted to the 3 studies with archived original sera was extended to approximately 25 years. There remained no increase in the mortality from all causes after transfusion associated non-A, non-B hepatitis.
Seeff LB, Buskell-Bales Z, Wright EC, Durako SJ, Alter HJ, Iber FL, Hollinger FB, Gitnick G, Knodell RG, Perrillo RP, et al. Long-term mortality after transfusion-associated non-A, non-B hepatitis. The National Heart, Lung, and Blood Institute Study Group. N Engl J Med. 1992; 327(27):1906-11.
Seeff LB, Miller RN, Rabkin CS, Buskell-Bales Z, Straley-Eason KD, Smoak BL, Johnson LD, Lee SR, Kaplan EL. 45-year follow-up of hepatitis C virus infection in healthy young adults. Ann Intern Med. 2000; 132(2):105-11.
Harris DR, Gonin R, Alter HJ, Wright EC, Buskell ZJ, Hollinger FB, Seeff LB; National Heart, Lung, and Blood Institute Study Group. The relationship of acute transfusion-associated hepatitis to the development of cirrhosis in the presence of alcohol abuse. Ann Intern Med. 2001; 134(2):120-4.
Lin HJ, Seeff LB, Barbosa L, Hollinger FB. Occurrence of identical hypervariable region 1 sequences of hepatitis C virus in transfusion recipients and their respective blood donors: divergence over time. Hepatology. 2001; 34(2):424-9.
Seeff LB, Hollinger FB, Alter HJ, Wright EC, Cain CM, Buskell ZJ, Ishak KG, Iber FL, Toro D, Samanta A, Koretz RL, Perrillo RP, Goodman ZD, Knodell RG, Gitnick G, Morgan TR, Schiff ER, Lasky S, Stevens C, Vlahcevic RZ, Weinshel E, Tanwandee T, Lin HJ, Barbosa L. Long-term mortality and morbidity of transfusion-associated non-A, non-B, and type C hepatitis: A National Heart, Lung, and Blood Institute collaborative study. Hepatology. 2001; 33(2):455-63.
Serum
The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.
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Subjects
Cases: 647
Control 1: 597
Control 2: 521
Last Modified: April 5, 2024, 4:13 p.m. -
Age
Case Control 1 Control 2 All N % N % N % N % 11-15 1 0.15 1 0.17 1 0.19 3 0.17 16-20 16 2.47 12 2.01 8 1.54 36 2.04 21-25 22 3.40 23 3.85 17 3.26 62 3.51 26-30 33 5.10 23 3.85 26 4.99 82 4.65 31-35 22 3.40 21 3.52 24 4.61 67 3.80 36-40 48 7.42 41 6.87 32 6.14 121 6.86 41-45 70 10.82 78 13.07 55 10.56 203 11.50 46-50 106 16.38 88 14.74 81 15.55 275 15.58 51-55 125 19.32 117 19.60 102 19.58 344 19.49 56-60 104 16.07 99 16.58 86 16.51 289 16.37 61-65 55 8.50 54 9.05 47 9.02 156 8.84 66-70 18 2.78 17 2.85 26 4.99 61 3.46 71-75 18 2.78 18 3.02 12 2.30 48 2.72 76-80 9 1.39 3 0.50 4 0.77 16 0.91 81-85 . . 1 0.17 . . 1 0.06 86-87 . . 1 0.17 . . 1 0.06
Last Modified: April 5, 2024, 4:13 p.m. -
Sex
Case Control 1 Control 2 All N % N % N % N % Female 147 22.72 137 22.95 124 23.80 408 23.12 Male 500 77.28 460 77.05 397 76.20 1357 76.88
Last Modified: April 5, 2024, 4:13 p.m. -
Race
Case Control 1 Control 2 All N % N % N % N % Not Black 538 83.15 503 84.25 442 84.84 1483 84.02 Black 109 16.85 94 15.75 79 15.16 282 15.98
Last Modified: April 5, 2024, 4:13 p.m.
Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3 of the BioLINCC handbook describes the components of the review process
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Material Types
Last Modified: Nov. 30, 2015, 2 p.m. -
General Freeze/Thaw Status
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Visits (Vials)
02/26/2018
Serum Total Month 1 1,280 1,280 Month 2 38 38 Month 3 972 972 Month 4 30 30 Month 5 56 56 Month 6 75 75 Month 7 89 89 Month 8 123 123 Month 9 117 117 Month 10 101 101 Month 11 89 89 Month 12 75 75 Month 13 71 71 Month 14 59 59 Month 15 57 57 Month 16 54 54 Month 17 67 67 Month 18 70 70 Month 19 63 63 Month 20 53 53 Month 21 47 47 Month 22 42 42 Month 23 32 32 Month 24 21 21
Last Modified: April 5, 2024, 4:13 p.m. -
Visits (Subjects)
02/26/2018
Serum Total number of subjects Average volume (ml) per subject Month 1 579 6.32 Month 2 19 6.86 Month 3 502 7.27 Month 4 14 6.14 Month 5 25 7.16 Month 6 35 7.39 Month 7 43 7.09 Month 8 55 7.52 Month 9 54 7.00 Month 10 45 7.73 Month 11 37 7.79 Month 12 39 5.81 Month 13 37 5.57 Month 14 30 6.49 Month 15 31 5.36 Month 16 30 4.92 Month 17 32 5.72 Month 18 32 6.80 Month 19 30 6.48 Month 20 23 7.85 Month 21 21 7.50 Month 22 18 8.64 Month 23 13 10.19 Month 24 8 11.44
Last Modified: April 5, 2024, 4:13 p.m.