Natural History Study of Non-A, Non-B Post-Transfusion Hepatitis (NANB-TAH) - Catalog

  • Name

    Natural History Study of Non-A, Non-B Post-Transfusion Hepatitis (NANB-TAH)

  • Accession Number

    HLB00901212a

  • Acronym

    NANB-TAH

  • Related studies
    (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)
  • BSI Study IDs

    NAN

  • Is public use dataset

    False

  • Keywords
  • Ingestion Status
    Released
  • Has Study Datasets

    True

  • Has Specimens

    True

  • Specimen ID Type
    Coded
  • Study Website
  • The Framingham Heart Study Group requires that the requestor must obtain full or expedited IRB/Ethics Committee review and approval to obtain these data. Waivers or a determination that the research is exempt from ethical regulations do not suffice.

    False

  • Clinical Trial URLs
  • Study type
    Epidemiology Study
  • Collection Type
    Open BioLINCC Study
  • Cohort type
    Both
  • Interventions
  • Study Open Date (Data)

    2012-03-06

  • Study Open Date (Specimens)

    2012-03-06

  • Date materials available

    2012-03-05

  • Last updated

    2023-02-07

  • Study period

    1988 - 2001

  • Study Contacts
  • NHLBI Division

    DBDR

  • Classification
    Transfusion Medicine
  • HIV study classification
    non-HIV
  • COVID study classification
    non-COVID
  • Pre-Website # of Specimens Shipped

    0

  • # of Returned Specimens

    0

  • Primary Publication URLs
    N/A
  • Conditions
    Blood Transfusion
    Hepatitis, Viral, Human
    Liver Diseases
  • Objectives

    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.

  • Background

    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.

  • Participants

    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.

  • Design

    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.

  • Conclusions

    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.

  • Disease classification
  • Publications

    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.

  • Mat types
    Serum
  • Network

The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.

  • Subjects

    Cases: 647

    Controls: 1,118


    Last Modified: March 13, 2025, 10:22 a.m.
  • Age

     

    Total Subjects

    < 18

    12

    18-24

    70

    25-29

    87

    30-34

    63

    35-39

    108

    40-44

    184

    45-49

    271

    50-54

    326

    55-59

    308

    60-64

    191

    65-69

    72

    70-74

    48

    75+

    25


    Last Modified: March 13, 2025, 10:24 a.m.
  • Sex

     

    Total Subjects

    Male

    1,357

    Female

    408


    Last Modified: March 13, 2025, 10:22 a.m.
  • Race

     

    Total Subjects

    Not Black

    1,483

    Black

    282


    Last Modified: March 13, 2025, 10:22 a.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. PDF Section 3.0 of the BioLINCC Handbook describes the components of the review process.

  • Material Types

    Serum


    Last Modified: March 13, 2025, 10:22 a.m.
  • General Freeze/Thaw Status

    Majority of serum is unthawed


    Last Modified: March 13, 2025, 10:22 a.m.
  • Visits (Vials)

    03/13/2025

     

    Serum

    Total Vials

    Month 1

    1,044

    1,044

    Month 2

    29

    29

    Month 3

    839

    839

    Month 4

    13

    13

    Month 5

    40

    40

    Month 6

    55

    55

    Month 7

    57

    57

    Month 8

    88

    88

    Month 9

    85

    85

    Month 10

    77

    77

    Month 11

    67

    67

    Month 12

    62

    62

    Month 13

    58

    58

    Month 14

    50

    50

    Month 15

    47

    47

    Month 16

    46

    46

    Month 17

    58

    58

    Month 18

    59

    59

    Month 19

    52

    52

    Month 20

    45

    45

    Month 21

    41

    41

    Month 22

    38

    38

    Month 23

    31

    31

    Month 24

    21

    21


    Last Modified: March 13, 2025, 10:22 a.m.
  • Visits (Subjects)

    03/13/2025

     

    Serum

    Total number of subjects

    Average volume (mL) per subject

    Month 1

    474

    6.06

    Month 2

    15

    6.18

    Month 3

    420

    7.11

    Month 4

    8

    6.44

    Month 5

    18

    8.06

    Month 6

    25

    8.24

    Month 7

    28

    7.49

    Month 8

    38

    8.43

    Month 9

    39

    7.42

    Month 10

    33

    8.65

    Month 11

    30

    8.18

    Month 12

    32

    6.04

    Month 13

    31

    5.57

    Month 14

    25

    6.91

    Month 15

    25

    5.56

    Month 16

    25

    5.14

    Month 17

    27

    6.12

    Month 18

    26

    7.15

    Month 19

    25

    6.66

    Month 20

    19

    8.32

    Month 21

    18

    7.69

    Month 22

    16

    8.91

    Month 23

    13

    9.96

    Month 24

    8

    11.44


    Last Modified: March 13, 2025, 10:22 a.m.