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

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

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.

Subjects

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

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

    Control 1: 597

    Control 2: 521


    Last Modified: July 28, 2014, 1:36 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: Aug. 25, 2015, 2:42 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: Aug. 25, 2015, 2:42 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: Aug. 25, 2015, 2:42 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

  • Material Types

    Last Modified: Nov. 30, 2015, 2 p.m.
  • General Freeze/Thaw Status
  • 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: Feb. 26, 2018, 2:52 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: Feb. 26, 2018, 2:52 p.m.