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Citation
Snow, Kristin (2024). The Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis Trial (HALT-C) (Version 7) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/d1m7-ye92
Data Availability Statement
Data from the The Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis Trial (HALT-C) [(Version 7) https://doi.org/10.58020/d1m7-ye92] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
Acknowledgment Statement
The HALT-C study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the HALT-C (https://doi.org/10.58020/d1m7-ye92) study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the HALT-C study and does not necessarily reflect the opinions or views of the HALT-C study, NIDDK-CR, or NIDDK.
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General Description

The Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis Trial (HALT-C) was a randomized clinical trial of long-term use of peginterferon alfa-2a in patients with chronic hepatitis C. The study investigated whether long-term antiviral therapy could prevent progressive liver disease—including cirrhosis, liver failure, hepatocellular carcinoma, and death—in chronic hepatitis C participants. Participants with chronic hepatitis C and advanced fibrosis who failed to respond to prior treatment with peginterferon and ribavirin were enrolled in the study. The participants, who were stratified according to stage of fibrosis, were randomly assigned to receive either peginterferon or no therapy for 3.5 years. The primary outcome measure was progression of liver disease, as indicated by death, hepatocellular carcinoma, hepatic decompensation, or, for those with bridging fibrosis at baseline, an increase in the Ishak fibrosis score of 2 or more points. Results showed that the level of serum aminotransferases, the level of serum hepatitis C virus RNA, and histologic necroinflammatory scores all decreased significantly with treatment, but there was no significant difference between the groups in the rate of disease progression.

Some of the patients with hepatitis C-related advanced liver disease developed hepatocellular carcinoma (HCC), and there is an existing matched set of samples from these patients and controls. Please see the HCC Documents detailing the description of this set of samples and guidelines for its use in validating serum biomarkers. Investigators interested in using this set should make sure to refer to it specifically in their requests.

Objectives

The HALT-C study sought to determine if long-term interferon therapy over several years suppresses the hepatitis C virus and prevents progression to cirrhosis and liver cancer in patients with chronic hepatitis C.

Outcome Measure

The primary outcome measure was progression of liver disease, as indicated by death, hepatocellular carcinoma, hepatic decompensation, or, for those with bridging fibrosis at baseline, an increase in the Ishak fibrosis score of 2 or more points. Serious adverse events, events requiring dose reductions, and quality of life were measured as secondary outcomes.

Eligibility Criteria

Participants of at least 18 years of age who met the following criteria were enrolled:

  • Positive for hepatitis C

  • Previous treatment with any interferon or interferon and ribavirin for at least 3 months

  • Documented non-response to treatment with interferon

  • Liver biopsy demonstrating significant liver scarring

Patients with other liver diseases, unstable major medical diseases or conditions, major complications of cirrhosis, and recent abuse of alcohol and/or illicit drugs were excluded.

Outcome

The HALT-C study showed that long-term therapy with peginterferon did not reduce the rate of disease progression in patients with chronic hepatitis C and advanced fibrosis, with or without cirrhosis, who did not have a response to initial treatment with peginterferon and ribavirin.

Research Area

Liver Disease, Multidisciplinary Research

Study Type

Interventional

Study Sites

12

Study Start Date

2000-06

Study End Date

2009-10

Condition

Hepatocellular Carcinoma, Cirrhosis of Liver, Hepatitis C Virus Infection, Cancer

Keywords

Chronic Hepatitis C, Hepatocellular Carcinoma (HCC), Liver Disease Progression, Necroinflammatory, Peginterferon, Ribavirin, Serum Aminotransferases, Liver Bioposy

NIDDK Division

DDN

1,382
Participants

Target Population
Adults
Location statistics is not available for this study

Public Documents Table
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Description
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File Format
Compliance
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Non-Public Documents (7)
Non-Public Documents Table
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Description
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Datasets (174)
Datasets Table
Dataset Name
Description
# of Records
# of Variables
File Format(s)
Specimens (340,517)
Specimens Table
Specimen
Count
DNA15963
EBV PBMC (2nd)4263
Liver Tissue29737
PB-PBMC7
Plasma14057
Serum275391
Whole Blood1099