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HALT-C Study

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  • claudine intexas
    Antiviral therapy with peginterferon and ribavirin leads to a sustained virologic response in approximately half of patients with chronic hepatitis C. Patients
    Message 1 of 1 , Oct 1, 2002
      Antiviral therapy with peginterferon and ribavirin leads to a
      virologic response in approximately half of patients with chronic
      hepatitis C. Patients who achieve a sustained loss of hepatitis C
      (HCV) usually have marked improvements in liver histology. Lesser but

      important degrees of improvement in liver histology also occur in
      interferon-treated patients who fail to achieve a virologic response.

      Furthermore, data from a recent controlled study suggest that
      interferon in nonresponder patients can maintain the histologic
      Interferon therapy may also reduce the incidence of hepatocellular
      carcinoma and improve survival in patients with cirrhosis.

      The HALT-C (Hepatitis C Antiviral Long-Term Treatment against
      Cirrhosis) trial is a multicenter, randomized, controlled study,
      sponsored by
      the National Institute of Diabetes and Digestive and Kidney Diseases
      (NIDDK), designed to determine if long-term treatment with
      peginterferon in
      previous nonresponders with advanced hepatic fibrosis can prevent
      cirrhosis and reduce the risk of developing end-stage liver disease
      hepatocellular carcinoma.

      Nonresponders to previous treatment with interferon, interferon and
      ribavirin, or peginterferon will be re-treated initially with
      peginterferon alfa-2a (Pegasys, Hoffmann-LaRoche) in a dose of 180
      �g/wk and
      ribavirin in a dose of 1,000 to 1,200 mg/d for 24 weeks (the lead-in
      Those who become HCV-RNA negative will continue treatment for 48
      whereas those who remain HCV-RNA positive will enter the formal
      protocol and be randomly assigned either to continue treatment with
      peginterferon alfa-2a alone (90 �g/wk) for an additional 42 months or
      be followed
      without treatment. Patients will be followed with outpatient visits
      blood tests every 3 months. Liver biopsies will be performed at
      baseline and after 2 and 4 years of treatment.

      The study goal is to enroll as many as 1,800 patients into the
      phase and to randomize 900 patients into the controlled phase to
      receive long-term peginterferon or no therapy. This sample size
      provides 90%
      power to detect a decrease in the annual rate of development of
      cirrhosis or its complications from 6% per year among controls to 3%
      per year
      in those treated.

      Primary outcome variables to be assessed in the two groups of

      Progression to cirrhosis on liver biopsy (Ishak fibrosis score 5 or
      Development of hepatic decompensation as shown by an increase in the
      Child-Turcotte-Pugh score to 7 or above, variceal hemorrhage,
      spontaneous bacterial peritonitis, or hepatic encephalopathy
      Development of hepatocellular carcinoma

      Secondary outcomes include quality of life and serious adverse

      The study is being conducted under a contract from the NIDDK at 11
      clinical centers in the United States, with the support of a virology

      laboratory and a data-coordinating center. The study is also
      supported by a
      clinical research and development agreement with Hoffmann LaRoche and

      is cosponsored by the National Cancer Institute, the National
      of Allergy and Infectious Diseases, and the National Center on
      Health and Health Disparities.

      Clinical centers
      Massachusetts General Hospital, Dr. Jules Dienstag

      National Institutes of Health, Dr. Marc Ghany

      Saint Louis University, Dr. Adrian Di Bisceglie

      University of California at Irvine, Dr. Timothy Morgan

      University of Colorado, Dr. Gregory T. Everson

      University of Connecticut Health Center, Dr. Herbert Bonkovsky

      University of Massachusetts, Dr. Raymond Koff

      University of Michigan, Dr. Anna Lok

      University of Southern California, Dr. Karen Lindsay

      University of Texas, Southwestern, Dr. William E. Lee

      Virginia Commonwealth University, Dr. Mitchell L. Shiffman

      Virology core laboratory
      University of Washington, Drs. David Gretch and Chihiro Morishima

      Data coordinating center
      New England Research Institutes, Dr. Elizabeth C. Wright

      Dr. James Everhart, Project Officer

      Dr. Patricia Robuck, Co-Project Officer

      Dr. Leonard Seeff, Scientific Advisor

      A secondary goal of the HALT-C trial is to conduct ancillary studies
      virology and immunology of hepatitis C, markers of fibrosis and
      quantitative tests of liver function, nutritional issues in hepatitis
      C, host
      genetic factors in fibrosis progression, the role of steatosis in
      fibrosis progression, and screening tests for hepatocellular

      Patients with chronic hepatitis C who have bridging fibrosis or
      cirrhosis on liver biopsy and who have failed previous
      therapy may be eligible to enroll in HALT-C and can be referred to
      one of the
      11 clinical centers. Patients who have already received peginterferon

      and ribavirin and who did not respond may be eligible to enroll
      into the randomized phase of the study without re-treatment. A more
      detailed description of the study and contact information is
      available on
      the Web at http://www.haltctrial.org/.

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