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Interferon Appears to Slow Progression, cancer & death

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  • claudine intexas
    NATAP www.natap.org ... Interferon Appears to Slow Progression, cancer & death in this Japanese Study (this article is available in full at the NATAP website)
    Message 1 of 1 , Jan 30, 2001
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      NATAP
      www.natap.org
      ---------------

      Interferon Appears to Slow Progression, cancer & death
      in this Japanese
      Study
      (this article is available in full at the NATAP
      website)

      Lancet Volume 357, Number 9251 20 January 2001

      Abstract:
      In a prospective randomised controlled study, 90
      patients with chronic
      active
      hepatitis C and compensated cirrhosis were assigned
      symptomatic
      treatment or
      interferon alfa (IFN-). We report data on
      decompensation, detection of
      hepatocellular carcinoma, and mortality rates. IFN-
      gave a sustained
      response
      in only a small proportion of patients, but worsening
      of compensated
      cirrhosis was prevented and development of
      hepatocellular carcinoma was
      inhibited, increasing the survival rate. The risk
      ratio of IFN- versus
      symptomatic treatment decreased by 0�250 for
      progression to Child-Pugh
      grade
      B, 0�256 for detection of hepatocellular carcinoma,
      and 0�135 for a
      fatal
      outcome.

      HCV RNA "disappeared" in 7/45 (16%) IFN treated
      patients and in none of
      the
      45 controls.

      Maximum, minimum, and mean follow-ups were 11.8, 2.6,
      and 8.2 years,
      respectively,for controls, and 12.0, 4.4, and 9.2
      years for patients
      given
      IFN-. The two groups were well balanced for the major
      prognostic
      factors of
      chronic hepatitis C and cirrhosis.

      During follow-up, 25 (56%) of the controls and 13
      (29%) of the patients
      given
      IFN- were rated grade B or worse (p=0�018).

      IFN- decreased the cumulative incidence of worsening
      of the Child-Pugh
      score (figure)

      Hepatocellular carcinoma was detected in 33 (73%) of
      the 45 controls
      and 12
      (27%) of the 45 patients given IFN- (p<0�001)

      For patients with mean ALT 80 IU during this trial,
      these numbers were
      23
      (79%) of 29 controls and 10 (33%) of 30 patients given
      IFN- (p=0�033).

      26 (58%) of the controls and 5 (11%) patients in the
      IFN- group died
      during
      follow-up (p<0�001);

      the cumulative proportion of overall survival was
      higher in the group
      given
      IFN-a.

      This means less risk for progression carcinoma and
      death for those
      receiving
      IFN:
      By univariate analysis, the risk ratios of IFN- versus
      symptomatic
      treatment
      were 0�302 (95% CI 0�156-0�583) for progression to
      Child-Pugh B, 0�244
      (0�126-0�475) for development of hepatocellular
      carcinoma, and 0�169
      (0�065-0�440) for death, respectively. By multivariate
      analysis, the
      risk
      ratios of treatment were 0�250 (0�124-0�505) for
      progression to
      Child-Pugh B,
      0�256 (0�125-0�522) for development of hepatocellular
      carcinoma, and
      0�135
      (0�049-0�372) for death, respectively (table).

      The effects of IFN- on liver function,
      hepatocarcinogenesis, and
      survival
      rate are still controversial. The disagreement seems
      to be related to
      the
      annual rate of hepatocarcinogenesis in patients with
      type C cirrhosis
      being
      much greater in Japan than in the USA;2 in countries
      with low rates,
      much
      larger groups of patients are needed for the same
      statistical power. A
      second
      possible explanation is the difference in the
      patients' backgrounds:
      factors
      in addition to hepatitis C virus (HCV) infection (eg,
      occult hepatitis
      B viru
      s [HBV] infection3) and predisposing
      characteristics involving race or life-style (such as
      alcohol intake).
      Japan
      has a high rate of HBV carriers; occult HBV infection
      in patients with
      type C
      cirrhosis may contribute to their high rate of
      hepatocarcinogenesis. A
      third
      explanation may be the different treatments used.

      Hepatocellular carcinoma was detected in only two
      (13%, 2-40%) of our
      15
      patients with a complete response to IFN-(HCV RNA
      disappeared) or
      partial
      response (mean ALT <80 IU); the relative risk was 0�12
      (0�03-0�48). In
      ten
      (33%, 17%-53%) of the 30 patients who did not respond
      to IFN-(ALT
      remained 80
      IU), carcinoma was detected; the proportion was
      smaller than for the
      controls
      (23 [79%] of 29 patients; p=0�033), but inhibition of
      carcinogenesis by
      IFN-was weak. Some part of such inhibition by IFN-
      seems to involve its
      lessening of hepatic inflammation.


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