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Durability of Sustained Virologic response in patients with Chronic Hepatitis c after treatment With Interferon 2b Alone or in Combination with Ribavirin

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  • claudine intexas
    NATAP - www.natap.org ... AASLD Dallas, Nov 9-13 Reported by Jules Levin see NATAP website for extensive ongoing AASLD coverage Abstract 281. Durability of
    Message 1 of 1 , Nov 28, 2001
      NATAP - www.natap.org
      ----------------------

      AASLD
      Dallas, Nov 9-13
      Reported by Jules Levin
      see NATAP website for extensive ongoing AASLD coverage


      Abstract 281. Durability of Sustained Virologic
      response in patients with Chronic Hepatitis c after
      treatment With Interferon 2b Alone or in Combination
      with Ribavirin

      This study looked at 400 patients in 3 studies who
      achieved a sustained response. The key findings were:

      1. late relapse (after achieving the sustained
      response) occurred only in 2.5% of patients
      2. the late relapsers occurred within the first 2
      years. There were no relapsers after 2 years
      3. 2 relapsers had detectable HCV-RNA in the liver; 3
      had detectable HCV-RNA in the liver and did not
      relapse
      4. the risk of relapse after achieving sustained
      response was 5%

      The purpose of this study was to assess the durability
      of response in patients who were sustained responders
      24 weeks after therapy. John McHutchison reported in
      an oral session on a analysis of 2089 patients from 3
      large scale international studies comparing interferon
      alfa-2b alone to interferon alfa-2bplus ribavirin
      (Davis et al, NEJM 1998;339:1493, McHutchison et al
      NEJM 1998; 339:1485; Poynard et al, Lancet
      1998;352:1426).
      Many of these patients have been followed for up to 4
      years. This analysis looked at the 558 patients who
      achieved a sustained response to evaluate their rate
      of failure. Of the 558 SVRs 455 patients received
      IFN+RBV and 103 patients received IFN. 395 of the 558
      agreed to participate in this long-term follow-up. All
      patients were treatment-na�ve or relapsers and
      received 24 or 48 weeks treatment. Of the 395
      patients, 151 na�ve received IFN/RBV for 48 weeks, 112
      na�ve patients received IFN/RBV for 24 weeks, 59
      relapsers received IFN/RBV for 24 weeks, 61 received
      IFN alone for 48 weeks, and 12 received IFN alone for
      24 weeks (4 na�ve 24 weeks, 61 na�ve 48 weeks, 8
      relapse 24 weeks).

      Serum HCV-RNA was measured by NGI LLQ 100 copies/ml.
      These patients are also assess yearly for disease
      progressionby physical exam and hemotological and
      biochemical (ALT/AST) testing. This analysis was
      completed as of February 2001 and the endpoint was
      viral relapse after achieving sustained response.
      About 2/3 of patients were male, 42-47 years of age,
      and about 74-79 kg. 37% were genotype 1, 26% genotype
      2, 34% genotype 3, and 3% genotype 4/5. Although there
      is a low percentage of genotype 1 in this analysis
      McHutchison said that they found no difference in
      study outcomebetween genotyp 1 vs non-genotype 1.
      Baseline fibrosis Metavir Stage: 60-80% of patients
      had F0-F1. 12-29% had F3/F4. And 4-20% had missing
      information. Baseline viral load was 3.0-4.1 million
      copies/ml. ALT was 3.2 to 3.6 times the upper limit of
      normal.

      RESULTS

      --59% of the 395 patients in the study have been
      followed for 4 years after the end of treatment, 3%
      for 5 years, 26% for 3 years, 8% for 2 years, and 3%
      for 1 year.

      --Only 10 out of 395 patients (2.5%) who had a
      sustained response (24 weeks after ending treatment)--


      -7/10 had received IFN/RBV

      -5 of 7 were na�ve and relapsed in 3-24 weeks after
      stopping therapy

      -2 of 7 were relapsers
      -3/10 patients received IFN alone

      --All 10 late relapsers reappearance of HCV-RNA within
      2.5 years after stopping therapy or 2 years after the
      24 week follow-up period.

      --There have been no relapses after 2 years of
      follow-up.

      --Researchers looked at na�ve vs relapser, 24 vs 48
      weeks treatment, genotype 1 vs non-genotype 1, low vs
      high viral load, low vs higher fibrosis, and found no
      factor predicted relapse

      --The overall risk for late relapse looking out to 4
      years was <5%, when using Kaplan-Meier curve, except
      for the 12 patients who received IFN alone for 24
      weeks who had a high risk for late relapse

      The corresponding actuarial likelihood (Kaplan-Meier)
      of maintaining response after 4 years in patients who
      initially achieved SR is: IFN/RBV 24 weeks therapy
      na�ve 97%, IFN/RBV 48 weeks therapy na�ve 99%, and
      IFN/RBV 24 weeks therapy relapsers 96%

      --There were 5 patients who had HCV-RNA detected in
      their liver (not blood) in the 24 week post-treatment
      liver biopsy. These 5 patients were sustained
      responders so they had PCR negative in the blood. Two
      of the 5 subsequently relapsed

      --95% had normal ALT during the long-term follow-up of
      this study

      --One patient developed liver cancer (hepatocellular
      carcinoma). He had pre-existing cirrhosis, was a
      sustained responder (I think he was a previous
      relapser IFN alone) who has not relapsed. HCC
      developed 39 months after treatment. Other than this 1
      patient there was no evidence of hepatic
      decompensation as documented by physical exam



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