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Re: [GIWorld-Hepatitis] 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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  • sylvati
    how can you have detectable HCV-RNA in the liver without relapsing?? love Sylv ... From: claudine intexas To: Web Warriors
    Message 1 of 2 , Dec 5, 2001
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      how can you have detectable HCV-RNA in the liver without relapsing?? love
      Sylv

      ----- Original Message -----
      From: claudine intexas <claudineintexas@...>
      To: Web Warriors <HepCWebWarriors@yahoogroups.com>; GIWorld-Hepatitis
      <giworld-hepatitis@yahoogroups.com>
      Sent: Thursday, November 29, 2001 6:57 AM
      Subject: [GIWorld-Hepatitis] Durability of Sustained Virologic response in
      patients with Chronic Hepatitis c after treatment With Interferon 2b Alone
      or in Combination with Ribavirin


      > 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-naïve or relapsers and
      > received 24 or 48 weeks treatment. Of the 395
      > patients, 151 naïve received IFN/RBV for 48 weeks, 112
      > naïve 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 naïve 24 weeks, 61 naïve 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 naïve 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 naïve 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
      > naïve 97%, IFN/RBV 48 weeks therapy naïve 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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    • claudine intexas
      ... Hi Sylv, I don t think anyone could answer this, not at this point in time. However, the nature of this virus is to replicate itself rapidly, so I doubt if
      Message 2 of 2 , Dec 5, 2001
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        --- sylvati <sylvati@...> wrote:
        > how can you have detectable HCV-RNA in the liver
        > without relapsing?? love
        > Sylv

        Hi Sylv,
        I don't think anyone could answer this, not at
        this point in time. However, the nature of this virus
        is to replicate itself rapidly, so I doubt if this
        happens very often. Most people who have a durable
        response also have no detectable virus in their livers
        either.
        Claudine

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