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    Medscape Gastroenterology MEDLINE Abstracts Interferon Therapy for HCV What s new in interferon therapy for Hepatitis C in this easy-to-navigate collection of
    Message 1 of 1 , Jul 31, 2000
      Medscape Gastroenterology

      MEDLINE Abstracts
      Interferon Therapy for HCV

      What's new in interferon therapy for Hepatitis C in this
      easy-to-navigate collection of recent MEDLINE abstracts
      compiled by the editors at Medscape. [Medscape
      Gastroenterology 2(4), 2000]



      Utility of Early Testing for HCV Viremia as
      Predictive Factor of Sustained Response During
      Interferon or Interferon Plus Ribavirin Treatment

      Castro FJ, Esteban JI, Sauleda S, et al
      J Hepatol. 2000 May;32(5):843-9

      Background/Aim: To evaluate the utility of early testing for
      hepatitis C viremia as a predictor of treatment outcome during
      interferon or combination therapy.
      Methods: We studied 184 patients with chronic hepatitis C
      who received interferon and were monitored for HCV RNA.
      Sixty-two patients received interferon alone for 12 months and
      122 patients, who were still HCV RNA positive at 2 months,
      received an additional 12-month course of interferon and
      ribavirin combination therapy.
      Results: Using this strategy, sustained response occurred in a
      total of 34 patients (18.5%). Independent variables associated
      with sustained response were HCV genotype (p=0.06), viral
      load < or = 5.1 logs/ml (p= 0.005) and negative HCV RNA at 1
      month (p<0.0001) in the interferon group, and female sex
      (p=0.04), genotype (p=0.03), viral load < or = 5.5 logs/ml
      (p=0.01), normal ALT (p=0.001) and decline in viral load > or
      = 1.2 logs/ml after 2 months of interferon monotherapy
      (p<0.001) and negative viremia at 5 months of ribavirin onset
      (p<0.0001) in the combination therapy group. Persistence of
      viremia at 1 month of interferon monotherapy and at 5 months of
      combination therapy were the strongest predictors of
      non-response (negative predictive value of 100% and 99%,
      respectively).
      Conclusions: Qualitative assessment of HCV RNA during
      treatment is the strongest predictor of sustained response during
      interferon or combination therapy for chronic hepatitis C.

      Effects of 1-Year Interferon-Alpha 2a
      Treatment in Patients With Chronic Hepatitis C
      and Persistently Normal Transaminase Activity

      Tran A, Longo F, Ouzan D, et al
      Scand J Gastroenterol. 2000 Apr;35(4):433-7

      Background: Certain chronic hepatitis C carriers have
      persistently normal transaminase activity. The aims of this study
      were to determine the virologic and histologic effects of 1 year of
      interferon-alpha treatment in such patients.
      Methods: Thirty-one patients were followed up in our Liver
      Unit. Eleven accepted interferon-alpha therapy; the 20 others
      were not treated and served as controls. Interferon-alpha, 3
      MU, was given thrice weekly for 1 year. Serum was examined
      for hepatitis C virus (HCV)-RNA before, at the end of, and 6
      months after treatment. Liver biopsy was performed 6 months
      after the cessation of treatment in 10 of 11 treated patients (one
      refused biopsy) and after a mean of 30.6+/-22.7 months in the
      20 untreated patients.
      Results: At the end of follow-up two of the treated patients had
      undetectable serum HCV-RNA and five had increased alanine
      aminotransferase (ALAT) values. In contrast, only one of the
      untreated patients had abnormal ALAT activity. All 20 untreated
      patients were constantly viremic. No significant histologic
      improvement was observed in the treated patients evaluated by
      means of post-treatment liver biopsy. The mean annual
      progression rate of fibrosis was very slow and similar in the
      treated and untreated patients (0.09 (range, 0-0.62) versus 0.07
      (range, 0-0.60) fibrosis units).
      Conclusions: One year of interferon-alpha treatment can
      suppress HCV-RNA in patients with chronic hepatitis C and
      persistently normal ALAT values followed up over long periods.
      The rate of fibrosis progression in such patients is very slow, and
      therapeutic strategies should take this fact into account. Antiviral
      treatment is debated for patients without fibrosis in initial biopsy
      specimens.

      Combination Therapy With Interferon-Alpha
      Plus N-Acetyl Cysteine for Chronic Hepatitis C: A
      Placebo Controlled Double-Blind Multicentre
      Study

      Grant PR, Black A, Garcia N, Prieto J, Garson JA
      J Med Virol. 2000 Aug;61(4):439-442

      A small pilot study in patients with chronic hepatitis C (HCV)
      infection suggested that antiviral treatment with interferon (IFN)
      plus N-acetyl cysteine (NAC) was more effective than treatment
      with interferon alone [Beloqui et al. (1993) Journal of Interferon
      Research 13:279-282]. An attempt was made to confirm this by
      performing a placebo-controlled double-blind study at 8 medical
      centres in Spain and Italy. One-hundred forty-seven patients
      with chronic HCV infection were investigated, 73 received 3MU
      IFN-alpha thrice weekly plus NAC 1800 mg daily and 74
      received IFN alone. Treatment was continued for 6 months and
      patients were followed up for a further 6 months. Amongst
      patients receiving IFN plus NAC, sustained virological
      responses were observed in 5.5%, transient responses in 26%
      and non-response in 68.5%. The figures for patients receiving
      IFN only were 4.1%, 24.3% and 71.6% respectively. Sustained
      virological response was significantly associated with non-type 1
      genotypes (P = 0.045) and with low pre-treatment viraemia
      levels (P = 0.034). Biochemical response (serum ALT
      concentrations) correlated with virological outcome in 97% (n =
      139) of cases. Patients who experienced a sustained virological
      response also showed reduction in the Knodell histological
      activity index. It is concluded that patients with chronic HCV
      infection are very unlikely to benefit from the addition of
      N-acetyl cysteine to conventional therapy with interferon-alpha.
      Copyright 2000 Wiley-Liss, Inc.

      Decorin and Actin Expression and Distribution
      in Patients With Chronic Hepatitis C Following
      Interferon-Alfa-2b Treatment

      Jarmay K, Gallai M, Karacsony G, et al
      J Hepatol. 2000 Jun;32(6):993-1002

      Background/Aims: Chronic hepatitis C can lead to cirrhosis
      and hepatocellular carcinoma. Interferon-alfa therapy may
      prevent the progression of the disease. The expressions of
      decorin and alfa-smooth muscle cell actin of the extracellular
      matrix play a central role in liver fibrosis. We set out to assess
      the expressions of these proteins in chronic hepatitis C patients,
      and to evaluate how they can be modified by interferon-alfa
      therapy.
      Methods: Twenty chronic hepatitis C patients received
      interferon-alfa-2b therapy for 6 months (group I) or 12 months
      (group II). Liver biopsy samples were taken before and after the
      therapy. The alfa-smooth muscle actin-positive cells were
      determined with a monoclonal antibody, and decorin expression
      was detected with a polyclonal antibody. The cells were
      evaluated with a semiquantitative scoring method. For statistical
      analysis, non-parametric methods were used.
      Results: Before the therapy, alfa-smooth muscle actin-labeled
      cells and marked decorin expression were present throughout all
      the acinar zones. Interferon-alfa-2b therapy resulted in significant
      decreases in both the number of alfa-smooth muscle
      actin-positive cells and the decorin expression. The alfa-smooth
      muscle actin-positive cells and decorin expression correlated
      with the histological activity index (R=0.72, p<0.03, R=0.68,
      p<0.05).
      Conclusions: This study demonstrates that a large number of
      alfa-smooth muscle actin-positive cells and a marked decorin
      expression are frequent findings in chronic hepatitis C. Treatment
      with interferon-alfa-2b for 12 months reduced the number of
      labeled cells and the decorin expression. The results suggest that
      interferon-alfa-2b is capable of interfering with fibrogenesis in an
      early and presumably still reversible phase of chronic hepatitis C.

      Cost-Effectiveness of 24 or 48 Weeks of
      Interferon Alpha-2b Alone or With Ribavirin as
      Initial Treatment of Chronic Hepatitis C.
      International Hepatitis Interventional Therapy
      Group

      Wong JB, Poynard T, Ling MH, Albrecht JK, Pauker SG
      Am J Gastroenterol. 2000 Jun;95(6):1524-30

      Objective: Initial therapy with ribavirin and interferon alpha-2b
      results in a higher sustained virological response than interferon
      alone, but this regimen is expensive. We aimed to examine the
      cost-effectiveness of 24- or 48-wk initial treatment with
      combination therapy versus interferon alone for patients who
      have chronic hepatitis C.
      Methods: Data from recent randomized clinical trials comparing
      combination therapy to interferon alone were applied to a
      previously published computer cohort simulation to project
      lifelong clinical and economic outcomes. Natural history and
      economic estimates were based on published literature, expert
      panel estimates, and actual variable cost and reimbursement
      data.
      Results: Using treatment stopping rules, sustained viral negative
      response rates would be 33.1% and 39.8% for patients
      receiving 24 versus 48 wk of ribavirin/interferon, compared with
      14.3% for 48 wk of interferon alone. Compared to the interferon
      alone strategy, 24 or 48 wk of combination therapy should
      prolong life expectancy by 1.4 to 2.0 yr at marginal
      cost-effectiveness ratios of $4,400 to $5,400 per discounted
      quality-adjusted life-year (DQALY) gained. Compared to 24
      wk of combination therapy, 48 wk of combination therapy
      should prolong life expectancy by 0.6 yr at a marginal
      cost-effectiveness ratio of $7,700 per DQALY gained. The
      results were robust, with 24 or 48 wk of combination therapy
      remaining preferred and cost-effective in sensitivity analysis
      compared with interferon alone.
      Conclusion: For patients with chronic hepatitis C, 24 or 48 wk
      of ribavirin and interferon should prolong life and be
      cost-effective when compared with 48 wk, of interferon alone.

      Recovery From Chronic Hepatitis C in
      Long-Term Responders to Ribavirin Plus
      Interferon Alfa

      Fontaine H, Chaix ML, Lagneau JL, Brechot C, Pol S
      Lancet .2000 Jul 1;356(9223):41

      In 45 sustained responders to interferon alfa and rlbavirin, we
      found long-lasting elimination of hepatitis C virus RNA from
      serum and liver, together with histopathological improvement,
      suggesting complete recovery from chronic hepatitis C.

      Acute Pancreatitis Attributed to the Use of
      Interferon Alfa-2b

      Eland IA, Rasch MC, Sturkenboom MJ, et al
      Gastroenterology. 2000 Jul;119(1):230-233

      Two patients experienced episodes of acute pancreatitis shortly
      after starting treatment with interferon alfa-2b (IFN-alpha) for a
      chronic hepatitis C infection. The first patient was a 40-year-old
      man who developed acute pancreatitis after 15 weeks of
      treatment with 3 MU IFN-alpha subcutaneously (SC) 3 times
      weekly and 1200 mg ribavirin. After disappearance of symptoms
      and normalization of laboratory values, oral intake of solid foods
      and IFN-alpha therapy were restarted. Within hours, a relapse
      of acute pancreatitis occurred. A rechallenge with IFN-alpha 4
      days later was followed by a prompt increase in serum lipase
      level, and IFN-alpha therapy was discontinued. The second
      patient was a 38-year-old man who developed acute pancreatitis
      2 hours after SC administration of 5 MU IFN-alpha. Ultrasound
      endoscopy showed sludge in the gallbladder. The patient was
      rechallenged 5 weeks later with 3 MU IFN-alpha SC. Although
      serum amylase and lipase levels increased after readministration
      of IFN-alpha, treatment was continued. The patient was
      readmitted 2 weeks later with severe abdominal pain, and
      IFN-alpha administration was discontinued. Considering the
      temporal relationship between the start of IFN-alpha treatment
      and development of acute pancreatitis, the absence of other clear
      etiologic factors for acute pancreatitis, disappearance of
      symptoms after discontinuation of IFN-alpha, and positive
      reactions to rechallenge, IFN-alpha is the most probable cause
      for development of acute pancreatitis in these patients.

      CONTENTS
      Utility of Early
      Testing for
      HCV Viremia as
      Predictive
      Factor of Sustained
      Response During
      Interferon
      or Interferon Plus
      Ribavirin
      Treatment

      Effects of 1-Year
      Interferon-Alpha 2a
      Treatment in Patients
      With
      Chronic Hepatitis C
      and
      Persistently Normal
      Transaminase Activity

      Combination Therapy
      With
      Interferon-Alpha Plus

      N-Acetyl Cysteine for

      Chronic Hepatitis C:
      A
      Placebo Controlled
      Double-Blind
      Multicentre
      Study

      Decorin and Actin
      Expression
      and Distribution in
      Patients
      With Chronic
      Hepatitis C
      Following
      Interferon-Alfa-2b
      Treatment

      Cost-Effectiveness of
      24 or
      48 Weeks of
      Interferon
      Alpha-2b Alone or
      With
      Ribavirin as Initial
      Treatment
      of Chronic Hepatitis
      C.
      International
      Hepatitis
      Interventional
      Therapy Group

      Recovery From Chronic

      Hepatitis C in
      Long-Term
      Responders to
      Ribavirin Plus
      Interferon Alfa

      Acute Pancreatitis
      Attributed
      to the Use of
      Interferon
      Alfa-2b


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