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High Dose Induction Therapy With Consensus Interferon Followed By Combination Therapy With Ribavirin

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  • claudine intexas
    From: JuLev@aol.com NATAP - www.natap.org High Dose Interferon Here is a study reported at DDW 2001 on using high dose Consensus Interferon (up to 27 ug per
    Message 1 of 1 , Sep 9, 2001
      From: JuLev@...
      NATAP - www.natap.org

      High Dose Interferon

      Here is a study reported at DDW 2001 on using high
      dose Consensus Interferon (up to 27 ug per day. The
      tolerability seems questionable but the preliminary
      results are interesting. I think higher doses of
      pegylated interferon and induction dosing of pegylated
      interferon are likely to be studied but not in thevery
      near future. Here is the link to the report on hi-dose
      Consensus Interferon:

      High Dose Induction Therapy With Consensus Interferon
      Followed By Combination Therapy With Ribavirin For
      Treatment-Naive Hepatitis C Patients-- (DDW 2001)

      A
      HREF="http://www.natap.org/2001/ddw/ddw_15_high_dose080101.htm"

      http://www.natap.org/2001/ddw/ddw_15_high_dose080101.htm</A>

      Reports Highlights from
      Digestive Disease Week
      May 20-23, 2001
      Atlanta, Georgia

      High Dose Induction Therapy With Consensus Interferon
      Followed By Combination Therapy With Ribavirin For
      Treatment-Naive Hepatitis C Patients

      Stephan Kaiser, Christian Kreysel, Holger Hass,
      Michael Gregor, Univ of Tuebingen, Tuebingen Germany

      Abstract:
      Interferon treatment in combination with ribavirin has
      an efficacy in patients with chronic hepatitis C with
      sustained response rates of about 40%: However,
      response rates in genotype 1 patients with high viral
      load are considerably lower. Recent studies have shown
      improved response rates using consensus interferon
      (CIFN) especially in genotype 1 and high viral load
      patients.

      In the present study, the efficacy of a CIFN induction
      therapy followed by CIFN / ribavirin combination
      treatment in naive patients with chronic hepatitis C
      is evaluated. 147 patients of a total of 300 have so
      far been included. All patients had elevated ALT
      values and were viremic. Histologic confirmation of
      chronic inflammation by liver biopsy was obtained in
      all patients. Patients (n=105) are treated with CIFN
      with 18 ug QD for 4 weeks, followed by 9 ug QD for 8
      weeks.

      In one treatment group patients (n=42) receive CIFN 27
      ug QD for 4 weeks, followed by 8 weeks of CIFN 18 ug
      QD. Thereafter, treatment is continued in all
      treatment groups with CIFN at a dose of 9 ug QD or TIW
      with or without ribavirin (at 7.5 or 15 mg/kg/d) for
      another 36 weeks.

      After 12 weeks of therapy, a primary response with
      undetectable serum HCV-RNA was observed in 73% of
      patients in the CIFN 18/9 ug QD group and in 86% in
      the CIFN 27/18 ug group. Interestingly, a negative
      HCV-RNA could be shown in 63% of all patients treated
      with CIFN 18/9 ug QD already after 2 weeks of therapy.

      In the group of patients treated with CIFN 27/18 ug a
      negative PCR was demonstrated in 74% at 2 weeks of
      therapy. Within the first 4 weeks of therapy a
      significant rise in ALT levels was noted in 67% of all
      patients. This effect was observed more frequently
      with the higher dose of CIFN given in the treatment
      group with CIFN 27/18 ug, however, did not lead to any
      dose reduction or discontinuation of therapy.

      Due to side effects the CIFN had to be reduced in 11%
      of patients and discontinued in 6% of patients. All
      genotype 2 and 3 patients so far responded to therapy,
      whereas 65% of genotype 1 patients responded.
      Furthermore, CIFN may even offer acceptable response
      rates as a monotherapy in hepatitis C patients, where
      ribavirin is not tolerated or contraindicated. The
      further follow-up of this study will show the
      additional effect of ribavirin and whether the high
      initial response rates will translate into
      corresponding sustained response rates.

      Preliminary HCV RNA response at week 24 in na�ve
      patients receiving daily CIFN (Consensus IFN) + RBV

      CIFN 27/18/9 ug once daily + RBV 1000/1200 mg once
      daily:

      83% (n=17) with genotype 1 were PCR negative; 98%
      (n=7) with genotype 2/3 were PCR negative
      CIFN 18/9 ug once daily / 9 ug TIW + RBV 1000/1200 mg
      once daily

      67% (n=46) with genotype 1 were PCR negative; 94%
      (n=17) with genotype 2/3 were PCR negative

      HCV RNA response at week 24 in na�ve patients treated
      with CIFN +/- RBV

      77% (n=20) receiving CIFN+1000/1200mg RBV were PCR
      negative*
      69% (n=25) receiving CIFN with 600-800 mg RBV were PCR
      negative*
      53% (n=18) receiving CIFN without RBV were PCR
      negative
      * all patients with initial treatment of 18/8 ug CIFN
      once daily, then 9 ug CIFN tiw



      Kaiser reported the 1st phase viral load decline was
      greater and more prolonged when using the high dose
      CIFN of 27 (3 logs) vs the 18 dose (2 logs)

      Kaiser concluded CIFN with a high (up to 27 ug) and
      daily dose regimen is moderately well-tolerated for at
      least 12 weeks of initial therapy. With the dose
      regimens used, transient lab abormalities (ALT
      elevations) ocurred, not leading to clinically
      relevant observations. WBC and platelet depressions
      seem to occur as frequent with CIFN 18 ug/day and more
      commonly with CIFN ug/day induction than with IFN-2b
      10 MU/day. If these data hold up this regimen may be
      useful in difficult to treat patients. Patients with
      genotype 1 treated with 27 ug show up to 5 log decline
      in 2 days. 27 ug is not significantly better than 18
      ug for patients with HCV genotype 2 or for patients
      with genotype 2 with low viral load. For patients with
      genotype 1 and high baseline viral load 27 ug CIFN
      shows better early response than 18 ug CIFN.

      Adverse Events Week 12

      -----------27/18 Dose (n=39) --------18/9 Dose (n=123)

      myalgia ------34 ------------------------89
      fatigue ------36 -----------------------112
      headache -----33 ------------------------96
      ALT>10x normal---9 ----------------------7
      Depression ----6 ------------------------17


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