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High-Dose Consensus Interferon Successfully Treats Many Patients Who Failed Combination Therapy

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  • claudine intexas
    High-Dose Consensus Interferon Successfully Treats Many Patients Who Failed Combination Therapy End-of-Treatment Data Support Earlier 24-Week Results Nov. 21,
    Message 1 of 1 , Aug 31, 2001
      High-Dose Consensus Interferon Successfully Treats
      Many Patients Who
      Failed Combination Therapy

      End-of-Treatment Data Support Earlier 24-Week Results


      Nov. 21, 2000 (Philadelphia)�Re-treatment with
      high-dose consensus
      interferon (interferon alfacon-1, Infergen, Amgen)
      eradicates hepatitis
      C
      virus in a significant number of patients who failed
      previous therapy.
      In
      an ongoing study of more than 500 treatment-resistant
      patients, all had
      previously received at least three months of a
      combination of
      interferon
      alpha-2b plus ribavirin.

      Lead author Maria Sjogren, M.D., M.P.H. of Walter Reed
      Army Medical
      Center
      in Washington, DC evaluated patients who had relapsed
      (23% of subjects)
      or
      did not respond (77%) after combination therapy. All
      patients entering
      the
      study had detectable HCV RNA blood levels, elevated
      ALT, and chronic
      hepatitis documented by liver biopsy. Dr. Sjogren
      reported her results
      at
      the fifty-first annual meeting of the American
      Association for the
      Study
      of Liver Diseases, held in Dallas, Texas in October.

      Re-treatment consisted of an initial eight weeks of
      consensus
      interferon
      at a dose of 15 micrograms (mcg) daily. Patients were
      then randomized
      to
      receive either 15 mcg of the drug three times a week
      or 9 mcg daily for
      the next 16 weeks. At the end of this period (a total
      of 24 weeks),
      patients who had undetectable HCV RNA levels in their
      blood continued
      on
      their dosage for another 24 weeks (out to week 48). If
      patients were
      still
      HCV RNA-positive at 24 weeks, they were withdrawn from
      the study. The
      majority of patients had cleared the virus by week 24,
      Dr. Sjogren
      notes,
      "So we have 60% of the original population that went
      on for 24 more
      weeks."

      The two treatment groups were equivalent in terms of
      gender, race,
      baseline HCV RNA level, proportion of relapsers and
      non-responders, and
      genotype (91% genotype-1 in both groups).

      Most of the prior relapsers who remained in treatment
      past week 24 were
      HCV RNA-negative at week 48, at either interferon dose
      � 83% of
      patients
      receiving 15 mcg thrice weekly, and 77% of patients on
      9 mcg a day.
      Prior
      non-responders continuing to 48 weeks on high-dose
      consensus interferon
      did better on 9 mcg per day than on 15 mcg three times
      a week � 40% of
      the
      daily dosage patients were HCV RNA-negative vs. 16% of
      those on 15 mcg
      thrice weekly.

      Many genotype-1 subjects, who as a group are the most
      resistant to
      treatment, also responded to high-dose consensus
      interferon. As
      expected,
      prior relapsers did better than prior non-responders.
      At week 48, 67%
      of
      relapsers were HCV RNA-negative vs. 37% of
      non-responders.

      Patients tolerated high-dose consensus interferon
      well. During the
      first
      eight weeks of treatment (with 15 mcg interferon
      daily), 72% of
      patients
      maintained the full dose. After randomization, 95% of
      patients stayed
      on
      their full dose up to week 24. At the 24-week point,
      40% of patients
      were
      dropped from the study because they still had
      detectable HCV RNA levels
      (20% of relapsers and 48% of non-responders were
      dropped).

      "In terms of side effects, certainly the higher dose
      was a little less
      tolerable, the 15 mcg, although we only gave it three
      times a week. The
      patients that received Infergen daily had a better
      time than the ones
      that
      were three times a week and had less amount of side
      effects," Dr.
      Sjogren
      said. "So, I think based on what we are seeing in the
      results, 9 mcg
      daily
      is probably the way to go."

      At this point, Dr. Sjogren concludes that prior
      non-responders do
      better
      on 9 mcg of consensus interferon daily than on 15 mcg
      three times a
      week.
      For prior relapsers, both treatment regimens produced
      excellent results

      about 80% in each group cleared virus by 48 weeks.

      "[With] this interferon, for some reason, we have
      great responses in
      the
      relapsers, so I think somehow the half-life [of the
      drug] is still
      doing
      the job," Dr. Sjogren says. "But why give more if you
      get away with
      less
      and have less side effects and probably less cost as
      well?"

      Even genotype-1 patients, the most difficult to treat,
      showed
      encouraging
      results during re-treatment with consensus interferon.
      Dr. Sjogren
      considers this finding important because genotype-1 is
      the most
      prevalent
      group of patients in North America.

      The study continues, with final results expected in
      the summer of 2001.
      "Obviously, the proof of the whole thing is at the end
      of the study,
      the
      sustained response rate. But so far, week 48 data is
      quite interesting
      and
      suggestive of a good sustained response in the
      future," Dr. Sjogren
      speculates.

      She says it is still a problem about what to do for
      patients who have
      failed previous therapy. "This is a population that
      hasn't been
      addressed
      that much. You know, everybody obviously tries
      interferon and
      ribavirin,
      and now with the new interferons [they are] going to
      try the same
      thing.
      But then what do you do after that [when] dual therapy
      doesn't work?
      And I
      think that illustrates that here's another avenue that
      you can try in
      some
      patients."

      Dr. Sjogren predicts that the new pegylated
      interferons will not
      entirely
      solve the problem, either. "One should not give up on
      these
      hard-to-treat
      patients," she says. "Looking at new ways of
      administering interferon
      is a
      good way to go � not to lose hope, not to just give up
      but continue
      on...
      Maybe they don't have to wait [for pegylated
      interferons]."

      For other recent news on hepatitis C and its
      treatment, visit Med On
      Scene
      (http://www.medonscene.com/) for coverage of research
      presented in May
      in
      Rotterdam, Holland at the meeting of the European
      Association for the
      Study of the Liver.


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