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Rofecoxib (Vioxx) Prevents Reduction in Platelets During Pegasys Therapy for HCV: short term pilot study

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    NATAP - www.natap.org Rofecoxib (Vioxx) Prevents Reduction in Platelets During Pegasys Therapy for HCV: short term pilot study Reported by Jules Levin 54th
    Message 1 of 1 , Nov 15, 2003
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      NATAP - www.natap.org

      Rofecoxib (Vioxx) Prevents Reduction in Platelets During Pegasys
      Therapy for HCV: short term pilot study

      Reported by Jules Levin
      54th AASLD Meeting
      Oct 25-29, 2003
      Boston, MA

      David H Van Thiel and researchers at University Medical Center,
      Maywood, IL reported at AASLD (Oct 2003) on seeing increase of
      platelets during treatment for HCV with Pegasys. In order to improve
      tolerability for HCV IFN/RBV therapy non-steroidal ant-inflammatory
      medications are often used, such as Motrin, Tylenol, Advil, etc.
      Vioxx is an anti-arthritis drug sometimes often used by doctors for
      the same purpose, to reduce the body aches, arthralgia and myalgia,
      associated with IFN/RBV therapy. This pilot study reports for the
      first time that Vioxx may also improve platelet count reductions
      associated with IFN/RBV therapy, called thrombocytopenia.

      Thrombocytopenia (reduced platelet count) is a major limiting factor
      in the treatment of chronic hepatitis C with interferon preparations.
      This is particularly true for individuals with advanced disease
      because of a combination of factors that include: 1) reduced
      thrombopoietin production by the diseased liver, 2) hypersplenism and
      3) actions of interferon per se:

      The use of a Cox II inhibitor like rofecoxib (Vioxx) is known to
      inhibit the inflammatory and vasoconstriction actions of prostacyclin
      but has little or no effect on prostaglandin production and any
      adverse effect on iNOS and the production of NO, actions that are
      inhibited by nonselective NSAIDS.

      The aim of the present short-term pilot study was to define the
      effect of rofecoxib combined with Pegasys as compared to Pegasys
      therapy alone for chronic hepatitis C on platelet numbers and the
      expected decline in platelet numbers associated with Pegasys therapy.


      18 subjects with chronic hepatitis C documented by positivity for
      anti-HCV, HCV-RNA and abnormal liver injury tests and a liver biopsy
      consistent with chronic hepatitis C were treated with Pegasys 180ug
      SQ weekly plus daily oral rofecoxib (12.5mg/day) (n = 9) or Pegasys
      alone (n = 9) for 8 weeks.

      The changes in Hgb, WBC, platelet count, serum ALT, AST, BUN,
      creatinine and viral load were assessed weekly in both groups.

      No differences in the levels of Hgb or WBC counts were evident
      between the two groups treated with Pegasys. Similarly, no change in
      the serum ALT, AST, BUN and creatinine levels were observed between
      the 2 groups.

      In contrast, the platelet count declined from a mean baseline value
      of 193�13 in the group treated with Pegasys and rofecoxib such that
      at 8 weeks, the value was 162�12, a 16% decline. The decline in
      platelet count in the group not using rofecoxib was 41% with a
      reduction in platelets from 166 �18 to a value of 89�11. (All
      comparisons p<0.005).

      These data demonstrate that rofecoxib, when used in combination with
      Pegasys to treat advanced chronic hepatitis C, results in a highly
      significant reduction in the decline in platelet numbers associated
      with Pegasys therapy. Importantly, this platelet sparing effect of
      rofecoxib is not associated with an alteration in the values for Hgb,
      WBC, BUN or creatinine.

      This suggests that patients with advanced disease (stage 3 or 4), who
      have baseline thrombocytopenia, should be treated with rofecoxib as
      well as Pegasys in an effort to avoid high-grade thrombocytopenia
      that might limit the dose or duration of Pegasys therapy when used
      alone to treat chronic hepatitis C.




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