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