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Introductory
Note:
Provided by members of the Registry Scientific Advisory
Board:
Karen Lindsay, MD Associate Professor,
Department of Medicine, University of Southern California,
Willis Maddrey, MD Professor of
Internal Medicine University of Texas, Southwestern
Medical Center at Dallas |
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| Chronic
hepatitis C infection is a serious worldwide medical
problem which, if left untreated, may advance to
end-stage liver disease, primary liver cancer, and
death. At least three million Americans have been
infected, the majority of whom are unaware of their
disease. Ribavirin therapy, when combined with unmodified
or pegylated interferon alpha, has significantly
increased both viral clearance as measured by sustained
virological response rates as well as liver biopsy
improvement in patients with chronic hepatitis C.
However, potential birth defects following pregnancy
exposure to ribavirin are a concern, because ribavirin
is teratogenic in all animal models tested. As a
result, ribavirin is designated FDA Pregnancy Category
X. Despite product label warnings against becoming
pregnant, pregnancies continue to occur in women
exposed to ribavirin, and insufficient data is available
to counsel them. The Ribavirin Pregnancy Registry
is designed to gather prospective data on ribavirin
exposure in pregnancy and pregnancy outcomes in
order to determine actual risk.
I
have the privilege to chair a dedicated group
of scientific advisors to the Ribavirin Pregnancy
Registry. We all feel that this Registry is an
important program which addresses a significant
potential public health issue. We need the assistance
of our colleagues in hepatology, gastroenterology,
infectious disease, primary care medicine, maternal
fetal health, and pediatrics to ensure the Registry’s
success. The Board strongly encourages colleagues
to prospectively (before the outcome of the pregnancy
is known) enroll individuals with pregnancy exposures
to ribavirin in the Registry as early in pregnancy
as possible. The Registry can be contacted through
this website or by phone (click
here for information). Exposures are defined
as direct (a female taking ribavirin during pregnancy
or within 6 months prior to pregnancy), or indirect
(through the female’s male sexual partner
taking ribavirin within 6 months of the last menstrual
period or during pregnancy).
We
would really appreciate your participation and
assistance by informing others about this important
project. Please feel free to forward this web
page to any of your colleagues. We encourage you
to print and distribute the Registry Announcement
available in a pdf file (click
here for link). Slides describing the Registry
are available and can be downloaded for your use
(click here for link).
Finally, if you are aware of any organizations
who would be interested in working with us by
sending an email about the Registry to their members,
please contact Paige Churchill by email or phone.
Thank
you very much for helping to make this Registry
a success.
Sincerely,
Karen L. Lindsay, M.D.
Board Executive Committee Chair (October 2004-December 2008)
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