Expanded Indications Bring More Complications in Hepatitis C
Treatment New Patients Receive Strong Warnings about Potential Risk
to Fetus with Combination Therapy
February 8, 1999 (Philadelphia) - After just six months
on the market, revised safety information tells doctors and
patients to be even more cautious in the use of combination therapy
to treat hepatitis C. A "black box" warning in the revised
prescribing information for Rebetron (Schering-Plough) warns that
patients and their partners must use two forms of contraception
because of the risk of birth defects or loss of a pregnancy from
combination therapy.
Even if only one partner is taking Rebetron, both members of the
couple need to use adequate contraception during therapy and for
six months after the end of treatment. Rebetron consists of
interferon-alfa plus ribavirin. It is the ribavirin component that
is blamed for the risks to the fetus.
The U.S. Food and Drug Administration recently approved Rebetron
combination therapy for patients with hepatitis C who had never
been treated before. Previously, only people who had failed a
previous treatment could receive Rebetron. But at the same time as
it allowed wider use, the FDA increased the warnings to reflect the
danger of the combination therapy during pregnancy. Ever since
Rebetron was first approved, Schering-Plough has maintained a
registry to track people on the therapy who become pregnant.
Dr. Enrique Molina, a hepatologist and assistant professor of
clinical medicine at the Center for Liver Diseases, University of
Miami, Florida, says no patients with pregnancy-related
complications from Rebetron treatment have been referred to his
practice yet. However, he feels physicians need to counsel patients
carefully before prescribing Rebetron and says, "If a patient is
not willing to practice strict contraception, that's certainly a
contraindication for ribavirin. It makes a bigger difference for
younger patients than for older ones. Many of our patients are 40
or 50 and already practicing contraception so it's not a big issue
for them, but for those that are younger, it's definitely an
important point for physicians to stress."
Dr. Molina also considers other potential risk factors before
prescribing the combination therapy. He is particularly concerned
about the anemia that ribavirin can cause. "A patient at high risk
for cardiac disease or hemolysis or one with existing severe anemia
that might be complicated by ribavirin is better off starting on
Infergen." Infergen is a newer bioengineered interferon that
differs from standard interferons, such as Intron A.
The side effects of combination treatment should also be
reviewed carefully with each patient, according to Dr. Molina. "I
explain that side effects at the beginning of interferon therapy
are worse in some patients-not only the headaches, fever and
flu-like illness, but general fatigue and malaise-and are probably
made even worse by the addition of anemia from ribavirin. The
patients with the worst anemia are the patients with the worst
fatigue. There is an additive effect, and the two drugs together
cause worse side effects," he says.
"Patients should know that during the first week or two of
treatment, the side effects are going to be at their worst no
matter how mild or how bad, but by the end of a month they'll be
tolerable," Dr. Molina says. "Most patients will be able to carry
on normal lives with some limitations, and they will be able to
continue treatment.
"When patients are taking Rebetron, it's vital they are tested
every two weeks at the beginning of treatment, especially their CBC
[complete blood count] and platelets, not only to monitor efficacy
but also side effects. Liver chemistry should be checked monthly,
but tests for anemia are the most important," Dr. Molina says. He
recommends patients have ANA [antinuclear antibody test] and
thyroid tests before beginning treatment, especially if they have
an autoimmune background. These tests should be rechecked after
three months.
According to Dr. Molina, treatment should last for a year. "At
the end of three months of interferon monotherapy, we recheck to
see if the treatment is effective. When a patient is on combination
therapy, we should probably wait longer than three months to decide
whether he is responding or not. Many patients respond to Rebetron
after the three-month mark."
Distributed by: Patients NewsWire
Link to FDA page with link to updated Rebetron warnings:
http://www.fda.gov/cder/approval/index.htm
Patients Newswire
Contact: Derek Moran derek@pond.com (610) 525-1589
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