Questions and Answers:
1. Who is a candidate for combination therapy?
FDA has approved the Rebetron combination therapy for the treatment
of chronic hepatitis C patients with compensated liver disease who
have relapsed following alpha interferon therapy.
2. What is the percentage of success?
At six months post treatment, 45.7% who received the combination
therapy had undetectable virus levels.
3. What is the dosage for the combination therapy?
The recommended dosage for combination therapy is 3 MIU of
interferon (Intron A) injected subcutaneously three times per week
and 1000 - 1200 mg of ribavirin (Rebetol) capsules administered
orally in a divided daily (morning/evening) dose.
4. What is the recommended duration of combination therapy?
The recommended duration for the combination therapy is 24
5. What are the side effects associated with combination
The most common side effects are: Flu-like symptoms, such as
headache, fatigue, muscle pain, and fever which appear to decrease
in severity as treatment continues. Psychiatric disorders have also
been reported. These adverse events include depression, which may
be severe and rare cases of suicidal thoughts and suicidal
attempts. Combination therapy is associated with the destruction of
red blood cells which may be severe enough to result in anemia.
Combination therapy is associated with a significant risk of
abnormal fetal development. Women of childbearing potential should
not begin combination therapy until a report of a negative
pregnancy test has been obtained.
6. Is combination therapy effective with naïve patients
(those who have never received interferon therapy)?
At present, FDA has approved Rebetron combination therapy only for
HCV patients who have relapsed after alpha interferon therapy. The
preliminary analysis of data from a recent study indicates that the
use of combination therapy in naïve patients increases the
response rate in this group. Physicians can prescribe drugs for
individuals for whom they think it will be helpful. Therefore, they
could prescribe combination therapy for naïve patients.
Patients should discuss the use of combination therapy with their
7. Is combination therapy effective with non- responders (those
who did not respond to interferon therapy)?
At present, FDA has approved Rebetron only for HCV patients who
have relapsed after initally responding to alpha interferon therapy
and NOT for non-responders (those who did not respond to interferon
therapy). Data for the use of combination therapy for
non-responders are not available yet and patients who did not
previously respond to interferon therapy should discuss the use of
combination therapy with their treating physicians.
8. When can we get Rebetron combination therapy?
A physician must prescribe Rebetron. It is expected to become
available nationwide the week of June 8, 1998.
9. Are there other treatments for hepatitis C patients who have
relapsed following alpha interferon therapy?
At the present time there are no other FDA approved treatments,
however, a recent article in Hepatology (April 1998) reports an
improved response rate for relapsed patients using increased doses
of interferon (Infergen by Amgen) with this group. Intron-A by
Schering Biotech and Roferon(R)-A by Hoffman LaRoche were not used
in this study.
10. What is the cost for combination therapy?
A six-month treatment with Rebetron will cost between $6,400 and
$8,600 depending upon dosage.
SOURCE: The American Liver Foundation, 1425 Pompton Avenue,
Cedar Grove, NJ; 07009 1-800-GO LIVER (465-4837) -
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