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Treatment Agreement for:  Interferon/Ribavirin Therapy
Interferon is given by injection under the skin, and some local pain
or redness may occur at the site of the injection.  The most
common side effects of interferon are flu-like symptoms,
especially fever, fatigue, chills, nausea, headache, poor appetite,
and muscle and joint pains. 
These symptoms usually begin to
occur two-eight hours after the injection.  These side effects occur
in nearly all patients within the first one-three doses of interferon,
but these side effects often go away or decrease considerably over
the duration of therapy.  Patients taking daily or increased doses of
interferon are likely to suffer more side effects.  Taking Tylenol
usually helps to lessen the side effects.  Lethargy and fatigue can
persist throughout therapy along with the above listed side effects.
Interferon treatment can also lead to decreases in the white blood
cell count and in platelets (particles in the blood that help the blood
clot).  This is usually not serious and is quickly reversible once
interferon treatment is stopped.  Because of the drops in blood
count, it is crucial that you have your blood monitored on a

regular basis.  If you cannot make your appointments, therapy
will be discontinued.  Also, temporary mild skin rashes may occur,
and any pre-existing psoriasis or dermatitis may get worse while
on treatment.  Interferon treatment can also make pre-existingautoimmune diseases worse such as diabetes or rheumatoidarthritis.
Depression is often seen on interferon/ribavirin and on
interferon alone
.  This depression can be severe and suicidal
thoughts and even suicide attempts have been reported.  This
occurs in both patients with and without previous psychiatric
Less common side effects that are seen with interferon treatmentinclude diarrhea, vomiting, temporary hair loss, nervousness, dizziness, confusion, and increased irritability.
There are also several rare side effects that may occur while oninterferon treatment.  These include lung problems, such asirritation or pneumonia, and severe liver disease, possibly resulting in death.  Other rare effects include numbness or tingling in thehands and feet, visual disturbances, retinal hemorrhages (bleedingin the retina of the eye), and irregular heart rhythms.  Diabetesmellitus and hyperglycemia (high blood sugar levels) have alsobeen observed in patients on treatment with interferon.
Interferon treatment can lead to thyroid problems (eitheroveractivity or underactivity of the thyroid) in a small percentageof patients.  These thyroid problems can be controlled bymedication, but the treatment may have to be life-long.
If at any time during treatment you are not able to tolerate theseside effects, the interferon dose will be reduced, interrupted, ordiscontinued.
Ribavirin is taken in addition to interferonIt is taken orally
and is generally well-tolerated
.  The most common side effect of
ribavirin is hemolytic anemia.  As a result there are less cells that
carry oxygen to the tissues in your body.  This condition is more
common in older than in younger patients.  The anemia is usually
mild and improves with dose reduction of ribavirin.  Anemia
resolves once ribavirin therapy is discontinued.  You may
experience some increased shortness of breath on exertion. 

The anemia can be serious in patients who have kidney and/orheart problems.  Heart and/or lung problems associated withanemia occur in a small percentage of patients on ribavirin therapy.  Frequent blood tests are crucial to evaluate this
Other side effects that are common with ribavirin therapy includepruritis (localized or generalized itching), increased cough, andmuscle pain.  These effects are not considered serious and usually return to normal after the ribavirin is discontinued.  Side effects that occur rarely with ribavirin include gout (disease associated with increased amounts if uric acid in the blood andpainful inflammation of the joints) and effects on the nervoussystem such as depression, nervousness, insomnia (difficulty insleeping), and dizziness.
If at any time during treatment you are not able to tolerate
these side effects, the ribavirin dose will reduced, interrupted,
or discontinued
Studies in animals have shown that when ribavirin is given topregnant females, malformations in the offspring or death of thedeveloping embryo may occur.
This therapy must not be used by women or male partners of
women who are or may become pregnant during therapy and
during the six months after stopping therapy.  It is important
that both men and women on ribavirin use effective
contraception or remain sexually abstinent during treatment
and for six months after completion of treatment so that
pregnancy does not occur
During the treatment and follow-up periods, lab tests and medicalvisits are regular.  These visits are very important in order to checkyour blood chemistry, pregnancy status, liver, heart, and thyroidfunction.  Ongoing evaluation for depression and other mood disturbances while on treatment is vital.
________ I have read the information on the side effects ofpegylated interferon alfa 2a/ribavirin therapy, and desire to pursue ________ I have had a chance to ask questions regarding the risks and benefits of this therapy, and these questions have beenanswered to my satisfaction.  ________ I understand the importance and expectation of frequentfollow up visits and blood draws to evaluate my tolerance andresponse to this therapy.
________ I understand this therapy must not be used by women ormale partners of women who are or may become pregnant duringtherapy and six months after stopping therapy.  I have beencounseled on the importance that both men and women on ribavirin use 2 forms of birth control or remain sexually abstinentduring treatment and for six months after completion of treatmentso that pregnancy does not occur.
________ I understand the importance of maintaining alcohol anddrug abstinence and agree to do so.  Periodic urine toxicologyscreening may be done while on treatment.  I am aware of this andagreeable to this screening.
_______________________________ ____________Signature of Patient Date _______________________________ _____________Health Care Provider Date



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