Ii

HCVTreatment Process
Managementof

HCV

Hepatitis C virus infection represents a potentially serious problem within the
correctional environment. It is widely recognized that Hepatitis C infection may
result in chronic infection. However, currently there is no risk stratification data to
assist in predicting the outcome of Hepatitis C infection in any individual case.
Most studies show that at least 80% of persons with chronic Hepatitis C infection
will experience a mild course of the disease without the development of cirrhosis
or death from the infection. The remaining 20% will develop some form of
cirrhosis, mild to severe. Additionally, a small percentage of persons with severe
.

cirrhosis will develop liver cancer. It is this small percentage of persons with
severe cirrhosis and cancer that are most likely to benefit from current available
interventions. Unfortunately, at this time there is no way to predict how an
individual will respond to the Hepatitis C infection or the available treatments.
Medication treatments currently available for Hepatitis C infection are fraught with
side effects and complications. The side effects can be incapacitating and even
fatal. Individuals with certain medical and mental health conditions are at a high
risk for serious and potentially fatal complications. Therefore, inclusion and
exclusion criteria have been established to facilitate the selection of individuals
who are least likely to be harmed or experience serious complications from the
Hepatitis C medication treatment.

StaQe 1- Surveillance and Education
STEP 1
Intake Screening - Patients are screenedfor specific communicablediseasesat
the time of intake screening.
STEP 2
Health Assessment- Patients are screened for Hepatitis C risk factors at the
time of the intake health assessment or annual health appraisal. Hepatitis C risk
factors will be determined by addressing the following:

»
»
»
»
»
»
»
»

Historyof injectiondrug use.
Bloodtransfusionsreceivedprior to 1992.
Solid organ transplantationfrom an infecteddonor.
Occupationalexposureto infectedblood.
Birth from an infectedmother.
Sex with an infectedperson.
High-risksexual practices.
Intranasalcocaineuse.

If a patient has a positive response to any of the above risk factors, a referral to
the chronic care clinic will be recommended. If the patient declines the chronic
care visit, the declination will be documented in the patient's health record.

HCV Program - Alabama Department of Corrections
Treatment Process

Page 1 of 5
March 2004

STEP 3
Chronic Care Scheduled Visit - The chronic care encounter will be scheduled
to take place within 90 days of the health assessment. Patients will receive
education and counseling and may be offered a screening test for Hepatitis C,
based on a more comprehensive assessment of risk factors and medical
appropriateness. The HCV Patient Information/Education document is signed by
the patient and provider. (Attachment A)
STEP 4
Hepatitis C Antibody Testing - The Hepatitis C antibody test is recommended
for screening and is sufficient to exclude a diagnosis of chronic Hepatitis C
infection in most individuals with intact immune systems. A false negative
Hepatitis C antibody test may occur in a small number of inmates who are
immune-deficient (Le., HIV/AIDS). In patients with immune deficiency who have
an elevated ALT (indicating possible Hepatitis C infection) and a negative
Hepatitis C antibody test, a Hepatitis C RNA polymerase chain reaction (PCR)
should be performed.
STEP 5

Hepatitis C Antigen Testing - It has been demonstrated that approximately 10
to 15% of patients who contract Hepatitis C will spontaneously clear the virus. A
PCR HCV RNA antigen test will be completed.
If the test is positive the
evaluation will continue. If the test is negative, the patient should be instructed to
have the test repeated in five years.
STEP 6
Hepatitis A & B Vaccine - Patients who are HCV antibody positive will be
offered the HeQatitis A and B vaccines as indicated.

~ Administer Hepatitis A vaccine series unless it is known that the patient has
Hepatitis A disease or previous vaccination.
» Administer Hepatitis B vaccine series unless the patient was previously
vaccinated or serology indicates previous infection.
Stage II - Eligibility for Medication

Treatment
STEP 1

Baseline eligibility screening will be done pursuant to the comprehensive
surveillance, educational and vaccination program in Stage 1. Eligibility will be
considered for inmates that have at least a 24-month sentence remaining. The
reason for stipulating this minimum length of time is because:
1. Complex and time-consuming educational and clinical evaluation
requirements,
2. Adherence to treatment is essential to maximize successful outcomes,
and
3. Side effects should be monitored for at least 6 months post treatment.

HCV Program - Alabama Department of Corrections
Treatment Process

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March2004

STEP 2
.

Consentand EducationAttestation- The patientwill review and signthe HCV
Patient/Education Information document. (Attachment A) The patient will review
and sign the HCV Evaluation and Treatment Consent form in the "determining
eligibility" section. (Attachment C) CDC patient education material will also be
used to provide inmates with a more complete understanding of the disease
process.
STEP 3
Determining Eligibility - Patients with the conditions listed as absolute
exclusion criteria will be excluded from the eligibility pool because the risks
outweigh the benefits of therapy. Following is a list of absolute and relative
exclusion criteria. Patients who have an absolute exclusion criteria will not have
further evaluation or testing unless the condition(s) resolves or improves
(example pregnancy and anemia) in which case they will be reevaluated within
90 days of resolution.
Absolute Exclusion Criteria
0
0
0
0
0
0
0
0
0
0
0
0
0
0

Age =: 18 or ::: 60
Remaining incarceration time =:24 months.
Presence of an Axis I diagnosis that is not controlled and stable as
determined by the treating psychiatrist.
History of solid organ transplant. .
Presence or history of an autoimmune disor~er.
Presence or history of decompensated cirrhosis, presence or history of
ascites or encephalopathy (albumin ~ 3.2 gm/dl, bilirubin> 3.0 gm/dl).
CBC results outside acceptable limits (Hgb ~ 12 females, =: 13 for
males; WBC > 3,000; ANC ~ 1,500 & platelets =: 100,OOO/mm).
Creatinine::: 1.7 or creatinine clearance ~ 50 ml/minute.
Normal ALT «2.0 times normal at 0,3 and 6 months).
.
Positive pregnancy test.
Active TB
Auto Immune Disease e.g. - Lupus, Graves Disease, RA., M.S.,
Myasthenia Gravis
Cancer - not in remission
Hemoglobinopathies

"No further evaluation should be completed so long as the absolute criterion exists."

HCV Program - Alabama Department of Corrections
Treatment Process

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March 2004

Relative Exclusion Criteria

0 Hepatitis B Co-infection
0 Diabetes - poorly controlled with Hgb. A1C ~ 9.0
0 Ischemic Cardiac Disease or Cerebrovascular Disease
0 Hypertension- poorly controlled
0 CHF
0 Peripheral Vascular Disease - Symptomatic
0

COPD - severe

Seizures - poorly controlled
Active Thyroid Disease
Active Gout
Significant CNS Trauma - recent withinthe past six months
Poor adherence to treatment including ~ 80% of clinic visits and
medications, to the extent the inmate made the choices.
0 Alcohol and illicitdrug use within one year.
0 Interferon/Ribavirin sensitivity.
0 Life expectancy < 10 years.

0
0
0
0
0

The provider is required to review relative exclusion criteria with the
Regional Medical Director prior to proceeding with further evaluation.
STEP 4
Liver Biopsy - Liver biopsy provides a unique source of information on fibrosis
--and assessment of histology. The information obtained on liver biopsy allows
affected individuals to make a more informed choice about the initiation or
postponement of antiviral treatment. Thus, the liver biopsy is a useful part of the
informed consent process.
In general, a baseline assessment of liver histology offers a valuable standard for
subsequent comparisons. However, the appropriate interval for subsequent

evaluations is yet to be determined. A biopsy willbe required priorto initiating medication for patients with Hepatitis C viremia with genotype 1A or 1B. A
biopsy will not be required for genotypes 2, 3 & 4 and for patients with
compensated cirrhosis.

Stage III - Medication Treatment
The provider will initiate a treatment plan including medication treatment if the
patient is determined to be eligible and the patient consents for medical
treatment by signing patient education document and the HCV consent form in
the medication initiation section.

HCV Disease: Evaluating patient new to a facility on medication for HCV
disease
HCV Program - Alabama Department of Corrections
Treatment Process

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March 2004

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Patients arriving at a ADOC facility, either from the community or another ADOC
facility, who are on antiviral therapy for HCV disease will be evaluated within 72
hours for consideration of continuing or resuming medication therapy. There
should be a low threshold for continuing the medication for the first week while
evaluating the appropriateness of the medication regimen. As a part of this
evaluation, patients should be reviewed for the following:
1. Absolute exclusion criteria (but not the minimum remaining sentence
since they have already been on therapy).
2. Response to therapy as measured by viral load.
3. Dosing adjustment due to anemia.
4. Adherence
Continuing Therapy
Patients who are already on a potent antiretroviral regimen and who are adherent
to therapy should have the HVC medications continued by the physician during
the intake process. A complete medical record review and clinic visit should be
done within one week to review:
1. Medication adherence
2. Response to therapy
3. Medication side effects
4. Assure patient education material has been reviewed and consent forms
signed.
Resuming Therapy
Patients who are non-adherent to therapy or who have had an interruption in
medication for greater than 2 weeks should be evaluated in consult with the State
Medical Director prior to restarting antiretroviral therapy. If there is any question
about the adherence pattern the treatment should be continue for a week while
the information is being reviewed.

HCV Program - Alabama Department of Corrections
Treatment Process

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March 2004

Attachment A
HCV

- Patient Information/Education

Adopted from the Schering-Ploughmedicationguide and labelingdocument.
HEPATITIS C VIRUS
The Hepatitis C virus can and does damage the liver. However, the majority of patients
never experience symptoms while others can take from 10 to 15 years before
symptoms develop. The damage caused by the Hepatitis C virus may range from none
to mild, moderate or life threatening. Symptoms may include:

» Fatigue
»
~
~
~

Jaundice (yellowingof the eyes)
Nausea
Pain in the abdomen
Fever

»
~
~
»
~

MuscleAches
Joint Pain
Loss of appetite
Diarrhea
Vision Loss

HEPATITIS C TREATMENT
At the present time there is a medication treatment strategy that is FDA approved for
the treatment of the Hepatitis C infection: Pegylated Interferon and Ribavirin
combination treatment.
Patients are treated for 24-48 weeks and are followed for 24 weeks post-treatment. The
goal of treatment is to achieve sustained virologic clearance. Response to treatment is
defined as undetectable HCV RNA and normalization of ALT at 24 weeks post=-treatment.
It is important to note that there is no data regarding whether Pegylated Interferon
treatment will prevent transmission of HCV infection to others. Additionally, it is not
known if treatment with Pegylated Interferon will cure Hepatitis C or prevent cirrhosis,
liver failure, or liver cancer that may be the result of infection with the Hepatitis C virus.
Approximately 10-14% of patients discontinued treatment due to side effects. It is
recommended that patients receiving Pegylated Interferon, alone or in combination with
Ribavirin, be discontinued from treatment if HCV viral levels do not show an
improvement at 12 weeks or are absent at 24 weeks.
INDICATIONS
Pegylated Interferon is a treatment for some people who are infected with the Hepatitis
C virus. However, Pegylated Interferon/Ribavirin combination treatment can have
serious side effects that may cause death. Therefore the treatment is not for everyone.
Prior to beginning treatment, patients should discuss the risks and benefits so that they
are prepared to make an informed decision.
CONTRAINDICA

TIONS

Pegylated Interferon/Ribavirin combination treatment is contraindicated in:

~ Patientswith hypersensitivityto ribavirin or any other component of the product.
HCV Program- Alabama Departmentof Corrections
Patient EducationInformation
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Page 1 of 4
April 2003

» Women who are pregnant, planning to become pregnant or are breast-feeding.
» Men whose female partners are pregnant.
» Patients that have Hepatitis Caused by your immune system attacking your liver or
unstable liver disease.
» Patients that have abnormal red blood cells such as sickle-cell anemia or
thalassemia major.
» Patients with a history of significant or unstable cardiac disease should not be
treated with Pegylated Interferon/Ribavirin combination treatment.
Serious consideration and thought should occur before
Interferon/Ribavirin, is you have any of the following conditions:

Pegylated

taking

Conditions that may effect Treatment
Alcoholism
Depression or anxiet
Drug abuse or addiction
High blood pressure
Any kind of autoimmune disease
Previous heart attack, or heart problems
Hepatitis B infection
Liver problems other than Hepatitis C
HIV infection
Thyroid problems
Diabetes
Sleep problems
Cancer
Colitis
Bodv oraan transplants
Kidney problems
Bleedina problems
-SIDE EFFECTS
Patients may present with side effects within the first 12 weeks of treatment and many
continue to experience adverse events several months after discontinuation of
treatment.
In the combination treatment trial, dose reductions due to adverse reactions occurred in
42% of patients receiving Pegylated Interferon. In the Pegylated Interferon/Ribavirin
combination trial the most common adverse events were psychiatric which occurred
among 77% of the patients and included most commonly depression, irritability, and
insomnia. Pegylated Interferon/Ribavirin induced fatigue or headache was also found in
approximately two-thirds of patients and induced fever or rigors in approximately half of
the patients. Following is a description of the side effects experienced by patients
taking Interferon/Ribavirin treatment.
Mental Health And Suicide - Pegylated Interferon/Ribavirin therapies may cause mood
and behavior problems. Behavioral problems include irritability and depression. Some
patients become more aggressive and some think about hurting or killing themselves or
others.
Heart Problems - Some patients taking Pegylated Interferon/Ribavirin therapies may
develop problems with low blood pressure, fast heart rate and very rarely, heart attacks.

HCV Program - Alabama Department of Corrections
Patient Education Information
II

Page 2 of 4
April 2003

Blood Problems - Pegylated Interferon/Ribavirin therapies commonly lower two types
of blood cells, white blood cells and platelets. The therapies have also been shown to
decrease red blood cells, resulting in anemia. Anemia can be dangerous, especially if a
person has heart or circulatory problems.
Body Organ Problems - Pegylated Interferon/Ribavirin therapies have been shown to
cause damage to internal organs. Symptoms of severe abdominal pain can indicate
internal organ damage.
Birth Defects

-

Ribavirin may cause birth defects and/or death of the unborn child.
Extreme care must be taken to avoid pregnancy in female patients and in female

partnersof male patients.

.

- Pegylated Interferon causes or aggravates hypothyroidism and
hyperthyroidism. Hyperglycemia has been observed in patients treated with Pegylated
Interferon.
Diabetes mellitus has been observed in patients treated with alpha
interferons.

Endocrine Disorders

- Fatal
observed within
bloody diarrhea,
within 1-3 weeks
Colitis

and nonfatal ulcerative or hemorrhagic/ischemic colitis have been
12 weeks of the start of alpha interferon treatment. Abdominal pain,
and fever are the typical manifestations. The colitis usually resolves
of discontinuation of alpha interferons.

Autoimmune Disorders - Pegylated Interferon treatment may cause the development
or exacerbation of autoimmune disorders such as thrombocytopenia,
arthritis, systematic lupus, and psoriasis.

rheumatoid

Pancreatitis - Fatal and nonfatal pancreatitis has been observed in patients treated
with alpha interferon. Pegylated Interferon treatment should be suspended in patients
with signs and symptoms suggestive of pancreatitis and discontinued in patients
diagnosed with pancreatitis.
Common, Less Serious Side Effects
Flu symptoms:
Appetite:
Thyroid:
Skin reactions:
Hair Thinning:

Including headache, muscle aches, tiredness and fever.
Including nausea, loss of appetite, and weight loss.
Some patients develop changes in the function of their thyroid.
Symptoms include inability to concentrate, feeling cold or hot all the
time, a change in weight and skin changes.
Redness, swelling, and itching are common at the injection site.
Hair loss stops and hair growth returns after treatment is stopped.

On-Going Side Effects
A study showed that by the end of the 6-month follow-up period the incidence of
ongoing adverse events by body class in the PEG-INTRON 1.5/REBETOL groups was:
~ 33% (psychiatric),
);> 20% (musculoskeletal), and
HCV Program- Alabama Departmentof Corrections
Patient EducationInformation

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--

--

Page 3 of 4
April 2003

}> 10% (for endocrine and for GI).
In addition, approximately 10-15% of patients weight loss, fatigue and headache had
not resolved.
DOCUMENTATION
Education

OF EDUCATION

Session 1

. Screening

I understand that I have risk factors for Hepatitis C. I have been provided with the HCVPatient Information/Education material is adapted from the "Medication Guide"
established by Schering-Plough Research Institute. The information in this document
has been reviewed with me and I have that the opportunity to ask questions.
PATIENT'S SIGNATURE

DATE SIGNED

PROVIDER'S SIGNATURE

DATE SIGNED

Education Session 2 - HCV Positive
I understand that I have tested positive for the Hepatitis C virus. I have been provided
with the HCV-Patient Information/Education material is adapted from the "Medication
Guide" established by Schering-Plough Research Institute. The Tliformation in this
document has been reviewed with me and I have that the opportunity to ask questions.
PATIENT'S SIGNATURE

DATE SIGNED

PROVIDER'S SIGNATURE

DATE SIGNED

Education Session 3 . Treatment
I understand that I am eligible to receive Interferon/Ribavirin treatment. I have been
provided with the HCV-Patient Information/Education material is adapted from the
"Medication Guide" established by Schering-Plough Research Institute. The information
in this document has been reviewed with me and I have that the opportunity to ask
questions.
PATIENT'S SIGNATURE

DATE SIGNED

PROVIDER'S SIGNATURE

DATE SIGNED

HCV Program

-

Patient Education

Alabama Department of Corrections
Information

Page 4 of 4
April 2003

Attachment B

HCV - Provider Reference
Adopted from the Schering-Plough medication guide and labeling document.

HEPATITIS C VIRUS
The hepatitis C virus can and does damage the liver. However, the majority of patients
may never experience symptoms while others can take from 10 to 15 years before
symptoms develop. The damage caused by the hepatitis C virus may be minimal or

severe. Symptomsmay include:
~
~
~
~
~

Fatigue
Jaundice (yellowing of the eyes)
Nausea
Pain in the abdomen
Fever

.

~
~
>>>-

Muscle Aches
Joint Pain
Loss of appetite
Diarrhea
Vision Loss

HCV TREATMENT

At the present time there is a medication treatment strategy that is FDA approved for
the treatment of the Hepati~is C infection: Pegylated Interferon and Ribavirin
combination treatment.
Patients are treated for 24-48 weeks and are followed for 24 weeks post-treatment. The
goal of treatment is to achieve sustained virologic clearance. Response to treatment is
defined as undetectable-- HCV RNA and normalization of ALT at 24 weeks posttreatment.
It is important to note that there is no data regarding whether Pegylated Interferon
treatment will prevent transmission of HCV infection to others. Additionally, it is not
known if treatment with Pegylated Interferon will cure Hepatitis C or prevent cirrhosis,
liver failure, or liver cancer that may be the result of infection with the Hepatitis C virus.
Approximately 10-14% of patients discontinued treatment due to side effects. It is
recommended that patients receiving Pegylated Interferon, alone or in combination with
Ribavirin, be discontinued from treatment if HCV viral levels remain high after six
months of treatment.
INDICATIONS

Pegylated Interferon, peginterferon alfa-2b, is indicated for use alone or in combination
with REBETOL (ribavirin, USP) for the treatment of chronic hepatitis C in patients with
compensated liver disease who have not been previously treated with interferon alpha
and are at least 18 years of age.
However, Pegylated Interferon/Ribavirin combination treatment can have serious side
effects that may cause death. Therefore the treatment is not for everyone. Prior to
beginning treatment, patients should discuss the risks and benefits so that they are
prepared to make an informed decision.

HCV Program - Alabama Department of Corrections
Provider Reference

Page 1 of 5

April 2003

CONTRAINDICA

TrONS

Pegylated Interferon/Ribavirin combination treatment is contraindicated in:
~
~
~
~

Patients with hypersensitivity to ribavirin or any other component of the product.
Women who are pregnant, planning to become pregnant or are breast-feeding.
Men whose female partners are pregnant.
Patients that have hepatitis caused by your immune system attacking your liver or
unstable liver disease.
~ Patients that have abnormal red blood cells such as sickle-cell anemia or
thalassemia major.
~ Patients with a history of significant or unstable cardiac disease should not be
treated with Pegylated Interferon/Ribavirin combination treatment.
Serious consideration and. thought should occur before
Interferon/Ribavirin, is you have any of the following conditions:

Pegylated

taking

Conditions

that may effect Treatment
Alcoholism
Depression or anxiet
Drug abuse or addiction
High blood pressure
Any
kind of autoimmune disease
Previous heart attack, or heart problems
Hepatitis B infection
Liver problems other tQ?I1_HepatitisC
HIV infection
Thyroid problems
Diabetes
Sleep problems
Cancer
Colitis
Bodv oraan transplants
Kidney problems
Bleedina Rroblems
SIDE EFFECTS
Patients may present with side effects within the first 12 weeks of treatment and many
continue to experience adverse events several months after discontinuation of
treatment.
In the combination treatment trial, dose reductions due to adverse reactions occurred in
42% of patients receiving Pegylated Interferon/Ribavirin.
In the Pegylated
Interferon/Ribavirin combination trial the most common adverse events were psychiatric
which occurred among 77% of the patients and included most commonly depression,
irritability, and insomnia. Pegylated Interferon/Ribavirin induced fatigue or headache
was also found in approximately two-thirds of patients and induced fever or rigors in
approximately half of the patients. Following is a description of the side effects
experienced by patients taking Interferon/Ribavirin treatment.

HCV Program - Alabama Department of Corrections
Provider Reference
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Page 2 of 5
April 2003

Mental Health And Suicide - Pegylated Interferon/Ribavirin therapies may cause mood
and behavior problems. Behavioral problems include irritability and depression. Some
patients become more aggressive and some think about hurting or killing themselves or
others.

Heart Problems - Some patients taking Pegylated Interferon/Ribavirintherapies may
develop problemswith low blood pressure,fast heart rate and very rarely, heart attacks.
Blood Problems - Pegylated Interferon/Ribavirin therapies commonly lower two types
of blood cells, white blood cells and platelets. The therapies have also been shown to
decrease red blood cells, resulting in anemia. Anemia can be dangerous, especially if a
person has heart or circulatory problems.
Body Organ Problems - Pegylated Interferon/Ribavirin therapies have been shown to
cause damage to internal organs. Symptoms of severe abdominal pain can indicate
internal organ damage.

Birth Defects - Ribavirin may cause birth defects and/or death of the unborn child.
Extreme care must be taken to avoid pregnancy in female patients and in female
partnersof male patients.
Endocrine Disorders - Pegylated Interferon causes or aggravates hypothyroidism and
hyperthyroidism. Hyperglycemia has been observed in patients treated with Pegylated
Interferon.
Diabetes mellitus has been observed in patients treated with alpha
interferons.

Colitis - Fatal and nonfatal ulcerative or hemorrhagic/ischemiccolitis have been
.

observed within 12 weeks of the start of alpha interferon treatment. Abdominal pain,
bloody diarrhea, and fever are the typical manifestations. The colitis usually resolves
within 1-3 weeks of discontinuation of alpha interferons.

Autoimmune Disorders - Pegylated Interferon treatment may cause the development
or exacerbation of autoimmune disorders such as thrombocytopenia, rheumatoid
arthritis,systematiclupus, and psoriasis.
Pancreatitis - Fatal and nonfatal pancreatitis has been observed in patients treated
with alpha interferon. Pegylated Interferon treatment should be suspended in patients
with signs and symptoms suggestive of pancreatitis and discontinued in patients
diagnosed with pancreatitis.
Common, Less Serious Side Effects
Flu symptoms:
Appetite:
Thyroid:

Blood Sugar:

Including headache, muscle aches, tiredness and fever.
Including nausea, loss of appetite, and weight loss.
Some patients develop changes in the function of their thyroid.
Symptoms include inability to concentrate, feeling cold or hot all the
time, a change in weight and skin changes.
Some patients may develop diabetes.

HCV Program - Alabama Department of Corrections
Provider Reference

Page 3 of 5
April 2003

Skin reactions:
Hair Thinning:

Redness, swelling, and itching are common at the injection site.
Hair loss stops and hair growth returns after treatment is stopped.

On-Going Side Effects
A study showed that by the end of the 6-month follow-up period the incidence of
ongoing adverse events by body class in the PEG-INTRON 1.5/REBETOL groups was:
~ 33% (psychiatric),
~ 20% (musculoskeletal), and
>- 10% (for endocrine and for GI).
In addition, approximately 10-15% of patients weight loss, fatigue and headache had
not resolved.
MONITORING

It is recommended that patients receiving Pegylated Interferon, alone or in combination
with ribavirin, be discontinued from treatment if HCV viral levels remain high after 6
months of treatment.
Pegylated Interferon treatment should be suspended in patients with signs and
symptoms suggestive ~of pancreatitis and discontinued in patients diagnosed with
pancreatitis.
Patients were treated for 48 weeks and were followed for 24 weeks post-treatment.
Patients should receive an eye examination at baseline. Patients with preexisting
ophthalmologic disorders (e.g. diabetic or hypertensive retinopathy) should receive
periodic ophthalmologic exams during interferon alpha treatment. Any patient who
develops ocular symptoms should receive a prompt and complete eye examination.
Pegylated Interferon treatment should be discontinued in patients who develop new or
worsening ophthalmologic disorders.
Patients should undergo monthly pregnancy tests during treatment and for six months
post-treatment.
OUTCOME

Mono-therapy - A randomized study compared treatment with Pegylated Interferon to
treatment with INTRON A. The patients were not previously treated with interferon alta,
had compensated liver disease, detectable HCV RNA, elevated ALT, and liver
histopathology consistent with chronic hepatitis. Patients were treated for 48 weeks and
were followed for 24 weeks post-treatment.

HCV Program - Alabama Department of Corrections
Provider Reference
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April 2003