ATITIS C
CLINICAL
MANAGEMENT
PROGRAM

March 2004

Hepatitis C Clinical Management Program

Health Care Services'

Hepatitis C Clinical Management Program
L	

POLICY
The Health Care Services Division shall operate a Hepatitis C (HCV) Clinical
Management Program that ensures delivery of appropriate clinical services by an
interdisciplinary team for the diagnosis and management of chronic HCV. A system of
data management and reporting will be maintained to assist in clinical, administrative,
and quality management decisions.

H. PURPOSE
The California Department of Corrections HCV Clinical Management Program ensures a
consistent, appropriate, effective, and efficient approach to the clinical management of
persons infected with HCV.
III. PROCEDURE
A. Phase I: Screening and Initial Diagnosis (See Attachment I)
1. HCV Screening will be provided to all inmate-patients who request it, and offered
to all inmate-patients who have a history of intravenous drug use or other risk
factors for, or clinical findings compatible with, HCV. Each of these inmatepatients shall receive the Hepatitis C Patient Information Handout. See
Attachment A. A copayment will not be incurred for the initial request to be
tested for HCV.
2. All inmate-patients who request, or who are offered and agree to screening shall
have a hepatitis panel and liver function tests obtained.
3. All inmate-patients found to have the antibody to HCV shall have the viral
presence checked by the qualitative polymerase chain reaction (PCR) test
followed by a reflex quantitative test if positive (HCV RNA, PCR Qual w/Rfic).
A repeat ALT level shall be obtained one month after initial testing if the patient
is 45 years old or younger and the initial ALT level was less than two (2) times
the normal laboratory value.
4. All inmate-patients shall be informed of their test results by the primary care
provider (PCP). If test result is positive for HCV the inmate-patient shall be
informed in a face-to-face meeting with the PCP.
5. All inmate-patients who have positive PCR test results shall proceed to Phase II.
March 2004 .

'Hepatitis C Clinical Management Program

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6. Phase I terminates and Phase II begins on the date the inmate-patient is informed
of his or her positive HCV test result.
7. The anticipated time period for an inmate-patient to complete Phase I is three (3)
months.
B. Phase II: Initial Management After Diagnosis of HCV
I. Inmate-patients who have a positive PCR test result shall be followed in the HCV
Clinical Management Program and shall have a Hepatitis C Diagnostic/PreTreatment Flow Sheet (Phase I & II) and a Hepatitis C Clinical Evaluation Form
initiated. Refer to Attachments E and F.
2. Inmate-patients followed in the HCV Clinical Management Program shall receive
a Hepatitis C Patient Information handout and General Instructions for
Hepatitis C Patients handout Refer to Attachments A and B.
3. Inmate-patients who require vaccination against hepatitis A and/or hepatitis B
shall have the vaccination series completed no later than six (6) months after the
start of phase II.
4. During the evaluation process possible contraindications to effective therapy shall
be assessed since the intent is to enable medically eligible patients to complete a
course of monitored therapy, if tolerated. Refer to Attachment C
5. Genotype testing shall be done before consideration for liver biopsy since this
impacts eligibility for receiving combination therapy related to remaining length
of incarceration time.
6. A liver biopsy shall not be done and combination therapy shall not be started if
the patient is expected to be released or paroled before the entire process can be
completed. Refer to Attachment C
7. Inmate-patients 45 years old or younger undergoing the initial evaluation shall
have three (3) consecutive ALT tests performed at least one month apart and
within a period of no greater than three (3) months, unless one of these, or any
previous ALT tests, is documented to be two (2) times normal or greater.
8. Inmate-patients 45 years old or younger with ALT levels elevated to less than
two (2) times normal laboratory values for all three (3) consecutive ALT tests
performed as required in Phase II, Item 7, are not eligible for combination
therapy; however, they shall have a repeat ALT test at least once a year.
9. Inmate-patients older than 45 years of age do not require elevated ALT levels to
be considered for liver biopsy.
2
March 2004	

!Hepatitis C Clinical Management Program

Health Care Services!

10. Inmate-patients eligible for HCV treatment shall be offered testing for the
presence of HIV infection and counseling. Although HIV testing is not
mandatory to be considered for a liver biopsy and HCV treatment and
although HIV co-infection with HCV is not common among inmate-patients in
the CDC system, the presence of HIV sero-positivity may change treatment
decisions related to the liver biopsy results and HIV infection.
11. Inmate-patients who previously received appropriate combination therapy
for HCV but relapsed, or who did not respond to the therapy are currently not
candidates for re-treatment.
12. Inmate-patients who previously received appropriate combination therapy
for HCV but have findings consistent with re-infection or indications suggesting
current or recent substance abuse are nol candidates for re-treatment.
13. Inmate-patients not eligible for combination therapy shall have this decision
thoroughly discussed with them by the PCP. If the sole reason for ineligibility is a
Time to Parole Exclusion, the PCP shall advise the inmate-patient that if his/her
parole date changes, the inmate-patient should file a Request for Health Care
Services form CDC 7362 for an appointment to inform the PCP of the parole date
change. There will be no co-pay charge for this appointment. The discussion of
ineligibility shall be documented in the Unit Health Record (UHR).
14. Inmate-patients who do not wish to he treated currently with combination therapy
or who are not eligible for comb ination therapy shall continue to be followed
every six (6) to twelve (12) months through the HCV Clinical Management
Program and advised of new treatment opt ions. as they become available. Inmatepatients who are paroling shall estersC Attachment M and a copy of
Attachments E and F.
15. A referral to an appropriate medical spo. ialist and/or the Medical Authorization
Review (MAR) HCV Sub-committee ma% he considered for inmate-patients with
issues regarding treatment eligibilit) or clinical management.
16. Once counseling has been provided die urnentation of the discussion shall be
recorded in the UHR and the tarnias steps in the diagnostic and therapeutic
process shall be documented using the iiwm shown in Attachment E.
17. To qualify for a liver biopsy and combination therapy an inmate-patient's parole
date shall occur at least 10 or 16 month, nom the time the PCP refers the patient
for a liver biopsy by completing the Request for Services form CDC 7243,
depending on genotype. Inmate-patients with genotype 2 or 3 with less than
ten (10) months to parole from the tune the PCP refers the patient for a liver
biopsy by completing the Request fur Services form CDC 7243, and inmateMarch 2004	

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[Hepatitis C Clinical Management Program

Health Care Services'

patients with genotype 1, 4 or 6 with less than sixteen (16) months to parole from
the time the PCP refers the patient for a liver biopsy by completing the Request
for Services form CDC 7243 do not qualify for biopsy and combination therapy.
18. Inmate-patients eligible for HCV treatment shall have the following issues
discussed: the reasons and requirement for a liver biopsy; the requirement for a
signed treatment contract; possible medical therapies; possible side effects related
to treatment, and treatment success rates. Refer to Attachment A and D.
19. Inmate-patients who agree to treatment shall have signed contracts in their UHR
in order to proceed to Phase III. Refer to Attachment G.
20. At the time the inmate-patient signs

the HCV biopsy and treatment contract,
the PCP shall refer the inmate-patient for a liver biopsy by completing a Request
for Services form CDC 7243.

21. Except

for those inmate-patients 45 years old or younger with ALT levels
elevated to less than two (2) times normal laboratory values during testing
required in phase II section 8, the anticipated time period for an inmate-patient to
complete Phase II is two (2) months. This excludes the hepatitis A and/or
hepatitis B vaccination process as it may take up to six (6) months to complete the
series.

C. Phase III: Staging by Liver Biopsy and Combination Therapy
1. Inmate-patients being considered for liver biopsy shall have their cases reviewed
by the MAR HCV Sub-committee.
2. Inmate-patients

referred to the MAR HCV Sub-committee shall have bad a
Hepatitis C Diagnostic/Pre-Treatment Flow Sheet and a Hepatitis C Clinical
Evaluation Form completed prior to the referral. Refer to Attachments E and F.
Sub-committee may request that the PCP obtain additional
consultations or studies prior to approval for a liver biopsy.

3. The MAR IICV

4. Inmate-patients

referred to the MAR HCV Sub-committee shall have a thorough
review of their mental health history documented in the UHR by a mental health
clinician. Refer to Attachment H.

5. Inmate-patients who are otherwise eligible for a liver biopsy and agree to a liver
biopsy and have a signed Biopsy and Treatment Contract shall have a liver biopsy
approved and scheduled.

March 2004

4

klepatitis C Clinical Management Program

Health Care Services)

6. Inmate-patients approved for liver biopsy shall have a medical hold placed on
them to prevent transfer until the liver biopsy has been completed and the decision
to begin combination therapy has been made based on the biopsy results.
7. In general, the liver biopsy should be completed within three (3) months from the
time the PCP requests that a liver biopsy be performed by completing the Request
for Services form CDC 7243.
8. Inmate-patients who have had a liver biopsy shall have their cases reviewed by
the MAR HCV Sub-committee prior to initiation of combination therapy,
9. Inmate-patients whose liver biopsy results are consistent with stage 2-3 fibrosis or
greater, and who otherwise meet inclusion criteria will be offered combination
therapy as shown in Attachment J.
10. Patients that are HIV-infected, whose liver biopsy results are consistent with
stage 2 fibrosis or greater, and who otherwise meet inclusion criteria are also
eligible for combination therapy.
11. Inmate-patients whose liver biopsy results are consistent with stage 2 fibrosis or
less, and inmate-patients who are HIV infected and whose liver biopsy results are
consistent with less than stage 2 fibrosis, are currently not eligible for
combination therapy, but shall be followed every six (6) to twelve (12) months in
the HCV Clinical Management Program and reconsidered for liver biopsy every
four (4) years.
12. If there are questions of eligibility regarding liver biopsy or combination therapy,
the PCP working through the MAR HCV Sub-committee may submit a request
for consideration for review and decision to the Health Care Review Subcommittee.
13. The anticipated time period from the HCV screening request made by the
inmate-patient to the initiation of combination therapy is nine (9) months, except
for patients 45 years old or younger with ALT levels elevated to less than two (2)
times normal during testing required in phase II section 8.
14. Inmate-patients receiving combination therapy shall be seen by the PCP weekly
for the first two weeks and monthly thereafter beginning with the fourth (4) week.
15. Inmate-patients receiving combination therapy shall have appropriate evaluations
and laboratory tests as outlined in Attachments I, J, K1 or 1(2.
16. Inmate-patients in the Mental Health program who are receiving interferon may
be seen on a more frequent basis as determined by the interdisciplinary treatment
team.
March 2004	

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Vlepatitis C Clinical Management Program

Health Care Services'

17. Assuming treatment is well-tolerated (see #20 and #21), inmate-patients with
genotype 2 or 3 complete a six (6) month course of combination therapy, and PCR
testing at three (3) months is not needed.
18. Inmate-patients with genotype 1, 4 or 6 who are receiving combination therapy
shall have a quantitative PCR test performed after the first three (3) months of
therapy to determine response. Those who achieve more than a 2-log reduction •
in viral titer at 3 months are considered "responders." Those whose viral titer at
three (3) months remains within two (2) logs of the pre-treatment value are
considered "non-responders." Inmate-patients with genotype 1, 4 or 6 who are
non-responders at three (3) months shall have combination therapy discontinued
19. Assuming treatment is well-tolerated (sec #20 and #21) inmate-patients with
genotype 4 or 6 who are responders to combination therapy at 3 months shall
continue therapy for an additional nine (9) months to complete a total of
twelve (12) months.
20. Inmate-patients who develop clinical complications while receiving Combination
therapy shall be evaluated and if deemed appropriate, combination therapy may be
adjusted or discontinued. Refer to Attachment L.
21. Inmate-patients who develop neuropsychiatric complications while receiving •
interferon shall be referred immediately for a mental health evaluation and the
designated mental health professional shall be contacted. If deemed appropriate,
combination therapy may be adjusted or discontinued.
22. The decision to discontinue or adjust combination therapy may be discussed with
the MAR HCV Sub-committee, or an appropr iate specialist.
23. All inmate patients who complete combination therapy (6 months for genotypes 2
and 3; 12 months for responders %nth genotypes 1,4, and 6) will be tested for the
presence of HCV with a qualitatia e Kit w ith reflex quantitative PCR to assess
response.
24. "Responders" to combination thcram shall continue in the HCV Clinical
Management Program after treatment o completed in order to document longterm remission for twelve (12) month. or until parole. This will assist in program
evaluation.
25. "Non-responders" to combination thcram shall continue to follow-up in the HCV
Clinical Management Program at le..ot ci cry twelve (12) months and will be
advised of new treatment options, as thci become available.

March 2004

'Hepatitis C Clinical Management Program

Health Care Services'

26.

Inmate-patients with a documented history of stage 4 fibrosis or clinical cirrhosis
shall have an alpha fetoprotein level checked every six (6) to twelve (12) months
to screen for hepatocellular carcinoma.

27.

Inmate-patients with elevated alpha fetoprotein may be considered for a CT scan,
sonogram, and/or referral to an appropriate specialist.

28.

Inmate-patients who have received a liver biopsy and combination therapy who
are paroling shall receive a copy of Attachments E, F, K1 or K2 and M.

29.

The Utilization . Management (UM) Nurse will track the baseline viral load
utilizing the UM Database for inmate-patients who qualify for combination
therapy. Additionally, inmate-patients with genotype 1, 4 or 6 receiving
combination therapy will have repeat viral load performed after three months of
therapy to determine response. Included in the UM Database are the dates and
results of pertinent laboratory tests and liver biopsies. Results will be compiled
by the UM Nurse and presented to the MAR HCV Sub-committee.

March 2004	

7

Attachment A
California Department of Corrections

Hepatitis C Clinical Management Program

HEPATITIS C
PATIENT INFORMATION
WHAT IS HEPATITIS C?
Hepatitis is any inflammation of the liver. The most common causes of liver inflammation are viruses, drugs, and alcohol.
Hepatitis C is one of the viruses which may cause liver inflammation or hepatitis.
HOW IS IT SPREAD?
Hepatitis is most commonly acquired from contaminated needles (including tattooing needles), snorting drugs, using shared
paraphernalia, or from a blood transfusion prior to 1990. Other risk factors for hepatitis C include hemodialysis or job
exposure to human blood. At the present time, there is no vaccine to prevent hepatitis C infection.
DIAGNOSIS
Most people with the infection look and feel well and they have usually had the virus for many years before the diagnosis.
The infection is usually diagnosed when abnormalities are found on a routine blood test or at the time of blood donation.
After acquiring the hepatitis C virus, the infected individual makes antibodies against the virus (Hepatitis C virus antibodies).
These antibodies are detected during screening for hepatitis C. Although disease-specific antibodies usually signify
immunity from the disease they attack, in the case of hepatitis C, the antibodies are noi protective and having antibodies does
not mean the infection has resolved or that the patient is immune. The vast majority of those with hepatitis C virus
antibodies also carry the virus.
If you have antibody to hepatitis C, you will have a blood test to determine if the hepatitis C virus is present. If you test
positive for the virus, you have hepatitis C infection.
After the hepatitis C rims is detected, another important test to perform is the viral genotype. Genotypes are subgroups of
the virus sharing genetic properties. The various genotypes of hepatitis C have different behaviors and respond differently to
treatment. Hepatitis C genotypes 1, 2, 3, and 4, are the most common. Genotypes 2 and 3 are the most responsive to
treatment.
WHAT DOES THE HEPATITIS C VIRUS DO?
You cannot live without your liver. It removes drugs from your system and it produces many essential products, including
cholesterol, proteins, and clotting factors. The hepatitis C virus inhabits liver cells and causes inflammation. Over time, this
ongoing inflammation injures the structure and function of the liver cells. In most persons, this is typically a very slow
process. Only some (10 to 20 percent) of persons with hepatitis C go on to develop serious liver injury, and in those persons,
it takes many years (10 to 40). Alcohol use will cause any person with hepatitis C to develop more rapid and severe liver
injury. In those persons with advanced hepatitis C disease, severe liver scarring (cirrhosis), and even liver cancer
(hepatocellular carcinoma) or failure may occur.
SYMPTOMS
Most people carrying the virus feel well. In those persons in whom the disease progresses, symptoms generally are minimal
until the disease is quitmadvanced. The severity of the disease can be assessed by history and examination, laboratory
markers and, most reliably, by liver biopsy. End stage liver disease may result in abdominal swelling (ascites); mental
confusion (encephalopathy); bleeding from the esophagus or stomach due to varices (enlarged veins); liver cancer; or other
serious complications.
•
TREATMENT
If repeated blood tests show the liver is functioning differently than normal, a liver biopsy may be performed. This test is
done in a clinical setting, and the patient generally does not stay for more than a few hours to be observed after the biopsy is
completed. It requires using a special needle to pierce the skin and obtain a small piece of the liver for microscopic
examination, to determine the degree of liver damage. This is one of the most important factors in deciding whether drug
treatment for the hepatitis C virus might be offered.
At present, there arc only a few drugs available to treat hepatitis C. The course of therapy is long and must be uninterrupted
to get the maximum chance for cure. It is typically associated with some unpleasant side effects, although many can be
managed with physician monitoring and medication adjustments. With this therapy, about 50 to 60 percent of patients clear
the infection and are considered cured. However, a person can still be re-infected if re-exposed to hepatitis C. There is no
evidence that treatment administered at the last stages of I-ICV significantly reduces the effectiveness of the drug treatment.
Currently there are no studies to show that therapy actually increases the lifespan or reduces the already low risk of
developing cirrhosis or cancer,

Attachment B

California Department of Corrections

Hepatitis C Clinical Management Program

GENERAL INSTRUCTIONS
FOR HEPATITIS C PATIENTS
• AVOID USE OF ALCOHOL
• DO NOT USE INJECTION DRUGS
• DO NOT "SNORT" DRUGS
• DO NOT GET ANY ILLEGAL TATTOOS
• DO NOT SHARE YOUR TOOTHBRUSH, RAZOR, OR OTHER PERSONAL CARE ITEMS
• REDUCE WEIGHT IF OVERWEIGHT
• EAT A WELL-BALANCED HEART HEALTHY DIET
• DRINK PLENTY OF FLUIDS
• GET ADEQUATE REST AND REGULAR EXERCISE
• STOP SMOKING
•

ASPIRIN AND IBUPROFEN (MOTRIN, ADVIL) SHOULD BE USED WITH EXTREME

CAUTION AND ONLY AFTER DISCUSSION WITH YOUR PHYSICIAN

• YOU MAY USE ACETAMINOPHEN (TYLENOL) FOR PAIN OR OTHER
ACETAMINOPHEN CONTAINING MEDICATIONS, BUT THE DOSE SHOULD NOT
EXCEED 4 GRAMS PER DAY. CHRONIC USE SHOULD BE AVOIDED
• AVOID TAKING SUPPLEMENTAL IRON
• DO NOT DONATE BLOOD, TISSUE, OR ORGANS
• MINIMIZE USE OF PAIN MEDICATIONS, ESPECIALLY NARCOTICS

ATTACHMENT C

CALIFORNIA DEPARTMENT OF CORRECTIONS

HEPATITIS C CLINICAL MANAGEMENT PROGRAM

Exclusion Criteria for Combination Therapy*
No biopsy or treatment

if an early release date: generally less than ten [10] months from the time
the primary care provider refers the inmate-patient for a liver biopsy by completing the Request
for Services fomi CDC 7243 for genotypes 2 and 3, or less than sixteen [16] months from the
time the primary care provider refers the inmate-patient for a liver biopsy by completing the
Request for Services form CDC 7243 for other genotypes.
•

An early release date: generally less than ten [10] months from the time the primary care
provider refers the inmate-patient for a liver biopsy by completing the Request for
Services form CDC 7243 for genotypes 2 and 3, or less than sixteen [16] months from
the time the primary care provider refers the inmate-patient for a liver biopsy by
completing the Request for Services form CDC 7243 for other genotypes

•

Poorly controlled cardiopulmonary, cerebrovascular or thyroid disease, blood dyscrasias,
seizures, cancer, diabetes mellitus (hemoglobin AK >8.5%), or renal insufficiency
(creatinine >2 mg/dL)

•

Inmate-patients 45 years old or younger with ALT levels elevated to less than two (2)
times normal laboratory values on three consecutive tests, at least one month apart, are
•
not eligible for treatment	

•

Decompensated cirrhosis – e.g. albumin <3, jaundice, ascites, varices, coagulopathy

•

Autoimmune disease

•

WBC <1,500/mm3, platelets <75,000/mm3

•

Hemolytic anemias, or hemoglobin <1 lgm/dL or hematocrit <33%

•

Solid organ transplantation

•

HIV infection w/CD4 Count <300

•

Poorly controlled psychiatric/psychological condition

•

Serious suicidal behavior in the past 12 months

•

History of illicit drug use, alcohol or other substance abuse, or other high risk behaviors
currently active or within the past 6-12 months

•

Inability to cooperate with treatment

•

Inability to give informed consent

•

Age >60 years

•

Pregnancy – a pregnancy test is required prior to initiating therapy

*Refer to drug manufacturer's warnings in addition to highlighted contraindications

Attachment P

CALIFORNIA DEPARTMENTOF CORRECTIONS

HEPATITIS C CLINICAL. MANAGEMENT PROGRAM

POTENTIAL SIDE EFFECTS
INTERFERON AND/OR RIBAVIRIN THERAPY
While you are taking interferon and/or ribavirin you may experience some of the side effects listed below. The
problem most commonly reported is flu-like symptoms. These symptoms are reduced by taking acetaminophen
(Tylenol ®) before each interferon injection. Drinking plenty of water and getting adequate rest and exercise also
help to minimize ill effects.
♦

Injection site inflammation **

♦

Nonspecific flu-like symptoms, such as:
headache
chills
fatigue
fever

♦

Gastrointestinal symptoms, such as:
loss of appetite
nausea
vomiting
diarrhea
heartburn or indigestion

♦

Psychiatric symptoms, such as:
depression
insomnia
anxiety
irritability

♦

Respiratory symptoms, such as:
cough
shortness of breath

♦

Skin disorders, such as:
hair loss
rash
itching
dry skin

♦

Blood element problems, such as:
reduced number of white blood cells**
reduction in platelets
Anemia

♦

Possible birth defects during and for 6 months after completion of therapy

**Pegylated interferon's most noticeable side effect

Attachment E
HEPATITIS C CLINICAL MANAGEMENT PROGRAM

CALIFORNIA DEPARTMENT OF CORRECTIONS

Age:

Date of Birth:

SEROLOGY

Date

Results

HEMATOLOGY/COAG.

Date

Results

HCV ANTIGEN

Date

Results

OTHER

Date

Results

CDC Form #

Page 1 of I

AttaFhmpnt F

CALIFORNIA DEPARTMENT OF CORRECTIONS

HEPATITIS C CLINICAL MANAGEMtN I EntatiHAM

HEPATITIS C CLINICAL EVALUATION FORM
CDC#:

Inmate:

Date:

ERPD:

Unit:

Facility:

Age:

PCP:

Allergies:

Genotype:_

HISTORY

PHYSICAL EXAMINATION

q Intake

REASON FOR VISIT:
q Other:

ASSOCIATED CONCERNS:
Ascites
q Yes
Bleeding
q Yes
Chest Pain
q Yes
Edema
q Yes
q Yes
Fatigue
Fever
q yes
Mental Status Change
q Yes
Nauseallomiting
q Yes
Shortness of Breath
q Yes
Comment/Other:

q F/U

q No
q No
q No
q No
q No
q No
q No
q No
q No

Vitals: T
BP

RR
Wt

Skin:
Neuro:
Cardiac:
Lungs:
Abdomen:
Extremities:
Other:
Comments:

BM/

q Normal q Abnormal:
q Normal q Abnormal:
q Normal q Abnormal:
q Normal q Abnormal:
q Normal q Abnormal:
q Normal q Abnormal:

ASSESSMENT
A. Diagnoses:

LIVER BIOPSY RESULTS:
DIAGNOSTIC/LAB RESULTS:
MEDICAL/SURGICAL HISTORY:
Anemia
q Yes
q Yes
Autoimmune Disease
q Yes
Blood Transfusion
Cardiovascular disease q Yes
Cirrhosis
q Yes
q Yes
COPD/RAD
q Yes
Diabetes
Encephalopathy
q Yes
day q y es
ETOH Use 
q Yes
HAV Immune
q yes
HBV Immune
q Yes
!VDU
Seizures
q Yes
q Yes
Suicide Attempt
Thyroid Disease
q Yes
Varices
q Yes
CDC 115 Violations
q Yes
q Yes
Previous HCV Rx

q No

No
No
No
No
q No
q No
q No
q No
q No
q No
q No
q No
q No
q No
q No
q No
q No
q
q
q
q

Other:
MEDICATIONS:
3.

2
3.
B Treatment Contraindications?
If Yes, explain

q Yes q No

PLAN
MEDICATIONS:
q INF q RBV q Lactulose qSpironolactone
q Other
q Other:
VS CHECK:
q Monthly q Quarterly q Other:
UI M INOSTICS/LABS:
q ABD U/S q Biopsy
q irit q CBC q TSH
ANA
AFP
•
Chem q Iron Studies q PT/INR q HIV
HCV Genotype
q HCV Viral Load
q Oyler.
MINES: q HAV q HBV q Other
I )II I q Regular
q Other:

0

I I ATION PROVIDED:
q Handouts q ETOH/Drug
[ ) Ors (specify):

0

q Medications

PIIIRR AL:

2.
4.

REVIEWED:
q Old records
q Consultant notes
q Previous visits/notes q Radiological studies
q Diagnostic/lab studies q Prior records ordered
COMMENTS-

r MAR HCV Sub-committee

Specialist (indicate type):
Specialist (indicate type):
q Oyler Chronic Care Program:
16,4

h“±" . • h.

next visit: q 90 days q30 days q Other

days]

Signature: q MD qDO qNP
I Luc

CDC Form #

Page 1 of 1

ATTACHMENT G

CALIFORNIA DEPARTMENT OF CORRECTIONS	

HEPATITIS C CLINICAL MANAGEMENT PROGRAM

HEPATITIS C BIOPSY AND TREATMENT CONTRACT
Treatment of hepatitis C is reserved for those eligible patients who understand the commitment to
therapy, will tolerate and comply with the course of treatment, and agree to avoid all activities that may
worsen their liver disease, or infect themselves or others with the hepatitis C virus or other bloodborne
pathogens. Every patient who is considered for treatment must complete this contract before a liver
biopsy is performed and before initiation of therapy.
Patient's
Initials
I understand that a medical hold will be placed on me until the liver biopsy is performed and the biopsy
results are discussed with me.
I understand that the therapy may be of no benefit to me and that it may not eradicate my hepatitis C
infection.
I have been informed that side effects of treatment of hepatitis C may include fatigue, body aches, and
other serious side effects that may persist throughout the course of therapy.
I understand that I may be tested for HIV before beginning treatment
could seriously impact my hepatitis C infection and its treatment.

as

the presence of the HIV virus

I understand that the course of therapy may continue for 12-months and that periodic blood testing will
be a necessary part of the hepatitis C treatment program.
I understand that treatment for hepatitis C may cause psychiatric side effects, especially depression.
I understand that I must not become pregnant or attempt to impregnate my spotise during my hepatitis C
antiviral treatment or for 6 months after cessation of treatment. I understand that I must use two forms
of birth control during heterosexual activity during treatment and for 6 months after treatment ends.
	

I understand that my failure to comply with the therapy or its monitoring may result in discontinuation
of therapy.
I understand that alcohol injures the liver and that drinking alcohol is forbidden.

	

I understand that I must abstain from any activity that permits exchange of body fluids that may
transmit the hepatitis C virus or other bloodbome pathogens. This includes tattooing, sexual activity in
prison, IV drug use, and intranasal drug use.
	

I understand that I may be required to undergo random blood or urine testing for substance abuse and
that any positive test will result in discontinuation of, or loss of eligibility for, treatment.
I understand that completion of this contract does not guarantee that I will be endorsed for hepatitis C
treatment.

	

	

My initials above and my signature below signify my understanding of, and agreement to comply with,
the requirements enumerated above. I understand that failure to comply may result in loss of eligibility
for therapy or discontinuation of therapy in progress.

Date

Inmate Signature	

Witness Signature

	

Date

cc: Unit Health Record
Inmate
CDC Form #	

Page 1 of 1

Attachment H

CALIFORNIA DEPARTMENT OF CORRECTIONS

HEPATITIS C CLINICAL MANAGEMENT PROGRAM

HEPATITIS C ANTIVIRAL TREATMENT CANDIDATE
PSYCHIATRIC/PYSCHOLOGIC REVIEW

•

MENTAL HEALTH HISTORY:
Is there any history of psychiatric illness and what are the diagnoses? Discuss cognitive impairment if applicable:

Describe any suicidal ideation and/or attempts in the last 12 months:

Describe compliance with therapeutic programming and medication treatment over the last 12 months:

If inmate-patient is currently enrolled in the Mental Health Program, what is the level of care (ex: CCCMS, EOP)
and where are they housed (ex: Ad-Seg EOP, PSU):1

Describe any known usage of recreational drugs and/or alcohol over the last 12 months:

List any current psychiatric medications:

Disposition/Plan: (check appropriate box)

q No mental health contraindications to HCV treatment
Refer for mental health evaluation before HCV treatment decision
TID Refer to Interdisciplinary Treatment Team (IDTT) before HCV treatment decision
111

q Other:
COMMENTS:

Inmate Patient Name (Print)

	

Evaluator Name and Title (Print)	
CDC Form #

CDC'

Date
Evaluator Signature
Page 1 of 1

CALIFORNIA DEPARTMENT OF CORRECTIONS

Attachment I
HEPATITIS C CLINICAL MANAGEMENT PROGRAM

HEPATITIS C PRACTICE GUIDELINES
The initial HCV evaluation will include:
HISTORY:
> History of present condition	
> Current symptoms, including frequency and	
severity	
â Current medications	

> Past medical history
> Drug allergies
P Lifestyle factors
) Family history

EXAMINATION:

P Vital signs
P Examination of:	
Skin	
Neurological system	
Head/Neck
Heart
Lungs
Abdomen
Extremities

:r

Examination, if clinically indicated, of:

Pelvis/Rectum
a Other organ systems

ASSESSMENT:
Se Diagnoses

P Treatment Contraindications
PLAN:

P Medications
â Vaccinations:
Hepatitis A
Hepatitis B
Se Laboratory tests:
CBC
Hepatitis serology
If inmate-patient found to have the antibody to II( A ° bum a qualitative PCR with reflex to quantitative
Chemistry panel
Liver function tests
TSH
ANA
HIV
Iron, Ferritin
P Laboratory/ Diagnostic studies if clinically indicated
II
UN pv‘ Ird or documented by biopsy)
Abdominal Ultrasound (If cirrhosis is cl	 .ca.4
Alpha Fetoprotein (If cirrhosis is clinically SLINN■ ted i n documented by biopsy)
Liver Biopsy (If eligible for combination therapi
Genotype (Do not need to recheck)
P Education (e.g. nutrition, exercise, alcohol/illicit drug u.c. medication management, smoking cessation)
) Referral to hepatologist and/or other specialist or Ulu ° nu ( are Program, as clinically indicated
P Interval to next visit

Revised 05/11/04

Page I of 2

Attachment J
NOTE: SEND COPY OF PHYSICIAN'S ORDER FOR MEDICATION
TO PHARMACY AFTER EACH ORDERS IS SIGNED
Physician's Orders and Medications
(Orders must be dated,
nd signed)

Problem

ortlerDate Time

X

Start Peginterferon AlfA-2a (Pegasys) ONCE WEEKLY
24 weeks Genotype 2 and 3 and 48 weeks Genotype 1, 4 or 6
180 mcg (1mL)

RIBAVIRIN DOSING
GENOTYPE 2 AND 3 - 24 weeks
2 x 200 mg In AM 2 x 200mg In PM

GENOTYPE 1, 4 OR 6 - 48 weeks
, 2 x 200mg In AM 3 x 200mg In PM

<165

>165 Ws

3 x 200mg In AM 3 x 200mg in PM

Anti Ira Therapy R

T

IN D R N

•

1 X

PRE-TREATMENT: Hepatitis Serology, HCV Antibody, HCV quanl byPCR, Genotype, CBC, INR,
Chem Panel*, TSH, ANA Fe/Ferritin, Later13x, HIV (recommended)
FIRST WEEK: CBC
SECOND WEEK: CRC
FIRST MONTH: CDC, Chem Panel• ,
SECOND MONTH: CRC
THIRD MONTH: ALL GENOTYPES: CBC, TSH, Chem Panel*;
GENOTYPE 1, 4, 6 ONLY: HCV QUANT BY PCR
FOURTH MONTH: CRC
FIFTH MONTH: CBC
SIXTH MONTH: ALL GENOTYPES: CBC, TSH, Chem Pater;
GENOTYPE 2, 3 ONLY: HCV QUAL with reflex QUANT BY PCR
SEVENTH MONTH: GENOTYPE 1, 4, 6 ONLY: CBC
EIGHTH MONTH: GENOTYPE 1,4,6 ONLY: CRC
NINTH MONTH: GENOTYPE 1, 4, 6 ONLY: CBC, Chem Panel*, TSH
TENTH MONTH: GENOTYPE 1, 4, 6 ONLY: CBC
ELEVENTH MONTH: GENOTYPE 1, 4, 6 ONLY: CBC
TWELFTH MONTH: ALL GENOTYPES: HCV QUAL with reflex QUANT BY PCR
GENOTYPE 1, 4, 6 ONLY: CBC, TSH, Chem Panel*
EIGHTEENTH MONTH: GENOTYPE 1,4, 6 ONLY: HCV QUAL WITH REFLEX QUANT BY PCR
Chem Panel must Include ALT, billrubin, albumin, and emetinIne

ROOM

INSTITUTION

ALLERGIES

CDC NUMBER, NAME (LAST, FIRST, MI)

Confidential
diem inforrnalion
See W I Code. Sedions 4514 and 552B

PHYSICIAN'S ORDERS •
CDC 7221 (11/01)
59B

DEPARTMENT OF CORRECTIONS

DOB:
REL DATE.

TBCODE