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CONTENTS
THE INFORMATION PROVIDED IN THIS PACKAGE WILL GUIDE THE CLINICIAN THROUGH THE FOLLOWING;
* Who qualifies for treatment?
- SECTION 100 Pg 3
* What pre-treatment test need to be done?
- WORKING UP FOR TREATMENT Pg 4
* The Shared Care Treatment Plan
- THE TREATMENT PLAN Pg 5
- THE PLAN FOR GP Pg 6
* What blood test and when?
- WHAT TO ORDER & WHEN Pg 9
* PATTERNS OF VIROLOGICAL RESPONSE Pg 10
* What do I need to look out for?
- MANAGEMENT OF SIDE EFFECTS Pg 11
* Who should not be treated?
* - CONTRAINDICATIONS Pg 14
* When should I be worried?
- STANDARD DOSE & DOSE REDUCTION Pg 15
* Who do I contact?
- CONTACTS Pg 17
THIS SHARED CARE PROTOCOL IS INTENDED TO SUPPORT CLINICIANS TREATING PATIENTS WITH HEPATITIS C
WITH PEG INTERFERON & RIBAVIRIN COMBINATION THERAPY.
3
SECTION 100
PATIENTS MUST FULFIL THE FOLLOWING GOVERNMENT CRITERIA:
* HCV RNA POSITIVE
* 18 yrs PLUS
* NAĪVE PATIENT
IE: NO PRIOR IFN OR PEG IFN
* COMPENSATED LIVER DISEASE
* BOTH PARTNERS MUST AGREE TO USE 2 FORMS OF EFFECTIVE CONTRACEPTION.
* FEMALE PARTNER OR PATIENT MUST NOT BE PREGNANT
ALSO CONSIDER
* ACUTE HEPATITIS
o Compassionate Access Scheme
* CIRRHOTICS WITH THROMBOCYTOPENIA
o Platelets >90,000
* RENAL IMPAIRMENT
o Requires Ribavirin dose reduction
* CURRENT CLINICAL TRIALS
4
WORKING UP FOR TREATMENT
Please ensure all referrals & current results are Faxed to the;
Att: Hepatology Nurse
Liver Clinic
St Vincent’s Hospital
35 Victoria Parade,
Fitzroy 3065
FAX: 03 9288 3596
Pre Treatment Pathology
o HCV PCR, Genotype + Viral Load,
o LFT, FBE, TFTab, SMS, Iron & Copper studies
o HIV & HBVab if required
Please ensure vaccinations for Hep A & B are up to date.
Liver Biopsy’s although not required for treatment are recommended in some instances & can be organised through the clinic.
Ultra Sound &/or Liver Biopsy - Recommended if
o Duration of virus longer than 20 yrs
o History of heavy alcohol use
Monthly LFT, FBE are required for the duration of treatment & all results MUST be Faxed to the Hepatology Nurse on Ph: 9288 3596
5
THE TREATMENT PLAN
Treatment Duration:
Genotypes 1, 4, & 6 48 weeks
Genotypes 2 & 3 24 weeks
Genotypes 2 & 3 with Cirrhosis (F3 / F4 Metavir score) are treated for 48 weeks
Education & first injection of therapy is done at St Vincent’s Hospital, 35 Victoria Parade on the 4th Floor of the Daly Wing, by the Hepatology Nurse Ph: 9288 3580
Follow ups will be fortnightly for the first month then monthly throughout treatment for monitoring of side effects &
pathology r/v.
* At 3 months an assessment will be made by the specialist in clinic to determine the plan for further treatment.
* Cirrhotics at risk of bone marrow suppression should be monitored every 2 months in clinic.
* Non Cirrhotics can be monitored every 3 months in clinic, if psychologically stable.
* Psychologically at risk should be monitored by the GP, SVHM psychiatrist & specialist along with weekly contact with the CNC.
6
THE PLAN – For GP’s
At Each Review Visit
SVHM Hepatology Nurse:
* Please CHECK the patients
o Mood swings &
o Sleep pattern
o Appetite & any
o Weight loss
o Itches and rashes
o Any other side effects
* CHECK compliance
* RE-INFORCE contraception
o Two effective forms
* RE-INFORCE abstinence or a reduction of alcohol intake
o 4 standard drinks for men & 2 for women per week
* PATHOLOGY R/V
o Haemoglobin, White cell count
o Neutrophils, Platelets
o ALT
FAX Results & Follow Up Letters to Hepatology Nurse 9288 3596
7
THE PLAN
Non Cirrhotics
GP - R/V Monthly
SVH - Every Two / Three Months
* 2 Weeks R/V with GP
Side effects & pathology r/v
* 4 weeks R/V with Specialist & CNC
side effects & pathology r/v
script & drug pick up
* 8 weeks R/V with GP
Side effects & pathology r/v
* 12 weeks R/V with GP
Side effects & pathology r/v
* 16 weeks R/V with Specialist & Nurse
Side effects & pathology r/v script & drug pick up
Then monthly there after until treatment has ceased.
If by chance the patient becomes unwell, monthly
Appointments at SVHM would be necessary.
8
THE PLAN – Cirrhotics
GP- R/V Monthly
SVHM - Every Alternative Second Month.
NOTE: These patients are at risk of neutropenia &
thrombocytopenia & are more likely to need dose reductions.
* 2 Weeks R/V with GP
Side effects & pathology r/v
* 4 weeks R/V with Specialist & Nurse
Side effects & pathology r/v. Script & drug pick up
* 8 weeks R/V with GP
Side effects & pathology r/v
* 12 weeks R/V with Specialist & Nurse
Side effects & pathology r/v script & drug pick up
* 16 weeks R/V with GP
Side effects & pathology r/v script & drug pick up
Then monthly there after until treatment has ceased.
If by chance the patient becomes symptomatic monthly appointments would be necessary with the specialist.
9
WHAT TO ORDER & WHEN?
PLEASE FAX ALL RESULTS TO 9288 3596
GENOTYPES 2 & 3 - 24 WEEKS
* Week 2 LFT, FBE
* Week 4 LFT, FBE, HCV PCR
* Week 8 LFT, FBE
* Week 12 LFT, FBE, TFT
* Continue Monthly LFT, FBE
* End of treatment - 24 weeks LFT, FBE, TFT, HCV PCR
GENOTYPES 1,4,6 & CIRRHOTIC GENTOYPES 2 & 3 – 48 WKS
* Week 2 LFT, FBE
* Week 4 LFT, FBE, HCV PCR
* Week 8 LFT, FBE
* Week 12 LFT, FBE TFT, PCR & VL
Only continue if there has been a 2 log drop in the viral load.
* Continue Monthly LFT, FBE
* Week 24 LFT, FBE, TFT
* Monthly LFT, FBE
* End of treatment - 48 weeks LFT, FBE TFT, PCR & VL
POST TREATMENT FOLLOW UPS
* 4 weeks post treatment LFT,FBE
* 12 weeks post treatment LFT, FBE
* 24 weeks post treatment LFT, FBE TFT, PCR
Please see inclosed treatment pathology flow sheet.
10
6mths
Sustained Response (SVR) CURE
Breakthrough
Relapser
Partial
Response
HCV RNA
Undetectable
Baseline
Treatment
Detection limit
Non Responder
Patterns of Virological Response
TIME
HCV RNA
6mths
Sustained Response (SVR) CURE
Breakthrough
Relapser
Partial
Response
HCV RNA
Undetectable
Baseline
Treatment
Detection limit
Non Responder
11
MANAGEMENT OF COMMON SIDE EFFECTS
PEG Combination Treatment can cause a range of side effects;
* Initial side effects
o Headaches,
o Muscle & joint aches & pains,
o Fevers & chills,
The initial week is usually the worst & these common flu like symptoms can take about 6-8 weeks to subside. With 20% of patients not experiencing side effects at all.
Patient are advised to take Panadol as required & increase their fluids
* Common RIBAVIRIN side effects
o Dry cough
o Dry Itchy Skin & Rashes
+ No soap, moisturisers and or Chickweed Gel from health food shops.
o Tiredness secondary to Anaemia
+ Occurs within 2 to 4 weeks of commencement of therapy
+ Maximum drop in the first 8 weeks
+ Monitor haemoglobin baseline, week 2 & then 4 weekly
+ Haemoglobin less than 100g/L for 2 consecutive weeks will need dose reduction, please notify Hepatology Nurse.
+ Haemoglobin less than 80g/L, cease treatment
Cardiac Disease:
+ ECG over 50yr pre treatment
Renal Disorder:
+ Ribavirin is secreted through the kidneys.
+ Ribavirin should not be administered to patients with creatinine clearance less than 50ml/min.
12
BONE MARROW SUPPRESSION
* Common Peg Interferon Side effects
o Hair thinning
o Poor appetite, weight loss
o Irritability, anxiety, mood swings
o LFT do not always normalise on Peg.
o Neutropenia
+ Decrease in neutrophil counts are common.
+ Dose reduce for levels < 0.75 – notify Hepatology Nurse.
+ Cease if counts < 0.5 – notify Hepatology Nurse.
+ Neutrophils should normalise 4 weeks after stopping.
o Thrombocytopenia
+ Platelet counts decrease in about 30-50% of the patients on therapy.
+ Dose reduction of Peg IFN for counts < 50,000
+ Severe thrombocytopenia 30,000 cease treatment.
+ Cirrhotic patients on need platelets > 90,000
+ Dose reduce Cirrhotics as above.
* Uncommon Peg Interferon Side effects
o Thyroid Abnormality
+ Serious adverse events & dose modifications are rare.
+ Pre existing thyroid dysfunction does not preclude combination therapy; patients will need an Endocrinology r/v prior to treatment.
+ Prior to therapy patients should be tested for TFTs/ antithyroid antibodies & TFTs every 12 weeks during treatment.
13
NEUROPSYCHIATRIC DISORDERS
* Interferon can cause significant neuropsychiatric side effects including; depression, anxiety, impaired concentration, sleep disturbance, irritability, intolerance, fatigue, sexual dysfunction, apathy & confusion.
* Mood Swings appears to be more common in people who have had similar problems in the past. We tend to see these within the first 3 months. Low dose SSRI are advised.
* Clinicians should monitor;
o Mood swings,
o Sleep patterns,
o Weight
o & ask about suicidal idealisations.
If possible confirm with partner/significant other.
* If concerned of an “at risk” patient contact.
o 1) Hepatology Nurse –
o 2) SVHM Specialist –
o The Hepatology Nurse will arrange a referral to the psychiatrist at SVHM before treatment & if advisable during therapy.
* SSRI’s are commonly prescribed which may act on the specific neurochemical targets (in particular serotonin) mediating these depressive side effects.
Most of these side effects are reversible once treatment has ceased.
14
CONTRAINDICATIONS
* PEG-Interferon may be contraindicated in people experiencing a
o profound depression illness
o previous drug induced psychosis
o attempted suicides
o psychiatric illness i.e. bipolar disorders,
As the treatments exacerbate this pre existing illness.
These patients require a formal psychiatric review & monitoring at the St Vincent’s Liver Clinic
* Ribavirin is teratogenic, consequently combination treatment is not made available to women who are pregnant; &/or breastfeeding or thinking about planning a pregnancy; or to men whose partners are pregnant.
* People undergoing treatment must agree to use two forms of effective contraception during & for six months after treatment.
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STANDARD DOSE & DOSE REDUCTION
Roche PEGASYS & RIBARVIRIN
STANDARD DOSE: - Go to the original link at the bottom of this article to view the tables in the powerpoint presentation for all information below.
Peg IFN DOSE REDUCTIONS:
Laboratory values
Reduce dose if
For 1 month then R/V dose again.
Discontinue if Neutrophils <0.75
To135mcg
R/V path in 2wks
<0.5
Platelets
Cirrhotics
<50,000
<35,000
To 90mcg
R/V path in weekly
25,000
RIBAVIRIN REDUCTIONS:
Hb:
<100g/L
Less 200mgs til stable
<85g/L
Discontinue Ribavirin when Haemoglobin <20g/L
Genotype
Pegasys Dose
(Weekly)
Ribarvirin Dose
(Daily)
NO Of 200mg Tablets
1 & 4
180mcg
(s/c injection)
<75kg = 1000mg
>75kg = 1200mg
2 morning & 3 evening
3 morning & 3 evening
2 & 3
180mcg
800mg
2 morning & 2 evening
16
SCHERING-PLOUGH
PEGATRON & RIBAVIRIN
Dose & Dose Reduction
STANDARD DOSE:
PEG IFN DOSE REDUCTIONS:
RBV DOSE REDUCTIONS:
Weight
Range (kg)
40 -
46
47 - 53
54 - 60
61 - 64
65 - 72
73 -80
81 - 85
86 -90
91 - 100
Redipen per .5mL
(as written on script)
100
100
100
100
120
120
150
150
150
PEG-IFN Weekly Dose (mcg)
70
80
90
100
108
120
135
135
150
INJ Volume (mL)
(what patient dials up)
0.35
0.4
0.45
0.5
0.45
0.5
0.45
0.45
0.5
RBV Daily
Dose (mg)
800
800
800
800
1000
1000
1000
1200
1200
Morning
Evening
2
2
2
2
2
2
2
2
2
3
2
3
2
3
3
3
3
3
Laboratory Value
Reduce dose if
For 4 wks the R/V
Discontinue
White Blood Cells
< 1.5
To 0.35mL
on the same Strength Redipen
r/v pathology in
2 wks.
1.0
Neutrophils
< 0.75
0.5
Platelets
< 50,000
25
Haemoglobin
< 100 g/L
600mg
<85 g/L
Haemoglobin
(In Pts with stable Cardiac Disease)
> 20 g/L Decrease in Hb during any 4 week period of treatment results in a permanent dose reduction of .
<120 g/L
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CONTACTS
* Kate Mellor
Hepatology Nurse Consultant
Gastroenterology Department
Level 4 Daly Wing
35 Victoria Parade
Fitzroy 3065.
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Ph:
Mob:
Fax: 03 9288 3596
* SVHM Specialist can be contacted through the Gastroenterology Department.
Address as above
Ph:
Fax: 03 9288 3590
* Marianne Crowe
Hepatology Nurse Consultant
Gastroenterology Department
Level 4 Daly Wing
35 Victoria Parade
Fitzroy 3065.
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Ph:
Fax: 03 9288 3596
* Lai-Me Lam
Out Patient Pharmacist
SVHM
Ph: 03 9288 3462
Fax: 03 9288 4174
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