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1
GP’s Guide to theHCV SHARED CARE
PROGRAM
KATE MELLOR. RN.HEPATOLOGY NURSE CONSULTANT
35 VICTORIA PARADEFITZROY, VICTORIA3065
PH: (03) 9288 2259FAX: (03) 9288 3596
Jan 2010
ST VINCENT’S HOSPITAL. MELBOURNE
2
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.
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SECTION 100PATIENTS MUST FULFIL THE FOLLOWING
GOVERNMENT CRITERIA:
HCV RNA POSITIVE
18 yrs PLUS
NAÏVE 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
Compassionate Access Scheme CIRRHOTICS WITH THROMBOCYTOPENIA
Platelets >90,000 RENAL IMPAIRMENT
Requires Ribavirin dose reduction CURRENT CLINICAL TRIALS
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WORKING UP FOR TREATMENT
Please ensure all referrals & current results are Faxed to the; Att: Hepatology NurseLiver Clinic
St Vincent’s Hospital35 Victoria Parade,Fitzroy 3065FAX: 03 9288 3596
Pre Treatment Pathology HCV PCR, Genotype + Viral Load, LFT, FBE, TFTab, SMS, Iron & Copper studies HIV & HBVab if requiredPlease ensure vaccinations for Hep A & B are up to date.
Liver Biopsy’s although not required for treatment arerecommended in some instances & can be organisedthrough the clinic.
Ultra Sound &/or Liver Biopsy - Recommended if Duration of virus longer than 20 yrs History of heavy alcohol use
Monthly LFT, FBE are required for the duration oftreatment & all results MUST be Faxed to the
Hepatology Nurse on Ph: 9288 3596
5
THE TREATMENT PLANTreatment Duration:Genotypes 1, 4, & 6 48 weeks Genotypes 2 & 3 24 weeksGenotypes 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 theDaly 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.
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THE PLAN – For GP’s
At Each Review Visit
SVHM Hepatology Nurse: 03 9288 3580
Please CHECK the patients Mood swings & Sleep pattern Appetite & any Weight loss Itches and rashes Any other side effects
CHECK compliance
RE-INFORCE contraception Two effective forms
RE-INFORCE abstinence or a reduction of alcohol intake 4 standard drinks for men & 2 for women per week
PATHOLOGY R/V Haemoglobin, White cell count Neutrophils, Platelets ALT
FAX Results & Follow Up Letters to Hepatology Nurse 9288 3596
7
THE PLAN – Non Cirrhotics
GP - R/V MonthlySVH - Every Two / Three Months
2 Weeks R/V with GPSide effects & pathology r/v
4 weeks R/V with Specialist & CNCside effects & pathology r/vscript & drug pick up
8 weeks R/V with GP Side effects & pathology r/v
12 weeks R/V with GPSide effects & pathology r/v
16 weeks R/V with Specialist & NurseSide effects & pathology r/v script & drug pick up
Then monthly there after until treatment has ceased. If by chance the patient becomes unwell, monthlyAppointments at SVHM would be necessary.
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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 GPSide effects & pathology r/v
4 weeks R/V with Specialist & NurseSide effects & pathology r/v. Script & drug pick up
8 weeks R/V with GPSide effects & pathology r/v
12 weeks R/V with Specialist & NurseSide 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 monthlyappointments would be necessary with the specialist.
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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
HC
V R
NA
6mths
Sustained Response (SVR) CURE
Breakthrough
Relapser
Partial Response
HCV RNA Undetectable
Baseline Treatment
Detection limit
Non Responder
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MANAGEMENT OF COMMON SIDE EFFECTS
PEG Combination Treatment can cause a range of side effects; Initial side effects
Headaches, Muscle & joint aches & pains, Fevers & chills,
The initial week is usually the worst & these common flu like symptomscan take about 6-8 weeks to subside. With 20% of patients notexperiencing side effects at all. Patient are advised to take Panadol as required & increase their fluids
Common RIBAVIRIN side effects Dry cough Dry Itchy Skin & Rashes
• No soap, moisturisers and or Chickweed Gel from health food shops.
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 treatmentRenal Disorder: • Ribavirin is secreted through the kidneys. • Ribavirin should not be administered to patients with
creatinine clearance less than 50ml/min.
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BONE MARROW SUPPRESSION
Common Peg Interferon Side effects Hair thinning Poor appetite, weight loss Irritability, anxiety, mood swings LFT do not always normalise on Peg.
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.
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 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.
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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; Mood swings, Sleep patterns, Weight & ask about suicidal idealisations.
If possible confirm with partner/significant other.
If concerned of an “at risk” patient contact. 1) Hepatology Nurse – 03 9288 3580 2) SVHM Specialist – 03 2988 3580
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.
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CONTRAINDICATIONS
PEG-Interferon may be contraindicated in people experiencing a
profound depression illness previous drug induced psychosis attempted suicides 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:
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
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SCHERING-PLOUGHPEGATRON & RIBAVIRINDose & 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 MellorHepatology Nurse ConsultantGastroenterology DepartmentLevel 4 Daly Wing 35 Victoria Parade Fitzroy 3065.
katherine.mellor@svhm.org.auPh:03 9288 2259Mob: 0407 511 299Fax: 03 9288 3596
SVHM Specialist can be contacted through the
Gastroenterology Department. Address as abovePh: 03 9288 3580 Fax: 03 9288 3590
• Marianne CroweHepatology Nurse ConsultantGastroenterology DepartmentLevel 4 Daly Wing 35 Victoria Parade Fitzroy 3065.
marianne.crowe@svhm.org.auPh:03 9288 3597Fax: 03 9288 3596
Lai-Me Lam Out Patient Pharmacist SVHMPh: 03 9288 3462 Fax: 03 9288 4174
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