Transcript Powerpoint Template - St Vincent's Hospital, Melbourne

GP’s Guide to the
HCV SHARED CARE
PROGRAM
ST VINCENT’S HOSPITAL. MELBOURNE
KATE MELLOR. RN.
HEPATOLOGY NURSE CONSULTANT
35 VICTORIA PARADE
FITZROY, VICTORIA3065
PH: (03) 9288 2259
FAX: (03) 9288 3596
Jan 2010
1
CONTENTS
THIS SHARED CARE PROTOCOL IS INTENDED TO SUPPORT
CLINICIANS TREATING PATIENTS WITH HEPATITIS C
WITH PEG INTERFERON & RIBAVIRIN COMBINATION THERAPY.
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
- THE PLAN FOR GP
Pg 5
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
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SECTION 100
PATIENTS 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
3
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
 HCV PCR, Genotype + Viral Load,
 LFT, FBE, TFTab, SMS, Iron & Copper studies
 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
 Duration of virus longer than 20 yrs
 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
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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.
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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
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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.
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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 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. 8
WHAT TO ORDER &
WHEN?
PLEASE FAX ALL RESULTS TO 9288 3596
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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.
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Continue Monthly
Week 24
Monthly
End of treatment - 48 weeks
LFT, FBE
LFT, FBE, TFT
LFT, FBE
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.
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Patterns of Virological
Response
Treatment
Baseline
Non Responder
HCV RNA
Relapser
Breakthrough
Partial
Response
Detection limit
Sustained Response
(SVR) CURE
HCV RNA
Undetectable
6mths
TIME
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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 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

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 treatment
Renal 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 13
ceased.
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:
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
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
<50,000
To 90mcg
R/V path in weekly
Cirrhotics
25,000
<35,000
RIBAVIRIN REDUCTIONS:
Hb:
<100g/L
Less 200mgs til
stable
<85g/L
.
Discontinue Ribavirin when Haemoglobin <20g/L
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SCHERING-PLOUGH
PEGATRON & RIBAVIRIN
Dose & Dose Reduction
STANDARD DOSE:
Weight
Range (kg)
40 46
47 53
54 60
61 64
65 72
73 80
81 85
86 90
91 100
Redipen per .5mL
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)
0.35
0.4
0.45
0.5
0.45
0.5
0.45
0.45
0.5
800
800
800
800
1000
1000
1000
1200
1200
2
2
2
2
2
2
2
3
2
3
2
3
3
3
3
3
(as written on script)
(what patient dials up)
RBV Daily
Dose (mg)
Morning
Evening
2
2
PEG IFN DOSE REDUCTIONS:
Laboratory Value
Reduce dose if
For 4 wks the R/V
Discontinue
White Blood Cells
< 1.5
1.0
Neutrophils
< 0.75
Platelets
< 50,000
To 0.35mL
on the same
Strength Redipen
r/v pathology in
2 wks.
600mg
<85 g/L
0.5
25
RBV DOSE REDUCTIONS:
Haemoglobin
Haemoglobin
(In Pts with stable
Cardiac Disease)
< 100 g/L
> 20 g/L Decrease in Hb during any 4 week
period of treatment results in a permanent
dose reduction of .
<120 g/L
16
CONTACTS

Kate Mellor
Hepatology Nurse Consultant
Gastroenterology Department
Level 4 Daly Wing
35 Victoria Parade
Fitzroy 3065.
•
[email protected]
Ph:03 9288 2259
Mob: 0407 511 299
Fax: 03 9288 3596
[email protected]
Ph:03 9288 3597
Fax: 03 9288 3596
Marianne Crowe
Hepatology Nurse Consultant
Gastroenterology Department
Level 4 Daly Wing
35 Victoria Parade
Fitzroy 3065.
Lai-Me Lam
Out Patient Pharmacist
SVHM
Ph: 03 9288 3462
Fax: 03 9288 4174

SVHM Specialist can be
contacted through the
Gastroenterology Department.
Address as above
Ph: 03 9288 3580
Fax: 03 9288 3590
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