Presentation on theme: "1 GP’s Guide to the HCV SHARED CARE PROGRAM KATE MELLOR. RN. HEPATOLOGY NURSE CONSULTANT 35 VICTORIA PARADE FITZROY, VICTORIA3065 PH: (03) 9288 2259 FAX:"— Presentation transcript:
1 GP’s Guide to the HCV SHARED CARE PROGRAM KATE MELLOR. RN. HEPATOLOGY NURSE CONSULTANT 35 VICTORIA PARADE FITZROY, VICTORIA3065 PH: (03) 9288 2259 FAX: (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 100Pg 3 What pre-treatment test need to be done? - WORKING UP FOR TREATMENTPg 4 The Shared Care Treatment Plan - THE TREATMENT PLANPg 5 - THE PLAN FOR GPPg 6 What blood test and when? - WHAT TO ORDER & WHENPg 9 PATTERNS OF VIROLOGICAL RESPONSE Pg 10 What do I need to look out for? - MANAGEMENT OF SIDE EFFECTSPg 11 Who should not be treated? - CONTRAINDICATIONSPg 14 When should I be worried? - STANDARD DOSE & DOSE REDUCTIONPg 15 Who do I contact? - CONTACTSPg 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 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
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 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
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 4 th 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: 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 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 2LFT, FBE Week 4LFT, FBE, HCV PCR Week 8LFT, FBE Week 12LFT, FBE, TFT Continue MonthlyLFT, FBE End of treatment - 24 weeksLFT, FBE, TFT, HCV PCR GENOTYPES 1,4,6 & CIRRHOTIC GENTOYPES 2 & 3 – 48 WKS Week 2 LFT, FBE Week 4LFT, FBE, HCV PCR Week 8LFT, FBE Week 12LFT, FBE TFT, PCR & VL Only continue if there has been a 2 log drop in the viral load. Continue Monthly LFT, FBE Week 24LFT, FBE, TFT Monthly LFT, FBE End of treatment - 48 weeksLFT, FBE TFT, PCR & VL POST TREATMENT FOLLOW UPS 4 weeks post treatmentLFT,FBE 12 weeks post treatmentLFT, FBE 24 weeks post treatmentLFT, FBE TFT, PCR Please see inclosed treatment pathology flow sheet.
11 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.
12 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.
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; 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.
14 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.
15 STANDARD DOSE & DOSE REDUCTION Roche PEGASYS & RIBARVIRIN STANDARD DOSE: Peg IFN DOSE REDUCTIONS:. Laboratory values Reduce dose ifFor 1 month then R/V dose again. Discontinue if Neutrophils<0.75To135mcg R/V path in 2wks <0.5 Platelets Cirrhotics <50,000 <35,000 To 90mcg R/V path in weekly25,000 RIBAVIRIN REDUCTIONS: Hb:<100g/LLess 200mgs til stable <85g/L Discontinue Ribavirin when Haemoglobin <20g/L GenotypePegasys Dose (Weekly) Ribarvirin Dose (Daily) N O Of 200mg Tablets 1 & 4180mcg (s/c injection) <75kg = 1000mg >75kg = 1200mg 2 morning & 3 evening 3 morning & 3 evening 2 & 3180mcg800mg 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) 100 120 150 PEG-IFN Weekly Dose (mcg) 708090100108120135 150 INJ Volume (mL) (what patient dials up) 0.350.40.450.50.450.50.45 0.5 RBV Daily Dose (mg) 800 1000 1200 Morning Evening 2222 2222 2222 2222 2323 2323 2323 3333 3333 Laboratory ValueReduce dose ifFor 4 wks the R/VDiscontinue White Blood Cells< 1.5To 0.35mL on the same Strength Redipen r/v pathology in 2 wks. 1.0 Neutrophils< 0.750.5 Platelets< 50,00025 Haemoglobin< 100 g/L600mg<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
17 CONTACTS Kate Mellor Hepatology Nurse Consultant Gastroenterology Department Level 4 Daly Wing 35 Victoria Parade Fitzroy 3065. firstname.lastname@example.org Ph:03 9288 2259 Mob: 0407 511 299 Fax: 03 9288 3596 SVHM Specialist can be contacted through the Gastroenterology Department. Address as above Ph: 03 9288 3580 Fax: 03 9288 3590 Marianne Crowe Hepatology Nurse Consultant Gastroenterology Department Level 4 Daly Wing 35 Victoria Parade Fitzroy 3065. email@example.com Ph:03 9288 3597 Fax: 03 9288 3596 Lai-Me Lam Out Patient Pharmacist SVHM Ph: 03 9288 3462 Fax: 03 9288 4174