بروتوكول العلاج بالانترفيرون طويل المفعو

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بسم الله الرحمن الرحيم :

بسم الله الرحمن الرحيم

Egyptian Ministry of Health Protocol For Management of HCV :

Egyptian Ministry of Health Protocol For Management of HCV By : Dr. M.Abd El Wahab El Abgeegy Hepato-Gastroenterologist Teaching Hospitals & Institutes

Advisory Board for HCV Treatment :

Advisory Board for HCV Treatment Prof. Sherif A. Fattah; Med. Military Academy Prof. Ali Monis; Ain Shams University. Prof. A. Rahman El Zayadi; Ain Shams University. Prof. Shoukry Hunter; Cairo University. Prof. Abul Dahab El Sahly: Cairo University. Prof. Seham Abdel Rehim; Alexandria university. Prof. Ahmed Medhat Nasr; Assuit University.

Slide 5:

The WHO has declared hepatitis C a global health problem, with approximately 3% of the world’s population infected with HCV. In Egypt the situation is quite worse. Egypt has the highest prevalence of hepatitis C in the world. The national prevalence rate of HCV antibody positivity has been estimated to be between 10-13%. Chronic HCV is the main cause of liver cirrhosis and liver cancer in Egypt and, indeed, one of the top five leading causes of death. Genotype 4 represents over 90% of cases in Egypt. Magnitude of the problem

Goals of HCV Therapy :

Goals of HCV Therapy Primary goal : * Eradication of HCV infection Secondary goals : * Slow disease progression. * Improve the histology. * Reduce risk of HCC. * Improve quality of life.

Questions ?? :

Questions ?? Who will be treated ? Who will not be treated ? How to prepare the patient for treatment ? How to treat ? For how long ? How to follow up during treatment ? How to deal with side effects ? Rules of stoppage of treament . How to follow up after treatment?

Inclusion criteria :

Inclusion criteria Age 18-60 years old. Detectable HCV RNA. CBC (Hb > 11 , Neutrophils >1500 , platelets > 75.000). Albumin ≥ 3.5 , Prothrombin conc. ≥ 60 %. If diabetic Hb A1c < 8.5

Inclusion criteria :

Inclusion criteria If high enzymes with liver biopsy > A1 and/or >F0 . If normal enzymes biopsy must be ≥ A2 and/or ≥ F2. Compensated cirrhosis (F4 or 5/6 & 6/6) if there is no varices

Inclusion criteria :

Inclusion criteria Age 18-60 years old. Detectable HCV RNA. CBC (Hb > 11 , Neutrophils >1500 , platelets > 75.000). Albumin ≥ 3.5 , Prothrombin conc. ≥ 60 %. If diabetic Hb A1c < 8.5

Inclusion criteria :

Inclusion criteria If high enzymes with liver biopsy > A1 and/or >F0 . If normal enzymes biopsy must be ≥ A2 and/or ≥ F2. Compensated cirrhosis (F4 or 5/6 & 6/6) if there is no varices.

Questions ?? :

Exclusion criteria :

Exclusion criteria Age > 60 years. Decompensated liver disease. Impaired synthetic function (Abumin < 3.5 , prothrombin conc.< 60 %). Cytopenias ( Hb < 11 g/dL ,Neutrophils < 1500 , Platelets < 75.000 ). Uncontrolled comorbidities (Severe HTN , CHF , COPD , IHD…). Pregnancy. BMI > 35

Exclusion criteria :

Exclusion criteria Thyroid dysfunction (except who is cleared from endocrinologists). Autoimmune liver disease ( ANA > 1/40 ). Severe pre-existing psyciatric conditions. Solid organ transplantation : ( Kidney , Heart , Lung…). Drug abusers and alcoholics (Alcohol > 30gm/day = faiure of ttt). Metavir A1 & F0. Metavir A1 & F1 with normal enzymes. Relapsers and non-responders treated before by combined pegylated interferon / ribavirin will not be treated.(MOH).

Questions ?? :

Questions ?? 3. How to prepare the patient for treatment ? Step 1 Step 2

HCV Ab +ve :

HCV Ab +ve Step 1 :

Step 2 : :

Step 2 : TSH. Alfa feto protein. HCV PCR Quantitative. ANA titre. Antibilharzial Antibody. Fundus examination. ECG (ages above 40 years). Pregnancy test in females. If diabetic : do Hb A1c. Liver biopsy.

Step 2 : :

Step 2 : TSH. Alfa feto protein. HCV PCR Quantitative. ANA titre. Antibilharzial Antibody (Treat if +ve 3 doses one week inbetween). Fundus examination. ECG (ages above 40 years). Pregnancy test in females. If diabetic : do Hb A1c. Liver biopsy.

Liver biopsy :

Liver biopsy F1 F3 F4 Metavir score : Chronic hepatitis A… F… Ishak score : Chronic hepatitis Grade … /18 & stage …/6 F2

Scoring system of fibrosis in liver biopsy :

Scoring system of fibrosis in liver biopsy

Liver biopsy is mandatory except in : :

Liver biopsy is mandatory except in : Medical and paramedical personnel. Genotypes 2 and 3. Extrahepatic manifestations. Those who started treatment elsewhere and has virological response (HCV PCR is negative).

Role of liver biopsy :

Role of liver biopsy Patients with minimal fibrosis ( F0 ) : * to be excluded * to be followed up with liver biopsy every 3-5 years Patients with advanced fibrosis ( F4 ) : * to be included if there is no varices. * Surveillance for HCC even after SVR every 6 months by U/S and AFP. Patients with normal ALT : (done 3 times within the last 6 months) * willl not be treaeted except ≥ A2 and/or ≥ F2.

Questions ?? :

Treatment :

Treatment Pegylated Interferon : S.C. once weekly Pegylated Interferon alfa-2a 180 µg / week regardless of body weight. Pegylated Interferon alfa-2b 1.5 µg /kg/week. Ribavirin : 15 mg /kg/day Or weight < 75 kg : 1000 mg /day – weight > 75 kg : 1200 mg /day ( in 2 or 3 divided doses with meals ) Give the maximum tolerated dose. ( non adherence affects SVR )

Questions ?? :

For How long ? :

For How long ? For 48 weeks

Questions ?? :

Follow up during teatment :

Follow up during teatment CBC , ALT , AST , T.Bil , s.creatinine done weekly in the first month then monthly till end of treatment. TSH : every 12 weeks. Alfa feto protein : every 24 weeks. Fundus examination : every 24 weeks. ( except in diabetics and hypertensives every 12 weeks ). HCV PCR quantitative at 12 week. HCV PCR qualitative at 24,48 and 72 weeks.

650 . 000 :

650 . 000

650 . 0 :

650 . 0 1 IU / ml = 5 copies / ml

Slide 34:

SVR

Positive Virological Response :

Positive Virological Response RVR -ve PCR after 4 weeks (86 % SVR) EVR C -ve PCR after 12 weeks (76 % SVR) EVR P 2 log decrease after 12 weeks (56 % SVR) SVR –ve PCR only after 72 weeks

Questions ?? :

Managemient of adverse effects :

Managemient of adverse effects Constitutional symptoms : Flu like symptoms : Paracetamol Gastro-intestinal symptoms : (RBV) Nausia , loss of appettite , dry mouth. Weight loss : (6-10 % of body weight )

Management of adverse effects (cont.) :

Management of adverse effects (cont.) Asthenia and Fatigue : (anemia,hypothyroid,depression) Cytopenias : IFN affects all blood elements (bone marrow supression ). RBV affects RBCs (hemolysis).

Management of adverse effects (cont.) :

Management of adverse effects (cont.) IFN & RBV dose modifications in relation to hematological changes (Bennet et,al. 2008)

Management of adverse effects (cont.) :

Management of adverse effects (cont.) Thyroid disease : (F/U by TSH every 12 weeks) Hypothyridism (replacement therapy) Hyperthyroidism (β blockers,radioactive iodine ablation,discontinuation of ttt ) Retinpathy : Retinal hemorhage -› discontinuation if retinal lesions or worsening of previous lesion. Close F/U of fundus examination especially in predisposed patients (diabetic and hypertensive).

Management of adverse effects (cont.) :

Management of adverse effects (cont.) Depression (25 %) (IFN) : (Antidepressant : Paroxetine , Citalopram) Dry Cough (RBV) : Oedema of mucosa of respiratory system. Hair loss (IFN ): -› topical preparations ( reversible within 6 months of stoppage of ttt ) Dermatological side effects : (RBV) : itching (avoid prolonged sun exposure , symptomatic and rarely ↓ RBV dose) (IFN) : injection site reaction -› slow injection , rotation of site of injection

Questions ?? :

Rules of stoppage of treatment :

Rules of stoppage of treatment At 12 weeks when viral load does not decrease by at least 2 logs. At 24 weeks with any degree of viremia (+ve PCR by qualitative testing). Those with negative PCR at 24 & 36 weeks will continue till 48 weeks then stop. Appearance of severe and uncontrolled side effects.

Questions ?? :

Follow up after treatment :

Follow up after treatment SVR : Qualitative PCR & LFTs yearly. Pateints with F4 even achieving SVR : as before +( AFP and US every 6 months). Non responder : as CLD every 3 months. Relapsers : as CLD every 3 months.

Cases ???? :

Cases ????

Case 1 :

Case 1 55 years old female with HCV Ab +ve , BMI 32 , HCV PCR : 2516 IU/ml , ALT 34/31 , AST 28/31 , Liver biopsy 4/18 2/6 (A1 F1), CBC : Hb 13.2 , WBCs 4400(N:1900) , Platelets 155.000, albumin 3.9 , PC :99 %. Is she candidate for ttt or not ??? Yes she is candidate because she has high ALT and fibrosis more the F0

Case 2 :

Case 2 28 years old male with HCV Ab +ve , HCV PCR : 5.340.000 IU/ml , ALT 25/37 , AST 20/37 , Liver biopsy 4/18 1/6 (A1 F1) , CBC : Hb 15.4 , WBCs 7400(N:4300) , Platelets 364.000, albumin 4.4,PC :100%. Is he candidate for ttt or not ??? NOT candidate because he has normal enzymes with biopsy less than A2 F2 For close F/U of transaminases

Case 3 :

Case 3 39 years old female with HCV Ab +ve , HCV PCR : 2.300.000 IU/ml , ALT 65/31 , AST 46/31 , Liver biopsy 3/18 0/6 (A1 F0), CBC : Hb 10.6 , WBCs 5400(N:2100), Platelets 215.000, albumin 4.3,PC :89%. BMI : 43 Is she candidate for ttt or not ??? Not candidate (F0) and search for another cause of high transaminases.

Case 4 :

Case 4 45 years old male with HCV Ab +ve , HCV PCR : 370.000 IU/ml , ALT 23/12 , AST 19/12 , Liver biopsy 7/18 3/6 (A2 F2) , Antibilharzial antibody 1/640 , CBC : Hb 11.5 , WBCs 3.400(N:1950) , Platelets 113.000, Upper endoscopy revealed : grade III oesophageal varices , albumin 3.9 , PC : 69%. Is he candidate for ttt or not ??? Yes after eradication of OV by EVL because he is not F4

Case 5 :

Case 5 51 years old male with HCV Ab +ve , HCV PCR : 65400 IU/ml , ALT 55/31 , AST 99/31 , Liver biopsy : 10/18 5/6 (A2 F4) , Antibilharzial antibody 1/80 , CBC : Hb 12.0 , WBCs 3.100(N:1700), Platelets 55.000, Upper endoscopy revealed : No varices , albumin 3.6 ,PC : 70% , Abdominal U/S reaveled coarse liver and splenomegaly. Is he candidate for ttt or not ??? No because of thrombocytpenia

Slide 54:

THANK YOU