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HCV Checklist PATIENT NAME: CLINICAL CRITERIA DOB: 1. Please indicate desired treatment regimen (including medications, dose of each medication, duration of therapy) _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ 2. DIAGNOSIS: Chronic Hepatitis C Infection a. Genotype _______ Subtype (if applicable)_______( please attach results) b. HCV RNA Level within the past 12 months: Level:______________ Date:____/_____/____(attach results) 3. Yes No Yes Patient with current alcohol or illicit drug use No If yes to above question, is patient receiving or has been offered counseling/treatment 4. Yes No Prescribed by gastroenterologist, infectious disease specialist, hepatologist, primary care provider experienced in treating hepatitis C infection or primary care provider with treatment recommendation from any aforementioned specialist (to include recommendations received via Telemedicine or phone) a. If consultation occurred, provide name of specialist who was consulted: Name________________________, Phone______________________ 5. Yes No Is patient treatment experienced? (If ‘Yes’ answer a, b & c If no go to Liver Assessment )) a. List regimen patient has received including duration of therapy: _______________________________________________________________________________________ b. Yes No Did Patient complete regimen? If not, reason for discontinuation of therapy _______________________________________________________________________________________ c. What was patient’s response to therapy? Relapser. Non-responder (Includes null responders (serum HCV RNA levels declined less than 2 log10 IU/ml by week 12) and partial responders (≥ 2 log10 IU/ml response whose virus remained detectable by week 24) LIVER ASSESSMENT 1. Yes No Does the patient have one of the following extra-hepatic manifestation of HCV Infection: Lymphoma, Vasculitis, or Renal Disease 2. Yes No Does the patient have APRI > 1.0, METAVIR Score >= F3 (Bx. Date ________), Transient Elastography Score >= 9.5 kiloPascals, FibroTest >= 0.58, radiographic imaging consistent with cirrhosis or physical examination findings consistent with cirrhosis 3. Yes No Does the patient have decompensated liver disease 4. Yes No Is treatment to be co-managed with a gastroenterologist, infectious disease specialist or hepatologist PATIENT NAME: DOB: 6. Yes No Has patient previously had a liver transplant? 7. Yes No Does patient have hepatocellular carcinoma awaiting liver transplantation a. If answered Yes above, please answer a) through c) below: a) Anticipated transplant date: ____/____/____ b) Does patient meet Milan criteria? Please indicate which of the following criteria is met: 1 HCV Checklist Single hepatocellular carcinoma, presence of tumor 5cm or less in diameter, OR Multiple tumors with each being 3cm or less in diameter. No extrahepatic manifestations of cancer or evidence of vascular invasion of tumor Neither of the above apply c) Yes No Prescriber received an authorization for liver transplant per plan policy? INTERFERON INTOLERANCE (Does the patient have clinical intolerance or contraindication to interferon documented by at least one of the following?) 8. Yes No a. If answer is ‘Yes’, please check all that apply and provide documentation: Known hypersensitivity reactions such as urticaria, angioedema, bronchoconstriction, anaphylaxis, or Stevens-Johnson syndrome to alpha interferon, including PEGASYS, or any of its components Hepatic decompensation (Child-Pugh score > 6 [class B and C]) in cirrhotic patients before treatment or ≥6 in cirrhotic CHC patients co-infected with HIV before treatment Uncontrolled psychiatric condition (i.e. schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder) Suicidal behavior within the past 12 months Severe concurrent medical disease (uncontrolled diabetes, significant ischemic heart disease, obstructive pulmonary disease) Autoimmune hepatitis or autoimmune disorder (eg, dermatomyositis, immune[idiopathic] thrombocytopenia purpura, inflammatory bowel disease, interstitial lung disease, interstitial nephritis, polymyositis, psoriasis, rheumatoid arthritis, sarcoidosis, and systemic lupus erythematosus). Uncontrolled seizures Moderate or severe retinopathy Symptomatic hepatitis C induced cryoglobulinemia Uncontrolled hyper/hypothyroidism Hepatocellular cancer awaiting transplant Baseline platelet count ≤70,000 cells/mm3 Baseline absolute neutrophil count (ANC) ≤1,500 cells/mm3 Baseline hemoglobin ≤10 g/dL REQUIRED LABS (Must be within 6 weeks of request- please attach laboratory results) AST, ALT, Bilirubin, Albumin, INR, Platelet count, ANC, Hgb, SCr REQUIRED SCREENING HIV Screening, Hepatitis A and B screening including: HBsAg, anti-HBs, anti-HBc, HAV Ab REQUIRED VACCINATIONS Patient has completed or initiated Hepatitis A and Hepatitis B vaccination series 2