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1 EVALUATION Baseline Labs Obtain at time or prior to initial evaluation CBC with diff PT/INR CMP HCV Genotype (obtained PRIOR TO consult visit) HCV RNA (obtained PRIOR TO consult visit) Hep A IgG Hep BsAg, Hep BsAb, Hep BcAb HIV Ab (unless negative within the past 12 months) IL28-B (if not cost prohibitive) Iron panel and Ferritin Pre-treatment labs Obtain within 60 days of starting treatment CBC with differential Comprehensive metabolic panel PT, PTT, INR Fasting lipid panel TSH/Free T4 Vitamin D 25 OH Uric acid (If receiving telaprevir) Urinalysis Women of child bearing potential HCG AFP & abdominal sonogram if cirrhotic Hgb A1C if diabetic HIV RNA and CD4 if co-infected

2 The following should be current within the past 6 months: HCV RNA quantitative assay HIV test Baseline examinations prior to starting therapy: Review patient s medications for drug/drug interactions (http://www.hepdruginteractions.org) Retinal exam within 12 months if diabetic or hypertensive Cardiology consult if known CAD or high risk for CAD ABSOLUTE CONTRAINDICATIONS to treatment: Decompensated cirrhosis Uncontrolled hyper/hypothyroidism Active substance abuser (See Treatment section below) Inability to cooperate with treatment Uncontrolled psychiatric diagnosis Suicidal behavior within the past 6 months Female pregnant, nursing or unable to use contraception: patient will be asked to use two methods of contraception. Hgb < 11g/dl or Hct < 33% Creatinine > 2mg/dl Platelets < 25,000/mm3 Severe concurrent medical disease: uncontrolled diabetes, significant ischemic heart disease, uncontrolled HIV with advanced immunosupression, ACTIVE, untreated autoimmune disease e.g. RA, Psoriasis Hypersensitivity to interferon RELATIVE CONTRAINDICATIONS to treatment Refuses or cannot take an anti-depressant if indicated while on treatment Poorly controlled diabetes Hgb > 8.5 Obesity BMI > 35 Inadequate social support Age > 69 years old

3 Evaluation of HCV Patients with Cirrohsis All patients with chronic HCV should be evaluated for severity of liver disease and degree of inflammation. The following laboratory abnormalities may be found in patients with cirrhosis: neutropenia, thrombocytopenia (< 150,000 platelets/ml), prolonged INR, reversal of AST to ALT ratio, elevated bilirubin or low albumin. Gastroenterology referral for all patients with cirrhosis. Diagnostic tests for cirrhosis: Liver biopsy Consider if result will changes plans for treatment in both mono-infected patients & co-infected patients. For example, utilize biopsy results to persuade patients who are good candidates to receive treatment or reassure patient who are poor candidates that they can wait for future therapy. Fibrosure assay If liver biopsy recommended but patient unable or unwilling to undergo liver biopsy. Guidelines for the Treatment of Patients with Cirrhosis (International Liver Transplantation Society 2003): Consider treatment MELD Score Child-Pugh Score Strongly consider < 18 < 7 Possibly consider No, avoid treatment > 25 > 11 Guidelines for referral for liver transplantation: Any patient with evidence of decompensated cirrhosis (e.g., ascites, variceal bleeding, encephalopathy, hepatorenal syndrome, hepatocellular carcinoma) and/or a MELD score of 10 or more.

4 TREATMENT Interventions for all patients with HCV infection: Provide with educational materials regarding hepatitis C infection. Abstain from alcohol, tobacco & illicit drugs. Length of abstinence period from alcohol is between 3 to 6 months and will be determined by the quantity of alcohol consumed. Patients will be drug free for 6 months prior to initiating therapy. Maintain BMI < 25 kg/m 2 Immunization for hepatitis A & hepatitis B for patients who are non-immune. Limit intake of acetaminophen to less than 2 grams/day. Vitamin D level should be maintained > 20 ng/ml in all patients and > 40 ng/ml in patients receiving treatment for hepatitis C. Choice of DAA to be discussed between NP and at least one Infectious Diseases MD. Assessment criteria includes: patient s clinical data (labs, h/o rash, h/o anemia, IL28-B genotype), age, insurance coverage. Lead in phase with ribavirin and peglated interferon may be considered with telaprivir to assess tolerance in the following patients: cirrhotic, anemia, significant psychiatric illness. Hepatitis C RNA quantitative assay should be obtained at 12 weeks & 24 weeks to confirm sustained virological response. Interventions for patients with HCV & cirrhosis: Gastroenterology referral for all patients with cirrhosis. Calculate MELD &/or Child-Pugh score. Hepatic ultrasound every 6 months. Alpha-fetoprotein (AFP) may considered in conjunction with ultrasound. Upper endoscopy for evidence of esophageal varices. Referral to transplant center of MELD score > 25. Avoid non-steroidal anti-inflammatory drugs.

5 Interventations for Patients Co-infected with HIV and Hepatitis C: Following are preliminary recommendations for the use of boceprevir or telaprevir in HIV patients coinfected with HCV genotype 1 based on current ART use. These recommendations may be modified as new drug interaction and clinical trial information become available. Patients not on ART: Patients receiving RAL + 2-NRTI: Patients receiving ATV/r + 2-NRTI: Patients receiving EFV + 2-NRTI: Use either boceprevir or telaprevir Use either boceprevir or telaprevir Use telaprevir at standard dose. Do not use boceprevir. Use telaprevir at increased dose of 1125 mg every 7 9 hours. Do not use boceprevir. Patients receiving other ARV regimens: HCV treatment contraindicated if patient is receiving one of the following antiretroviral drugs: darunavir, lopinavir and fosamprenavir. If HCV disease is minimal (i.e., no or mild portal fibrosis), consider deferring HCV treatment given rapidly evolving HCV drug development. If good prognostic factors for HCV treatment response are present IL28B CC genotype or low HCV RNA level (<400,000 International Unit [IU]/mL) consider use of PegIFN/RBV without HCV NS3/4A PI. On the basis of ART history and HIV genotype testing results, if possible, consider switching to the ART regimens listed above to permit the use of boceprevir or telaprevir. For patients with complex ART history or resistance to multiple classes of ART, consultation with experts regarding the optimal strategy to minimize the risk of HIV breakthrough may be needed. In such patients, telaprevir may be the preferred HCV NS3/4A PI because its duration of use (12 weeks) is shorter than that of boceprevir (24 to 44 weeks). All co-infected patients should receive 48 weeks of triple drug therapy. Based on Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents March 27, 2012

6 MANAGEMENT OF COMPLICATIONS OF HCV TREATMENT Anemia management with ribavirin dose reduction initially: RBV should be reduced to 600 mg or reduced in 200 to 400 mg increments for hemoglobin levels less than 10 g/dl, and temporarily discontinued for a hemoglobin level less than 8.5 g/dl If necessary may need to decrease below ribavirin dose to less than 600mg per day. When anemia is stable and viral load has been undetected at weeks 4 and 12 (telaprevir) or weeks 8 and 12 (boceprevir) consider resuming the 600mg dose. If Hgb < 8.0 after decreasing dose of ribavirin, then add erythropoietin. Start with 40,000 Units per week, may need to increase to 60,000 Units per week. Consider transfusion if Hgb remains < 8.0 after adjustment of ribavirin dose & treatment with erythropoietin. If ribavirin is stopped for > 7 days, then other agents for hepatitis C must be discontinued also. Neutropenia: If ANC, < 750, reduce dose of PeglIFN alfa-2a to 135 mcg/kg per week. If ANC < 500, start Neupogen 300mcg/sc/week. Monitor ANC after 1 week and every 2 weeks thereafter G-CSF should be injected 2 days prior to PeglIFN injections Thrombocytopenia: Manage with dose reduction of pegelated interferon: If platelets drop to < 50,000/mm 2, then reduce dose of peg IFN-2a from 180 ug to 90 ug per week. If platelet < 25,000/mm 2, discontinue until resolution. November 18, 2012

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