Updates in Hepatitis C Treatment 2015

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1 Disclosure Updates in Hepatitis C Treatment 2015 Lindsey Childs Kean, PharmD, MPH, BCPS Clinical Assistant Professor Department of Pharmacotherapy and Translational Research University of Florida College of Pharmacy St. Petersburg Campus I have NO actual or potential conflict of interest in relation to this educational activity or presentation. I will be discussing off label uses of medications in this presentation. Learning Objectives Pharmacists At the end of the presentation, learners should be able to: Describe the route of transmission and risk groups of hepatitis C infection Recommend an appropriate treatment regimen for a patient with chronic hepatitis C Identify potential drug drug interactions with approved direct acting antivirals Learning Objectives Technicians At the end of the presentation, learners should be able to: Identify patient risk groups for hepatitis C infection Determine the drug class for a given directacting antiviral List one side effect of each approved directacting antiviral Meet HS HS is a 55 yo WM with chronic HCV Prior injection drug and alcohol use Prior relapse with peginterferon + ribavirin HCV Genotype 1a AST 80 units/ml, ALT 110 units/ml, Child Pugh A HTN controlled on lisinopril and amlodipine Milk Thistle for his liver Epidemiology 170 million people infected worldwide Highest prevalence in Africa, Asia 1.3% prevalence in United States (U.S.) 4% in U.S. veterans Up to 80% in injection drug users Lavanchy D. Liver Int 2009;29: Shepard CW. Lancet Infect Dis 2005;5: World Health Organization. April

2 Risk Factors Injection Drug Use Intranasal Drug Use Blood Transfusion Prior to 1992 Body Piercings and/or Tattoos Needlesticks Mother to Child (less common) Sexual (rare) Sharing razors, toothbrushes (rare) Screening CDC Birth Cohort Screening: All born between Those in certain high risk groups United States Preventive Services Task Force Those at high risk should be screened Birth Cohort Screening can be considered United States Preventive Services Task Force. June Natural History Diagnostic Testing 100 patients infected with HCV develop chronic infection 1 5 die of cirrhosis or liver cancer develop chronic liver disease 5 20 develop cirrhosis HCV Antibody HCV Viral Load Interpretation Positive Undetectable Prior exposure Cleared acute infection or successful chronic infection treatment Positive Detectable Current acute or chronic infection Negative Undetectable Not exposed or infected Negative Detectable??? False negative antibody test (?) Clinical Presentation Genotypes Acute Mostly asymptomatic Nonspecific Symptoms Malaise Weakness Anorexia Jaundice Chronic Mostly asymptomatic until late stage Complications include cirrhosis (decompensated) and HCC Extrahepatic Manifestations: Cryoglobulinemia, Renal Disorders, Skin Conditions, Insulin Resistance and Type 2 Diabetes, Lymphomas Genotypes 1 6 Genotype 1b most prevalent worldwide 75% U.S. patients have Genotype 1 Genotype 1 most difficult to treat (historically) Problems currently with Genotype 3 Simmonds P. Hepatology 2005;42:

3 Fibrosis Staging Stage Description 0 No Fibrosis 1 Portal Fibrosis 2 Septal Fibrosis 3 Bridging Fibrosis 4 Cirrhosis How to Diagnose F3 or F4 Fibrosis Liver Biopsy Transient Elastography Imaging (nodular contour = cirrhosis) Non invasive markers FIB 4 Score APRI Cox North PP. January Child Pugh Score 1 Point 2 Points 3 Points Total Bilirubin (mg/dl) <2 2 3 >3 Serum Albumin (g/dl) > <2.8 INR < >2.3 Ascites None Mild Moderate Severe Hepatic Encephalopathy None 5 6 Points: Child Pugh A 7 9 Points: Child Pugh B 10+ Points: Child Pugh C Controlled with medication Refractory Other Baseline Tests & Counseling Testing HIV Screening HBV Screening HAV and HBV Immunization if susceptible Counseling Transmission Risks Avoidance of Alcohol Avoidance of Hepatotoxic Medications HS Again HCV Life Cycle What is HS s most likely route of transmission of Hepatitis C? A. Vertical (mother to baby) B. Blood Transfusion C. Injection Drug Use D. Tattoo Suzuki T. Advanced Drug Delivery Reviews 2007;59:

4 Chronic HCV Treatment Goals Response Definitions Prevent complications Virological response is surrogate endpoint Prevent clinical progression Prevent death Response Name Sustained Virological Response (SVR) Sustained Virological Response 12 (SVR 12 ) Definition Undetectable viral load 24 weeks after end of treatment Undetectable viral load after end of treatment Non response Definitions Response Name Definition Null Responder Fail to achieve at least 2 log drop in viral load by week 24 Partial Responder Greater than 2 log drop in viral load, but failed to achieve undetectable levels by week 24 Virological Relapse End of Treatment Response, but detectable viral load during 24 weeks after treatment ends Breakthrough Reappearance of viral load during treatment 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% Genotype 1 Genotype 2,3 Overall SVR Rates: HCV Treatments Over Time 0% Interferon Monotherapy PEG + RBV 1st Generation PI + PEG + RBV SOF Containing Regimen Rosen HR. N Engl J Med 2011;364: , Sovaldi [package insert]. Gilead Sciences, Inc When and Whom to Treat Highest Priority: Fibrosis Stage 3 or 4 Liver Transplant Recipients Severe Extrahepatic Manifestations Other Priority Groups as Resources Allow: Fibrosis Stage 2 HIV or HBV Co infection Other Concomitant Liver Disease Debilitating Fatigue, Type 2 Diabetes, Porphyria cutanea tarda When and Whom to Treat To Prevent Transmission: MSM with High Risk Sexual Practices Active Injection Drug Users Incarcerated People Long Term Hemodialysis Patients HCV infected Women who Wish to Get Pregnant 4

5 Treatment Guidelines Treatment naïve Genotype Recommended Recommended Recommended Recommended 1a 1b SIM + SOF + RBV SIM + SOF OBV/PTV/r + DSV + RBV OBV/PTV/r + DSV x (+ RBV if cirrhosis) DCV + SOF +RBV DCV + SOF +RBV 2 SOF+ RBV (16 if cirrhosis) DCV + SOF 3 SOF + RBV + PEG DCV + SOF +RBV 4 LDV/SOFx OBV/PTV/r + RBV SOF + RBV 5, 6 LDV/SOF LDV = Ledipasvir, SOF = Sofosbuvir, SIM = Simeprevir, RBV = Ribavirin, OBV = Ombitasvir, PTV = Paritaprevir, r = Ritonavir, DSV = Dasabuvir, DCV= Daclatasvir, PEG = Peginterferon n/a Treatment Guidelines Treatment Experienced Genotype Recommended Recommended Recommended Recommended Recommended 1a 1b 1a/1b, compensated cirrhosis 24 weeks SOF + SIM* +RBV SOF + SIM* +RBV LDV/SOF + RBV x OBV/PTV/r* + DSV + RBV OBV/PTV/r* + DSV OBV/PTV/r* + DSV + RBV (24 for 1a) DCV + SOF DCV + SOF SOF + SIM* +RBV n/a n/a DCV + SOF + RBV 2 SOF+ RBV x weeks SOF + RBV + PEG DCV + SOF + RBV 3 SOF + RBV + PEG DCV + SOF + RBV 4 LDV/SOFx SOF + RBV + PEG OBV/PTV/r + RBV x SOF + RBV 5, 6 LDV/SOF SOF + RBV +PEG LDV = Ledipasvir, SOF = Sofosbuvir, SIM = Simeprevir, RBV = Ribavirin, OBV = Ombitasvir, PTV = Paritaprevir, r = Ritonavir, DSV = Dasabuvir, DCV = Daclatasvir, PEG = Peginterferon *Only for patient who did not respond to PEG/RBV (can t be a non responder to PI regimen) n/a Treatment Guidelines HIV/HCV Coinfection Same treatment as non HIV infected Do NOT interrupt HIV treatment for HCV treatment HCV Drug HIV Drugs OK HIV Drugs Not OK LDV/SOF All others EVG/Cobi, TPV OBV/PTV/r RAL, T 20, TDF, FTC, EFV, RIL, DRV, LPV/r 3TC, ATV SIM RAL, RIL, MVC, T 20, TDF, FTC, 3TC, ABC EFV, ETR, NVP, Cobi, HIV PIs RBV All others AZT, ddi, d4t LDV/SOF: Increases TDF levels Monitor CrCl Avoid in CrCl < 60mL/min OBV/PTV/r: Duplicate ritonavir Reduce/hold separate ritonavir, coadminister HIV PI with OBV/PTV/r DCV: Dose changes due to CYP 3A4 Interactions Decrease to 30mg daily with atazanavir/ritonavir Increase to 90mg daily with efavirenz or etravirine Treatment Guidelines Other Special Populations Decompensated Cirrhotics: *Specialist referral*: GT 1, 4: LDV/SOF + RBV OR 24 weeks GT 2, 3: SOF + RBV x up to 48 weeks Post Liver Transplant GT 1, 4: LDV/SOF + RBV OR 24 weeks OR SOF + SIM +RBV x weeks (GT 1 only) OR OBV/PTV/r + DSV + RBV GT 2, 3: SOF + RBV Renal Impairment CrCl > 30mL/min: all treatments ok CrCl < 30mL/min: no safety/efficacy data Treatment Guidelines: Regimens NOT Recommended Monotherapy with ANY drug PEG RBV alone Boceprevir or Telaprevir containing regimens HS Again What are the treatment options for HS (treatment experienced, genotype 1a, compensated cirrhosis)? A. LDV/SOF B. LDV/SOF + RBV C. OBV/PTV/r + DSV + RBV D. SOF + SIM +RBV E. DCV + SOF +RBV F. All of the above 5

6 Direct Acting Antiviral Drug Classes Drug Class Mechanism of Action Name Suffix NS3/4A Protease Inhibitor previr NS5A Replication Complex Inhibitor asvir NS5B Nucleot(s)ide Analog NS5B Non Nucleotide Analog Polymerase Inhibitor Polymerase Inhibitor buvir buvir NS5B Inhibitor/ NS5A Replication Complex Inhibitor Combination: Sofosbuvir/Ledipasvir (Harvoni) Genotype 1, 4, and 6 only Dosing: 400mg/90 mg daily Duration: Treatment naïve Treatment experienced without cirrhosis Treatment experienced with cirrhosis 24 weeks Side effects: Fatigue, headache, nausea, insomnia Harvoni [Package Insert]. Gilead Sciences Sofosbuvir/Ledipasvir Drug Drug Interactions Acid reducing agents PGP inducers (rifampin, carbamazepine, phenytoin, St. John s Wort, etc.) Statins Tenofovir NS5A Inhibitor/NS3/4A Protease Inhibitor/ booster + Non Nucleoside NS5B Polymerase Inhibitor: Ombitasvir/Paritaprevir/ritonavir + Dasabuvir (Viekira Pak) Genotype 1, 4 only Dosing: 2 x 12.5/75/50mg daily + 250mg BID (dasabuvir) with food Duration: weeks, depending on genotype and if cirrhotic Side Effects: Fatigue, nausea, pruritus, insomnia, asthenia Harvoni [Package Insert]. Gilead Sciences Viekira Pak [Package Insert]. Abbvie Inc Drug Drug Interactions Avoid Anticonvulsants: carbamazepine, phenytoin, phenobarbital PDE5 inhibitors: sildenafil, vardenafil, tadalafil Antiretrovirals: efavirenz, certain PIs Statins: lovastatin, simvastatin Others: gemfibrozil, rifampin, ethinyl estradiolcontaining oral contraceptives, St. John s Wort Drug Drug Interactions Monitor Antiarrhythmics: amiodarone, flecainide, propafenone, quinidine Statins: rosuvastatin, pravastatin Immunosuppressants: cyclosporine, tacrolimus Others: amlodipine, omeprazole, fluticasone, furosemide, alprazolam Viekira Pak [Package Insert]. Abbvie Inc Viekira Pak [Package Insert]. Abbvie Inc

7 Nucleotide NS5B Polymerase Inhibitor Sofosbuvir (Sovaldi) Pan genotypic Dosing: 400mg daily with or without food Side effects: Nausea, fatigue, headache, insomnia, anemia Drug drug interactions: P glycoprotein inducers decrease SOF concentrations 2 nd generation NS3/4A Protease Inhibitor Simeprevir (Olysio) Genotype 1 primarily Dosing: 150mg daily with food If failed therapy with 1 st generation PI, do not use simeprevir Adverse events: photosensitivity, rash, nausea, myalgia, dyspnea Sovaldi [Package Insert]. Gilead Sciences Olysio [package insert]. Janssen Therapeutics Simeprevir Drug Interactions: Avoid Anti convulsants: phenytoin, carbamazepine PDE5 inhibitors: sildenafil, vardenafil, tadalafil Anti retrovirals: NNRTIs, PIs Antifungals: itraconazole, posaconazole, fluconazole, voriconazole Herbals: St. John s Wort, milk thistle Other: cyclosporine, rifampin, erythromycin, clarithromycin, dexamethasone Simeprevir Drug Interactions: Monitor Statins: simvastatin, atorvastatin, rosuvastatin Calcium channel blockers: amlodipine, diltiazem, verapamil, nifedipine Immunosuppressants: tacrolimus, sirolimus Digoxin Olysio [package insert]. Janssen Therapeutics Olysio [package insert]. Janssen Therapeutics NS5A Replication Complex Inhibitor: Daclatasvir (Daklinza) Pangenotypic Dosing: 60mg daily with or without food 30mg daily with strong CYP3A4 inhibitors 90mg daily with moderate CYP3A4 inducers Adverse Events: headache, fatigue Drug drug Interactions Avoid with strong CYP3A4 inducers (phenytoin, carbamazepine, rifampin, St. John s wort) Monitor statins, digoxin Daklinza [package insert]. Bristol Myers Squibb PEG, RBV Dosing Peginterferon alfa 2a (Pegasys) 180mcg sc qweek Proclick Autoinjectors Prefilled Syringes Vials for reconstitution Peginterferon alfa 2b (PegIntron) 1.5 mcg/kg sc qweek Redipens Vials for reconstitution Both have set doses: 50mcg 150mcg Ribavirin Dosing < 75 kg: 1000 mg/day (600 mg qam/400 mg qpm) >75 kg: 1200 mg/day (600 mg BID) 7

8 PEG, RBV Adverse Drug Events Treatment Monitoring Ribavirin Anemia Teratogenicity Nausea, vomiting, diarrhea Peginterferon alfa Flu like symptoms Psychiatric symptoms Neutropenia Thrombocytopenia Alopecia Cough Injection Site Reactions HCV Viral Load baseline, 4 weeks, end of treatment, after treatment CBC baseline, 4 weeks, as indicated Liver Function Tests baseline, 4 weeks, as indicated SCr/BUN baseline, 4 weeks, as indicated TSH every if receiving peginterferon Pregnancy Test baseline and monthly if receiving ribavirin US Department of Veterans Affairs HS Again Future Therapies Which regimen would YOU choose for HS s Hepatitis C infection? A. LDV/SOF B. LDV/SOF + RBV C. OBV/PTV/r + DSV + RBV D. SOF + SIM +RBV E. DCV + SOF +RBV Asunaprevir Faldaprevir Grazoprevir GS 9857 BMS Deleobuvir GS 9669 Elbasvir GS 5816 PI 688 Summary Hepatitis C is transmitted primarily by blood to blood contact Hepatitis C can lead to chronic infections and significant morbidity and mortality Helpful Resources Guidelines: Drug Drug Interaction Database: Hepatitis C treatment involves at least 12 weeks of direct acting antiviral therapy 8

9 References American Association for the Study of Liver Disease/Infectious Disease Society of America/International Antiviral Society USA. August Accessed August 28, Centers for Disease Control and Prevention. Hepatitis C FAQs for Healthcare Professionals. March Accessed March 13, Cox North PP. Evaluation and Staging of Liver Fibrosis. January Accessed April 25, stagingmonitoring/evaluation staging/core concept/all Daklinza [package insert]. Bristol Myers Squibb. August Farnik H, Zeuzem S. New antiviral therapies in the management of HCV infection. Antivir Ther. 2012;17: Ghany MG, Strader DB, Thomas DL, et al. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 2009;49: Harvoni [package insert]. Gilead Sciences, Inc. March Lavanchy D. The global burden of hepatitis C. Liver Int 2009;29: Manns MP, Foster GR, Rockstroh JH, et al. The way forward in HCV treatment finding the right path. Nat Rev Drug Discov. 2007;6: References Olysio [package insert]. Janssen Therapeutics. March Rosen HR. Chronic Hepatitis C infection. N Engl J Med 2011;364: Shepard CW, Finelli L, Alter MJ. Global epidemiology of hepatitis C virus infection. Lancet Infect Dis 2005;5: Simmonds P, Bukh J, Combet C, et al. Consensus proposals for a unified system of nomenclature of hepatitis C virus genotypes. Hepatology 2005;42: Sovaldi [package insert]. Gilead Sciences, Inc. March Suzuki T, Ishii K, Aizaki K, et al. Hepatitis C viral life cycle. Advanced Drug Delivery Reviews 2007;59: United States Preventive Services Task Force. Screening for Hepatitis C Virus in Adults. June Accessed March 23, United States Department of Veterans Affairs. Interferon and Ribavirin Treatment Side Effects. March Accessed March 13, side effects.asp Viekira Pak [package insert]. Abbvie Inc. March World Health Organization. Hepatitis C Fact Sheet. April Accessed March 13, Updates in Hepatitis C Treatment 2015 Lindsey Childs Kean, PharmD, MPH, BCPS Clinical Assistant Professor Department of Pharmacotherapy and Translational Research University of Florida College of Pharmacy St. Petersburg Campus 9

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