Hepatitis C Update on New Treatments

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1 Hepatitis C Update on New Treatments Kevork M. Peltekian, MD, FRCPC 44th Annual Dalhousie Spring Refresher Course - Therapeutics April 5 - April 7, 2018 Halifax Convention Centre

2 Disclosures Conflicts of Interest Neither I, nor any immediate family member has any financial relationship with, or interest in, any commercial interest connected with this presentation. Off-Label Drug Use The of material in this CPD activity will not include discussion of unapproved or investigational uses of products or devices.

3 Why Do We Need To Engage You? Modelled Prevalence is 1.0% (Plausibility Range %) 3

4 When Do We Need To Engage You? 4

5 How Do We Need To Engage You? The Canadian Liver Foundation recommends that all adults (baby-boomers) born between 1945 and 1975 be tested for hepatitis C once. 5

6 Is There Another Reason To Engage You? HCV in the US: Gaps in Practice 1. Yehia BR, et al. PLoS One. 2014;9:e

7 Questions I Will Try Answer What is new regarding HCV treatment? Who is eligible for treatment of HCV? Why should every primary care providor be diligent in identifying HCV cases and treating them? 7

8 Case: 56-Yr-Old Woman Presenting to Primary Care A 56-yr-old woman visits your office She has recently moved to the area following a promotion and is looking for a primary care clinician She is not aware of having been tested for hepatitis C virus infection previously The Canadian Liver Foundation recommends that all adults (baby-boomers) born between 1945 and 1975 be tested for hepatitis C once.

9 Talking to Patients About Hepatitis C Testing CDC. Guide to Comprehensive Hepatitis C Counseling and Testing.

10 Current All-Oral Therapies Highly Effective

11 Back to Our Case A 56-yr-old woman visits your office She has recently moved to the area following a promotion and is looking for a primary care clinician Routine hepatitis C antibody test: reactive (positive) and her HCV RNA by PCR is detectable with HCV viral load reported in Log10 is 5.78 IU/L or 600,000 IU/L

12 Counseling for HCV-Infected Individuals AASLDIDSA. HCV Guidelines 2017.

13 Recommendations for Additional Follow-up of Initial HCV Testing Testing for hepatitis C genotype all genotypes can be treated, but genotype will guide choice of antiviral therapy Ultrasound to look for signs of portal hypertension (advanced cirrhosis) and identify fatty liver disease Testing for HBsAg and HIV Testing for CBC, renal (Cr) + liver functions (INR, Bilirubin, Albumin) and enzymes (ALT, AST, ALP) Assess presence of cirrhosis by: Clinical or Laboratory Testing Liver Biopsy (invasive) FIB-4 Index (simple) Imaging by Elastography VCTE Fibroscan (long wait list) MR Elastography (limited and expensive)

14 Back to Our Case FIB-4 Index = (54 64) (155 68) = 2.70 (F2-3) 14

15 Recommendations for When and in Whom to Initiate HCV Treatment Treatment for all: Unless pts already have short life expectancy, treatment is recommended for all pts with chronic HCV infection, regardless of genotype and fibrosis level [1] Treatment even at lower-stage fibrosis (F0-F1) improves survival [1] Barriers to access: Contrary to these recommendations, some insurers including provincial pharmacare restrict coverage to pts with F2-F4 (moderate fibrosis or cirrhosis) [2] 1. AASLD/IDSA. HCV Guidelines. April DHHS National Viral Hepatitis Action Plan

16 Potential Future Scenario When to Refer to an Experienced Hepatitis C Treater Treatment naïve HCV infection Re-infection (not relapse) with HCV No advanced fibrosis Renal impairment Active substance use Prior treatment with pegylated interferon/ribavirin HIV or HBV coinfection Compensated or decompensated (ascites, encephalopathy or bleeding varices) cirrhosis Recurrent HCV after liver transplantation Liver mass

17 HCV Therapy Regimens Maverit Zepatier Harvoni Epclusa Vosevi 17

18 Recommendations for First Line Therapy for HCV 18

19 Adverse Events Newer hepatitis C medications do not have same adverse events as interferon and are generally well tolerated Most common adverse events and management strategies in pre-education session Headaches: nonpharmacologic management strategies, limits of OTC pain relievers and liver disease Anemia: still a concern when ribavirin needed (not used as first line therapy anymore) Other common adverse events: fatigue, nausea, diarrhea Encourage pts to report bothersome or unusual adverse events

20 Pretreatment: Look for Potential Drug Drug Interactions Review all herbals/supplements, prescription and OTC medications, including contraceptives and proton pump inhibitors Ask about PRN usage of other drugs Consult with clinical pharmacist when possible Key resource:

21 Recommended Follow-up After Hepatitis C Treatment Virologic cure does not protect against reinfection AASLD/IDSA. HCV Guidelines 2017.

22 Benefits of Curing HCV Extend Beyond the Liver SVR 12 weeks after completing Rx 1. Smith-Palmer J, et al. BMC Infect Dis. 2015;15: Negro F, et al. Gastroenterology. 2015;149: George SL, et al. Hepatology. 2009;49:

23 Key Points All pts born should be screened for hepatitis C virus infection Virtually all pts with hepatitis C virus infection should be treated, regardless of genotype and fibrosis Prevents morbidity, progression of fibrosis, hepatocellular carcinoma Many pts can be treated in primary care setting Refer pts with decompensation (ie, ascites) Current treatments include pangenotypic and ribavirin-free options More than 95% rate of cure for most genotypes Most therapies are 8-12 wks, ribavirin free, all oral, once daily

24 Questions or Comments Send me an if you are interested in becoming HCV treater

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