HEPATITIS C (HCV) CME ACCREDITED INTERACTIVE TRAINING 2015

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1 CME ACCREDITED INTERACTIVE TRAINING SESSION: HEPATITIS C 2015 LIVER DISEASE Community Academic Research

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3 CME ACCREDITED INTERACTIVE TRAINING SESSION: HEPATITIS C (HCV) INTRODUCTION This event was an Accredited Group Learning Activity (Section 1) as defined by the Maintenance of Certification program of The Royal College of Physicians and Surgeons of Canada, and approved by the University of Calgary Office of Continuing Medical Education and Professional Development. Participants claimed 1.0 study credit for their participation. During the CARE at DDW 2015 Education Program, CARE Liver Disease Faculty member Dr. Hemant Shah (Toronto Western Hospital) ran an interactive training session that provided a review of the major developments in the Hepatitis C Virus (HCV) in recent years. Topics included in his presentation were epidemiology of HCV, how to screen and assess patients, and most prominently, preferred treatment options available. Dr. Shah presented this content on behalf of the rest of the CARE Liver Disease Faculty involved in the development of this slide deck. Members include: Dr. Hemant Shah (ON, University Health Network) Dr. Jordan Feld (ON, University Health Network) Dr. Alnoor Ramji (BC, St. Paul s Hospital) Dr. Sergio Borgia (ON, William Osler Health Centre) Dr. Sayumya Jayakumar (AB, Alberta Health Services) Liver Disease

4 2 CME ACCREDITED INTERACTIVE TRAINING SESSION: HCV CME ACCREDITED INTERACTIVE TRAINING SESSION: HEPATITIS C (HCV) HCV REVIEW Prevalence & Impact Prevalence of HCV has increased by 2.3% from 1990 to , with million people infected worldwide. 2 The prevalence in Canada is estimated at about 250,000, but this is likely too low due to underdiagnosis of the virus. In actuality, HCV affects closer to 400,000 people in Canada. 3 Each year in Canada, there are approximately 3,469 new cases of HCV and an estimated 369 deaths. 4 The burden of HCV is greatest among men aged The most common methods of transmission for HCV are exposure to injection drug use (58%), blood transfusions (11%), hemophilia (0.4%), and other (31%). 3 Pathogenesis and Natural History of HCV Persons infected with HCV develop acute infection, for which only 20-30% are symptomatic. Of those who develop an acute infection, approximately 25-40% will experience spontaneous clearance of the HCV RNA % go on to develop a chronic infection. Patients with chronic disease will eventually develop cirrhosis, and if left untreated/undetected 1-4% can develop hepatocellular carcinoma (HCC). It is important to screen for at risk patients in order to treat earlier and prevent any further problems. SCREENING The increasing rate of HCV-related morbidity/mortality in North America is primarily the result of a largely unidentified cohort of baby boomers ( ). 5 The Centers for Disease Control and Prevention (CDC) in the U.S. estimates that baby boomers account for three fourths of all HCV infections and that anywhere from 45-85% of those living with HCV infection are unaware that they have it. 5 The CDC has now recommended that baby boomers be screened for HCV. Individuals who have participated or been exposed to the higher risk factors outlined below in Table 1 should be screened for HCV. 6 TABLE 1: RISK FACTORS THAT SUGGEST SCREENING FOR HCV HIGH RISK INTERMEDIATE RISK OTHER Injection Drug Use (IDU): past, present, or even just once Incarceration: exposures to injection or tattooing materials, physical trauma, unprotected sex Born, traveled, or resided in a region in which HCV infection is more common Receipt of health care where there is a lack of universal precautions Blood transfusions, blood products, or organ transplant before 1992 in Canada Hemodialysis Infant born to mother with HCV infection Needle stick injuries Sharing sharp instruments/personal hygiene materials, tattooing, body piercing, scarification, female genital mutilation, intranasal/inhalation drug use, homelessness, higher risk sexual behaviour

5 CME ACCREDITED INTERACTIVE TRAINING SESSION: HCV 3 ASSESSMENT There are three main components of assessment. 1. Severity of liver disease (fibrosis) Ideally recognize early stages of fibrosis to prevent liver-related complications and treat before development of cirrhosis Non-invasive techniques and laboratory tests (including serum panels and transient elastography (Fibroscan)) are replacing previous gold standard liver biopsy Transient elastography is a simple ultrasound-based technique that determines liver stiffness and correlates well with fibrosis, however it fails in up to 20% of patients (especially the overweight/obese) Non-invasive tools are good for cirrhosis vs minimal fibrosis and have high correlation with biopsy (adequate for most HCV patients) 2. Co-morbidities May alter decisions about need for or type of therapy Concomitant diseases or other health issues may take priority over HCV, though medical history is important Pay particular attention to cardiac history (RBV related anemia), renal disease, seizure disorders, psychiatric/autoimmune disorders, hemoglobinopathy and HIV co-infection 3. Extra-hepatic manifestations (EHM) of the hepatitis C virus Up to 75% of patients will develop an EHM during their illness Many conditions and syndromes (eg. cryoglobulinaemia) linked to hepatitis C, others still emerging Patients will often need to be treated for other indications as well 7 TREATMENT The treatment landscape for HCV has changed drastically over the past year. There are a number of guidelines (AASLD/ EASL, Canadian guidelines) that have been developed to help specialists with treatment decisions. What follows is an overview of treatment recommendations and evidence based-research to support the different treatment options for Genotype 1, 2 and 3 patients. Genotype 1 Table 2 and 3 below outline the preferred treatment options for genotype 1 HCV patients. TABLE 2: TREATMENT-NAÏVE G1 PATIENTS PATIENT TYPE Genotype 1a, Genotype 1b, Genotype 1a, Genotype 1b, FIRST LINE SOF/LDV x 8-12w * 3D x 12w SOF/LDV x 8-12w * SOF/LDV x 12w SOF/LDV x 12w ALTERNATIVE (IFN-FREE) * Consider use of 12-week SOF/LDV regimen if baseline HCV RNA 6 million IU/mL. TABLE 3: TREATMENT-EXPERIENCED G1 PATIENTS PATIENT TYPE Genotype 1a, Genotype 1b, Genotype 1a, Genotype 1b, FIRST LINE SOF/LDV x 12w 3D x 12w SOF/LDV x 12w * SOF/LDV/RBV x 12w SOF/LDV/RBV x 12w ALTERNATIVE (IFN-FREE) SOF/LDV x 24w SOF/LDV x 24w *, G1a, null responders treated with 3D+RBV should receive 24 weeks of therapy.

6 4 CME ACCREDITED INTERACTIVE TRAINING SESSION: HCV TREATMENT HARVONI (Sofosbuvir/Ledipasvir) HARVONI was the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection. The treatment duration is either 8, 12 or 24 weeks depending on prior treatment history, cirrhosis status, and baseline viral load. Eight weeks with sofosbuvir+ledipasvir can be considered for treatment naïve patients without cirrhosis who have a baseline HCV load under 6 million IU/mL. Three studies (ION-1, ION-2, and ION-3) examined sofosbuvir and ledipasvir at 12 and 24 weeks in three patient populations: GT1 treatment naïve including cirrhotics, GT1 treatment naïve non-cirrhotic, and GT1 treatment-experienced including cirrhotics and PI failures. Each study achieved an overall SVR rate of 97%, and of the failures, only 0.1% had a breakthrough (due to nonadherence). See Figure 1. Many other studies over the course of 2014/2015 have reinforced the efficacy of sofosbuvir in terms of high SVR rates. LDV/SOF LDV/SOF+RBV SVR12(%) / 211/ 212/ 215/ 202/ 201/ 206/ 102/ 107/ 108/ 110/ weeks 24 weeks 8 weeks 12 weeks 12 weeks 24 weeks ION-1 ION-3 ION-2 GT 1 treatment-naïve non-cirrhotic cirrhotics and P1 failures GT 1 treatment-naïve GT 1 treatment experienced including including cirrhot- FIGURE 1: PHASE 3 SUMMARY OF ION-1, ION-2, AND ION-3 HOLKIRA PAK (3D ± R): This combination is comprised of paritaprevir (ABT-450), ritonavir, ombitasvir (ABT-267) and dasabuvir (ABT-333). It is approved in Canada for usage in Genotype 1 patient populations. The Phase III SAPPHIRE-I and -II trials demonstrated high rates of sustained virologic response (96%) to this 12-week interferon-free regimen among non-cirrhotic, treatment-naïve and treatment-experienced patients with HCV genotype 1. Response rates did not differ by HCV subtype (1a vs. 1b) or prior treatment response (partial responder, relapser, vs. null responder), and an additional trial (TURQUOISE-1) revealed encouraging results among patients with compensated cirrhosis (SVR12, 92%). See Figure 2. This regimen was generally well tolerated although ribavirin-related side effects including hemolytic anemia, and drug-drug interactions, including those attributable to ritonavir, will require consideration with the clinical use of this therapy. The PEARL III and IV studies further exemplified the high SVR rates and also showed that RBV is not needed for G1b non-cirrhotic patients. However, G1a null-responder cirrhotics are one group that may benefit from 24 weeks of 3D+R SAPPHIRE-I SAPPHIRE-II PEARL-III PEARL-II PEARL-IV TURQUOISE-II / SVR12(%) Overall GT1a GT1b Overall GT1a GT1b RBV Without RBV Without RBV Without 12wks 24wks RBV RBV RBV tx tx Cirrhosis Treatment Naïve Experienced Naïve Experienced Naïve Naïve/Experienced Subtype GT1a/b GT1a/b GT1b GT1b GT1a GT1a/b FIGURE 2: SUMMARY OF 3D ± R PHASE 3 TRIALS

7 CME ACCREDITED INTERACTIVE TRAINING SESSION: HCV 5 GENOTYPE 2 & 3 Tables 4 and 5 below outline the preferred treatment options for genotype 2 and genotype 3 patients. TABLE 4: PREFERRED TREATMENT OPTIONS FOR GENOTYPE 2 HCV PATIENTS PATIENT TYPE FIRST LINE ALTERNATIVE (IFN-FREE) Treatment-naïve SOF/RBV x 12w None Treatment-experienced, Treatment-experienced, ** Inferior regimen SOF/RBV x 12w SOF/PEG/RBV X 12w None SOF/RBV x 16w** TABLE 5: PREFERRED TREATMENT OPTIONS FOR GENOTYPE 3 HCV PATIENTS PATIENT TYPE FIRST LINE ALTERNATIVE (IFN-FREE) Treatment-naïve, SOF/RBV x 24w SOF/LDV/RBV x 12w Treatment-naïve, SOF/RBV x 24w SOF/LDV/RBV x 12w Treatment-experienced, Treatment-experienced, SOF/RBV x 24w SOF/PEG/RBV x 12w SOF/LDV/RBV x 12w SOF/RBV x 24w* SOF/LDV/RBV x 12w *SOF/RBV x 24w is effective for G3 patients except for treatment-experienced cirrhotic Sofosbuvir: In the FUSION trial, for patients with HCV G2 or G3, treatment with sofosbuvir and ribavirin was effective for patients where peginterferon and ribavirin was not an option. Efficacy was increased among patients with G2 infection and those without cirrhosis. Data from this study along with the VALENCE study shows that 12 weeks of SOF/RBV may not be enough for treatment experienced patients with G2. In previously treated patients with HCV genotype 3 infection, 16 weeks of therapy was significantly more effective than 12 weeks. Genotype 3 patients are regarded as among the most difficult to treat patients The VALENCE trial, showed Sofosbuvir plus Ribavirin (SOF-RBV) for 24 weeks in G3 patients achieved an SVR12 rate of 90% in non-cirrhotic patients but only 64% in patients with cirrhosis. The LONESTAR-2 trial (a small phase II trial) showed SOF plus peg/rbv for 12 weeks achieved an SVR rate of 83% in all genotype 3 patients (regardless of cirrhosis status). The BOSON 3 trial (presented at EASL 2015), showed that genotype 3 treatment-experienced cirrhotic patients achieved an SVR rate of 86% with SOF-Peg/RBV. The results validate that therapeutic options still need to be further investigated for this patient population. CONCLUDING REMARKS The landscape of hepatitis C will continue to change. By understanding when to screen patients, what the risk factors are, how to assess a patient, and the most appropriate therapy for each genotype, it is possible to provide the best patient care. For more information, please visit us at

8 ABOUT THE LIVER DISEASE FACULTY The CARE (Community. Academic. Research. Education) Faculty is a pan-canadian group of leaders in their field who gather, discuss and address gaps in knowledge, to develop education initiatives that frame news from a Canadian perspective. The vision of the CARE Faculty is to share opinions and update Canadian specialists with news and developments from key conferences framed in a Canadian perspective. The mission of the CARE Faculty is to enhance medical education, with the explicit goal of improving patient outcomes. This CARE PUBLICATION provides educational updates on current trends in medicine. Views expressed in this report are those of the faculty. All information is provided for general informational purposes only, on an as is basis, without any representations, warranties or conditions, whether express or implied, statutory or otherwise, including, without limitation, any representations, warranties or conditions as to quality, accuracy, completeness, currency, reliability, efficacy, or fitness for a particular purpose. This information is not a substitute for informed medical advice. Support for the distribution of this report was provided by Gilead Sciences Inc. Copyright 2015 by CARE. All rights reserved. This publication or any portion thereof, in print, electronic copy or any other form, cannot be reproduced without the express written consent of CARE. Any information, data, analysis, or results reproduced from another source remains the property of its authors.

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