HEPATITIS C DISCUSSION GUIDE:

Transcription

1 HEPATITIS C DISCUSSION GUIDE: INFORMATION AND ANSWERS TO AID YOUR COUNSELING OF PATIENTS INDICATION HARVONI is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults. Warnings and Precautions Risk of Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with HARVONI due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia. Risk of Reduced Therapeutic Effect of HARVONI Due to P-gp Inducers: Rifampin and St. John s wort are not recommended for use with HARVONI as they may significantly decrease ledipasvir and sofosbuvir plasma concentrations. Related Products Not Recommended: HARVONI is not recommended for use with other products containing sofosbuvir (SOVALDI ). Adverse Reactions Most common ( 10%, all grades) adverse reactions were fatigue and headache. Drug Interactions In addition to rifampin and St. John s wort, coadministration of HARVONI is also not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of ledipasvir and sofosbuvir, reducing the therapeutic effect of HARVONI. Coadministration of HARVONI is not recommended with simeprevir due to increased concentrations of ledipasvir and simeprevir. Coadministration is also not recommended with rosuvastatin or co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate due to increased concentrations of rosuvastatin and tenofovir, respectively. Consult the full Prescribing Information for HARVONI for more information on potentially significant drug interactions, including clinical comments. Please see full Prescribing Information at

2 CHRONIC HEPATITIS C (HEP C) GENOTYPE 1 (GT 1) PATIENT DISCUSSION GUIDE CHANGE IN HEP C CAN START WITH YOU GUIDE CONTENTS: SCREEN DIAGNOSE CONNECT ABOUT HARVONI The goal for Hep C patients is to achieve cure. Cure, also known as sustained virologic response (SVR), is defined as no detectable hepatitis C virus (HCV) in the blood at 12 or more weeks after therapy is complete. 2,3 To help your patients with that goal, use this guide to: Counsel your patients about Hep C Answer any questions that may arise Inform them about HARVONI as a treatment option for chronic HCV GT 1 adult patients Warnings and Precautions Risk of Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with HARVONI due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia. Risk of Reduced Therapeutic Effect of HARVONI Due to P-gp Inducers: Rifampin and St. John s wort are not recommended for use with HARVONI as they may significantly decrease ledipasvir and sofosbuvir plasma concentrations. Related Products Not Recommended: HARVONI is not recommended for use with other products containing sofosbuvir (SOVALDI ). Adverse Reactions Most common ( 10%, all grades) adverse reactions were fatigue and headache. YOUR ROLE You play a critical role in the management of your patients Hep C. Connection to treatment evaluation starts with you from screening patients to linking them to specialist care. Let s begin! 2

3 SCREENING FOR HEP C ANTIBODIES Of the approximately 3.5 million Americans with chronic Hep C infection, only half have been diagnosed. 4 KEY POINTS: In the United States, Hep C is the most common chronic bloodborne infection 5 50% of chronic Hep C patients in the United States are undiagnosed they don t know they have the infection 4 Three-quarters of all those infected with Hep C are baby boomers (people born between 1945 and 1965) 6 The Centers for Disease Control and Prevention (CDC), US Preventive Services Task Force (USPSTF), and American Association for the Study of Liver Diseases (AASLD) recommend a one-time screening of all baby boomers for Hep C, regardless of other risk factors 3,7,8 For a comprehensive list of other reasons and risk factors for screening, visit Screening for Hep C antibodies is accomplished through a simple blood test A positive Hep C antibody test result does not necessarily mean your patient has an active infection. Another blood test is needed to confirm the diagnosis of Hep C. (If you choose a lab s reflex-testing option at the screening step, a second blood draw will not be necessary if your patient s antibody test is positive) Hep C can be cured with treatments that are interferon-free and offer simple dosing PATIENT What is Hep C and why should I be screened for it? Hep C is an inflammation of the liver caused by a viral infection. It is important to identify if you have Hep C because the virus can damage your liver. Hep C can be cured. Will my insurance cover the screening test? As of September 2010, all new private health plans must pay for screening of persons at high risk for infection and for the one-time screening of baby boomers, those born between 1945 and Medicare patients are covered without cost-sharing. Also, most state Medicaid programs cover preventive services for adults. 9 3

4 DIAGNOSING CHRONIC HEP C INFECTION About 15%-25% of patients clear the Hep C virus spontaneously within the first few months after initial infection. 10 KEY POINTS: If the antibody screening test is positive, a second blood test that detects and measures the amount of Hep C RNA (viral load) is needed to confirm a chronic infection Your patient will need to have another blood draw if the reflex-testing option was not selected when you ordered the screening test If the RNA test result is positive, your patient has an active Hep C infection, which means the virus is present in the blood Patients who do not have symptoms or who have a low viral load can still have liver disease progression 11 Remind the patient that Hep C can be cured PATIENT How did I get Hep C? How long have I had it? Hep C is a bloodborne virus that is spread by direct contact with the blood of an infected person. 12 It is possible to get Hep C by injecting drugs or using nonsterile tattoo needles. People who received blood transfusions before 1992 may also be at risk of having Hep C infection. While less likely, it s also possible to get it by sharing personal care items such as toothbrushes, razors, or nail clippers with someone who has Hep C. However, it cannot be spread through casual contact, including shaking hands or sharing food and drinks. There is more information about the ways it can be transmitted at We may never know exactly when you contracted Hep C. (Through sensitive patientphysician questioning and dialogue, a risk factor from your patient s history may be revealed.) What is Hep C doing to my body? Why was my Hep C antibody test result positive, but my Hep C RNA test result was negative? Now that you ve confirmed I have Hep C, what happens next? Hep C is a serious disease that can result in longterm health problems, including liver damage, liver failure, or even death. 13 A negative Hep C RNA test result means you were exposed to the virus, but you are not chronically infected with Hep C. The next step is to connect you with a Hep C specialist who will evaluate you for treatment. 4

5 CONNECTING PATIENTS TO A HEP C SPECIALIST Your staff s assistance in scheduling the first appointment can help ensure the patient follows through on the initial visit to the Hep C specialist. KEY POINTS: Tell your patient that you would like him/her to see a Hep C specialist Explain that the Hep C specialist will conduct more tests to evaluate the patient s liver health and determine treatment options Select a specialist who: Has experience currently treating patients with Hep C Is accepting new patients Can accommodate cultural or language preferences Has an office conveniently located for your patient The Hep C specialist will evaluate the patient and then discuss treatment options and next steps Assure the patient that you will be available to answer questions after the first specialist appointment and throughout treatment At the end of the discussion with your patient, make sure: You have answered any questions he/she may have Your patient is motivated to move forward to possible treatment PATIENT What kind of tests will the specialist do? Will you contact the specialist or help me contact the specialist to make an appointment? [If not already performed,] the specialist will confirm the diagnosis with a test that measures how much virus is in your blood (viral load). The specialist will also run tests to determine your genotype and to assess the health of your liver. I can assist you in scheduling the specialist appointment, and will contact you after the appointment as a follow-up. 5

6 HARVONI OVERVIEW KEY POINTS: HARVONI is the simplest regimen available for adult patients with chronic HCV genotype 1, 1 the most common genotype in the US. 14 HARVONI is an interferon- and ribavirin-free tablet taken once daily for 12 weeks in most patient types and can be considered for 8 weeks in treatment-naïve, non-cirrhotic patients with baseline viral load <6 million IU/mL. 1 For treatment-experienced patients with cirrhosis, 24 weeks of treatment is recommended 1 HARVONI delivered cure (sustained virologic response, or SVR) rates of 94% 99% across Hep C genotype 1 subjects 1,a,b,c,d High cure (SVR) rates were observed in a broad range of subjects, including those with cirrhosis, previous treatment experience, advanced age, and high BMI 1,15-17 HARVONI clinical studies did not exclude subjects taking diabetes medications or subjects who were stable on an anticoagulant regimen The most commonly observed side effects ( 10%, all grades) with HARVONI were fatigue (13% 18%) and headache (11% 17%). 1 Discontinuation rates due to adverse events (AEs) were 0% 1% across HARVONI clinical trials 1 Study Designs a ION-1 1,15 : a randomized, open-label trial evaluating HARVONI with or without ribavirin (RBV) in genotype 1 treatment-naïve subjects (N=865) with or without cirrhosis. Subjects were randomized in a 1:1:1:1 ratio to receive HARVONI for 12 weeks, HARVONI + RBV for 12 weeks, HARVONI for 24 weeks, or HARVONI + RBV for 24 weeks, and stratified by presence or absence of cirrhosis and HCV genotype (1a vs 1b). SVR rates for all treatment-naïve subjects enrolled in the 24-week treatment groups in the ION-1 trial (N=434) were not available at the time of the interim analysis. b ION-2 1,16 : a randomized, open-label trial evaluating HARVONI with or without RBV in genotype 1 HCV-infected subjects (N=440) who failed prior therapy with an interferon (IFN)-based regimen, including regimens containing an HCV protease inhibitor. Subjects were randomized in a 1:1:1:1 ratio to receive HARVONI for 12 weeks, HARVONI + RBV for 12 weeks, HARVONI for 24 weeks, or HARVONI + RBV for 24 weeks, and stratified by presence or absence of cirrhosis, HCV genotype (1a vs 1b), and response to prior therapy (relapse/breakthrough vs nonresponse). c ION-3 1,17 : a randomized, open-label trial in genotype 1 treatment-naïve subjects (N=647) without cirrhosis. Subjects were randomized in a 1:1:1 ratio to receive HARVONI for 8 weeks, HARVONI + ribavirin (RBV) for 8 weeks, or HARVONI for 12 weeks, and stratified by HCV genotype (1a vs 1b). d Sustained virologic response (SVR) was the primary endpoint and was defined as HCV RNA less than LLOQ (25 IU/mL) at 12 weeks after the cessation of treatment. 1 Achieving SVR is considered a virologic cure. 2 Relapse was a secondary endpoint. 1 Drug Interactions In addition to rifampin and St. John s wort, coadministration of HARVONI is also not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of ledipasvir and sofosbuvir, reducing the therapeutic effect of HARVONI. 6

7 PATIENT What is HARVONI? What are my chances for getting cured with HARVONI? What possible side effects can I expect? HARVONI is a treatment for adults with chronic hepatitis C genotype 1 infection, 1 which is the most common type of Hep C in the US. 14 Your Hep C specialist will determine the length of your treatment which depends on whether or not you ve been treated before, the level of virus in your body, and how advanced your liver disease is. With HARVONI, there are no interferon injections, ribavirin, or complex regimens. 1 In clinical trials, HARVONI cured 94%-99% of subjects with the most common type of Hep C, regardless of whether the subject had previously been treated for Hep C or not. 1 The cure rate for the 8-week treatment consideration for subjects who had never been treated, did not have cirrhosis, and had lower levels of Hep C in the blood (<6 million IU/mL) was 97% in clinical trials. 1 (See previous page for study design information.) The most common side effects of HARVONI include tiredness and headache. 1 What will my Hep C specialist want to know about my health before starting HARVONI? The Hep C specialist will need to know about: Any liver problems other than hepatitis C infection Any severe kidney problems or dialysis Any other medical conditions you have Current pregnancy or plans to become pregnant. It is not known if HARVONI will harm an unborn baby 1 Current breastfeeding or plans to breastfeed. It is not known if HARVONI passes into breast milk 1 Drug Interactions, continued Coadministration of HARVONI is not recommended with simeprevir due to increased concentrations of ledipasvir and simeprevir. Coadministration is also not recommended with rosuvastatin or co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate due to increased concentrations of rosuvastatin and tenofovir, respectively. Consult the full Prescribing Information for HARVONI for more information on potentially significant drug interactions, including clinical comments. 7

8 PATIENT What should I consider if I m taking other medications? Discuss with your Hep C specialist all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. HARVONI may affect the way certain other medicines work, and other medicines may affect how HARVONI works. 1 Where can I get more information on HARVONI? Support Path is a program for patients that offers educational resources as well as a 24/7 help line that you can call with any questions. Call MYPATH ( ) or visit mysupportpath.com. You can also visit the HARVONI website at harvoni.com. Will my insurance cover HARVONI and what part of the cost will I pay? Support Path can help you understand your insurance costs, verify your benefits, and assist with the prescription approval process. There is also a HARVONI co-pay coupon for eligible patients with commercial insurance. Warnings and Precautions Risk of Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with HARVONI due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia. Risk of Reduced Therapeutic Effect of HARVONI Due to P-gp Inducers: Rifampin and St. John s wort are not recommended for use with HARVONI as they may significantly decrease ledipasvir and sofosbuvir plasma concentrations. Related Products Not Recommended: HARVONI is not recommended for use with other products containing sofosbuvir (SOVALDI ). Adverse Reactions Most common ( 10%, all grades) adverse reactions were fatigue and headache. 8

9 Drug Interactions In addition to rifampin and St. John s wort, coadministration of HARVONI is also not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ ritonavir. Such coadministration is expected to decrease the concentration of ledipasvir and sofosbuvir, reducing the therapeutic effect of HARVONI. Coadministration of HARVONI is not recommended with simeprevir due to increased concentrations of ledipasvir and simeprevir. Coadministration is also not recommended with rosuvastatin or coformulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate due to increased concentrations of rosuvastatin and tenofovir, respectively. Consult the full Prescribing Information for HARVONI for more information on potentially significant drug interactions, including clinical comments. Please see full Prescribing Information at REFERENCES: 1. HARVONI Prescribing Information. Gilead Sciences, Inc. Foster City, CA. March US Department of Health and Human Services, Center for Drug Evaluation and Research. Draft Guidance for Industry. Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. October AASLD, IDSA, IAS-USA. Recommendations for testing, managing, and treating hepatitis C. Accessed January 5, Yehia BR, Schranz AJ, Umscheid CA, Re VL. The treatment cascade for chronic hepatitis C virus infection in the United States: a systematic review and meta-analysis. PLoS ONE. 2014;9(7): Centers for Disease Control and Prevention. Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. MMWR Morb Mortal Wkly Rep. 1998;47(RR-19): Centers for Disease Control and Prevention. Hepatitis C information for health professionals: statistics and surveillance. hepatitis/hcv/statisticshcv.htm. Updated September 13, Accessed October 24, Smith BD, Morgan RL, Beckett GA, et al. Recommendations for the identification of chronic hepatitis C virus infection among persons born during MMWR Recomm Rep. 2012;61(RR-4): US Preventive Services Task Force. Screening for hepatitis C virus infection in adults: US Preventive Services Task Force recommendation statement. Published June 25, Accessed October 24, Health Affairs. Health policy brief: preventive services without cost sharing. Health Aff (Millwood). December 28, Chen SL, Morgan TR. The natural history of hepatitis C virus (HCV) infection. Int J Med Sci. 2006;3(2): Heller T, Seeff LB. Viral load as a predictor of progression of chronic hepatitis C. Hepatology. 2005;42(6): Centers for Disease Control and Prevention. HIV/AIDS and viral hepatitis. Updated March 6, Accessed January 22, Centers for Disease Control and Prevention. Hepatitis C FAQs for the public. Updated December 9, Accessed January 22, Nainan OV, Alter MJ, Kruszon-Moran D, et al. Hepatitis C virus genotypes and viral concentrations in participants of a general population survey in the United States. Gastroenterology. 2006;131(2): Afdhal N, Zeuzem S, Kwo P, et al; for the ION-1 Investigators. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014;370(20): Afdhal N, Reddy KR, Nelson DR, et al; for the ION-2 investigators. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014;370(16): Kowdley KV, Gordon SC, Reddy KR, et al; for the ION-3 Investigators. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014;370(20): Protocol for: Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014;370: Protocol for: Afdhal N, Reddy KR, Nelson DR, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014;370: Protocol for: Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014;370: HARVONI, the HARVONI logo, SOVALDI, SUPPORT PATH, GILEAD, and the GILEAD logo are trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners Gilead Sciences, Inc. All rights reserved. HVNP /15