HCV in 2017: New Therapies and New Opportunities. Presentation prepared by: Date prepared: OBJECTIVES
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1 Project ECHO HCV Collaborative HCV in 217: New Therapies and New Opportunities Paulina Deming, PharmD Assistant Director Hepatitis C Programs, ECHO Institute Associate Professor College of Pharmacy University of New Mexico Health Sciences Center Albuquerque, NM August 15, 217 Presentation prepared by: Date prepared: OBJECTIVES For pharmacists: 1. Describe the clinical and economic burden associated with hepatitis C virus (HCV) infection 2. Describe new therapeutic options for the treatment of chronic HCV 3. Use national algorithms and guidelines to guide treatment strategies for patients with HCV infection 4. Discuss challenges to HCV treatment in New Mexico For technicians: 1. Identify risk factors for chronic HCV infections 2. Recognize new HCV therapies 3. Describe health systems challenges which can affect outcomes of HCV therapy 4. Identify challenges to HCV treatment 1
2 Hepatitis C is a Global Health Problem Estimated 17 million persons with HCV infection worldwide Prevalence of infection > 1% 2.5%-1% 1%-2.5% NA World Health Organization 28 ( Hepatitis C Genotypes 6 major genotypes (1 6), most with subtypes Genotype 1 GT 1b different than GT 1a GT 2 easier to treat than GT 3 GT 3 associated with higher mortality, steatohepatitis Alter MJ et al. N Engl J Med 1999; 341:
3 Risk Factors for HCV Infection Persons born between Received blood transfusion or organ donation prior to 1992 Current or former injection drug users Chronic hemodialysis patients Any known blood exposure to HCV positive blood Persons with HIV Children born to HCV infected mother Hepatitis C: Progression of Disease Time Normal Liver 2 25 years 25 3 years Chronic Hepatitis HCV Infection Cirrhosis HCC ESLD Death 3
4 HCV is Not Just a Liver Disease Common Symptoms of HCV in Absence of Cirrhosis Fatigue Impaired cognitive function (brain fog) Migratory arthralgia or myalgia Depression Extrahepatic Manifestations of Chronic HCV Renal Disease Lymphomas Neuropathy Dermatologic Manifestations Diabetes Neurological Impairments Changes in HCV Therapy 4
5 Goals of HCV Therapy Cure Defined as sustained virologic response (SVR) Improvements in liver function Improvements in fibrosis, reversal of cirrhosis? Improvements in extrahepatic manifestations of HCV Differences in Therapy Interferon Based Injectable Long duration of treatment High side effect profile Multiple laboratory abnormalities Low cure rates Direct Acting Antivirals Oral Short durations Minimal side effects Minimal laboratory abnormalities High cure rates 5
6 The Evolution of Highly Effective Treatment 1 BOC and TPV LDV/ SOF SOF PrOD SMV 89+ >9 > DCV+ SOF >9 EBR/ GZR >9 SOF/ VEL >9 SOF/ VEL/ VOX >9 217 GLE/ PIB >9 8 6 RBV Standard IFN 1998 PegIFN IFN 6 mos 16 IFN 12 mos IFN/ RBV 6 mos IFN/ RBV 12 mos PegIFN RBV 12 mos PegIFN/ RBV/ BOC or TPV 6-12 mos PegIFN/ RBV/ SMV wks PegIFN/ RBV/ SOF wks LDV/ SOF 8-12 wks PrOD + RBV wks SOF + DCV 12 wks EBR/ GZR wks SOF/ VEL 12 wks SOF/ VEL/ VOX 12 wks GLE/ PIB 8-12 wks HCV Direct Acting Antivirals (DAAs) Target NS3/4A: Protease Inhibitors ( previr) NS5A: Replication Complex Inhibitors ( asvir) NS5B: Polymerase Inhibitors ( buvir) Boceprevir Telaprevir Simeprevir Paritaprevir Grazoprevir Glecaprevir Voxilaprevir Ledipasvir Ombitasvir Daclatasvir Elbasvir Velpatavir Pibrentasvir Nucleotide: Sofosbuvir Non nucleoside: Dasabuvir 6
7 Side Effect Profile of DAAs Overall very well tolerated Most commonly reported side effects: Headache Fatigue Nausea Diarrhea (reported with voxilaprevir) Laboratory Abnormalities Overall not common Most common laboratory abnormalities: ALT elevations Concomitant use of ethinyl estradiol with PrOD or glecaprevir/pibrentasvir Elbasvir/grazoprevir Bilirubin elevations Many DAAs inhibit bilirubin transporters Anemia with concomitant use of ribavirin Ribavirin causes hemolytic anemia 7
8 Main Drug Interaction Concerns for DAAs New DAAs overall have low potential for causing drug drug interactions Amiodarone with sofosbuvir and other DAA: Serious symptomatic bradycardia Potential for other drugs to lower DAA concentrations: Strong CYP3A inducers: carbamazepine, oxcarbazepine, phenobarbital, phenytoin Strong intestinal P glycoprotein inducers: rifabutin, rifampin, rifapentine St. John s wort Statins: Interactions vary by DAA and statin Acid suppressive therapy: Ledipasvir and velpatasvir solubility decreases with increases in ph Requires acidity for absorption Case Study: Managing Interactions 48 yo female admitted to hospital with orders including PPI drip Patient s home medications include ledipasvir/sofosbuvir 8
9 druginteractions.org Also available as an app: hepichart Use of HCV DAAs in Renal Insufficiency and Cirrhosis Ledipasvir/ sofosbuvir Elbasvir/gra zoprevir Sofosbuvir/ velpatasvir Sofosbuvir/ velpatasvir/ voxilaprevir Glecaprevir/ pibrentasvir Use in renal impairment or endstage renal disease? > 3 ml/min Safe to use in all levels of renal impairment including dialysis > 3 ml/min > 3 ml/min Safe to use in all levels of renal impairment including dialysis Use in cirrhosis? Childs Class A, B or C Child Class A Childs Class A, B or C Child Class A Child Class A 9
10 Ledipavir/Sofosbuvir Harvoni [package insert]. Foster City, CA: Gilead Sciences, Inc.; 216. Combination of NS5B polymerase inhibitor (Sofosbuvir); NS5A inhibitor (ledipasvir) Administration One tablet once daily with food or without food Requires acidic environment for absorption Indicated for GT 1 and 4 ION Phase 3 Program (ION 1, ION 2, ION 3) Efficacy Summary 1 LDV/SOF LDV/SOF+RBV SVR12 (%) / / / / Weeks 24 Weeks 8 Weeks 12 Weeks 12 Weeks 24 Weeks ION 1 GT 1 treatment naïve including cirrhotics 22/ / / 216 ION 3 GT 1 treatment naïve non cirrhotic 12/ 19 17/ / 19 11/ 111 ION 2 GT 1 treatment experienced including cirrhotics and PI failures 97% (1886/1952) overall SVR rate Error bars represent 95% confidence intervals. Afdhal N, et al. N Engl J Med 214; 214 Apr 12 [Epub ahead of print] Kowdley K, et al. N Engl J Med 214; 214 Apr 11 [Epub ahead of print] Afdhal N, et al. N Engl J Med 214; 214 Apr 12 [Epub ahead of print] 1
11 Elbasvir/ Grazoprevir (EBR/GZR) Fixed dose combination tablet 5 mg elbasvir (NS5A replication complex inhibitor) 1 mg grazoprevir (NS3/4A protease inhibitor) Dosing: 1 tablet per day with or without food Approved Feb. 216 Indicated for HCV genotypes 1 and 4 Patients with GT 1a require pre treatment resistance testing If present, must add ribavirin and extend treatment duration to 16 weeks Laboratory Abnormalities and Adverse Effects Increased risk of ALT elevations 5x ULN in 1% of patients 2% in women, Asian race, or patients aged 65 years or older Occurred at treatment week 8 or later Mostly asymptomatic Resolved with ongoing or completed therapy Monitor LFTs every 4 weeks or as clinically indicated Adverse effects: Fatigue, headache, and nausea 11
12 Elbasvir Grazoprevir in Treatment Naïve HCV GT 1, 4 or 6 C EDGE TN: Results C EDGE TN: SVR12 Results by Genotype 299/ / /131 18/18 8/1 Primary efficacy analysis included all patients who received 1 dose of drug. Source: Zeuzem S, et al. Ann Intern Med. 215;163:1-13. Slide courtesy of HCV Online; H. Nina Kim MD, MSc and David Spach MD Sofosbuvir/Velpatasvir Fixed dose combination of sofosbuvir (NS5B inhibitor) and velpatasvir (NS5A inhibitor) Approved June 28, 216 for chronic HCV genotypes 1, 2, 3, 4, 5, or 6 Treatment naïve Treatment experienced (Peg IFN/RBV with or without PI) Epclusa [package insert]. Foster City, CA: Gilead Sciences, Inc.;
13 ASTRAL-1: SOF/VEL STR for 12 Weeks in GT 1, 2, 4, 5, 6 HCV-Infected Patients SVR12 by Cirrhosis Status or Treatment History SVR12 (%) / /51 12/ /423 Total Non-Cirrhotic Cirrhotic Treatment- Naïve 2/21 Treatment- Experienced Error bars represent 95% confidence intervals. Feld, AASLD, 215, LB-2. Feld JJ, et al. N Engl J Med DOI: 1.156/NEJMoa Sofosbuvir/Velpatasvir/Voxilaprevir Combination of NS5B polymerase inhibitor (Sofosbuvir); NS5A inhibitor (Velapatasvir); NS3/4A protease inhibitor (Voxilaprevir) Administration One tablet once daily with food Approved July 18, 217 Vosevi [package insert]. Foster City, CA: Gilead Sciences, Inc.;
14 Indications: DAA Treatment Experienced Patients Patients with genotype 1, 2, 3, 4, 5, or 6 who were previously treated with an NS5A inhibitor Patients with genotype 1a or 3 infection previously treated without an NS5A inhibitor No advantage of using sofosbuvir/velpatasvir/voxilaprevir over sofosbuvir/velpatasvir for retreatment of patients with GT 1b, 2, 4, 5, or 6 POLARIS 1: SOF/VEL/VOX for 12 Weeks in NS5A Inhibitor Experienced HCV GT 1 6 SVR12 Results Overall and by Cirrhosis Status SVR12, % relapses 1 on treatment failure** 2 withdrew consent 1 LTFU 1 withdrew consent 1 LTFU 6 relapses 1 on treatment failure** 1 withdrew consent 253/263 14/ /121 Overall* No Cirrhosis Cirrhosis * p <.1 for superiority compared with prespecified 85% performance goal for SOF/VEL/VOX ** Exposure was consistent with non adherence Bourliere M, AASLD 216, Oral
15 POLARIS 1: SOF/VEL/VOX for 12 Weeks in NS5A Inhibitor Experienced HCV GT 1 6 SVR12 by Genotype and Cirrhosis Status No Cirrhosis Cirrhosis SVR12, % * Overall GT 1 GT 1a GT 1b GT 2 GT 3 GT 4/5/ *1/1 patient with GT unknown achieved SVR12; 4/4 patients with GT 1 other (cirrhosis, n=2; no cirrhosis, n=2) achieved SVR12; Includes only GT 4 patients. Data on file, Gilead Sciences 29 POLARIS-4: SOF/VEL/VOX or SOF/VEL for 12 Weeks in Non-NS5A Inhibitor DAA- Experienced HCV GT 1 4 SVR12 by Genotype and Cirrhosis Status No Cirrhosis Cirrhosis SOF/VEL/VOX 12 Weeks Overall SVR12 97% SOF/VEL 12 Weeks Overall SVR12 9% SVR12, % GT 1a GT 1b GT 2 GT 3 GT GT 1a GT 1b GT 2 GT 3 GT 4 Data on file, Gilead Sciences 3 15
16 Adverse Reactions and Laboratory Abnormalities Adverse reactions: Headache Fatigue Diarrhea Nausea Laboratory abnormalities: increases in total bilirubin Voxilaprevir can inhibit bilirubin transporters Glecaprevir/Pibrentasvir Combination of Glecaprevir an NS3/4A protease inhibitor Pibrentasvir an NS5A inhibitor Dosage and administration: 3 tablets once daily with food Approved Aug. 3,
17 Indications and Duration of Therapy HCV Genotype Prior Treatment Experience Without Cirrhosis With Compensated Cirrhosis 1,2,3,4,5,6 Naïve 8 weeks 12 weeks 1,2,4,5,6 Pegylated interferon, ribavirin and/or sofosbuvir 8 weeks 12 weeks 3 Pegylated interferon, ribavirin and/or sofosbuvir 16 weeks 16 weeks 1 NS3/4A (NS5A naïve) 12 weeks 12 weeks NS5A (NS3/4A naïve) 16 weeks 16 weeks Glecaprevir Pibrentasvir for 8 or 12 weeks in Non Cirrhotic GT 1 ENDURANCE 1: Baseline Characteristics Patients (%) with SVR ITT-PS GLE-PIB x 8 Weeks GLE-PIB x 12 Weeks 332/ / / /332 ITT-PS-PP ITT-PS population: ITT excluding patients with HIV coinfection or treatment experience with sofosbuvir ITT-PS-per protocol (PP) population: ITT-PS excluding patients with premature discontinuation of study drug, virologic failure before Week 8, and missing SVR12 data Source: Zeuzem S, et al. AASLD 216.Abstract
18 Glecaprevir Pibrentasvir in Treatment Naïve Non Cirrhotic GT 3 ENDURANCE 3 Study: Results ION-3: SVR 12 by Treatment Duration and Regimen (ITT Analysis) Patients with SVR 12 (%) / / /157 GLE-PIB SOF + DCV GLE-PIB 12-Week Regimens 8-Week Regimen GLE-PIB = glecaprevir-pibrentasvir; SOF = sofosbuvir; DCV = daclatasvir ITT = Intent-to-treat Source: Foster G, et al. EASL 217. Abstract GS-7. Glecaprevir Pibrentasvir in Genotype 1 6 with Renal Disease EXPEDITION 4: Results SVR12 by Type of Analysis Patients with SVR12 (%) discontinuation 1 lost to follow-up 12/14 12/12 ITT mitt ITT, intent-to-treat analysis; mitt, modified intent-to-treat analysis Source: Gane E, et. al, AASLD 216. Abstract
19 Adverse Reactions and Laboratory Abnormalities Adverse reactions reported: Headache, fatigue, nausea, diarrhea Rates similar to placebo Laboratory abnormalities: Serum bilirubin abnormalities in approximately 3% of patients Glecaprevir/pibrentasvir can affect bilirubin transporters Joint guidelines of the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) Updated frequently check online for most current version of guidelines Available at: 19
20 HCV in New Mexico New Mexico has the highest prevalence of HCV in the US Milliman 213: Health Care Reform and Hepatitis C: Convergence of Risk and Opportunity (analysis of NHANES, MarketScan 21, Medicare 5% Sample, and Medicaid Contributor data. Does not include prison population)..4% 1.3% Slide courtesy Dr. David Scrase 2
21 Centennial Treatment Criteria Expanded Effective Sept 15, 217 All members over age 17, all HCV genotypes, with F level or greater of fibrosis Case Study: Systems Challenges to Effective Therapy Patient on HCV therapy At 4 5 weeks of therapy, questions regarding use and dosing of ribavirin were identified and pharmacist did not authorize refill of therapy to complete HCV course until these issues were clarified 21
22 Conclusions Chronic HCV infections pose a high healthcare burden DAA therapies are highly effective with SVR rates >9% New therapies available for patients with all genotypes, renal insufficiency, and prior DAA failure Regimens are well tolerated, have limited drug interactions, and few laboratory abnormalities Need for increased screening to identify patients and link to treatment Remaining Challenges in HCV Therapy HCV treatment in patients with decompensated cirrhosis Screening and identifying patients with chronic HCV Treatment interruptions Concerns for HCV resistance Access to HCV therapy 22
23 Resources AASLD/IDSA HCV Treatment Guidelines: Available at: HCV Drug Interactions (University of Liverpool): Available at: druginteractions.org Educational material, clinical calculators, HCV therapy summaries (University of Washington) Available at: Project ECHO HCV Collaborative End of Presentation Questions? 23
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