Updates in the Treatment of HCV
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1 Updates in the Treatment of HCV Misty Miller, Pharm.D., BCPS, AAHIVP Associate Professor University of Oklahoma College of Pharmacy September 21 st, 2018
2 Overview
3 HCV Review and Definitions
4 HCV Genotypes U.S. 12% < 1% 1% 1% GT 1 GT 2 GT 3 GT 4 16% GT 5 GT 6 70%
5 HCV Life Cycle Jazwinski AB, et al. Gastroenterol Hepatol 2011;7(3):
6 HCV Genome Jazwinski AB, et al. Gastroenterol Hepatol 2011;7(3):
7 Approved Agents NS5A inhibitors NS5B inhibitors NS3/4A inhibitors (protease) Elbasvir Sofosbuvir Glecaprevir Ledipasvir Pibrentasvir Velpatasvir Grazoprevir asvir buvir previr
8 Resistant Mutations
9 Treatment Options
10 Elbasvir/grazoprevir Zepatier [PI] Whitehouse Station, NJ: Merck & Co, Inc.; 2017.
11
12 Ledipasvir/sofosbuvir Harvoni [PI] Foster City, CA: Gilead Sciences, Inc.; 2017.
13 Glecaprevir/pibrentasvir
14 Velpatasvir/sofosbuvir
15 Regimen Options Elbasvir/grazoprevir (Zepatier ) Ledipasvir/sofosbuvir (Harvoni ) Glecaprevir/pibrentasvir (Mavyret ) Velpatasvir/sofosbuvir (Epclusa ) GT1 GT2 GT3
16 Efficacy Treatment-Naïve Regimen Population (n) SVR12 (%) ELB/GRZ x 12 weeks (Zepatier ) LED/SOF x 12 weeks (Harvoni ) G/P x 8 weeks (Mavyret ) VEL/SOF x 12 weeks (Epclusa ) GT 1 +/- cirrhosis (288) 1a 92 1b 99 GT1 +/- cirrhosis (214) 98 GT1 (335), GT2 (145), GT3 (145) No cirrhosis GT1 (328), GT2 (238), GT3 (277) +/- cirrhosis
17 Complicating Characteristics
18 Ribavirin
19 Goals of Treatment SVR = Sustained Virologic Response
20 Current Recommendations (Treatment-naïve) hcvguidelines.org
21 Genotype 1 No Cirrhosis HCV Regimen Grazoprevir/elbasvir 1 Glecaprevir/pibrentasvir Ledipasvir/sofosbuvir Velpatasvir/sofosbuvir Duration 12 weeks 8 weeks 12 weeks 12 weeks 1. Only if no significant NS5A resistant mutation
22 Genotype 1 - Cirrhosis HCV Regimen Grazoprevir/elbasvir 1 Glecaprevir/pibrentasvir Ledipasvir/sofosbuvir Velpatasvir/ sofosbuvir Duration 12 weeks 1. Only if no significant NS5A resistant mutations
23 Genotypes 2 and 3 No cirrhosis Glecaprevir/pibrentasvir x 8 weeks Velpatasvir/sofosbuvir x 12 weeks Cirrhosis Glecaprevir/pibrentasvir x 12 weeks Velpatasvir/sofosbuvir x 12 weeks 1 1. For GT3, only use if Y93 mutation not present
24 Special Populations
25 Treatment-Experienced
26 HBV Reactivation U.S. Food and Drug Administration. Accessed July 31, Demonte A, et al. J Clin Virol 2016;78:27-30.
27 Recommendations for HBV Co-infected AASLD/IDSA/IAS USA. Accessed July 31, 2018.
28 HIV Co-Infection
29 Renal Impairment Genotype Regimen 1 Grazoprevir/elbasvir x 12 weeks 1, 2, 3 Glecaprevir/pibrentasvir x 8-16 weeks
30 Decompensated Cirrhosis
31 Potential Drug Interactions
32 Amiodarone Sovaldi [PI] Foster City, CA: Gilead Sciences, Inc.; 2017.
33 Acid Suppressants Harvoni [PI] Foster City, CA: Gilead Sciences, Inc.; 2017.;
34 Statins Zepatier GRZ/ ELB Harvoni LED/ SOF Mavyret G/P Atorvastatin 20mg Avoid Fluvastatin LPD LPD Lovastatin LPD Avoid Pitavastatin LPD Pravastatin 50% Epclusa VEL/ SOF Rosuvastatin 10mg Avoid 10mg 10 mg Simvastatin LPD Avoid Zepatier [PI] Whitehouse Station, NJ: Merck & Co, Inc.; 2017.; Harvoni [PI] Foster City, CA: Gilead Sciences, Inc.; 2017.;
35 Miscellaneous Interactions Zepatier [PI] Whitehouse Station, NJ: Merck & Co, Inc.; 2017.; Harvoni [PI] Foster City, CA: Gilead Sciences, Inc.; 2017.;
36 Regimen Selection
37 Navigating Treatment Decisions
38 Patient One
39 Patient Two
40 Patient Three
41 Patient Four - Referral
42 Monitoring
43 Preventive Care
44 Pre-Treatment
45 During Treatment
46 Adverse Effects Summary Zepatier GRZ/ ELB Harvoni LED/ SOF Mavyret G/P Epclusa VEL/ SOF Fatigue Headache Nausea Diarrhea Insomnia Asthenia Lipase Zepatier [PI] Whitehouse Station, NJ: Merck & Co, Inc.; 2017.; Harvoni [PI] Foster City, CA: Gilead Sciences, Inc.; 2017.;
47 Post-Treatment
48 Treatment Costs (8 wks)
49 Prior Authorization Tips
50 Medication Access
51 AbbVie Assistance Programs
52 Gilead Assistance Programs
53 Merck Assistance Programs
54 Recommended Resources
55 Updates in the Treatment of HCV Misty Miller, Pharm.D., BCPS, AAHIVP Associate Professor University of Oklahoma College of Pharmacy September 21 st, 2018
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