Updates in the Treatment of HCV Misty Miller, Pharm.D., BCPS, AAHIVP Associate Professor University of Oklahoma College of Pharmacy September 21 st, 2018
Overview
HCV Review and Definitions
HCV Genotypes U.S. 12% < 1% 1% 1% GT 1 GT 2 GT 3 GT 4 16% GT 5 GT 6 70%
HCV Life Cycle Jazwinski AB, et al. Gastroenterol Hepatol 2011;7(3):154-62.
HCV Genome Jazwinski AB, et al. Gastroenterol Hepatol 2011;7(3):154-62.
Approved Agents NS5A inhibitors NS5B inhibitors NS3/4A inhibitors (protease) Elbasvir Sofosbuvir Glecaprevir Ledipasvir Pibrentasvir Velpatasvir Grazoprevir asvir buvir previr
Resistant Mutations
Treatment Options
Elbasvir/grazoprevir Zepatier [PI] Whitehouse Station, NJ: Merck & Co, Inc.; 2017.
Ledipasvir/sofosbuvir Harvoni [PI] Foster City, CA: Gilead Sciences, Inc.; 2017.
Glecaprevir/pibrentasvir
Velpatasvir/sofosbuvir
Regimen Options Elbasvir/grazoprevir (Zepatier ) Ledipasvir/sofosbuvir (Harvoni ) Glecaprevir/pibrentasvir (Mavyret ) Velpatasvir/sofosbuvir (Epclusa ) GT1 GT2 GT3
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 1 99 2 98 3 95 1 98 2 99 3-95 www.hepctip.ca/clinical-trial-results/
Complicating Characteristics
Ribavirin
Goals of Treatment SVR = Sustained Virologic Response
Current Recommendations (Treatment-naïve) hcvguidelines.org
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
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
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
Special Populations
Treatment-Experienced
HBV Reactivation U.S. Food and Drug Administration. https://www.fda.gov/drugs/drugsafety/ucm522932.htm. Accessed July 31, 2018. Demonte A, et al. J Clin Virol 2016;78:27-30.
Recommendations for HBV Co-infected AASLD/IDSA/IAS USA. www.hcvguidelines.org. Accessed July 31, 2018.
HIV Co-Infection
Renal Impairment Genotype Regimen 1 Grazoprevir/elbasvir x 12 weeks 1, 2, 3 Glecaprevir/pibrentasvir x 8-16 weeks
Decompensated Cirrhosis
Potential Drug Interactions
Amiodarone Sovaldi [PI] Foster City, CA: Gilead Sciences, Inc.; 2017.
Acid Suppressants Harvoni [PI] Foster City, CA: Gilead Sciences, Inc.; 2017.;
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.;
Miscellaneous Interactions Zepatier [PI] Whitehouse Station, NJ: Merck & Co, Inc.; 2017.; Harvoni [PI] Foster City, CA: Gilead Sciences, Inc.; 2017.;
Regimen Selection
Navigating Treatment Decisions
Patient One
Patient Two
Patient Three
Patient Four - Referral
Monitoring
Preventive Care
Pre-Treatment
During Treatment
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.;
Post-Treatment
Treatment Costs (8 wks)
Prior Authorization Tips
Medication Access
AbbVie Assistance Programs
Gilead Assistance Programs
Merck Assistance Programs
Recommended Resources
Updates in the Treatment of HCV Misty Miller, Pharm.D., BCPS, AAHIVP Associate Professor University of Oklahoma College of Pharmacy September 21 st, 2018