A Cure is Within Reach:
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1 A Cure is Within Reach: A Review of the New HCV Medications Misty Miller, Pharm.D., BCPS, AAHIVP Clinical Assistant Professor University of Oklahoma College of Pharmacy September 11, 2015
2 Pre Assessment #1
3 Pre Assessment #2
4 Overview
5 Epidemiology
6 Pathophysiology
7 HCV Course
8 HCV Genotypes
9 Transmission
10 Screening
11 Goals of Treatment SVR = Sustained Virologic Response
12 Treatment Considerations
13 Historical Treatment Options
14 New HCV Treatment Options
15 HCV Life Cycle
16 HCV Genome
17 Sofosbuvir
18 Sofosbuvir
19 Potential Drug Interactions
20 Adverse Effects
21 Simeprevir
22 Simeprevir
23 Adverse Effects
24 Potential Drug Interactions
25 Clinical Trials of Note
26 COSMOS No to mild fibrosis SIM/SOF/RBV SIM/SOF SIM/SOF/RBV SIM/SOF 12 weeks 24 weeks 96% (26/27) 90% (13/14) 79% (19/24) 93% (14/15) Advanced fibrosis/ cirrhosis 93% (25/27) 94% (13/14) OPTIMIST 1 97% (150/155) OPTIMIST 2 84% (86/103) 93% (28/30) 100% (16/16)
27 Ledipasvir/ Sofosbuvir
28 Ledipasvir
29 Adverse Effects
30 Potential Drug Interactions
31 Clinical Trials of Note Population (n) Duration (weeks) % SVR 12 ION 1 Treatment naïve, +/ cirrhosis (865) ION 2 Treatment experienced, +/ cirrhosis (440) ION 3 Naïve, non cirrhotic (647) ION 4 HIV co infected (335) 12 96
32 Daclatasvir
33 Daclatasvir
34 Adverse Effects
35 Potential Drug Interactions
36 Clinical Trials of Note Population (n) % SVR 12 ALLY1 Advanced cirrhosis, genotypes 1 6; n=60 83 Post liver transplant, genotypes 1 6; n=53 94 Daclatasvir + sofosbuvir + ribavirin x 12 weeks ALLY3 Genotype 3; tx naïve; n= Genotype 3;tx experienced; n=51 86 Daclatasvir + sofosbuvir x 12 weeks
37 Ombitasvir, paritaprevir, dasabuvir, ritonavir (3D)
38
39 3D
40 Adverse Effects
41 Potential Drug Interactions
42 Clinical Trials of Note Population (n) % SVR 12 SAPPHIRE1 Treatment naïve, genotype 1a; 3D +/ riba 97/90 Treatment naïve, genotype 1b; 3D +/ riba 99 TURQUOISE Cirrhosis; 3D + riba x 12 weeks; n= II Cirrhosis; 3D + riba x 24 weeks; n=172 96
43 Ribavirin
44 Ribavirin
45 Adverse Effects
46 Dose Reduction Dose decrease to 600mg Permanently discontinue No cardiac history Hgb < 10 g/dl Hgb < 8.5 g/dl Cardiac history Decrease of 2g/dLin 4 weeks Hgb < 12 g/dl despite dose reduction
47 Potential Drug Interactions
48 Clinical Trials of Note Population (n) % SVR 12 All received sofosbuvir + ribavirin POSITRON Genotypes 2 & 3, tx naïve; 12 weeks. N= FUSION Genotype 2, tx exp; 12 weeks. N=36 86 Genotype 2, tx exp; 16 weeks. N=32 94 Genotype 3; tx exp; 12 weeks. N=64 30 Genotype 3; tx exp; 16 weeeks. N=63 62 VALENCE Genotype 2; 12 weeks. N=73 93 Genotype 3, no cirrhosis; 24 weeks. N= Genotype 3, cirrhosis; 24 weeks. N=60 68
49 Current Recommendations
50 Treatment Eligibility Highest priority High priority Transmission risk Advanced fibrosis or Fibrosis MSM compensated cirrhosis Organ transplant HIV co infection Active IVDU Type 2 3 cryoglobulinemia HBV co infection Incarcerated persons Proteinuria, nephrotic syndrome, glomerulonephritis Debilitating fatigue Type 2 DM Persons on long term hemodialysis Women of childbearing age
51 Genotype 1 No cirrhosis Cirrhosis 1 Daclatasvir + sofosbuvir x 12 Daclatasvir + sofosbuvir x 24 weeks 1 weeks 1,2 1 Ledipasvir/sofosbuvir x 12 weeks LED/SOF x 12 if naïve LED/SOF x 24 weeks if tx exp 1a 3D + ribavirin x 12 weeks 3D + ribavirin x 24 weeks 1b 3D x 12 weeks 3D x 12 weeks 1 Simeprevir + sofosbuvir x 12 Simeprevir + sofosbuvir x 24 weeks 2 weeks 2 1. Class I, Level B (no cirrhosis); Class IIa, Level B (cirrhosis) 2. Addition of ribavirin optional
52 Genotype 2 No cirrhosis Daclatasvir + sofosbuvir x 12 weeks 1 Sofosbuvir + ribavirin x 12 weeks 1. Class IIa, Level B 2. Class IIb, Level C Cirrhosis Daclatasvir + sofosbuvir x 24 weeks 1 Sofosbuvir + ribavirin x 16 weeks 2
53 Genotype 3 No cirrhosis Daclatasvir + sofosbuvir x 12 weeks Cirrhosis Daclatasvir + sofosbuvir x 24 weeks Sofosbuvir + ribavirin + pegylated interferon x 12 weeks Sofosbuvir + ribavirin x 24 weeks (alternative regimen)
54 Special Populations
55 HIV Co Infection
56 Decompensated Cirrhosis
57 Renal Impairment
58 Geriatric Patients
59 Pregnant Patients
60 Future Options
61 Class Approved Investigational NS3/4A inhibitors Simeprevir (TMC 435) Paritaprevir (ABT 450) NS5A inhibitors Ledipasvir (GS 5885) Ombitasvir (ABT 267) Daclatasvir (BMS790052) NS5B inhibitors Faldaprevir (BI201335) Asunaprevir (BMS ) Vaniprevir (MK 7009) Danoprevir (RG 7227) Vedroprevir (GS 9451) Grazoprevir (MK 5172) ABT 493 GS 9857 Elbasvir (MK 8742) Sovaprevir (ACH 1625) Ravidasvir (PPI 668) Samatasvir (IDX 719) ACH 3102 ABT 530 MK 8408 GS 5816 Nucleoside Sofosbuvir (PSI 7851) Mercitabine (RG7128) Valopicitabine (NM283) Balapiravir (R1626) ACH 3422 MK 3682 Non nucleoside Dasabuvir (ABT 333) ABT 072 Beclabuvir (BMS ) Setrobuvir (ANA598) GS 9669
62 Grazoprevir/elbasvir
63 Monitoring
64 Pre Treatment
65 During Treatment
66 Post Treatment
67 Access to HCV Treatment
68 Costs and Prior Auths Ombitasvir/paritaprevir/ritonavir $76,653
69 Rationale for Treatment
70 Summary
71 HCV Treatment
72 Pre Assessment #1
73 Pre Assessment #2
74 A Cure is Within Reach: A Review of the New HCV Medications Misty Miller, Pharm.D., BCPS, AAHIVP Clinical Assistant Professor University of Oklahoma College of Pharmacy September 11, 2015
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