A One-day Scientific Conference: Updates on Hepatitis C Treatments along with Consensus on Management of Hepatitis C in Iran
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1 A One-day Scientific Conference: Updates on Hepatitis C Treatments along with Consensus on Management of Hepatitis C in Iran Teheran, 22 July 2016 Massimo Colombo Treatment of HCV genotype 1 & 4 with DAAs Chairman Department of Liver, Kidney, Lung and Bone Marrow Units and Organ Transplant Head Division of Gastroenterology and Hepatology Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico University of Milan Milan, Italy
2 Financial Disclosures Grant and research support: BMS, Gilead Sciences Advisory committees: Merck, Roche, Novartis, Bayer, BMS, Gilead Sciences, Tibotec, Vertex, Janssen Cilag, Achillion, Lundbeck, GSK, GenSpera, AbbVie, Alfa Wasserman, Intercept Speaking and teaching: Tibotec, Roche, Novartis, Bayer, BMS, Gilead Sciences, Vertex, Merck, Janssen, AbbVie
3 The EASL 2015 HCV Treatment Recommendations Treatment Options IFN-free regimens GT Sofosbuvir + RBV 2, 3 Sofosbuvir/Ledipasvir (± RBV) 1, 4, 5, 6 Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir (± RBV) 1 Sofosbuvir + Simeprevir (± RBV) 1, 4 Sofosbuvir + Daclatasvir (± RBV) All Ombitasvir/Paritaprevir/Ritonavir (± RBV) 4 IFN-containing Pendingregimens Sofosbuvir PegIFNa + Velpatasvir + RBV (Epclusa) + sofosbuvir Grazoprevir PegIFNa + Elbasvir + (Zepatier) RBV + simeprevir All 1, 4 EASL HCV Treatment Recommendations, J Hepatol 2015
4 In Vitro Antiviral Activity of NS5A Inhibitors Stable HCV Replicon EC50 (pm) GT-1a GT-1b GT-2a GT-2b GT-3a GT-4a GT-5a GT-6a ABT Ombitasvir Daclatasvir ,000 NA Ledipasvir ,000 16, , Velpatasvir Elbasvir MK ACH ~150 NA NA NA NA Poordad F et al. AASLD 2015;Abstract 41
5 New Oral Treatment of HCV-1&4 SAFETY AND EFFICACY OF DAAs VALIDATED BY REAL LIFE STUDIES
6 SVR12, % HCV-TARGET: SVR with LDV/SOF±RBV in HCV-1 for 8, 12, and 24 Weeks LDV/SOF LDV/SOF+RBV Key baseline demographics Age: yr 73% Caucasian 65% HCV-1a; 27% HCV-1b 38% compensated cirrhosis 13% decompensated cirrhosis 53% treatment naive 150/ / / / 89 12/ 13 Terrault, AASLD 2015 abs# 94
7 McCombs et al; McGinnis et al; Afdhal et al; Aghemo et al; Marinho et al; Crespo et al; Calleja et al; Mauss et al, ILC2016 Barcelona Large Real-world Data Confirm Clinical Trial Results 16,236 HCV-1 Patients Nb=2363/4104/ /208/ /73/ / /1836/390/528 No impact of HIV, HBV, diabetes and obesity on SVR Following the EASL guidelines (93% vs 87%) Hypo Alb < 35g/l negative predictor of SVR
8 HCV-4. Summary of Interferon-free Therapies Lawitz et al NEJM Ruane EASL Esmat et al AASLD Kapoor et al AASLD Pol Hepatology 2014
9 New Oral Treatment of HCV-1&4 THE DIFFICULT-TO-TREAT PATIENT: THE IMPORTANCE OF TREATMENT DURATION AND RBV
10 EAP HEPATHER.SOF+DCV +/- RBV in HCV-1 Patients Advanced Liver Disease.32 French Centers F3/4, symptomatic cryoglobulinemic vasculitis, pre-/post-liver or renal transplant 319 (78%) GT1 cirrhosis and 307 (75%) TE (56% PI+PR),39 (81%) GT4 cirrhosis and 40 (83%) TE 46/ 54 12/ / / 80 20/ 20 3/ 3 47/ 47 18/ 18 26/ 34 9/ 9 203/ / 60 27/ 31 4/ 4 47/ 53 14/ 14 19/ 23 8/ 8 203/ / 66 Pol et al, EASL Vienna 2015, L03 Cirrhosis strongly associated with treatment failure RBV and 24 weeks of treatment improved SVR in cirrhotics and TE
11 UK EAP.Outcomes a Year after Successful DAA Therapy for Decompensated HCV Cirrhosis Adverse event Untreated All treated N=406 SVR24 N=317 Non SVR24 N=89 Virological failure N=53 Month 0-6 Month 0-6 Month 6-15 Overall Month 0-6 Month 6-15 Overall Month 0-6 Month 6-15 Overall Month 0-6 Month 6-15 Overall Died 13 (5%) 14 (3.4%) 26 (6.4%) 40 (9.9%) 0 (0%) 9 (2.8%) 9 (2.8%) 14 (15.7%) 17 (19.1% ) 31 (34.8%) 0 (0%) 3 (5.7%) 3 (5.7%) HCC 21 (8%) 17 (4.2%) 10 (2.5%) 27 (6.7%) 11 (3.5%) 6 (1.9%) 17 (5.4%) 6 (6.7%) 4 (4.5%) 10 (11.2%) 3 (5.7%) 3 (5.7%) 6 (11.3%) OLT 10 (3.8%) 29 (7.1%) 17 (4.2%) 46 (11.3%) 27 (8.5%) 12 (3.8%) 39 (12.3%) 2 (2.2%) 5 (5.6%) 7 (7.9%) 1 (1.9%) 5 (9.4%) 6 (11.3%) Decompensation 73 (28%) 72 (17.7%) 30 (7.4%) 87 (21.4%) 46 (14.5%) 16 (5%) 52 (16.4%) 26 (29.2%) Cheung et al, J Hepatol in press
12 Treatment of Hepatitis C Virus in Patients with Advanced Cirrhosis. The Hepa-C Registry Deaths 16 (2%), Breakthroughs 9 (1%), Relapses 45 (7%) MELD improved MELD worsened 36% 33% Kaplan-Meier survival estimates 99% 99% 97% 92% p < % 68% Time (days) MELD< 18 MELD MELD< 18 MELD Fernàndez-Carrillo, et al. ILC2016 Barcelona
13 All Oral Therapy of Post Transplant Recurrent HCV-1 SVR Reference SOF + Ribavirin 70% Charlton 2015 SOF Simeprevir ± Ribavirin 91% Brown AASLD 2014 SOF Daclatasvir ± Ribavirin 96% Coilly EASL 2015 SOF Ledipasvir ± Ribavirin 100%* Manns EASL 2015 PAR-r Ombitasvir Dasabuvir Ribavirin 97% Kwo 2014 Daclatasvir Simeprevir ± Ribavirin 93% Forns EASL 2015 * Child Pugh B NS5B PI NS5A
14 SVR12 (%) HCV-1,4 Kidney Transplanted Patients. A Multinational RCT of 12 vs 24 weeks LDV SOF LDV/SOF 12 Weeks LDV/SOF 24 Weeks 2 Lost to follow-up 57/57 55/57 Overall 51/51 51/53 6/6 4/4 GT 1 GT 4 Colombo et al EASL BCN 16 April 2016
15 New Oral Treatment of HCV-1&4 TREATMENT FAILURES: THE IMPORTANCE OF PRE- EXISTING AND TX -EMERGING RASs
16 Factors Associated with Virologic Response to IFN-free DAA Regimens in HCV PI+NUC (SMV+SOF) NS5A+NUC (DCV+SOF, LDV/SOF) PI+NS5A+nonNUC (PTVr+OMV+DSV) Importance of: Liver disease severity Addition of ribavirin Duration of treatment Presence of baseline resistance Pearlman et al, Clin Infect Dis 2011;52:
17 Why is Treatment Failure More Frequent in Advanced Liver Disease? Virologic response on treatment with SOF+RBV 24w in G1 pts with portal hypertension and/or decompensated liver disease Modeling early HCV kinetics to individualize DAA treatment duration in patients with advanced cirrhosis CPT A CPT B % RNA undetectable LSM 21kPa LSM<21kPa <LLQ <LLQ w2w4 w8 w12w24 w2w4 w8 w12w24 Time (days) Median time to cure was significantly longer in patients with FS 21 kpa (Fig. A) compared to those with FS<21 kpa (Fig. B) Afdhal et al, EASL 2014 London; Gambato and Canini et al, EASL 2016 Barcelona (SAT-210)
18 SVR12 (%) Pre-treatment NS5A RASs (NGS) and Response to SOF+LDV in HCV-1 Patients Martin R et al, AASLD 2015 abs 91
19 HCV Resistance Testing Prior to First-Line DAA Therapy Available, reliable, Interpretable, understadable* Not available Presence of NS5As RASs conferring high-level resistance (pop seq or >15%) Optimize therapy to avoid treatment failure Add ribavirin and/or increase treatment duration *recommended for GZR/EBR for US patients with GT1a Add RBV in TE patients with SOF/LDV, SOF/DCV, SOF/SMV With 3D, use RBV in GT1a, treat NR cirrhotics 24 weeks Use GZR/EBR 16 weeks with RBV in GT1a patients Pawlotsky et al, Gastroenterology 2016
20 Real-World Data. Resistance-Based HCV Re-treatment After DAA Regimen Failure Previous DAA Regimen Failure Retreatment Regimen SVR12 GT1: SMV + SOF ± RBV NS5A inhibitor containing regimen 91% LDV/SOF ± RBV 12 wks 8/8 LDV/SOF ± RBV 24 wks 9/10 OBV/PTV/RTV + DSV ± RBV 12 wks 3/3 OBV/PTV/RTV + DSV + RBV 24 wks 0/1 GT1: DCV or LDV + SOF ± RBV PI-containing regimen 86% SMV + SOF ± RBV 12 wks 2/2 SMV + SOF ± RBV 24 wks 1/1 OBV/PTV/RTV + DSV ± RBV 12 wks 3/4 GT3: SOF + RBV NS5A inhibitor containing regimen 100% DCV + SOF + RBV 12 wks 2/2 DCV + SOF ± RBV 24 wks 4/4 LDV/SOF + RBV 24 wks 1/1 Vermehren J, et al. EASL Abstract PS103
21 New Oral Treatment of HCV-1&4 WHAT IS AROUND THE CORNER
22 Pooled Analysis of ASTRAL. Twelve Wks SOF+VEL A Pangenotypic Regimen on the Block SVR12 (%) R (n=1) R (n=1) Feld JJ, et al. N Engl J Med Foster GR, et al. N Engl J Med. 2015
23 C-EDGE. 12-week Regimen of Grazoprevir + Elbasvir in Treatment-naive HCV-1,4,6 SVR12 299/ /246 68/70 144/ /131 18/18 8/10 No drug-related SAE; 2 deaths unrelated to drug No concurrent ALT/Bili increase Non-VF Breakthrough Relapse Zeuzem S, et al., Ann Intern Med 2015
24 Grazoprevir/Elbasvir (no RBV) Impact of Baseline NS5A RASs in Patients with HCV 1a,b GT1a-infected RAV Position SVR12 Patients with RAVs (NGS 1% ST) SVR12 Patients with RAVs (PopSeq) 28 61/68 (89.7%) 29/33 (87.9%) 30 14/23 (60.9%) 4/10 (40.0%) 31 15/23 (65.2%) 5/13 (38.5%) 93 9/14 (64.3%) 5/8 (62.5%) GT1b-infected RAV Position SVR12 Patients with RAVs (PopSeq) 28 4/4 (100.0%) 30 16/16 (100.0%) 31 17/19 (89.5%) 93 21/22 (95.5%) Jacobson I, et al. 66th AASLD; San Francisco, CA; November 13-17, 2015; Abst. LB-22
25 GZV/EBR. 16 Weeks+RBV Lead to High SVR Rate in HCV-1a with Baseline NS5A RASs (aa 28, 30, 31 and 93) Prevalence PR Non-responders with Baseline NS5A RAVs Population Sequencing EBR RAVs NS5A Class RAVs Next-Generation Sequencing at 1% ST EBR RAVs NS5A Class RAVs No RAVs: 51/52 (98%) No RAVs: 44/52 (85%) No RAVs: 48/52 (92%) No RAVs: 38/52 (73%) Jacobson I, et al. 66th AASLD; San Francisco, CA; November 13-17, 2015; Abst. LB-22.
26 Generic DAA Treatment for HCV Imported into Australia from China, India and Bangladesh. Redemption 99.6% (235/236) 99.2% (127/128) 100% (105/105) 94.4% 93.7% (136/144) (59/63) 97.4% (37/38) Freeman et al, EASL 2016 LB-4611
27 Where Do You Set the Bar in 2016 for Anti-HCV Therapy? >90% SVR Rates 12 weeks or less of treatment duration No need for Ribavirin No or minimal DDIs Lack of significant AEs
28
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