Shorter Durations and Pan-genotypic Regimens The Final Frontier. Professor Greg Dore
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1 Shorter Durations and Pan-genotypic Regimens The Final Frontier Professor Greg Dore
2 Disclosures Funding and speaker fees from AbbVie, Bristol-Myers Squibb, Gilead Sciences and Merck
3 Efficacy Evolution of HCV therapies PEG-IFN + RBV + SOF PEG-IFN + RBV + TVR PEG-IFN + RBV+ BOC PEG-IFN/RBV + SMV SOF/LDV SOF + DCV OMV/PTV/RTV + DSV + RBV EBR/GZR SOF/VEL PEG-IFN + RBV IFN + RBV IFN 48 weeks weeks 24 weeks 12 weeks Tolerability BOC: boceprevir DCV: daclatasvir; DSV: dasabuvir; EBR: elbasvir; GZR: grazoprevir; LDV: ledipasvir; OMV: ombitasvir; PEG-IFN: pegylated interferon; PTV: paritaprevir; RBV: ribavirin; RTV: ritonavir; SMV: simeprevir; SOF: sofosbuvir; TVR: telaprevir; VEL: velpatasvir 3 Adapted from Dore G, Feld JJ. Clin Infect Dis 2015;60:
4 DAA agents: licensed and in development 4 Simeprevir Paritaprevir Grazoprevir Voxilaprevir Glecaprevir Ledipasvir Daclatasvir Ombitasvir Elbasvir Velpatasvir Pibrentasvir Ruzasvir Sofosbuvir Dasabuvir Uprifosbuvir
5 In pursuit of Perfectovir Extremely high efficacy (>95%) No impact of resistance-associated substitutions Pan-genotypic Tolerance similar to placebo Simplified assessment and monitoring Ease of delivery (once daily, oral, short duration) Affordable! 5 Dore GJ & Feld JJ. CID 2015
6 In pursuit of Perfectovir Extremely high efficacy (>95%) No impact of resistance-associated substitutions Pan-genotypic Tolerance similar to placebo Simplified assessment and monitoring Ease of delivery (once daily, oral, short duration) Affordable! 6 Dore GJ & Feld JJ. CID 2015
7 Sofosbuvir/Velpatasvir GT1-6, treatment naïve and IFN exp. (28%), F0-4 (21% F4), 12 wks SVR12 % /41 24/30 5/11 11/11 18/30 202/215 66/70 100/ / /216 54/56 31/47 209/ / / / / /116 34/35 41/41 GT1 GT2 GT3 GT4 GT5 GT6 Feld JJ, et al. NEJM 2015; Foster GR, et al. NEJM 2015
8 Sofosbuvir/Velpatasvir Adverse Events >10% Patients, n (%) SOF/VEL 12 Week N=1035 Placebo 12 Week N=116 Headache 296 (29) 33 (28) Fatigue 217 (21) 23 (20) Nausea 135 (13) 13 (11) Insomnia 87 (8) 11 (9) Nasopharyngitis 121 (12) 12 (10) Cough 57 (6) 4 (3) Irritability 49 (5) 4 (3) Pruritus 33 (3) 5 (4) Dyspepsia 33 (2) 4 (3) 8 Jacobson I et al, ILC 2016
9 In pursuit of Perfectovir Extremely high efficacy (>95%) Incredibly well tolerated (similar to placebo) Pan-genotypic No significant impact of resistance-associated substitutions Simplified assessment and monitoring Ease of delivery (once daily, oral, short duration) Affordable! 9 Dore GJ & Feld JJ. CID 2015
10 10 Is the pursuit of shorter duration DAA therapy a major priority for Global HCV Elimination?
11 Potential Pros and Cons of Shorter Duration SOF/VEL (12 weeks) Shorter Duration (4-8 weeks) 11
12 Potential Pros and Cons of Shorter Duration SOF/VEL (12 weeks) Shorter Duration (4-8 weeks) Covers all major sub-populations YES Unlikely 12
13 Potential Pros and Cons of Shorter Duration SOF/VEL (12 weeks) Shorter Duration (4-8 weeks) Covers all major sub-populations YES Unlikely Simplicity HIGH Lower 13
14 Potential Pros and Cons of Shorter Duration SOF/VEL (12 weeks) Shorter Duration (4-8 weeks) Covers all major sub-populations YES Unlikely Simplicity HIGH Lower Toxicity MINIMAL May be increased or decreased 14
15 Potential Pros and Cons of Shorter Duration SOF/VEL (12 weeks) Shorter Duration (4-8 weeks) Covers all major sub-populations YES Unlikely Simplicity HIGH Lower Toxicity MINIMAL May be increased or decreased Non-adherence Forgiveness Probably HIGH May be lower 15
16 Sofosbuvir/Velpatasvir/Voxilaprevir POLARIS 2: GT1-6, DAA naive, F0-4 (18% F4, 0% GT3), 8 weeks SVR12 % % (95% CI 93-97%) 98% (95% CI 96-99%) 29/41 24/30 5/11 11/11 18/30 476/ / /215 66/70 100/ / /216 54/56 31/47 209/ /217 SOF/VEL/VOX 8 weeks SOF/VEL 12 weeks 16 Jacobson IM, et al. Gastroenterology 2017
17 Sofosbuvir/Velpatasvir/Voxilaprevir POLARIS 2: GT1-6, DAA naive, F0-4 (18% F4, 0% GT3), 8 weeks SOF/VEL/VOX 8 weeks SOF/VEL 12 weeks SVR12 % /169 29/41 24/30 5/11 11/11 18/30 170/ /215 66/70 100/101 61/63 201/216 57/59 61/63206/216 54/56 53/53 86/89 31/47 209/ /217 91/92 58/63 56/57 50/51 9/9 GT1a GT1b GT2 GT3 GT4 Other* 17 * 2 Other GT1, 18 GT5, 39 GT6 (9/9 SOF/VEL) Jacobson IM, et al. Gastroenterology 2017
18 Sofosbuvir/Velpatasvir/Voxilaprevir POLARIS 2: Adverse Events >10% Patients, n (%) SOF/VEL/VOX 8 Week N=501 SOF/VEL 12 Week N=440 Headache 134 (27) 99 (23) Fatigue 106 (21) 90 (20) Diarrhea 88 (18) 32 (7) Nausea 80 (16) 40 (9) Any Adverse Event 361 (72) 303 (69) Serious Adverse Events 15 (3) 7 (2) 18 Jacobson IM, et al. Gastroenterology 2017
19 SVR12 % 19 Glecaprevir/Pibrentasvir GT1-6, treatment naïve, F0-3, 8 and 12 weeks in Phase II/III trials / /41 24/30 5/11 11/11 18/30 400/ 202/215 66/70193/ 232/ 149/ 100/ / /216 54/56 222/ 43/ 111/ 2/ 28/ 9/ 31/47 209/ / weeks 12 weeks GT1 GT2 GT3 GT4 GT5 GT6 Kwo P, J Hepatology 2017; Zeuzem S, AASLD 2016; Kowdley K, AASLD 2016; Asselah T, AASLD 2016; Gane E, AASLD 2016; Foster G, ILC / 31
20 Glecaprevir/Pibrentasvir ENDURANCE 2: Adverse Events Patients, n (%) GLE/PIB 12 Week N=202 Placebo 12 Week N=100 Headache 24 (12) 12 (12) Fatigue 23 (11) 10 (10) Any Adverse Event 131 (65) 58 (58) Serious Adverse Events 3 (1) 1 (1) ALT (>3xULN) 1 (0.5) 8 (8) Bilirubin (3-10xULN) 1 (0.5) 0 (0) 20 Kowdley KV, et al. AASLD 2016
21 HCV care cascade in Australia: end ,000 Australians live with chronic HCV infection Pre-cirrhosis, naive Pre-cirrhosis, experienced Cirrhosis 21
22 HCV care cascade in Australia: end ,000 Australians live with chronic HCV infection Pre-cirrhosis, naive Pre-cirrhosis, experienced Cirrhosis 22
23 Where would shorter durations (4-6 weeks) help? Prisons, particularly remand and medium security settings Inpatient HCV treatment (e.g. PWID with infectious complications of injecting) Needle Syringe Program based treatment for PWID Acute HCV, including treatment of HCV reinfection When cost-effectiveness significantly enhanced (including generic LMIC settings) 23
24 Sofosbuvir/Velpatasvir/Voxilaprevir GT1, treatment naïve, F0-4, 4-8 weeks SVR12 % /41 24/30 5/11 11/11 18/30 36/36 31/33 14/15 13/15 4/15 202/215 66/70 100/ / /216 54/56 31/47 209/ /217 8 weeks (F0-3) 8 weeks (F4) 6 weeks (F0-3) 6 weeks (F4) 4 weeks (F0-3) 24 Gane E, et al. Gastroenterology 2016
25 DAA regimens for 6 weeks GT1, treatment naïve, F SVR12 % /41 24/30 5/11 11/11 18/30 100/101 31/47 26/30 202/215 66/70 19/20 201/ /216 54/56 19/20 8/14 14/15 209/ /217 SOF + GZR/EBR SOF/LDV + GS-9451 SOF/LDV + GS-9669 SOF + DCV/BCV/ASV SOF/VEL/VOX 25 Lawitz E, et al. Hepatology 2017; Kohli A, et al. AIM 2015; Sulkowski M,et al. Liver Inter 2016; Gane E, et al. Gastroenterology 2016
26 DAA regimens for 4 weeks GT1, treatment naïve, F SVR12 % /41 24/30 5/11 11/11 18/30 100/101 31/47 10/31 202/215 66/70 10/25 201/ /216 54/565/25 4/14 4/15 209/ /217 SOF + GZR/EBR SOF/LDV + GS-9451 SOF/LDV SOF + DCV/BCV/ASV SOF/VEL/VOX 26 Lawitz E, et al. Hepatology 2017; Kohli A, et al. AIM 2015; Sulkowski M,et al. Liver Inter 2016; Gane E, et al. Gastroenterology 2016
27 Future short duration studies Favourable sub-populations (F0-2, younger age, genotype/subtype): current DAA regimens Strategy studies: response-guided Acute/recent HCV New DAA combinations: SOF + GLE/PIB DAA + other classes: DAAs + long-acting non-oral agent 27
28 DAA regimens for 4 weeks GT1-3, treatment naive, F0-1, RNA <2 million, <50 years (mean, 39 years), PWUD SVR12 % % (1 LTFU) 75% (2 relapse, 2 LTFU) 29/41 24/30 5/11 11/11 18/30 12/16 15/16 202/215 66/70 100/ / /216 54/56 31/47 209/ /217 SOF/LDV + RBV SOF/LDV + RBV + PEG-IFN 28 Karup, et al. ILC 2017
29 Ultra-short DAA therapy: response-guided 3 weeks GT1b, treatment naive, F0-2, mean age years, RNA<500 IU/mL day 2 (18/26) SVR12 % /41 24/30 5/11 11/11 18/30 6/6 6/6 6/6 202/215 66/70 100/ / /216 54/56 31/47 209/ /217 SOF/LDV + ASV SOF + DCV + ASV SOF + DCV + SMV 29 Lau G, et al. Lancet Gastro Hepatol 2016
30 Ultra-short DAA therapy: response-guided 3 weeks GT1b, treatment naive, F0-2, mean age years, RNA<500 IU/mL day 2 (18/26) 29/41 11/11 18/30 6/6 24/30 6/6 5/11 6/6 202/215 66/70 100/ / /216 54/56 31/47 209/ / Lau G, et al. Lancet Gastro Hepatol 2016
31 Acute/recent HCV: DAA regimens 6 weeks SVR12 % % non-response=2 relapse=9 reinfection=1 LTFU=1 77% relapse=3 reinfection=1 LTFU=2 29/41 24/30 5/11 11/11 18/30 6/19 20/20 20/26 202/215 66/70 100/ / /216 54/56 31/47 209/ /217 SOF + RBV (HCV + HIV/HCV) SOF/LDV (HCV) SOF/LDV (HIV/HCV) 31 Martinello et al. Hepatology 2016; Deterding et al. Lancet ID 2016; Rockstroh et al. Lancet Gastro Hep 2017
32 TARGET3D: Treatment of recently AcquiRed hepatitis C with the 3D regimen or GLE/PIB Open label, multi-centre, sequential (Australia, NZ, UK) Closed to recruitment Recent HCV GT1 (n=30) PrOD +/- RBV 8 weeks (n=30) SVR 12 GLE/PIB Open to recruitment Sept 2017 Recent HCV GT1-6 (n=60) GLE/PIB 6 weeks (n=30) SVR 12 4 weeks (n=30) SVR 12 32
33 REACT: A randomised study of interferon-free treatment for recently acquired hepatitis C in people who inject drugs and people with HIV coinfection Phase III randomised, open-label, non-inferiority trial (AUS, NZ, NA, Europe) Randomised 1:1 Recent HCV GT 1-6 Primary and reinfection (n=250) Open to recruitment SOF/VEL 6 weeks (n=125) SOF/VEL 12 weeks (n=125) SVR12 SVR 12 33
34 Acknowledgements UNSW Australia A/Prof. Jason Grebely A/Prof. Gail Matthews Prof. Andrew Lloyd Dr. Behzad Hajarizadeh Dr. Maryam Alavi Dr. Tanya Applegate Ms. Pip Marks Dr. Marianne Martinello Prof. Carla Treloar Collaborators Prof. Margaret Hellard (Australia) Prof. Ed Gane (New Zealand) Dr. Philip Bruggmann (Switzerland) Prof. Olav Dalgard (Norway) Prof. Julie Bruneau (Canada) Dr. Jordan Feld (Canada) Prof. Alain Litwin (USA) Prof. Juergen Rockstroh (Germany) Dr. Mark Nelson (UK) Ms. Tracy Swan (USA)
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