A treatment revolution: current management for chronic HCV
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1 A treatment revolution: current management for chronic HCV Ray Chung, M.D. Director of Hepatology and Liver Center Kevin and Polly Maroni Research Scholar Massachusetts General Hospital
2 Disclosures Research Grants Gilead, Abbvie, Merck, BMS, Mass Biologics
3 HCV: Scope of the Problem 2016 >170 million infected worldwide >3M infected in U.S. HCV mortality surpassed HIV mortality in 2006 leading indication for liver transplant worldwide leading cause of HCC in US
4 Targets for Direct Acting Antivirals (DAA) C E1 E2 p7 NS2 NS3 NS4A NS4B NS5A NS5B Core Envelope Glycoproteins Protease Serine Helicase Protease Serine Protease Cofactor Needed for Replication Assembly RNA-dependent RNA polymerase NS3-4A protease inhibitors NS5A inhibitors NS5B polymerase inhibitors Nucleos(t)ide inhibitors non-nucleoside inhibitors McGovern B, Abu Dayyeh B, and Chung RT. Hepatology. 2008; 48:
5 Potential Therapeutic Targets in the HCV Lifecycle Transport and release Fusion and uncoating Translation HCV RNA RNA replication NS5B polymerase inhibitors Viral assembly NS5A inhibitors Polyprotein processing NS3/4A protease inhibitors NS5B NS3 NS4B CypA NS5A NS2 NS4B NS2 NS3 HCV NS proteins NS5A NS5B NS5A inhibitors
6 Chronology of HCV Therapeutics % % 40 34% 42% 39% 20 16% 6% 0 IFN 6 m IFN 12 m IFN/RBV 6 m IFN/RBV 12 m Peg-IFN 12 m Peg-IFN/ RBV 12 m Peg/RBV + DAA Adapted from Strader DB, et al. Hepatology. 2004;39:
7 Good news: SVR Reduces All- Cause and Liver-Related Mortality 530 pts with F4-6, IFN-based Rx, median F/U 8.4Y van der Meer A, JAMA, 2013
8 Targets for Direct Acting Antivirals (DAA) C E1 E2 p7 NS2 NS3 NS4A NS4B NS5A NS5B Core Envelope Glycoproteins Protease Serine Helicase Protease Serine Protease Cofactor Needed for Replication Assembly RNA-dependent RNA polymerase NS3-4A protease inhibitors NS5A inhibitors NS5B polymerase inhibitors Nucleos(t)ide inhibitors non-nucleoside inhibitors McGovern B, Abu Dayyeh B, and Chung RT. Hepatology. 2008; 48:
9 Characteristics of HCV DAA Classes Characteristic NS3 Protease inhibitors Nucleos(t)ide NS5B Polymerase inhibitors Nonnucleoside NS5B Polymerase inhibitors NS5A inhibitors Potency High; Variable among HCV genotypes Moderate-high; Pangenotypic Variable; Variable among HCV genotypes High; increasingly pangenotypic Barrier to Resistance Low 1a < 1b High 1a = 1b Very Low 1a < 1b Low 1a < 1b Drug Interaction Potential High Minimal Variable Low to moderate Comments 1 st gen: rash, anemia 2 nd gen: inc bilirubin (SMV) Single target Active site Allosteric; Many targets Multiple antiviral MOA
10 A Combination of DAAs Could Eliminate Resistant Variants Target Variant NS3 Linear NS3 Macrocyclic NS5A inhibitor NS5B nucleoside NS5B Palm NS5B Thumb V36M R S S S S S S S S NS5B Finger IFN RBV NS3 Protease T54A R S S S S S S S S R155K R R S S S S S S S A156T R R S S S S S S S D168V S R S S S S S S S NS5A L28V S S R S S S S S S Y93H S S R S S S S S S S282T S S S R S S S S S C316Y S S S S R S S S S NS5B M414T S S S S R S S S S R422K S S S S S R S S S M423T S S S S S R S S S P495S S S S S S S R S S From HCV DRAG S = Susceptible (< 4 fold shift in HCV replicon EC50) R = Resistant (>4 fold increase in EC50)
11 Genotype 1
12 The Promise of Triple Therapy Does Not Reach to All Groups Prior relapsers Prior partial responders Prior null responders Pooled T12/PR48 Pbo/PR48 SVR (%) n/n= 144/167 12/38 53/62 2/15 48/57 2/15 34/47 3/17 10/18 0/5 11/32 1/5 24/59 1/18 15/38 0/9 7/50 1/10 Stage No, minimal or portal fibrosis Bridging fibrosis Cirrhosis No, minimal or portal fibrosis Bridging fibrosis Cirrhosis No, minimal or portal fibrosis Bridging fibrosis Cirrhosis Zeuzem et al, NEJM 2011;364:
13 Pooled analysis of simeprevir (PI) plus PegIFN/RBV for treatment of treatment-naïve patients with genotype 1 Simeprevir: Once daily HCV protease inhibitor Two Phase III trials (n=785) Simeprevir 150 mg or placebo for 12 wks + PegIFN/RBV for 24 or 48 weeks (RGT) FDA approved November 2013 for gt1 HCV Jacobson IM et al. The Liver Meeting 2013; Abstract 1122; FDA AVDAC *; Choe SS et al The Liver Meeting Abstract 1500
14 Sofosbuvir (NI) + PEG/RBV: Phase 3 NEUTRINO Study (GTs 1,4,5,6) SVR12 n=327 n= Lawitz et al, NEJM April 23, 2013
15 Simeprevir + Sofosbuvir with or without RBV in gt 1 treatment-naïve and prior null responder patients: COSMOS Cohort 1 (n=80): Null responders F0-2 Cohort 2 (n=84): Naïve and null responders F SVR SVR No Ribavirin Ribavirin 12 weeks 24 weeks Lawitz E et al. Lancet. 2014; 384: No Ribavirin Ribavirin 12 weeks 24 weeks
16 ION-1: Sofosbuvir + Ledipasvir (NS5A Inhibitor) Genotype 1: Treatment Naïve, n=865 Cirrhosis in 16% n=468 SVR12 (%) / / / / weeks 24 weeks Afdhal N et al, N Engl J Med 2014;370:1889
17 ION-2: Sofosbuvir + Ledipasvir ± RBV Genotype 1 Treatment Experienced Cirrhosis in 20% n=440 SVR12 (%) / / / weeks 24 weeks Afdhal N et al, N Engl J Med 2014;370:1483
18 ION-3: Sofosbuvir + Ledipasvir +RBV Genotype 1 Treatment Naïve Non-Cirrhotic: 8 weeks vs 12 weeks* (n=647) SVR12 (%) 202/ / /216 Kowdley K et al, N Engl J Med 2014; 370: weeks 12 weeks 8 wk 12 wk *posthoc analysis of relapse rates: HCV RNA <6M 2% 2% HCV RNA >6M 10% 1%
19 ION-2: Sofosbuvir + Ledipasvir ± RBV Genotype 1 Treatment Experienced Patients With Cirrhosis n=88 SVR12 (%) /22 18/22 22/22 22/22 12 weeks 24 weeks Afdhal N et al, N Engl J Med 2014;370:1483
20 Paritaprevir (PI)/ritonavir/Ombitasvir (NS5A) + Dasabuvir (NNI) (PrOD)+ RBV SAPPHIRE-1 Genotype 1, treatment naïve, noncirrhotic,12 weeks n= SVR12 % 455/ / /151 PEARL III Trial, gt1b treatment naïve (n=419): PrOD+ RBV 99%, PrOD no RBV 99% Feld JJ et al, N Engl J Med 2014;370:
21 Paritaprevir/r/Ombitasvir + Dasabuvir + RBV SAPPHIRE-2 Genotype 1, treatment experienced, noncirrhotic, 12 weeks n= SVR12 (%) PEARL II Trial, gt1b treatment experienced (n=179): PrOD + RBV 97%, PrOD no RBV 100% Zeuzem S et al, N Engl J Med 2014; 370:1604
22 Paritaprevir/r/Ombitasvir + Dasabuvir + RBV TURQUOISE-II (n=380) Gt1 compensated cirrhosis (naïve and experienced) Response by group: Prior partial: 94 v 100 Poordad F et al NEJM 2014; 370:1973
23 Sofosbuvir/Ledipasvir + RBV in Decompensated Cirrhosis: Preliminary Results of a Prospective, Multicenter Study n=99 Randomized to SOF + LDV + RBV (600 mg w/escalation) for 12 or 24 wks Patients with GT 1 or 4 and decompensated cirrhosis Median albumin = g/l; Median platelets = 71-88K 12 Weeks 24 Weeks /52 42/47 26/30 24/27 19/22 18/20 Overall CPT B CPT C Flamm, Abst# 239, AASLD 2014
24 Sofosbuvir/Ledipasvir + RBV in Patients with Decompensated Cirrhosis: improved clinical status SAE = 10%-42% (only 4 considered treatment-related) 5 deaths: Septic shock (4), renal failure/cardiac arrest Changes in MELD CPT B CPT C 12 wk (n=30) 24 wk (n=29) 12 wk (n=23) 24 wk (n=24) 5 n=5 n= n=3 n=3 CPT B 4 3 CPT B Albumin 12 Weeks 24 Weeks BL PT Wk4 Baseline PT Wk CPT C BL PT Wk4 0 Baseline PT Wk4 Flamm, Abst# 239, AASLD 2014
25 Sofosbuvir/Ledipasvir + RBV in Patients With Post-Transplant Recurrence: SOLAR-1 n=223 (214 reported) Randomized to SOF/LDV +RBV (600mg w/escalation) for 12 or 24 weeks Post-transplant patients with GT 1 or 4, including cirrhotics Most cirrhotic patients with MELD > 10 (60%) Median platelets = K, median albumin = g/dl SVRT2 (%) Weeks 24 Weeks Changes in MELD (n=41) CP-B 12 Wk CP-B 24 Wk n=4 n= /55 55/56 25/26 24/25 22/26 15/18 3/5 2/3 F0-F3 CPT A CPT B CPT C -4-6 Charlton M, Gastro 2015;149:649
26 SOF/LDV x 12 wks in HCV-HIV coinfection: ION-4 (n=335, gt1,4) Naggie S et al, NEJM 2015; 373:
27 Genotype 2 and 3
28 Sofosbuvir in Treatment Naïve GT 2,3 Patients 100 FISSION Sofosbuvir 400mg + Ribavirin daily x12w 97 PEG-2a weekly + Ribavirin 800mg daily x24w SVR % n= Overall GT GT3 Lawitz E et al., NEJM 2013; 368:
29 Sofosbuvir/Ribavirin for Treatment-Naïve and Experienced Patients with Genotype 2 or 3: VALENCE SVR 12 G2 (blue), G3 (red) Phase 3 trial in Europe Amended to treat GT3 for 24 weeks SOF/RBV x12w (GT2, n=73) or 24W (GT3, n=250) Cirrhosis 14 23% 50 Treatment experienced 58% Discontinuation due to AE, n= No cirrhosis Cirrhosis Overall Zeuzem et al, N Engl J Med 2014; 370:1993
30 All-Oral Combination of Daclatasvir (NS5A) and Sofosbuvir in Patients with Gt 3: ALLY-3 ALLY-3 0 Weeks EOT SVR Treatment Naїve 19% w/ cirrhosis N=101 Daclatasvir + Sofosbuvir 99% 90% Prior Treatment 25% w/cirrhosis N=51 Daclatasvir + Sofosbuvir 99% 86% SVR F0-F3 = 96% (105/109) SVR F4 = 63% (20/32) No SAEs related to treatment, no premature D/C due to AEs Most AE mild: fatigue, headache, nausea, diarrhea Nelson, Hepatology 2015; 61:
31 SOF/RBV vs SOF/PEG/RBV in gt 3 and 2 : BOSON Foster G et al, Gastro 2015; 49:
32 BOSON: Overall SVR12 Foster G et al, Gastro 2015; 49:
33 Gt 3 SVR12 rates by Subgroup Foster G et al, Gastro 2015; 49:
34 What lies next?
35 Grazoprevir (PI) + Elbasvir (NS5A) for TN gt 1,4,6 (n=421) C-EDGE: Phase 3 trial Placebo crossover to GZR/EBR Stratified by cirrhosis, genotype/subtype Zeuzem S et al, Ann Intern Med 2015;163:1-13
36 SVR12: GZR/EBR for TN gt 1,4,6 Zeuzem S et al, Ann Intern Med 2015;163:1-13
37 C-EDGE: GZR/EBR for gt1,4,6 Treatment Experienced HCV
38
39 C-SURFER: GZR/EBR x 12 wks for gt 1 in CKD4-5 disease (75% on HD) n=122 TN and TE 6% cirrhotic 52% 1a, 48% 1b Roth D et al, Lancet 2015;386:
40 Toward a Pangenotypic regimen: SOF + Velpatasvir (NS5A) x 12 wks Feld J et al, NEJM 2015;373:2599
41 SOF + VEL for Genotype 3: ASTRAL-3 Foster G et al, NEJM 2015;373:2608
42 Summary All oral, tolerable, high efficacy regimens (>90% cure) are now SOC Several roads to the same IFN-free destination High barrier compounds desirable for simplified regimens but can be matched by combinations of DAA classes High SVR rates now possible in historically difficult populations (cirrhotics, decompensated, post-lt, HIV) We are on a path toward pangenotypic, shorter duration regimens Dec 2013 Sofosbuvir + P/R, Simeprevir + P/R for gt 1 Sofosbuvir + RBV for gt 2/3 Oct 2014 Sofosbuvir + simeprevir for gt1 Sofosbuvir/ledipasvir for gt1 Dec 2014 Paritaprevir/r/ombitasvir + dasabuvir +/- RBV for gt 1 July 2015 Daclatasvir + sofosbuvir for gt : Grazoprevir/elbasvir +/- RBV (Jan), SOF/VEL (mid-2016)
43 Who should be treated and how? Genotype 1 Sofosbuvir + ledipasvir x 8-24W (TE cirrhosis) 1a: Paritaprevir/r/ombitasvir + dasabuvir + RBV x 12-24W (cirrhosis) 1b: Paritaprevir/r/ombitasvir + dasabuvir x 12W (+/- cirrhosis) Sofosbuvir + simeprevir x 12-24W (cirrhosis) Grazoprevir/elbasvir x 12W (16W + RBV for 1a/high level RAVs) Genotype 2 SOF/RBV x 12W (naïve and experienced) Extend to 16W in cirrhotics Genotype 3 Daclatasvir and Sofosbuvir x 12 wks (noncirrhotic); 24 wks + RBV (cirrhotic) PEG/RBV/SOF x 12W SOF/RBV x 24W Ideally, all treated
44 AASLD/IDSA HCV Guidance
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