HCV In 2015: Maximizing SVR
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1 HCV In 2015: Maximizing SVR Alnoor Ramji Gastroenterology & Hepatology Clinical Associate Professor Division of Gastroenterology University Of British Columbia
2 Disclosures (within Last 24 months) Company Name Abbvie BI BMS Gilead Sci. Inc Relationship Investigator, consultant Investigator, Consultant Investigator, Consultant, Speaker Investigator, Consultant, Speaker; Grants Janssen (J. & J.) Lupin Novartis Merck & Co. Vertex Pharmaceuticals Investigator, Consultant, Speaker Consultant Investigator Investigator, Consultant, Speaker; Grants Investigator, Consultant, Grants.
3 Objectives Review available regimens to maximize SVR: The Advanced Compensated Cirrhotic patient Decompensated Cirrhosis DAA Failures Genotype 2 Genotype 3
4 The Advanced Compensated Cirrhotic Patient: Not All Cirrhotic s are Equal 64 y.o. male Geno 1a: a) Fibroscan 14.5 kpa, Plt 156, Albumin 37 b) Fibroscan 20.5 kpa., Plt 88, Albumin 34
5 Treatment-Experienced GT1 Cirrhotic Pts.: Paritaprevir/RTV/Ombitasvir + Dasabuvir + RBV 12 vs. 24 wks. (TURQUOISE II) GT1a wks 24 wks GT1b SVR12 (%) / 64 52/ 56 Naive 14/ 15 13/ 13 11/ 11 10/ 10 Relapse Partial Response 40/ 50 39/ 42 Null Response 0 22/ 22 18/ 18 Naive 25/ 25 20/ 20 Relapse Partial Response 6/7 3/3 14/ 10/ Null Response Poordad F, et al. NEJM 370:21;1973. Note: Turquoise III: Feld JJ, et al. ISVHLD 2015; Late breaker oral presentation 333.
6 TURQUOISE-II: Regimens of Paritaprevir/r/Ombitasvir and Dasabuvir With Ribavirin: Geno. 1 Cirrhosis, effect of Baseline Characteristicson SVR 12 Overall SVR12: 91.8% 96.5% HCV GT1a IL28B non-cc IL28B TT Platelet <90 x 10 9 /L Albumin <35 g/l AFP 20 ng/ml SVR12 Rate, % ± 95% CI Fried, et al. EASL Abstract O81. Reproduced with permission. Poordad F, et al. NEJM 370:21;1973. Supplement
7 OPTIMIST-2: SMV + SOF for 12 Wks in Cirrhotic Tx-Naive and Tx-Expd GT1 Pts: SVR12 SVR12 Rate Treatment history 12 Wks of Simeprevir + Sofosbuvir (n = 103) % (n/n) 95% CI Naive 88 (44/50) Experienced 79 (42/53) HCV subgenotype 1a 83 (60/72) a with Q80K 74 (25/34) a without Q80K 92 (35/38) b 84 (26/31) SVR12 Rate Platelet count 12 Wks of Simeprevir + Sofosbuvir (n = 103) % (n/n) 95% CI < 90,000/mm 3 68 (13/19) ,000/mm 3 87 (73/84) FibroScan score > 20 kpa 80 (12/15) > 12.5 to 20 kpa (11/11) Lawitz E, et al. EASL Abstract LP04.
8 Genotype 1 Naïve Cirrhosis (ION-1) (LDV/SOF±RBV x 12 or 24 wks.) SVR12 by Presence of Cirrhosis Absence of Cirrhosis Cirrhosis SVR12 (%) 179/17 32/33 9 LDV/SOF 178/17 33/33 8 LDV/SOF + RBV 181/18 31/32 2 LDV/SOF 179/17 36/36 9 LDV/SOF + RBV Mangia A, EASL, 2014, O Weeks 24 Weeks Afdhal N, et al. N Engl J Med 2014; 2014 Apr 12 [Epub ahead of print] Cirrhosis = 12.5 Kpa, 2-5% plt <90 or Albumin <35
9 SOF/LDV Therapy In Compensated cirrhosis: Role of RBV & Effect of Negative Predictors. SVR12, % Integrated analysis of > 500 pts with cirrhosis treated with LDV/SOF ± RBV Treatment-experienced pts had previously received PR +/- PI Total (N = 513) Treatment Naive (n = 161) Treatment Experienced (n = 352) Overall wks without RBV wks with RBV wks without RBV wks with RBV Baseline platelet count <75,000 32/38 (84) 9/10 (90) 23/28 (82) >75, /475 (97) 148/151 (98) 313/324 (97) Albumin <3.5 61/63 (97) 20/21 (95) 1/42 (98) > /450 (96) 137/140 (98) 295/310 (95) Reddy KR, et al. Hepatology. 2015;62:79-86.
10 SOF/LDV Therapy In Compensated Cirrhosis: Role of baseline NS5A RAV s Treatment experienced patients had previously received HCV PI or Peg/ Rbv SVR12, % (n/n)18 With NS5A RAVs Without NS5A RAVs Overall 91 (86/94) 98 (407/417) 12 wks without RBV 88 (23/26) 95 (86/91) 12 wks with RBV 94 (32/34) 97 (164/169) 24 wks without RBV 85 (17/20) 100 (113/113) 24 wks with RBV 100 (14/14) 100 (44/44) Reddy KR, et al. Hepatology. 2015;62:79-86.
11 DAA Failures And NS5A RAV s DAA Failures with Persistence of Variants: Persistence of NS5A RAV / TEV in 95-96% at week 48, and 86% at week 96. NS5B: 42% at week 48. NS3: 7% at week 48. Krishnan P, et al. EASL 2015; #0057. Wyles D, et al. EASL 2015; #O059.
12 Re-Treatment For DAA Failures: 24 Wks. LDV/SOF After Failure of 8-12 Wks. LDV/SOF-Based Therapy: SVR SVR12 (%) n/n = 0 29/ 41 15/ 22 All No Yes Cirrhosis Lawitz E, et al. EASL Abstract O / 19 24/ 30 5/ 11 8 Wks 12 Wks Previous Tx Duration 11/ 18/ No Yes BL NS5A RAVs
13 Re-Treatment For DAA Failures: 24 Wks. LDV/SOF: SVR12 by Base-line RAV s Number of NS5A RAV(s) Type of Single NS5A RAV 11/11 11/16 7/14 5/5 4/5 2/6 NS5B variants emerged during retreatment in 33% of pts (4/12) with virologic failure: S282T: n = 2; L159F: n = 1; S282T + L159F: n = 1 Adapted from Lawitz E, et al. Presented at EASL 2015; Oral presentation #O005.
14 Re-Treatment For DAA Failures. Should only consider if resistance testing available. At present consider: addition of RBV; duration; use multiple DAA s. LB-20 Retreatment of HCV Genotype 1 DAAfailures with Ombitasvir/Paritaprevir/r, Dasabuvir, and Sofosbuvir : Fred Poordad. LB-12: C-SWIFT Retreatment (Part B): 12 weeks of Elbasvir/Grazoprevir with Sofosbuvir and Ribavirin Successfully Treated GT1-infected Subjects who Failed Short-Duration All-Oral Therapy. Eric Lawitz
15 The Decompensated Patient
16 SOLAR-2: SVR12 and Safety in GT1 or 4 HCV by Liver Disease Subgroup Outcome Posttransplantation F0-F3 or CTP A LDV/SOF + RBV for 12 Wks (n = 86) LDV/SOF + RBV for 24 Wks (n = 82) Pre- and Posttransplantation CTP B or C LDV/SOF + RBV for 12 Wks (n = 78) LDV/SOF + RBV for 24 Wks (n = 82) SVR12, % (n/n) Genotype 1 96 (72/75) 98 (57/58) 88 (57/65) 89 (54/61) Genotype 4 91 (10/11) 100 (7/7) 57 (4/7) 86 (6/7) Safety, n (%) SAE 12 (14) 12 (15) 22 (28) 23 (28) Trt-related SAE 0 3 (4) 2 (3) 4 (5) Trt discont. for AE 0 1 (1) 1 (1) 4 (5) Deaths 2 (2) 1 (1) 3 (4) 4 (5) Manns M, et al. EASL Abstract G02.
17 ALLY-1: DCV/ SOF/ RBV x 12 Wks. SVR 12 by Child-Pugh Class and by Albumin Level By Child-Pugh Class By Albumin Level 11/12 30/32 9/16 10/11 30/31 10/18 Adapted from Poordad F, et al. Presented at EASL 2015; Oral presentation #L08.
18 Genotype 2
19 Genotype 2: BOSON: SOF/Rbv x 16 wks. vs. SOF/Rbv x 24 wks. vs. Peg/ Rbv / SOF x12 wks. Geno 2 all with cirrhosis and treatment experienced % 100% 94% 80 SVR (%) /15 17/17 15/16 0 SOF+RBV X 16 wks SOF+RBV X 24 wks PegIFN/RBV X 12 wks Foster G. et al. Gastroenterology Nov. 2015; 149:6
20 Genotype 3
21 Geno 3: BOSON: SVR12 by Treatment History and Cirrhosis Status SOF + RBV 16 wks SOF + RBV 24 wks SOF + PegIFN/RBV 12 wks SVR12 (%) n/n = 0 58/ 70 65/ 72 68/ 71 12/ 21 Treatment Naive 18/ 22 21/ 23 No Cirrhosis Cirrhosis No Cirrhosis Cirrhosis Foster G. et al. Gastroenterology Nov. 2015; 149:6 41/ 54 44/ 54 49/ 52 17/ 36 26/ 34 Treatment Experienced 30/ 35
22 ALLY-3: DCV + SOF x 12 weeks: SVR-12 Treatment-naive (n=101) or experienced (n=51), including patients with cirrhosis No cirrhosis Cirrhosis SVR12 (%) n/n = 0 105/ / 32 Overall Treatment-Naive Pts Of 16 pts with relapse, 11 had cirrhosis 1 of 16 relapses occurred between posttreatment Wks 4 and 12 73/ 75 11/ 19 Nelson DR, et al. Hepatology. 2015;61: / 34 9/ 13 Treatment- Experienced Pts
23 Sofosbuvir + Daclatasvir for GT-3 Patients: Preliminary Real-life Data from a French Multicenter Compassionate Use Program N=601 GT-3 patients 77% cirrhotic 73% treatment-experienced Treated with sofosbuvir + daclatasvir for 12 or 24 weeks Duration at physicians' discretion 22/29 52/59 11/12 5/6 CCO Slideset. Adapted from Hezode C, et al. Presented at EASL 2015; Poster #LP05.
24 All-Oral Treatment With Daclatasvir (DCV) Plus Sofosbuvir (SOF) Plus Ribavirin (RBV) for 12 or 16 Weeks in HCV Genotype (GT) 3-lnfected Patients With Advanced Fibrosis or Cirrhosis: The ALLY patients : (12 weeks, 24; 16 weeks, 26). Treatment experienced- 74% (10% prior relapse on SOF+RBV) 72% had cirrhosis V.. Leroy et al. AASLD 2015 LB-3
25 All-Oral Treatment With Daclatasvir (DCV) Plus Sofosbuvir (SOF) Plus Ribavirin (RBV) for 12 or 16 Weeks in HCV Genotype (GT) 3-lnfecleted Patients With Advanced Fibrosis or Cirrhosis: The ALL Y-3+ N (%) 12 wks (n=24) 16 wks (n=26) SVR-4 21 (88) 25 (96) Advanced fibrosis 6/6 (100) 8/8 (100) Cirrhosis 15/18 (83) 17/18 (94) Virologic breakthrough 0 0 Relapse 2 (8) 1 (4) V.. Leroy et al. AASLD 2015 LB-3
26 Summary Using available regimens we can optimize SVR: The advanced cirrhotic patient: Plt. <90.;? Albumin <3.5 When regimen s fail.. Use resistance testing prior to re-treatment? Role of Rbv?, duration of therapy, additional DAA s. Genotype 2: Tx. Exp. Cirrhotic: SOF/ Rbv x 24 wks. Genotype 3: PRS x12 Wks. or DCV/SOF+/- RBV: wks.
27 HCV In 2015: Maximizing SVR Alnoor Ramji Gastroenterology & Hepatology Clinical Associate Professor Division of Gastroenterology University Of British Columbia
28 DAA Failures And NS5A RAV s Baseline NS5A: ION-3: 116 of 647 had a NS5A variant at baseline (deep sequencing), with 90% SVR. Combined compensated cirrhosis patients with baseline NS5A treated with SOF/LDV +/- Rbv 12/24 wks. SVR 91% DAA Failures with Persistence of Variants: NS5A RAV / TEV in 95-96% at week 48, and 86% at week 96. NS5B: 42% at 48 weeks NS3/4A: 7% at 48 weeks Reddy KR, et al. Hepatology. 2015;62: Wyles D, et al. EASL 2015; #O059. Krishnan P, et al. EASL 2015; #0057.
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