Post-AASLD Martin Moehlen, MD, MPH Fellows Conference December 16, 2014
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1 Post-AASLD 2014 Martin Moehlen, MD, MPH Fellows Conference December 16, 2014
2 Objectives STOPAH Trial Chronic Hepatitis C Abbreviated Debrief General Considerations Late-Breaking Abstracts Summary
3 Recall Alcoholic Hepatitis Lecture from September 2014 Summary DF, MELD, GAHS, and ABIC have similar accuracy in predicting short-term mortality Prednisolone and pentoxifylline are effective treatments for alcoholic hepatitis The combination of prednisolone + pentoxifylline is not more effective than prednisolone alone (STOPAH UK trial ongoing) Effectiveness of NAC + prednisolone in alcoholic hepatitis needs to be studied (French study ongoing) 3
4 LB-1: Steroids or Pentoxifylline for Alcoholic Hepatitis: STOPAH Trial UK multi-center, double-blind RCT, four-arm study, with prednisolone (40 mg daily) and pentoxifylline (400 mg TID): Arm A: Placebo/Placebo x 4 weeks Arm B: Placebo/Prednisolone x 4 weeks Arm C: Pentoxifylline/Placebo x 4 weeks Arm D: Pentoxifylline/Prednisolone x 4 weeks N=1053 Primary endpoint: 28 d mortality Secondary endpoints: 90d and 1 year mortality
5 LB-1: Steroids or Pentoxifylline for Alcoholic Hepatitis: STOPAH Trial Inclusion Criteria: Clinical diagnosis of alcoholic hepatitis DF > 32 Exclusion Criteria: Alcohol abstinence > 6 weeks prior to randomization > 3 month duration of jaundice Use of study drugs within the past 6 months AST > 500 U/L or ALT > 300 U/L Renal failure (Cr > 5.6) or need for renal support GI hemorrhage Untreated sepsis
6 LB-1: Table 1 4 arms were similar in: Age Gender Ethnicity Alcohol consumption Mean days from admission to treatment initiation Laboratory values
7 LB-1: Primary Endpoint Analysis Mortality at 28 days
8
9 LB-1: Primary Endpoint Analysis OR in prednisolone arm for 28 d mortality: 0.61 (95% CI 0.41 to 0.90), p=0.014
10 LB-1: Secondary Endpoint Analysis
11 LB-1: Adverse Events Infection: More common in prednisolone group (13.5%) v no prednisolone group (7.9%), p=
12 LB-1: Steroids or Pentoxifylline for Alcoholic Hepatitis: STOPAH Trial Conclusions Prednisolone improves 28 day mortality No benefit after this time Pentoxifylline offers no benefit Abstinence is a major determinant of survival after 90 days
13 Chronic Hepatitis C Abbreviated Debrief
14 The HCV Proteins c c
15 DAA s Nomenclature and Mechanism of Action - previr = Protease Inhibitor Blocks the NS3-4A protease Simeprevir, paritaprevir, telaprevir, boceprevir Low barrier to resistance - buvir = Polymerase Inhibitors Blocks the NS5B protein Nucleotide (e.g. sofosbuvir) High barrier to resistance Non-nucleotide (e.g. dasabuvir) Low barrier to resistance - asvir = NS5A Inhibitor Blocks a nonstructural protein involved Ledipasvir, ombitasvir, daclatasvir Low barrier to resistance
16 All-oral DAA availability in the USA Muir A. HCV Symposium. AASLD 2014 Liver Meeting.
17 A word about Simeprevir Package Insert has been updated as of November Last accessed December 10, 2014.
18 AASLD-IDSA Guidelines hcvguidelines.org Anticipated to be updated in December 2014
19 Genotype 1
20 Genotype 1 Cirrhotics
21 What to do about GT1 cirrhotics that failed previous Boceprevir or Telaprevir therapy?
22 LB-6: Ledipasvir/Sofosbuvir: SIRIUS French, double-blind, placebo-controlled study Cirrhotics Biopsy, Fibroscan > 12.5 kpa, or Fibrotest > 0.75 and APRI > 2 Genotype 1 Treatment experienced to PEG/RBV and PEG/RBV/PI Primary endpoint: SVR12 in treatment-naive
23 LB-6: Ledipasvir/Sofosbuvir: SIRIUS
24 LB-6: Ledipasvir/Sofosbuvir: SIRIUS
25 LB-6: Ledipasvir/Sofosbuvir: SIRIUS
26 LB-6: Ledipasvir/Sofosbuvir: SIRIUS Overall SVR12 Rate
27 LB-6: Ledipasvir/Sofosbuvir: SIRIUS Safety Signals
28 LB-6: Ledipasvir/Sofosbuvir: SIRIUS AE s > 15%
29 LB-6: Ledipasvir/Sofosbuvir: SIRIUS Conclusions 97% of prior PI-failures achieved SVR12 Similar SVR12 between Ledipasvir/Sofosbuvir/RBV x 12 weeks Ledipasvir/Sofosbuvir x 24 weeks Ledipasvir/Sofosbuvir with and without RBV was safe and well tolerated
30 Genotype 1 Decompensated Cirrhotics
31 Abstract 239: Ledipasvir/Sofosbuvir: SOLAR-1 Prospective, 1:1 randomization to 12 to 24 weeks, multicenter study Decompensated Cirrhotics N=108 CTP B (N=59) or CTP C (N=49) Genotype 1 and 4 Treatment naïve or treatment experienced Primary endpoint: SVR12 in treatment-naive
32 Abstract 239: Ledipasvir/Sofosbuvir: SOLAR-1 Broad inclusion criteria: No history of major organ transplant, including liver No HCC Total bilirubin < 10 mg/dl Hemoglobin > 10 g/dl CrCl > 40 ml/min Platelets > 30,000 Stratified by CPT class B or C
33 Abstract 239: Ledipasvir/Sofosbuvir: SOLAR-1
34 Abstract 239: Ledipasvir/Sofosbuvir: SOLAR-1
35 Abstract 239: Ledipasvir/Sofosbuvir: SOLAR-1
36 Abstract 239: Ledipasvir/Sofosbuvir: SOLAR-1
37 Abstract 239: Ledipasvir/Sofosbuvir: SOLAR-1
38 Abstract 239: Ledipasvir/Sofosbuvir: SOLAR-1 Safety Signals
39 Abstract 239: Ledipasvir/Sofosbuvir: SOLAR-1 Conclusions Ledipasvir/Sofosbuvir + RBV for 12 weeks in a high SVR12 rate in HCV GT1 and GT4 and advanced liver disease Relapse rates were similar to relapse rates in patients with compensated cirrhosis Extending treatment duration to 24 weeks did not increase the response rate Virologic response was associated with improvements in bilirubin, albumin, MELD and CPT scores in both CPT class B and C patients
40 What is in the pipeline for GT1?
41 LB-7: Daclatasvir/Asunaprevir/Beclabuvir: UNITY-1 RCT, Phase 3 Genotype 1a or b Treatment naïve OR treatment experienced Non-cirrhotic Twice-daily, fixed-dose combination therapy (DCV-TRIO) Primary endpoint: SVR12 in treatment-naive
42 LB-7: Daclatasvir/Asunaprevir/Beclabuvir: UNITY-1 Treatment-experienced prior exposure to PEG/RBV and/or select DAA s Excluded DAA s: non-nucs, NS3 inhibitors, or NS5A inhibitors
43 LB-7: Daclatasvir/Asunaprevir/Beclabuvir: UNITY-1 Majority of patients (97%) completed treatment period: 8 patients discontinued due to lack of efficacy 3 patients discontinued due to an AE, yet achieved SVR12 1 patient discontinued due to pregnancy at week 6 and yet achieved SVR12
44 LB-7: Daclatasvir/Asunaprevir/Beclabuvir: UNITY-1 Overall SVR12 Rate
45 LB-7: Daclatasvir/Asunaprevir/Beclabuvir: UNITY-1 SVR12 by Patient Population
46 LB-7: Daclatasvir/Asunaprevir/Beclabuvir: UNITY-1 Other Virologic Endpoints
47 LB-7: Daclatasvir/Asunaprevir/Beclabuvir: UNITY-1 SVR12 by Baseline Factors
48 LB-7: Daclatasvir/Asunaprevir/Beclabuvir: UNITY-1 Virologic Outcomes
49 LB-7: Daclatasvir/Asunaprevir/Beclabuvir: UNITY-1 Resistance-associated variants (RAV s): Baseline detected in 34/302 GT 1a patients and 17/106 GT 1b 25/34 (74%) GT 1a achieved SVR12 All 17 GT 1b achieved SVR12 Virologic failure occurred in 34/415 (8%) patients NS5A, NS3, and NS5B-specific RAV s were most frequently observed among GT1a patients Only 2 GT1b with virologic failure 1 had GT2b and 1 had non-gt1a/1b!
50 LB-7: Daclatasvir/Asunaprevir/Beclabuvir: UNITY-1 Safety Signals
51 LB-2: Daclatasvir/Asunaprevir/Beclabuvir +/- RBV: UNITY-2 RCT, Phase 3 Genotype 1a or b Treatment naïve OR treatment experienced Cirrhotic Twice-daily, fixed-dose combination therapy (DCV-TRIO +/- RBV) Primary endpoint: SVR12
52 LB-2: Daclatasvir/Asunaprevir/Beclabuvir +/- RBV: UNITY-2 Cirrhosis: Compensated Child-Pugh class A Confirmation: Liver biopsy (METAVIR F4) Fibroscan > 14.6 kpa Fibrotest > 0.75 with APRI > 2 Platelets > 50,000/mm 3 INR < 1.7 Albumin > 3.5 g/dl Treatment-Experienced: Prior PEG/RBV and select DAA s (excluded NS5B, NS3 inhibitors, or NS5A inhibitors)
53 LB-2: Daclatasvir/Asunaprevir/Beclabuvir +/- RBV: UNITY-2 Cirrhosis confirmed mostly by liver biopsy and Fibroscan ¼ patients with Platelet count between 50,000 to 100,000; the rest > 100,000 Experienced cohort: 39% prior nulls; 9% partial responders, 18% relapsers; rest other prior nonresponse
54 LB-2: Daclatasvir/Asunaprevir/Beclabuvir +/- RBV: UNITY-2 SVR12
55 LB-2: Daclatasvir/Asunaprevir/Beclabuvir +/- RBV: UNITY-2 SVR12 by Subtype
56 LB-2: Daclatasvir/Asunaprevir/Beclabuvir +/- RBV: UNITY-2 Virologic Outcomes
57 LB-2: Daclatasvir/Asunaprevir/Beclabuvir +/- RBV: UNITY-2 Baseline RAV s: 26/28 (92%) with NS5A RAV s achieved SVR12 2/2 (100%) with NS3 RAV s achieved SVR12 No NS5B RAV s detected Sequencing data available only for 8 of 13 virologic failures and relapsers All of the 8 patients had some emergent RAV s
58 LB-2: Daclatasvir/Asunaprevir/Beclabuvir +/- RBV: UNITY-2 Safety Signals
59 UNITY-1 and UNITY-2 Take Home Points Overall SVR12 rates in both studies was excellent (> 90%) Highest SVR12 rates in: Genotype 1b in the DCV-TRIO (without RBV) in cirrhotic/non-cirrhotic naïve and non-cirrhotic treatment experienced patients (98-100%) RBV appears to be necessary to prevent relapse in the GT1a cirrhotic Baseline RAV s do not appear to be an issue However UNITY-1, GT1a with baseline RAV s had 74% achieved SVR12 Well-tolerated and safe
60 Genotype 3
61 LB-3: Daclatasvir/Sofosbuvir: ALLY-3 Non-randomized, Open-Label Study Genotype 3 Treatment naïve OR treatment experienced Cirrhotic or Non-cirrhotic Once daily fixed-dose Primary endpoint: SVR12
62 LB-3: Daclatasvir/Sofosbuvir: ALLY-3
63 LB-3: Daclatasvir/Sofosbuvir: ALLY-3 SVR12
64 LB-3: Daclatasvir/Sofosbuvir: ALLY-3 SVR12 by Baseline Factors
65 LB-3: Daclatasvir/Sofosbuvir: ALLY-3 SVR12 in Patients with Cirrhosis
66 LB-3: Daclatasvir/Sofosbuvir: ALLY-3 Virologic Failure
67 LB-3: Daclatasvir/Sofosbuvir: ALLY-3 Safety Signals
68 ALLY-3 Take Home Points Remember this was a non-randomized, open label study SVR12 rates high in both treatment-naïve and treatment-experienced, 90% and 86% respectively. However, in the cirrhotic naïve and cirrhotic experienced group, SVR12 was not as impressive, 58% and 69%, respectively Baseline RAV s do not appear to be an issue Well-tolerated and safe
69 LB-11: Ledipasvir/Sofosbuvir: ELECTRON-2 Two-center, open label study Genotype 3 Treatment experienced Cirrhotic or Non-cirrhotic Broad inclusion criteria: no BMI cut-off Plts > 50,000 Primary endpoint: SVR12
70 LB-11: Ledipasvir/Sofosbuvir: ELECTRON-2
71 LB-11: Ledipasvir/Sofosbuvir: ELECTRON-2 SVR12
72 Sofosbuvir-based Regimens for GT 3
73 LB-11: Ledipasvir/Sofosbuvir: ELECTRON-2 Virologic Failure 9 treatment failures 6 of the 9 had deep-sequencing analysis of NS5A and NS5B 1 patient failed amplification and analysis is ongoing for 2 No NS5A RAV s in 5 of 6 patients No NS5B specific RAV s in any of the 6 patients
74 LB-11: Ledipasvir/Sofosbuvir: ELECTRON-2 Safety Signals
75 LB-11: Ledipasvir/Sofosbuvir: ELECTRON-2 Safety Signals
76 LB-11: Ledipasvir/Sofosbuvir: ELECTRON-2 Take Home Points Ledipasvir/Sofosbuvir with RBV for 12 weeks resulted in SVR12 rates of 73 and 89% in treatment experienced patients with and without cirrhosis, respectively SVR12 rates were similar to previous reports with Sofosbuvir + RBV for 24 weeks and Sofosbuvir + PEG/RBV for 12 weeks
77 ALLY-3 Take Home Points Remember this was a non-randomized, open label study SVR12 rates high in both treatment-naïve and treatment-experienced, 90% and 86% respectively. However, in the cirrhotic naïve and cirrhotic experienced group, SVR12 was not as impressive, 58% and 69%, respectively Baseline RAV s do not appear to be an issue Well-tolerated and safe
78 Genotype 6
79 LB-11: Ledipasvir/Sofosbuvir: ELECTRON-2 Two-center, open label study, Ledipasvir/Sofosbuvir x 12 weeks Treatment naïve and treatment experienced Gane E. AASLD 2014
80 Genotype 1, Treatment naïve, Non-Cirrhotic Regimen Weeks Study SVR SOF/LDV (HCV RNA <6 million IU/mL) 8 ION-3 119/123 (97%) SOF/LDV (HCV RNA >6 million IU/mL) 12 ION-3 206/213 (95%) SIM/SOF* 12 COSMOS 20/21 (95%) Paritaprevir/r, dasabuvir, ombitasvir (genotype 1b) 12 PEARL III 207/209 (99.5%) Paritaprevir/r, dasabuvir, ombitasvir, ribavirin (genotype 1a) 12 PEARL IV 97/100 (97%) SOF/DCV* 12 41/41 (100%)
81 Genotype 1, Treatment naïve, Cirrhotic Regimen Weeks Study SVR SOF/LDV 12 ION-1 32/33 (97%) SIM/SOF* 24 COSMOS 10/10 (100%) Paritaprevir/r, dasabuvir, ombitasvir, ribavirin 12 or 24 (TBD) TURQUOISE II 92% (12 week); 96% (24 week)
82 Genotype 1, Treatment Experienced, Non-Cirrhotic Regimen Weeks Study SVR SOF/LDV 12 ION-2 83/87 (95%) SIM/SOF* 12 COSMOS 20/21 (95%) Paritaprevir/r, dasabuvir, ombitasvir, ribavirin 12 SAPPHIRE II 286/297 (95%)
83 Genotype 1, Treatment Experienced, Cirrhotic Regimen Weeks Study SVR SOF/LDV 24 ION-2 22/22 (100%) SIM/SOF* 24 COSMOS 10/10 (100%) Paritaprevir/r, dasabuvir, ombitasvir, ribavirin 12 or 24 (TBD) TURQUOISE II 92% (12 week); 96% (24 week)
84 Genotype 1, Treatment Experienced, Prior PI Regimen Cirrhosis Weeks Study SVR SOF/LDV No 12 ION-2 50/52 (96%) SOF/LDV Yes 24 ION-2 14/14 (100%) SOF/LDV Yes 24 Late Breaker-6 SOF/LDV, Ribavirin Yes 12 Late Breaker-6 75/77 (97%) 74/77 (96%) SOF/DCV* Mix 24 PEARL IV 21/21 (100%) SOF/DCV*, Ribavirin Mix 24 20/20 (100%)
85 Genotype 1, Treatment Experienced, SOF-based Failure Regimen Prior Regimen Weeks Study SVR SOF/LDV PEG/RBV/SOF x 12 weeks 12 Abstract /51 (98%) SOF/RBV x 24 weeks
86 Genotype 2 Regimen Prior Regimen Cirrhotic? Weeks Study SVR No 12 58/59 (98%), Naive Yes 12 10/11 (91%) SOF/RBV No 12 25/26 (96%) Treatment Experienced Yes 12 (**16) FUSION 12 week: 6/10 (60%) 16 week: 7/9 (78%) SOF/DCV* Sulkowski NEJM 2014
87 Genotype 3 Regimen Prior Regimen Cirrhotic? Weeks Study SVR SOF/RBV Naive Treatment Experienced (Not SOF) No 24 VALENCE 86/92 (93%) Yes 24 VALENCE 12/13 (92%) No 24 VALENCE 85/100 (85%) Yes 24 VALENCE 27/45 (60%) PEG/SOF/RBV SOF based Mixed 12 Esteban R EASL /22 (91%) SOF/LDV Naïve Mixed 12 Gane EJ EASL /25 (64%) SOF/LDV/RBV Naïve Mixed 12 Gane EJ EASL /26 (100%) SOF/LDV/RBV Treatment Experienced No 12 Late Breaker-11 25/28 (89%) Yes 12 Late Breaker-11 16/22 (73%) SOF/DCV* Naïve Treatment Experienced No Yes No Yes 12 Late Breaker-3 (ALLY-3) 73/75 (97%) 11/19 (58%) 32/34 (94%) 9/13 (69%)
88 Thank you!
89
90 Appendix/Back-Up Slides
91 LB-6: Ledipasvir/Sofosbuvir: SIRIUS Change in Lab Parameters
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