IFN-free therapy in naïve HCV GT1 patients
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1 IFN-free therapy in naïve HCV GT1 patients Paris Hepatitis Conference Paris, 12th January, 2015 Pr Tarik Asselah MD, PhD; Service d Hépatologie & INSERM U773 University Paris Diderot, Hôpital Beaujon, Clichy, France.
2 Disclosures Tarik Asselah, M.D; PhD Service d Hépatologie & INSERM U773 University Paris Diderot, Hôpital Beaujon, Clichy, France. Consultant/Speaker : AbbVie, Achillion, BMS, Gilead, Janssen, Merck, Roche.
3 IFN-free therapy in naïve HCV GT1 patients 1 Introduction : Direct-acting antivirals (DAAs) 2 Real-life data 3 IFN-free treatment (available/phase III) 4 Take home messages
4 HCV Genotype Distribution Worldwide HCV a global health challenge with ~ Million chronic HCV infections Genotype 1 is the most prevalent in most countries 1. Gower, E., et al., J Hepatol 2014; 61:S45 S57; 2. Messina J. et al. Hepatology, 2015;61:77-87
5 Goals obtained with Sustained Virological Response (SVR) Asselah-PHC2015-1/18 Maylin et al. Gastroenterology 2008; 3: Asselah et al. Liver Int. 2015;35 S1:56-64.
6 Knowledge of the viral cycle Asselah-PHC2015-2/18 Asselah et al. Liver Int. 2015;35 S1:56-64.
7 Direct-acting antivirals (DAAs) 5 NTR Capsid C Structural proteins Nonstructural proteins Envelope Glycoproteins E1 E2 Protease Inhibitors «PREVIR» Telaprevir Boceprevir Simeprevir Asunaprevir ABT-450 MK-5172 Sovaprevir ACH-2684 Asselah-PHC2015-3/18 NS1 NS2 3 NTR Metalloprotease Serine protease RNA helicase Cofactors NS3 NS4A NS4B NS5A Inhibitors «ASVIR» Daclatasvir Ledipasvir ABT-267 GS-5816 ACH-3102 PPI-668 GSK Samatasvir MK-8742 RNA Polymerase NS5A NS5B Polymerase Inhibitors «.UVIR» Nucs Non-Nucs Sofosbuvir VX-135 IDX ACH-3422 ABT-333 BMSPPI-383 GS-9669 TMC Schinazi R, Halfon P, Marcellin P, Asselah T. Liver Int 2014; 34 S1:69-78.
8 IFN-free therapy in naïve HCV GT1 patients 1 Introduction : Direct-acting antivirals 2 Real-life data 3 IFN-free treatment (available/phase III) 4 Take home messages
9 HCV-TARGET Safety and Efficacy : Real Life Data Real-world observational study of 2,063 patients treated with DAAs at academic (n=38) and community medical centers (n=15) in North America and Europe Started Therapy HCV-TARGET 2.0 N=2063 SOF/P/R N=384 SOF/RBV N=667 SOF/SMV/RBV 14.9% SOF/SMV 53.1% SOF/SMV N=784 SOF/SMV/RBV N=228 SOF/PegIFN/RBV 23.1% SOF/RBV 8.8% Genotype 1 Asselah-PHC2015-4/18 Jensen, AASLD, 2014, Oral #45
10 HCV-TARGET Efficacy and Safety of DAAs Regimens in Real Life SVR4, % GT 1 12 Wk Regimens n (%) Completed treatment Ongoing treatment D/C Prematurely* AE Death /303 SOF+SMV ±RBV SOF+SMV ±RBV n=228 SOF+SMV n=784 Total n= (82.9) 32 (14.0) 7 (3.1) 5 (2.2) 2 (0.9) 663 (84.6) 101 (12.9) 20 (2.6) 16 (2.0) 6 (0.8) 1613 (78.2) 379 (18.4) 71 (3.4) 44 (2.1) 12 (0.6) *Not all premature D/C are summarized. Full list available in final slides. Asselah-PHC2015-5/18 Jensen, AASLD, 2014, Oral #45
11 TRIO Health SVR12 for Genotype 1 Patients (Per Protocol) Data collected from academic (n=31) and community practices (n=119) ~52% of patients were treated with SOF/SMV Treatment-Naive % 99% 85% 80% 60% 40% 20% 0% n 69 Discontinuation Rates by Reason Adverse Events Non-Adherence Asselah-PHC2015-6/18 48 GT1 SMV + SOF ± RBV 1.4% (4) 1.8% (5) Dieterich, AASLD, 2014, Oral #46
12 IFN-free therapy in naïve HCV GT1 patients 1 Introduction : Direct-acting antivirals 2 Real-life data 3 IFN-free treatment (available/phase III) 4 Take home messages
13 Direct-Acting Antivirals Asselah-PHC2015-7/18 Asselah et al. Liver Int. 2015;35 S1:56-64.
14 GT 1 Naïve (ION-1) SVR12 by Presence of Cirrhosis Absence of Cirrhosis /178 33/33 Cirrhosis /179 36/36 SVR12 (%) /179 32/33 LDV/SOF LDV/SOF + RBV 12 Weeks 181/182 31/32 LDV/SOF LDV/SOF + RBV 24 Weeks Error bars represent 95% confidence intervals Asselah-PHC2015-8/18 Afdhal N, et al. NEJM 2014; 370(20):
15 SVR12: Absence of Cirrhosis vs. Cirrhosis (ION-2) Absence of Cirrhosis 98,9 95,4 86,4 81,8 80 SVR12 (%) Cirrhosis /87 19/22 LDV/SOF 89/89 18/22 LDV/SOF + RBV 12 Weeks 86/87 22/22 98,9 LDV/SOF 88/89 22/22 LDV/SOF + RBV 24 Weeks Error bars represent 95% confidence intervals Asselah-PHC2015-9/18 Afdhal N, et al. NEJM 2014; 370(20):
16 ION-3: Naïve Non-Cirrhotic GT 1 HCV Results: Non-Inferiority Comparison p=0.52 p=0.70 p=0.30 SVR12 (%) / /216 LDV/SOF LDV/SOF + RBV 20 0 Error bars represent 95% confidence intervals. Asselah-PHC /18 8 Weeks 206/ /216 LDV/SOF 12 Weeks Kowdley K, et al. NEJM 2014;370(20):
17 An Integrated Safety and Efficacy Analysis of >500 Patients with Compensated Cirrhosis Treated with LDV/SOF±RBV Wk 0 Wk 12 Wk 24 Wk 36 n=118 LDV/SOF SVR12 n=204 LDV/SOF + RBV SVR12 n=133 LDV/SOF SVR12 n=58 LDV/SOF + RBV SVR patients with HCV GT 1, compensated cirrhosis Pooled data from Phase 2 and 3 LDV/SOF ± RBV studies LONESTAR, ELECTRON, ELECTRON-2, Japan phase 3 study, ION-1, ION-2, SIRIUS Primary efficacy endpoint: SVR12 Bourliere, AASLD, 2014, Oral #82
18 Results: SVR12 by Treatment Regimen Treatment Treatment Naïve Naïve Overall SVR12 SVR12 Overall Duration Duration Regimen Regimen 98% 98% 12 wk wk 12 97% 97% 24 wk wk 24 99% 99% LDV/SOF LDV/SOF 96% 96% LDV/SOF + + RBV RBV LDV/SOF 99% 99% LDV/SOF 12 wk 96% 96% LDV/SOF + RBV 12 wk Duration/± RBV LDV/SOF 24 wk 98% 98% LDV/SOF + RBV 24 wk % % 97% 97% 80 Bourliere, AASLD, 2014, Oral #82 90
19 SAPPHIRE-I : Naïve GT1 HCV SVR12, % Patients Superiority threshold / / /151 All Patients GT1a-infected Patients GT1b-infected Patients 3D: Co-formulated Paritaprevir (ABT-450)/r/ombitasvir, 150 mg/ mg/25 mg QD; dasabuvir, 250 mg BID RBV: mg daily according to body weight (<75 kg and >75kg, respectively) The ITT SVR12 rate of 98.0% (95% CI, 95.8-) in GT1b-infected patients is superior to a calculated historical SVR12 control rate of 80% (95% CI, ) Asselah-PHC /18 Feld et al. NEJM 2014;370(17):
20 TURQUOISE-II: GT1- Cirrhotic Patients (N=380) 91.8 P= SVR12, % Patients Asselah-PHC /18 191/ / Weeks 3D + RBV 24 Weeks 3D + RBV Poordad et al. NEJM 2014;370(21):
21 SIM/SOF: COSMOS Cohort 2: METAVIR F3-F4, prior null responders or treatment-naïve (SVR12) GT 1b GT 1a without Q80K GT 1a with Q80K SVR12 (%) SMV/SOF±RBV Overall *Excluding patients who discontinued for non-virologic reasons GT, genotype; non-vf, non-virologic failure; RBV, ribavirin SMV, simeprevir; SOF, sofosbuvir; SVR12, sustained virologic response 12 weeks after planned treatment end Asselah-PHC /18 Lawitz et al. Lancet 2014; 384(9956):
22 Daclatasvir (NS5AI) + Sofosbuvir (NI) HCV RNA < LDQ* (%) % 95 %** DCV + SOF 40 DCV + SOF + RBV Missing 20 0 n= SVR12 ** missing data *LDQ : ARN VHC < 25 UI/ml Asselah-PHC /20 Sulkowski et al. NEJM 2014, 16; 370:
23 Daclatasvir + Asunaprevir + BMS GT 1 naïve without Cirrhosis GT 1 naïve with Cirrhosis All GT1a Asselah-PHC / GT1b D D + RBV Poordad et al. AASLD 2014, LB 7
24 C-SWIFT: Grazoprevir (MK-5172) + Elbasvir (MK-8742) +Sofosbuvir Asselah-PHC /18 Lawitz et al. AASLD 2014, LB33.
25 Sofosbuvir + GS 5816 (8-12 weeks) GT1 Naïves Non-Cirrhotic SOF + GS mg SOF + GS-5816 mg 96,3 SVR12 (%) /27 28/28 0 GT 1 Asselah-PHC /18 Tran et al. AASLD 2014, A80
26 IFN-free therapy in naïve HCV GT1 patients 1 Introduction : Direct-acting antivirals 2 Real-life data 3 IFN-free treatment (available/phase III) 4 Take home messages
27 Naïve HCV GT1 : Treatment options available in 2015 Sofosbuvir/Ledipasvir (Harvoni) No cirrhosis 8 w; Cirrhosis 12 w Paritoprevir/r/Ombitasvir (Viekira) + Dasabuvir (Exviera) + RBV 12 w Genotype 1b : without RBV Sofosbuvir (Sovaldi) + Simeprevir (Olysio) 12w Sofosbuvir (Sovaldi) + Daclatasvir (Daklinza) 12w
28 Take Home Messages IFN-free therapy in naïve HCV GT1 patients 1. Numerous DAAs with different mode of action are under development. 2. Combining DAAs result in high efficacy (SVR > 90%), and short treatment duration (8 or 12 weeks). 3. How far we can go by shortening treatment duration (4, 6 or 8 weeks) is under evaluation. 4. Will treatment fit all patients (genotypes, cirrhotics, etc.) or shall we need «a la carte» treatment? 5. Real-life data are mandatory : we expect decrease in SVR of 5-10% because of compliance or other factors (disease severity, DDI, etc ). 6. Improvement in screening and access to treatment is a future challenge. Asselah-PHC /18
29 References IFN-free therapy in naïve HCV GT1 patients 1. Maylin et al. Gastroenterology 2008; 3: Schinazi et al. Liver Int 2014; 34 Suppl 1: Asselah et al. Liver Int. 2015;35 S1: Afdhal et al. NEJM 2014; 370(20): Kowdley et al. NEJM 2014; 370(20): Lawitz et al. Lancet 2014; 384(9956): Sulkowski et al. NEJM 2014; 370(3): Feld et al. NEJM 2014; 370(17): Poordad et al. NEJM 2014; 370(21): Estrabaud et al. J Hepatol 2012; 57: Asselah-PHC2015
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