Treatment emergent variants to combined direct antiviral agents against hepatitis C virus
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1 Treatment emergent variants to combined direct antiviral agents against hepatitis C virus AB Pérez, N Chueca, Fernández-Caballero JA, M Álvarez, & F García, on behalf of HCVRESp & GEHEP004 study group
2 Background Most data on HCV resistance come from controlled clinical trials Real life data are being presented but are still lacking HCVRESp is a Spanish HCV Resistance Cohort including patients treated with DAA IFN-free regimens, endorsed by GEHEP Our main goal is to study the impact of resistance testing on the selection of the regimen used for retreatment and SVR rates
3 HCVRESp Open, prospective COHORT Adult (>18 y.o.), Chronic HCV hepatitis Naïve to IFN-free DAA GEHEP004 HCVRESp n=4348 SOF-SIM n=655 (15%) SOF-DCV n=765 (18%) SOF-LPV n=1838 (42%) 2D/3D n=1069 (25%) Others n=21 (0,4%)
4 Failing patients Patients failing DAA combinations, n=138 Sex 83% males Age (years, median) 53 (IQR 48-58) Viral load (Log IU/ml) 6,02 (IQR 5,58-6,47) Genotyping (baseline) GT-1 (6) GT-1a (39) GT-1b (41) GT-3 (14) GT-3a (12) 62% 22% GT 4 or 4a/c/d (20) 15% Others (6) 1%
5 Methods Sanger Sequencing: NS5B: re-genotyping & S282T; if Dasabuvir: 316, 414, 448, 553, 554, 556 y 559 NS5A: 28, 29, 30, 31, 32, 58, 62, 92 y 93 NS3: 36, 55, 56, 80, 122, 155, 168 y 170 Deep Sequencing of NS5B Mixed infection vs reinfection; S282T confirmation
6 Resistance Interpretation Lontok E et al; Hepatology Jun 10. doi: /hep
7 RAS by Genotype Genotype 1a (n=43) Genotype 1b (n=45) 30,2% 16,3% NS3 RAVs NS5A RAVs 31,1% 20,0% NS3 RAVs NS5A RAVs 23,3% 30,2% NS3+NS5A RAVs NO RAVs 11,1% 37,8% NS3+NS5A RAVs NO RAVs RAVs in 70% of GT-1a RAVs in 69% of GT-1b
8 RAS by Genotype Genotype 3 (n=28) Genotype 4 (n=22) NS3 RAVs 57,1% 42,9% NS5A RAVs NO RAVs 45,6% 22,7% 22,7% NS5A RAVs NS3+NS5A RAVs NS5B+NS5A RAVs 4,5% 4,5% NO RAVs RAVs in 43% of GT-3 RAVs in 55% of GT-4
9 Paritaprevir r /Ombitasvir/Dasabuvir 50,0% 8/10 (80%) with RAS 30% only NS5A RAS 50% NS5A+NS3+NS5B RAS 30,0% NS5A RAVs NS3+NS5A RAVs Genotype All NS5A NS3+NS5A+NS5B 80,0% (8/10) 30,0% (3/10) 50,0% (5/10) 1a 85,7% 2/7 Q30R,H58D 1b 66,7% 1/3 Y93H 4/7 Q80K,1R55K,D168V M28T,Q30R S556G 1/3 Q80K,S122T L31M
10 Sofosbuvir/Simeprevir No Sofosbuvir RAS 22/43 (51%) with PI RAs Most prevalent RAS: 168>155>80=122 48,9% 4,6% 2,3% NS3 RAVs NS5A RAVs NS3+NS5A RAVs Genotype All NS3 NS5A NS3+NS5A All 55,8% (24/43) 48,9% (21/43) 4,6% (2/43) 2,3% (1/43) 1a 66,6% 7/12 Q80K,R155K,D168E 1b 57,1% 10/21 R155Q, D168AHV, S122T 1/12 L31M 1/21 P58S - 1/21 D168V & L31M 4 44,4% 4/9 (D168HV) - -
11 Sofosbuvir/Daclatasvir 75,0% No Sofosbuvir RAS 21/24 (87,5%) with NS5A RAS Most prevalent RAS: 93>>30>31 NS5A RAVs 12,5% NS3+NS5A RAVs Genotype All NS5A NS3+NS5A All 87,5% (21/24) 75,0% (18/24) 12,5% (3/24) 1a 83,3% 2/6 (Q30H) 1b 100% 4/4 (L31MV,Y93H) 3 85,7% 12/14 Y93H 1/14 A30K 3/6 80K,122G,155K (NS3) 30EHR,31M (NS5A) - -
12 Sofosbuvir/Ledipasvir 54,5% S282T n=1 (UDS confirmed) 25/44 (57%) with NS5A RAS Most prevalent RAS 93>>31>30 NS5A RAVs 2,3% NS5B+NS5A RAVs Genotype N NS5A NS5B+NS5A 56,8% (25/44) 54,5% (24/44) 2,3% (1/44) 1a 69,2% 9/13 (28A,30HR,31M) 1b 85,7% 12/14 (30Q,31MV,58S,93H) ,0% 0/8 Y93H ,4% 4/9 28M,93H 1/9 30F 1/9 S282T & Y93H
13 Sofosbuvir/Ledipasvir 54,5% S282T n=1 (UDS confirmed) 25/44 (57%) with NS5A RAS Most prevalent RAS 93>>31>30 NS5A RAVs 2,3% NS5B+NS5A RAVs Genotype N NS5A NS5B+NS5A 56,8% (25/44) 54,5% (24/44) 2,3% (1/44) 1a 69,2% 9/13 (28A,30HR,31M) 1b 85,7% 12/14 (30Q,31MV,58S,93H) 3 0,0% 0/8 Y93H 3/8 A30K*V, L31I 4 44,4% 4/9 28M,93H 1/9 30F /9 S282T & Y93H
14 Frequency, characteristics of RAVs, and options for retreatment (n=138) RAVs Detected RAVS Detected (Clinically relevant) Re Tx RAVs Possible in* SOF/SIM (51.2 %) NS3: 22(51.2%) SOF/NS5A: 89% (31/35) 3D/2D: 55% (23/42) SOF/DCV (91.7 %) NS5A: 21(87.5 %) SOF/LPV 24W RBV 13% (3/24) SOF/SIM: GT1 84% (5/6) 3D: (10%) 1/10 SOF/LED (72,7 %) NS5A/B: 25(56.8 %) SOF/SIM: GT1/GT4 100% (30/30) SOF/NS5A 24W RBV: 43% (19/44) 3D/2D: 27% (8/30) PTV/OMS/DSV 10 8 (80 %) NS3/NS5A/NS5B: 8 (80%) * With currently approved regimens in Europe SOF/SIM 5/10 (50%) SOF/NS5A 2/10 (20%)
15 Genotype discordance 14/138 (10%) discordant genotype calls Reported Genotype before AAD Genotype (6) 1 GT 1 2 GT 4 3 GT 1b GT 1 subtype (8) 4 GT 1b 4 GT 1a NS5B Genotype at relapse GT 3a GT 1a GT 4d GT 3a GT 4a GT 1a GT 1b -1 case of mixed infection: 65% GT 1a + 35% genotipo 3
16 Relapse or Reinfection 31 Relapsers 35 paired samples 3 undergoing confirmation (same genotype) 1 reinfection Relapse (3a) Baseline (1a)
17 Conclusions We present the first real life data on genetic barrier and RAV prevalence at patients failing DAA regimens in Spain A high genetic barrier to resistance of Sofosbuvir, low to NS5A inhibitors, and low-moderate for PIs, has been confirmed. For NS5a inhibitors, special attention must be drawn to clinically significant RAVs Resistance testing offers important information for choosing the retreatment regimen, and for duration and the need to add ribavirine. Resistance testing brings additional information on accurate genotyping and reinfection episodes
18 Acknowledgments PI15/00713 PI Patients & their families HUSC molecular lab HCVRESp participants The study has been funded by RD12/0017/0006, Plan Nacional de I+D+I, ISCIII-Subdirección General de Evaluación, Fondo Europeo de Desarrollo Regional (FEDER), and PI
19 HCVRESp Cohort Complejo Hospitalario de Jaén: M Omar Complejo Hospitalario Santiago Compostela: A Aguilera CP Albolote: JJ Antón CP Castellón: C Mínguez EPHAG Andújar: C Delgado Hospital Arnau de Vilanova: J Flores Hospital de Baza: J Guilarte Hospital General de Alicante: S Reus, J Portilla, L Giner Hospital Carlos Haya: M Jiménez, M Delgado Hospital Cartagena: F Vera, O Martínez Hospital Costa del Sol: JM Rosales; N Montiel Hospital de Elche: M Masiá, F Gutierrez Hospital General de Valencia: M Diago, M GarciadelToro, MD Ocete Hospital General JM Morales Meseguer: P Antequera Hospital Gregorio Marañón: T Aldamiz-Echevarría, H Reigadas Hospital Universitario Virgen de la Arrixaca: C Galera Hospital Infanta Elena: A de la Iglesia, D Merino Hospital de Jerez: JC Alados Hospital de la Línea: F Téllez Hospital de La Paz: J González, S G. Bujalance, V Hontanón, R Micán Hospital Melilla: A Fernández Hospital Miguel Servet: A Martínez-Sapiña, MA Simón Hospital de Poniente: M Álvarez, E Fuertes, A Lozano Hospital Puerta del Mar: Clotilde Fernández Hospital de Puerto Real: F Téllez, JM Montero Hospital Reina Sofía de Córdoba: A Poyatos, A Rivero Hospital Reina Sofía de Murcia: E Bernal Hospital San Cecilio: J Salmerón, A Gila, E Ruiz Escolano, J Hernández-Quero, R Quiles Hospital Torrecárdenas: A Collado, MC Galvez, M Gonzalez, M Casado Hospital de Valdepeñas: P Reales Hospital de Valme: JA Pineda, E Suarez, S Bernal Hospital de Vinalopó: V Navarro, L Giner Hospital Virgen Macarena: Felipe Fernández Hospital Virgen de las Nieves: F Nogueras, M.A. López Garrido, S Espinosa Hospital Virgen del Rocío: JM Pascasio, P Viciana Hospital Virgen de la Victoria: J Santos
20 UDS for 282 confirmation Patient Sanger UDS S282CT WST Not confirmed S282T ASC Not confirmed S282T ACC UDS 100% S282R AGM Not confirmed
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