Real-World Outcomes with New HCV Antivirals in HIV/HCV-Coinfected Subjects: Madrid Coinfection Registry (Madrid-CoRE) Findings

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1 Real-World Outcomes with New Antivirals in HIV/-Coinfected Subjects: Madrid Coinfection Registry (Madrid-CoRE) Findings J. Berenguer, J. Gonzalez-García, M. Montes, Gil-Martin, E. Cruz-Martos, M. Calvo, M. Alcaraz, L. Dominguez-Dominguez,T. Aldámiz-Echevarría Abstract 78 Madrid-CoRe (Madrid Coinfection Registry): Baseline Characteristics Variable N = 23 Age years median (IQR) 5 (47 54) Male n (%) 1591 (78.4) CD4+ T cells/µl median (IQR) cart n (%) 57 ( ) 193 (95.1) Liver disease severity No cirrhosis n (%) 1125 (55.4) Compensated cirrhosis n (%) 754 (37.1) Decompensated cirrhosis n (%) 146 (7.2) Unknown n (%) 5 (.3) History of hepatocellular carcinoma n (%) 15 (.7) Liver transplantation n (%) 17 (.8) Liver transplantation waiting list n (%) Severe extrahepatic manifestations n (%) Anti- naïve n (%) Liver stiffness kpa median (IQR) Berenguer J, et al. 67th AASLD; Boston, MA; November 11-15, 216; Abst (.3) 143 (7.) 1256 (61.9) 11.4 ( )

2 Genotypes and DAA Combinations Ribavirin No. (%) Yes 627 (3.9) No 143 (69.1) Log 1 -RNA Median = 6.3 IQR = % Other N = % SOF+RBV SOF+SMV N = 27 N = % OBV/PTV/r DSV+OBV/PTV/r SOF+DCV N = 89 N = 259 N = % SOF/LDV N = % 818 G1a 447 G4 322 G1b 38 G3 135 Other Berenguer J, et al. 67th AASLD; Boston, MA; November 11-15, 216; Abst. 78. Treatment Outcomes by Severity of Liver-Disease No-C = no cirrhosis Co-C = compensated cirrhosis De-C = decompensated cirrhosis Decompensated cirrhosis, and therapy with SOF+SMV, SOF+RBV, and SMV+DCV were independently associated with treatment failure No SVRITT 1867 (92.) 154 (93.7) 69 (91.5) 118 (8.8) SVR (95% CI) ( ) ( ) ( ) ( ) Relapse 89 (4.4) 36 (3.2) 36 (4.8) 17 (11.6) Breakthrough 5 (.2) 3 (.3) 1 (.1) 1 (.7) DC Due to AE 14 (.7) 7 (.6) 5 (.7) 2 (1.4) DC Other 36 (1.8) 23 (2.) 1 (1.3) 3 (2.) Death 19 (.9) 2 (.2) 12 (1.6) 5 (3.4) * Severity of liver disease was not evaluated in 5 patients Berenguer J, et al. 67th AASLD; Boston, MA; November 11-15, 216; Abst. 78.

3 Treatment Outcomes by Genotype 1 1 G1a G1b No SVR ITT 754 (92.2) 439 (92.6) 274 (93.8) 38 (77.5) SVR (95% CI) ( ) ( ) ( ) ( ) Relapse 33 (4.) 18 (3.8) 9 (3.1) 6 (12.2) Breakthrough DC due to AE 7 (.9) 4 (.8) 1 (.3) 2 (4.1) DC other 17 (2.1) 11 (2.3) 4 (1.4) 2 (4.1) Death 7 (.9) 2 (.4) 4 (1.4) 1 (2.) No SVR ITT 31 (93.5) 156 (96.3) 117 (91.4) 28 (87.5) SVR (95% CI) ( ) ( ) ( ) ( ) Relapse 12 (3.7) 3 (1.8) 5 (3.9) 4 (12.2) Breakthrough 1 (.3) 1 (.6) DC due to AE 2 (.6) 2 (1.6) DC other 3 (.9) 2 (1.2) 1 (.8) Death 3 (.9) 3 (2.3) 1 1 G G No SVR ITT 283 (91.9) 136 (96.4) 13 (89.7) 17 (77.3) SVR (95% CI) ( ) ( ) ( ) ( ) Relapse 12 (3.9) 3 (2.1) 6 (4.1) 3 (13.6) Breakthrough 1 (.3) 1 (.7) DC due to AE 1 (.3) 1 (.7) DC other 6 (1.9) 2 (1.4) 3 (2.1) 1 (4.5) Death 5 (1.6) 4 (2.8) 1 (4.5) No SVR ITT 44 (9.4) 254 (92.7) 125 (88.) 24 (8.) SVR (95% CI) ( ) ( ) ( ) ( ) Relapse 25 (5.6) 1 (3.6) 13 (9.1) 2 (6.7) Breakthrough 2 (.4) 1 (.4) 1 (3.3) DC due to AE 3 (.7) 2 (.7) 1 (.7) DC other 9 (2.) 7 (2.5) 2 (1.4) Death 4 (.9) 1 (.7) 3 (1.) Berenguer J, et al. 67th AASLD; Boston, MA; November 11-15, 216; Abst. 78. Factors Associated with Treatment Failure by Logistic Regression Analysis Univariate analysis Multivariate analysis Variable OR 95% CI P OR 95% CI P Female sex No cirrhosis Ref. Ref. Comp. cirrhosis Dec. cirrhosis < Hep. carcinoma DSV+OBV/PTV/r Ref. Ref. SOF/LDV SOF+DCV OBV/PTV/r SOF+SMV < SOF+RBV SMV+DCV < Berenguer J, et al. 67th AASLD; Boston, MA; November 11-15, 216; Abst. 78.

4 Real World Effectiveness of Ledipasvir/Sofosbuvir (LDV/SOF) in Patients Coinfected With and HIV-1: A Comparative Analysis of Clinical Trials with Four Real World Cohorts S. Naggie, E. Rosenthal, S. Kattakuzhy, J. McGinnis, S. Naik, M. Natha, J. Llewellyn, R. Haubrich, A.O. Osinusi, L.M. Stamm, C. Cooper, D.T. Dieterich, M.S. Sulkowski Abstract 892 SVR12 in GT 1 HIV/ Coinfected Patients Treated with LDV/SOF for Weeks: Clinical Trials Compared to Real-World Cohorts Clinical Trials % 98% Real World Cohorts 1% 98% 98% 91% 91% SVR12 (%) ION 4 Study * ITT ERADICATE * ANRS HC31 SOFTRI TRIO Cohort1,2 * analysis in GT1 patients; *ITT analysis; Per Protocol; 1. ±RBV; 2. small number of patients may have received 8 weeks of LDV/SOF Naggie S, et al. 67th AASLD; Boston, MA; November 11-15, 216; Abst ASCEND2 VA USC1,2 Portugal1

5 SVR12 Rates under DAA-based Therapy from the National German Cohort Study: Does HIV Co-Infection Impair the Response to DAA Combination Therapy? J.K. Rockstroh, T. Lutz, S. Mauss, C. Cordes, H. Hillenbrand, A. Moll, H. Pfeiffer-Vornkahl, H. Butzbach, M. Cornberg, M.P. Manns, A. Baumgarte Abstract 97 Does HIV Co-infection Impair the Response to DAA Combination Therapy? Overall, 488 HIV/ coinfected and 5,657 mono infected subjects were included into this analysis HIV coinfected patients had good CD4-counts at baseline (63% >35 CD4-cells/µl; only 2.6% had a CD4-count below 2/µl) Baseline Characteristics: ITT Population Male (%) Age (mean +/- SD) Cirrhosis (%) Genotype (GT) 1 (%)/ GT 2 (%)/ GT3 (%) /GT4 (%) Treatment-naive LDV/SOF+/- RBV // or DAC + SOF +/-RBV// or OBV/PTV/r+DSV ± RBV for GT1 treatment (%) SOF + RBV // SOF + PegIFN + RBV // SOF + DAC// SOF/LDV + RBV for GT3 (%) SOF + PegIFN + RBV // or LDV/SOF+/- RBV // or OBV/PTV/r + RBV for GT4 treatment (%) Rockstroh J, et al. 67th AASLD; Boston, MA; November 11-15, 216; Abst. 97. Mono Infection (n=5657) HIV/ Coinfection (n=488) / /

6 SVR12 Results by Genotype (ITT Analysis) and SVR12 Response in Cirrhotics per Group (ITT) Genotype (ITT Analysis) Cirrhotics per Group (ITT) GT 1 GT 2 Rockstroh J, et al. 67th AASLD; Boston, MA; November 11-15, 216; Abst. 97. GT 3 GT