Hepatitis C Highlights from ILC / EASL 2016
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1 Hepatitis C Highlights from ILC / EASL 2016 VIII International Update Workshop in Hepatology Curitiba, Christoph Sarrazin St. Josefs-Hospital Wiesbaden and Goethe-University, Frankfurt am Main Germany
2 Disclosures Consultancies / Advisory boards: Abbott, Abbvie, BMS, Gilead, Janssen, Merck/MSD, Roche Research support: Abbott, Gilead, Janssen, Qiagen, Roche, Siemens Speaker: Abbott, Abbvie, Achillion, BMS, Gilead, Janssen, Merck/MSD, Qiagen, Roche, Siemens
3 Hepatitis C Highlights from EASL 2016 Acute Hepatitis C Real World Data 3D for HCV genotype 1+4 3D and cirrhosis LDV/SOF for 8 weeks in genotype 1 LDV/SOF and acid suppressive agents DAA-options for HCV genotype 3 Future treatment options HCV genotype 3 Portal Hypertension and DAA treatment Re-infection after DAA treatment HCC after SVR on DAA treatment Long-term outcome after DAA treatment
4 Acute hepatitis C studies AASLD 2015, CROI 2016, APASL 2016, EASL 2016 SOF+SMV 8 wks (IVDU) 1 14/15 93% (SVR16: 13/15) SOF+LDV 4 wks (IVDU) 1 14/14 100% (SVR16: 14/15) SOF+LDV 6 wks (HIV+) 2 22/26 85% SOF+RBV 12 wks (HIV+) 3 11/17 59% SOF+RBV 12 wks (HIV+) 4 11/12 92% SOF+RBV 6 wks (HIV+) 5 3/11 27% 0% 20% 40% 60% 80% 100% 120% 1 Basu P, et al. APASL 2016 #1074; 2 Rockstroh J et al CROI 2016; 3. Naggie et al. AASLD 2015 #1094; 4. Fierer et al. AASLD 2015 #1090; 5 Martinello et al. AASLD 2015 #1083 SOF+RBV variable, SOF+DAA 4-8 weeks looks promising
5 number of patients (n) German "Acute HCV" IV Study LDV/SOF for 6 Weeks (n=20) Acute HCV IV Study Acute HCV Monoinfection, Genotype 1 (55% 1a), Transaminases >10- fold, within 4 months after infection, LDV/SOF for 6 weeks HCV RNA < 15 IU/ml HCV RNA undetectable /20 week 2 week 4 week 6 FU 12 In parallel to viral load decline rapid normalization of ALT and bilirubin Deterding et al., EASL 2016, LB08
6 Hepatitis C Highlights from EASL 2016 Acute Hepatitis C Real World Data 3D for HCV genotype 1+4 3D and cirrhosis LDV/SOF for 8 weeks in genotype 1 LDV/SOF and acid suppressive agents DAA-options for HCV genotype 3 Future treatment options HCV genotype 3 Portal Hypertension and DAA treatment Re-infection after DAA treatment HCC after SVR on DAA treatment Long-term outcome after DAA treatment
7 Real-World Data Genotype 1+4 Germany German Hepatitis C Registry - 2D/3D Therapy 2D / 3D ± RBV; (N = 1017) Male 660 (65) Age, mean years ± SD 54.3 ± 12.5 BMI, mean kg/m 2 ± SD 26.2 ± 4.4 Caucasian 963 (95) HCV Genotype (88) 1a 261 (26) 1b 614 (60) Other 17 (2) (12) HCV RNA, mean 10 6 IU/mL ± SD 2.8 ± 4.0 (n = 973) Cirrhosis, n/n (%) 228/1017 (22) Compensated (Child-Pugh A) 149/228 (65) Decompensated (Child-Pugh B/C) 16/228 (7) Data not available 63/228 (28) Deviations in n-values for diagnostic parameters are due to missing documentation in the registry at the time point of analysis Hinrichsen et al., EASL 2016, GS07
8 Real-World Data Genotype 1+4 Germany German Hepatitis C Registry - 2D/3D Therapy GT1a* w/o cirrhosis GT1a* with cirrhosis GT1b w/o cirrhosis GT1b with cirrhosis GT4 w/o cirrhosis GT4 with cirrhosis N = 226 2D 3 (1) 2D + RBV 3 (1) N = N = 450 N = 164 N = 113 N = 12 7 (2) 2 (1) 1 (0.9) 1 (8) 3 (0.7) 4 (2) 106 (94) 11 (92) 3D 22 (10) 8 (15) 400 (89) 33 (20) 3 (3) 3D + RBV 198 (88) 44 (85) 40 (9) 125 (76) 3 (3) % of GT1 patients took the label-recommended regimen 92 94% of GT4 patients took the label-recommended regimen Hinrichsen et al., EASL 2016, GS07
9 S V R 1 2 / 2 4 (% P a t ie n t s ) Real-World Data Genotype 1+4 Germany German Hepatitis C Registry - 2D/3D Therapy G T T o t a l* G T 1 a G T 1 b G T 4 Without Cirrhosis G T T o t a l* G T 1 a G T 1 b With Cirrhosis 2 2 G T N a iv e (p e g -) IF N R B V T V R / B O C + p e g IF N + R B V High SVR rates independent of predictors or subgroups (incl. dialysis) Hinrichsen et al., EASL 2016, GS07
10 Hepatitis C Highlights from EASL 2016 Acute Hepatitis C Real World Data 3D for HCV genotype 1+4 3D and cirrhosis LDV/SOF for 8 weeks in genotype 1 LDV/SOF and acid suppressive agents DAA-options for HCV genotype 3 Future treatment options HCV genotype 3 Portal Hypertension and DAA treatment Re-infection after DAA treatment HCC after SVR on DAA treatment Long-term outcome after DAA treatment
11 Safety of 3D therapy in patients with cirrhosis Label-Change and study data PTVr/OBV/DSV ± RBV Post-Marketing Safety Database - 26 cases with death or transplantation (n=10) or liver dysfunction (n=16) Review by Expert Hepatic Panel - Risk factor for cases which were probably or possibly treatment related and with outcome death or transplantation was advanced cirrhosis prior to starting treatment PTVr/OBV/DSV ± RBV Review of all patients with cirrhosis from all sponsored trials patients with cirrhosis - 13 pts with decompensation event (1,2%) Risk factors for decompensation Label change PTVr/OBV ± DSV ± RBV Child A Child B Child C Recommended Not recommended (EMA)/ contraindicated (US) Contraindicated Poordad et al., 4th Optimize Meeting, Barcelona,
12 Hepatitis C Highlights from EASL 2016 Acute Hepatitis C Real World Data 3D for HCV genotype 1+4 3D and cirrhosis LDV/SOF for 8 weeks in genotype 1 LDV/SOF and acid suppressive agents DAA-options for HCV genotype 3 Future treatment options HCV genotype 3 Portal Hypertension and DAA treatment Re-infection after DAA treatment HCC after SVR on DAA treatment Long-term outcome after DAA treatment
13 Real-World data 8 weeks therapy German HCV Registry - LDV/SOF SVR rates per protocol 98% 99% 97% all pts. with 8 weeks treatment had <6 Mill IU/ml HCV RNA at baseline Relapse (n) Relapse associated with cirrhosis in the 8 weeks group (n=2) Buggisch et al., EASL 2016, SAT241
14 Hepatitis C Highlights from EASL 2016 Acute Hepatitis C Real World Data 3D for HCV genotype 1+4 3D and cirrhosis LDV/SOF for 8 weeks in genotype 1 LDV/SOF and acid suppressive agents DAA-options for HCV genotype 3 Future treatment options HCV genotype 3 Portal Hypertension and DAA treatment Re-infection after DAA treatment HCC after SVR on DAA treatment Long-term outcome after DAA treatment
15 SVR (%) Importance of acid suppressive agents LDV/SOF±RBV TRIO-network US with 2034 patients with LDV/SOF therapy 8 Wks. (n=282), 12 Wks. (n=1378), 24 Wks. (n=374) 100% 80% 60% 40% 20% PPI-No PPI-Yes 96% 94% Relapse 28 Death 2 LTFU 25 DC 14 Relapse 13 Death 2 LTFU 8 DC 4 No difference for subgroups (GT1a/b, cirrhosis, RBV, VL, sex, ethnicity, which proton pump inhibitor / PPI and dose of PPI) Lower SVR rates in patients with two times daily PPI (98% versus 91%; p=0.03) 0% 1497/ /468 LDV/SOF±RBV Afdhal et al., EASL 2016, LBP519
16 Hepatitis C Highlights from EASL 2016 Acute Hepatitis C Real World Data 3D for HCV genotype 1+4 3D and cirrhosis LDV/SOF for 8 weeks in genotype 1 LDV/SOF and acid suppressive agents DAA-options for HCV genotype 3 Future treatment options HCV genotype 3 Portal Hypertension and DAA treatment Re-infection after DAA treatment HCC after SVR on DAA treatment Long-term outcome after DAA treatment
17 Real-World Data Genotype 3 Germany German Hepatitis C Registry Cornberg et al., EASL 2016, SAT-208
18 Real-World Data Genotype 3 Germany German Hepatitis C Registry SOF/RBV 24 weeks with SVR ITT <80% >30% were treated with SOF/PEG/R DCV/SOF/RBV approx. 90% SVR Cornberg et al., EASL 2016, SAT-208
19 Hepatitis C Highlights from EASL 2016 Acute Hepatitis C Real World Data 3D for HCV genotype 1+4 3D and cirrhosis LDV/SOF for 8 weeks in genotype 1 LDV/SOF and acid suppressive agents DAA-options for HCV genotype 3 Future treatment options HCV genotype 3 Portal Hypertension and DAA treatment Re-infection after DAA treatment HCC after SVR on DAA treatment Long-term outcome after DAA treatment
20 Future treatment options for HCV Genotype 3 ABT493+ABT530 (Glecaprevir + Pibrentasvir) ±RBV 2. Generation NS3+NS5A±R for 8/12 weeks (Surveyor II) no cirrhosis n=29, 8 weeks ABT cirrhosis n=48, 12 weeks ABT ±RBV Muir et al., EASL 2016, PS098 and Kwo et al., EASL 2015, LB01
21 Hepatitis C Highlights from EASL 2016 Acute Hepatitis C Real World Data 3D for HCV genotype 1+4 3D and cirrhosis LDV/SOF for 8 weeks in genotype 1 LDV/SOF and acid suppressive agents DAA-options for HCV genotype 3 Future treatment options HCV genotype 3 Portal Hypertension and DAA treatment Re-infection after DAA treatment HCC after SVR on DAA treatment Long-term outcome after DAA treatment
22 Natural course of portal hypertension HVPG after DAA therapy HVPG decline by 20% or decline below 12mmHg as clinical end point with reduction in bleeding from varices, ascites, SBP, HRS, HE and death SOF+RBV for 48 Wks, HCV Genotype 1, Child A-C, n=50 HVPG measurement at baseline, end-of-treatment (n=37) and FU48 (n=9) SVR 72% (100% 5/5 HVPG <12 and 71% 27/38 HBVG 12mmHg) Baseline versus EOT (24% 20% decline) Baseline versus FU48 (89% 20% decline; 33% <12mm-Hg) Afdhal et al., EASL 2016, LBP518
23 Natural course of portal hypertension HVPG after SVR to DAAs & correlation with FS DAA-therapy, n=100 with SVR, Child A-B HVPG and TE measurement at baseline and FU16 (n=60) TE measurement at baseline and FU16 (n=40) Baseline HVGP 10-15mmHg 14% (3/21) normalized 29% (6/21) <10mmHg Baseline HVGP >15mmHg 5% (1/20) <10mmHg 20% increase HVPG TE: <12,4kPa Ø sign. HVPG versus >25.3kPa sign. HVPG Mandorfer et al., EASL 2016, PS005
24 Hepatitis C Highlights from EASL 2016 Acute Hepatitis C Real World Data 3D for HCV genotype 1+4 3D and cirrhosis LDV/SOF for 8 weeks in genotype 1 LDV/SOF and acid suppressive agents DAA-options for HCV genotype 3 Future treatment options HCV genotype 3 Portal Hypertension and DAA treatment Re-infection after DAA treatment HCC after SVR on DAA treatment Long-term outcome after DAA treatment
25 Risk of HCV reinfektion in MSM with HIV-infection European study group Men who have sex with men (MSM) European AIDS Treatment Network (NEAT) UK, Austria, Germany, France n=606 GT1 71%, GT4 18%, SVR 81%, spont. clearance 18% n=149 (24%) 1st reinfection 52% GT-switch, spont. clearance (16%) 25% risk of re-infection within 3 years HCV test every 3-6 months to prevent transmission Martin, Ingelitz et al., EASL 2016, PS006
26 Hepatitis C Highlights from EASL 2016 Acute Hepatitis C Real World Data 3D for HCV genotype 1+4 3D and cirrhosis LDV/SOF for 8 weeks in genotype 1 LDV/SOF and acid suppressive agents DAA-options for HCV genotype 3 Future treatment options HCV genotype 3 Portal Hypertension and DAA treatment Re-infection after DAA treatment HCC after SVR on DAA treatment Long-term outcome after DAA treatment
27 HCC after SVR on DAA-Therapy HCC IFN-era versus DAA-era in Austria Author Van der Meer Mean follow up (years) HCC (%) Coun try multip le Therapy various Bruno Italy IFN Veldt multip le Cardos o Japane se studies Franc e Japan Rutter Austri a approx. 1% per year PEG/RBV PEG/RBV IFN, PEG/RBV IFN/RBV, PEG/RBV 176 patients (m/f=103/60; mean age 56.8±10.5 yrs; genotype [GT1:145, GT2:2, GT3:19; GT4: 10; with 145 F4, 31 F3) with SVR after IFN/RBV-free DAA therapy and at least 48 weeks of treatmentfree follow up Pretreatment no evidence for HCC by imaging methods 12 (6.9%) were diagnosed with HCC (F4:10, F3:2, m/f=11/3; mean age 63.5±8.2yrs; GT1:11; GT3:2, GT4:1; CPS at baseline:a:6, B:5, C:1) within 1-13 months follow-up modified after D Ambrosio et al, Liver Intern 2016 (e-pub) Kocbial et al., EASL 2016, FRI-178
28 HCC after SVR on DAA-Therapy HCC-recurrence in Spain 58 patients with treated HCC (BCLC 0 and A) on complete response, who underwent DAA therapy ( ) Median time between HCC treatment and DAA initiation: 11 months (P ) Median time between last radiologic confirmation of complete response and DAA initiation: 1.7 months (P ) Tumor recurrence: 16 (27,6%) patients. Median follow-up after DAA therapy 3.5 months (1-8) Recurrence rate is significantly higher than expected based on previous studies Comparison: STORM trial (surgery/ablation of HCC followed by Sorafenib versus placebo) with a recurrence rate of approx. 25% at 1 year FU Reig et al., J Hepatol 2016 epub; Bruix et al., Lancet Oncol 2015
29 HCC after SVR on DAA-Therapy HCC first diagnosed and recurrence in Italy Child A-B patients, n=344, DAA-treatment (SVR 89%) Surveillance for weeks after end-of-treatment 29% 7,6% 3,2% Risk factors for HCC: previous HCC, Child stage, PLT count, TE Buonfiglioli et al., EASL 2016, LBP506
30 Hepatitis C Highlights from EASL 2016 Acute Hepatitis C Real World Data 3D for HCV genotype 1+4 3D and cirrhosis LDV/SOF for 8 weeks in genotype 1 LDV/SOF and acid suppressive agents DAA-options for HCV genotype 3 Future treatment options HCV genotype 3 Portal Hypertension and DAA treatment Re-infection after DAA treatment HCC after SVR on DAA treatment Long-term outcome after DAA treatment
31 Long term outcome after DAA-therapy Patients from France n=2156, no HCC, no decompensation, 63% cirrhosis, DAA-therapy 1/13-10/14 (SVR 90%) Follow-up until January 2016 (18 months) Dorival et al., EASL 2016, LBP505
32 Long term outcome after DAA-therapy Patients with (decomp.) cirrhosis from England DAA-therapy decompensated cirrhosis (n=409) with SVR 80% Control group decomp. cirrhosis 6 months before DAA-tx (n=261) Event All Treated (n=409) Untreated (n=261) Deaths 13 (3.2%) 15 (5.7%) Decompen sation 3 months follow-up 15 months follow-up 72 (17.6%) 73 (28.0%)* New HCC 19 (4.6%) 21 (8.0%) Sepsis 27 (6.6%) 15 (5.7%) New OLT 27 (6.6%) 10 (3.8%) Overall over 15 months 21% decompensation 6% HCC 12% transplant 5% death Hospital admissions MELD worsening >2 Total adverse outcomes 133 (32.5%) 83 (31.8%) 94 (23.0%) 99 (37.9%)* 213 (52.1%) 166 (63.6%)* * p< 0.05 between treated and untreated Event free survival - MELD <15 (71%) - MELD 15 (58%) Cheung et al., EASL 2016, PS097, Foster et al., J Hepatol 2016
33 Hepatitis C Highlights from EASL 2016 Acute Hepatitis C 6-8 weeks DAA combo Real World Data prove high efficacy Avoid high dose PPI together with LDV/SOF Treatment of HCV genotype 3 with cirrhosis remains challenging news drus in 1-2 years Portal Hypertension improve in a subgroup of patients only High risk of re-infection after DAA treatment in MSM Risk for HCC after SVR on DAA treatment: more data
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