Chronic Hepatitis C: Challenges in Special Populations
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1 Chronic Hepatitis C: Challenges in Special Populations Heiner Wedemeyer Hannover Medical School Germany 1
2 Disclosures Honoraria for consulting or speaking (last 5 years): Abbott, AbbVie, Biolex, BMS, Boehringer Ingelheim, Eiger, Gilead, ITS, JJ/Janssen-Cilag, Medgenics, Merck/Schering- Plough, Novartis, Roche, Roche Diagnostics, Siemens, Transgene, ViiV Research grants: Abbott, Abbvie, BMS, Gilead, Merck, Novartis, Roche, Roche Diagnostics, Siemens
3
4 Lasker Award 2016 Ralf Bartenschlager Charles M. Rice Michael J. Sofia
5 The hepatitis C-associated disease burden is increasing! Mortality due to HCV 2013 ~ HCV-Cirrhosis Mortality Increase 68% HCV-HCC Mortality Increase 292% Stanaway et al., Lancet Sep 10;388:1081-8
6 Hepatitis C is not only a liver disease! Cryoglobulinemia Autoimmune Diseases Fatigue, depression Vasculitis Diabetes Social and legal consequences.
7 HCV cure is associated with reduced mortality ALL CAUSE MORTALITY SVR patients have a survival similar to the general population Van der Meer AJ, et al. JAMA 2012 Van der Meer AJ, et al. JAMA 2014 Similar Data: France: Nahon et al., Gastroenterology 2017; 152: Italy: Bruno et al., J Hepatol 2016; 64: ; Scotland: Innes et al., J Hepatol 2017; 66: 19-27
8 HCV Therapy: EMA-Approved Direct Acting Antivirals 17. Jan. 2014: approval Sofosbuvir 16. Mai 2014: approval Simeprevir 26. Aug. 2014: approval Daclatasvir 18. Nov. 2014: approval Ledipasvir/Sofosbuvir 16. Jan 2015: approval Paritaprevir/Ombitasvir/r 16. Jan 2015: approval Dasabuvir : Velpatasvir/Sofosbuvir : Grazoprevir/Elbasvir Q3/4 2017: Glecaprevir/Pibrentasvir Q3/4 2017: Velpatasvir/Sofosbuvir/Voxilaprevir
9 HCV Therapy: Direct Acting Antivirals Paritaprevir/r Ombitasvir Dasabuvir Grazoprevir Elbasvir NS5A-Inhibitors asvirs Asunaprevir Simeprevir Protease- Inhibitors previrs Daclatasvir Daclatasvir Glecaprevir Simeprevir Pibrentasvir Voxilaprevir Sofosbuvir Velpatasvir Sofosbuvir Sofosbuvir Sofosbuvir Sofosbuvir Polymerase- Inhibitors buvirs Daclatasvir Ledipasvir Velpatasvir Non-Nucs Nucleos(t)ide Sofosbuvir + RBV Wedemeyer, Der Internist 2014 & Lancet 2015
10 SVR (%) Phase 2/3 studies of DAAs against HCV % With almost no side effects >50 x NEJM, Lancet, JAMA, Ann Intern Med, Lancet ID
11 When to start? Which treatment when? How long? Ribavirin yes/no? Resistance testing? Child B/C-cirrhosis? Impaired renal function? Optimal treatment for HCV Genotype 3? How to manage DAA failures?
12 Selecting the optimal HCV treatment HCV Genotype Stage of liver disease (F0-F4-decompensation) HCV Viral Load Kidney Function Selection of DAAs Ribavirin yes / no Duration 8, 12, 16, 24 weeks Costs DDI Adherance Comorbidities Age
13 EASL Recommendations 2016 EASL-Clinical Practice Guidelines September 2016
14 EASL Recommendations 2016 EASL-Clinical Practice Guidelines September 2016
15 EASL Recommendations 2016 EASL-Clinical Practice Guidelines September 2016
16 HCV-core-Antigen testing: Good correlation with HCV RNA but low HCV viremia may be missed with HCVcoreAg testing Heidrich et al. J of Viral Hepatitis 2014
17 Manfred Helga Stefan 52 years Child B Cirrhosis HCV GT3 PEG-IFNa/RBV relapser 59 years HCV GT1a Relapse after 8 weeks LDV/SOF 41 years Surgeon, needle stick Acute Hepatitis C GT 1b
18 How does HCV therapy influence immune responses?
19 HCV alters the systemic inflammatory milieu Healthy NASH Hepatitis C Hengst et al. J Infect Diseases 2016, Dec 15; 214:
20 which is not completely restored by HCV clearance! Hengst et al. J Infect Diseases 2016, Dec 15; 214:
21 Manfred Helga Stefan 52 years Child B Cirrhosis HCV GT3 PEG-IFNa/RBV relapser 59 years HCV GT1a Relapse after 8 weeks LDV/SOF 41 years Surgeon, needle stick Acute Hepatitis C GT 1b
22 Manfred 52 years Child B Cirrhosis (ascites) HCV GT3 PEG-IFNa/RBV relapser Albumin: 29 mg/dl Platelets: /µl egfr: 43 ml/min MELD 17 Chance for SVR in GT3 decompensated cirrhosis? Does liver function improve with HCV clearance? DAAs Decomp. Cirrhosis
23 Lower SVR rates in HCV-GT3 decompensated cirrhosis Sofosbuvir-Velpatasvir (Astral-4) Curry et al., N Engl J Med. 2015
24 Glecaprevir/Pibrentasvir may become a rescue option for GT3 Surveyor-II: GT weeks Wyles et al., AASLD 2016
25 Improvement of liver stiffness during and after IFN-free therapy of hepatitis C FibroScan ARFI Deterding, Wedemeyer, AP&T 2016 Attia, Potthoff, EASL-ILC 2016 Decrease of portal hypertension: Mandorfer et al. Journal of Hepatology Oct 2016
26 Improvement of MELD-Scores in patients with Child B/C cirrhosis by IFN-free therapy point of no return? n = 7 * including relapse patients documented at the timepoint of relapse Deterding et al., Aliment Pharmacol Ther. 2015
27 Manfred 52 years Child B Cirrhosis HCV GT3 SVR Albumin: 34 mg/dl Platelets: /µl egfr: 52 ml/min MELD 13 HCC despite HCV clearance? DAAs Decomp. Cirrhosis
28 HCCs still occur after HCV clearance Journal of Hepatology October 2016 Schlevogt&Wedemeyer, HepNet Journal Dec 2016
29 HCCs still occur after HCV clearance The Hannover Cohort DAAs SVR historical control HCV-RNA+ untreated Schlevogt, Mettke et al., unpublished
30 Manfred 52 years Child B Cirrhosis (ascites) HCV GT3 PEG-IFNa/RBV relapser Albumin: 24 mg/dl Platelets: /µl egfr: 37 ml/min MELD 21 Better to treat after liver transplantation? Decomp. Cirrhosis DAAs Post-Liver Tx
31 High SVR rates for IFN-free therapy after liver transplantation Daclatasvir + Sofosbuvir Herzer, Zeuzem et al., Transplant International; epub Dec Ledipasvir + Sofosbuvir Ciesek, Sterneck et al., Transpl Infect Dis 2016; 18: Kwok, Smith et al., Liver Transpl 2016; 22: Simeprevir + Sofosbuvir Crittenden, Cave et al., Liver Transpl 2016; 22: Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir Flisiak et al. AP&T 2016; 44: SVR-Rates 95%-100% No major safety signals, no increase in rejection episodes, improvement of liver function, regression of fibrosis
32 Manfred 52 years Child B Cirrhosis (ascites) HCV GT3 PEG-IFNa/RBV relapser Albumin: 29 mg/dl Platelets: /µl egfr: 43 ml/min MELD 17 Treatment: Velpatasvir/Sofosbuvir + Ribavirin (if NS5A RAS excluded w/o RBV possible) If SVR: Continue HCC screening! If MELD >18-20: List for Liver Transplantation and consider treatment after LTx Decomp. Cirrhosis Post-Liver Tx
33 Sustained Virological Response 8 vs. 12 weeks Helga LDV/SOF 8 weeks LDV/SOF12 weeks Overall 98.3 (827/841) 98.1 (1,289/1,314) Age 70 yrs 98.3 (762/775) 98.3 (1,151/1,171) > 70 yrs 98.5 (65/66) 96.5 (138/143) Treatment history Naïve 98.6 (757/768) 97.7 (516/528) Experienced 95.9 (70/73) 98.3 (773/786) Prior IFN 95.8 (69/72) 98.3 (759/772) Prior DAA 100 (4/4) 98.6 (142/144) Cirrhosis Other 100 (1/1) 100 (24/24) Yes 90.5 (19/21) 94.1 (176/187) 59 years HCV GT1b Relapse after 8 weeks LDV/SOF F1 fibrosis Fatigue No 98.5 (808/820) 98.8 (1,113/1,127) Baseline fibrosis stage* F0 F (240/243) 99.6 (266/267) F (79/81) 98.7 (151/153) F (18/19) 97.7 (85/87) F (19/21) 94.1 (176/187) Baseline viral load, IU/mL 2,000, (620/631) 98.4 (762/774) >2,000,000 6,000, (171/174) 97.4 (337/346) > 6,000, (21/21) 97.7 (173/177) Buggisch et al., submitted
34 HCV-RNA Assays differ! Lower HCV RNA values with the Abbott ART compared to Roche Cobas TaqMan Vermehren,, Wedemeyer Clin Infect Diseases 2016
35 Helga Does HCV resistance matter? Treatment options? 59 years HCV GT1b Relapse after 8 weeks LDV/SOF F1 fibrosis Fatigue
36 Resistance after NS5A-DAA failure PI + NUC? RBV? Longer therapy? NS5A- Inhibitors asvirs Combine 3-5 classes? New DAAs? Protease- Inhibitors previrs Non-Nucs Polymerase- Inhibitors buvirs Nucleos(t)ide Wedemeyer, Der Internist 2014 Sofosbuvir + RBV
37 Re-Treatment of NS5A failure patients Sofosbuvir/Velpatasvir/Voxilaprevir (Polaris-1) Bourlier,, Manns, AASLD 2016
38 Re-Treatment of NS5A failure patients with MK3682, Grazoprevir, Ruzasvir (C-SURGE) Wyles, Wedemeyer et al., AASLD 2016 & EASL 2017
39 Helga Why did she fail therapy? 7 different comedications 59 years HCV GT1b Relapse after 8 weeks LDV/SOF F1 fibrosis Fatigue
40 Comedication is very frequent in HCV infection DDIs can occur with all DAA regimens Höner zu Siederdissen et al., Clin Infect Dis 2016; 62: 561-7
41 Helga 59 years HCV GT1b Relapse after 8 weeks LDV/SOF F1 fibrosis Fatigue Why did she fail therapy? 7 different comedications Partial Gastrectomy 1986 Currently no re-treatment (F1-Fibrosis!) Wait for approval of new regimens with high efficacy against NS5A RASs
42 Stefan Treatment to prevent HCV transmission? How to treat? Safety of DAA therapy in severe hepatitis? Risk for HCV reinfection? 41 years Surgeon, needle stick Acute Hepatitis C GT 1a ALT 1860 U/L Bilirubin 14 mg/dl
43 IFNa monotherapy is highly effective in acute hepatitis C Infection Symptoms Presentation Acute hepatitis C Chronic hepatitis C Response to IFNa monotherapy German Acute HCV I Study ( ) Conventional interferon alpha-2b Monotherapy 6 month SVR 98% (n = 44) German Acute HCV II Study ( ) Peg-interferon alpha-2b Monotherapy 6 months SVR 89% (n = 89) German Acute HCV III Study ( ) Jaeckel et al., NEJM 2001 Wiegand et al., Hepatology 2006 Delayed versus immediate PEG-IFN-treatment Treament 6 months SVR delayed therapy 93%, SVR immediate therapy 90% (n = 132) Deterding et al., Lancet Infect Dis. 2013
44 IFN-free treatment of acute hepatitis C Infection Symptoms Presentation Acute hepatitis C Chronic hepatitis C host Immune response potency of required therapy SOF/RBV alone possible? no! 6 weeks SVR 32% (Martinello, Hepatology 2016; 64: ) How short is possible? (4-) 6 weeks! SVR 100% (Deterding, Lancet Infect Dis epub Oct )
45 number of patients (n) HCV RNA < 15 IU/ml, detectable HCV RNA undetectable week 2 week 4 week 6 FU 12 Deterding et al. Lancet Infect Diseases epub Oct
46 Early treatment of symptomatic acute hepatitis C is safe and leads to rapid improvement of symptoms Individual ALT levels over time Deterding et al. Lancet Infect Diseases epub Oct
47 However: Relapses with LDV/SOF for 6 weeks in acute HCV infection in HIV+ patients with high baseline viral load Rockstroh et al. CROI 2016
48 Cure of HCV infection does not lead to protective immunity! High rates of HCV re-infection in HIV+ MSM Ingiliz et al. J of Hepatology 2016 epub
49 Stefan 41 years Surgeon, needle stick Acute Hepatitis C GT 1a HCV-RNA 5.6 x 10 6 IU/ml HCV RNA kinetic, wait for 4 weeks If no significant decline: treat with LDV/SOF (6-) 8 weeks (only 4 week packages available) Alternative: wait for chronic hepatitis C No recommendation to treat all patients with acute hepatitis C!
50 Manfred Helga Stefan 52 years Child B Cirrhosis HCV GT3 PEG-IFNa/RBV relapser SOF-VEL +RBV (to avoid liver Tx) HCC monitoring 59 years HCV GT1a Relapse after 8 weeks LDV/SOF Re-Treatment Q3/ years Surgeon, needle stick Acute Hepatitis C GT 1b LDV/SOF 8 weeks no immunity!
51 AG Cornberg + AG Wedemeyer Acknowledgements CIM, Karolinska Institute: HG Ljunggren, N. Björkström HZI Braunschweig: C. Guzmán, L. Jänsch, R. Geffers Twincore: T. Pietschmann, E. Steinmann M. Manns, M. Cornberg, C. Falk, K. Deterding, B. Maasoumy, C. Höner zu Siederdissen, K. Port, A. Wranke, B. Schlevogt, S. Ciesek, H. Mix, T. v. Hahn Dr. Y. Serfert, Bianka Wiebner, D. Hüppe
52 Was kann der Patient noch tun? Kaffee ist gut für die Leber
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