HBV/HCV Eradication. Prof. Jean-Michel Pawlotsky, MD, PhD
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1 HBV/HCV Eradication Prof. Jean-Michel Pawlotsky, MD, PhD National Reference Center for Viral Hepatitis B, C and delta Department of Virology & INSERM U955 Henri Mondor Hospital University of Paris-Est Créteil, France
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4 (Ganem & Prince, N Engl J Med 2004;350: ) HBV Life Cycle
5 Control of HBV Infection by Antiviral Therapy
6 Available HBV Therapies Pegylated IFN-α Nucleoside/nucleotide analogues Entecavir Tenofovir Tenofovir/emtricitabine
7 5 Years Results of Tenofovir Therapy (HBeAg+ and -) HBeAg+ (n=266) HBeAg- (375) Normalized ALT 73% 85% HBV DNA <69 IU/mL (ITT) 65% 83% HBV DNA <69 IU/mL (on Rx) 97% 99% HBeAg loss 49% - HBe seroconversion 40% - HBsAg loss 10% - HBs seroconversion 8% - (Marcellin et al., Lancet 2013;381:468-75)
8 Histology Results Over 5 Years of Tenofovir (HBeAg+ and -) Knodell necroinflammatory score Ishak fibrosis score (Marcellin et al., Lancet 2013;381:468-75)
9 Long-Term Histology Results on Entecavir (HBeAg+ and -) Knodell necroinflammatory score Ishak fibrosis score *Median follow-up: 6 years (range: 3-7 years) (Chang et al., Hepatology 2010;52:886-93)
10 Prevention of HCC on Long- Term Tenofovir Therapy All patients (n=634) Cirrhotics (N=482) SIR = 0.50* 95% CI (0.294, 0.837) 1 st significant difference SIR = 0.45* 95% CI (0.227, 0.909) 1 st significant difference HCC incidence was reduced on TDF compared to the natural history model (REACH-B) In non-cirrhotics, the effect was visible after 2-3 years, significant after 6 years (Kim et al., EASL 2013)
11 HCC Incidence on ETV Therapy vs Historical LAM and Control Non-cirrhotics Cirrhotics (Hosaka et al., Hepatology 2013;58:98-107)
12 Summary HBV infection can be efficiently controlled in the long-term with current anti-hbv therapies This control is associated with significant improvement of liver histology and reduction of the incidence of liver complications, including decompensation, HCC, death HBV infection is only controlled, but not cured, because cccdna persists in hepatocytes and is transmitted to progeny cells
13 HBV Cure: Can we Do It?
14 (Ganem & Prince, N Engl J Med 2004;350: ) HBV Life Cycle
15 Long-Term HBsAg Kinetics on NUC Therapy 30 patients, median follow-up 102 months (IQR: months) HBsAg levels (Log 10 IU/mL) Months (Chevaliez S., et al., J Hepatol 2013;58:676-83)
16 Long-Term HBsAg Kinetics on NUC Therapy Mean HBsAg decline: = ± Log IU/mL/month Median time needed to clear HBsAg: = 52.2 yrs (IQR: ) (Chevaliez S., et al., J Hepatol 2013;58:676-83)
17 Definitive cure of HBV infection is a fantasy
18 HBV Entry Inhibitors HBV pres-derived peptides (Myrcludex) Model: Hemizygous upa +/- /RAG-2 -/- /pfp -/- mice highly repopulated with Tupaia belangeri hepatocytes infected with WHBV Treated animals Tupaia hepatocyte staining HBcAg staining HBV DNA levels on treatment (Petersen et al., Nat Biotechnol 2008;26:335-41)
19 Inhibitors of Nucleocapsid Formation Lamivudine (Deres et al., Science 2003;299:893-6)
20 GS-9620, a TLR7 Agonist HBV-infected chimpanzees HBcAg staining Day -28 (pre-treatment) Day 57 (end of treatment) (Lanford et al., Gastroenterology 2013;144: )
21 Targeting cccdna Induce hepatocyte turnover in order to reduce the relative amount of cccdna Destroy cccdna Silence cccdna
22 Epigenetic Control of cccdna Activity by IFNα HBV-infected upa/scid mice treated or not by IFNα Pregenomic RNA production pres/s RNA production cccdna amount (Cai et al., Antimicrob Agents Chemother 2012;56: )
23 Summary Several experimental approaches are currently aiming at clearing/controlling/silencing cccdna None of them appears to be clinically credible in the short to mid-term Thus, scientifically speaking, HBV cure is a fantasy
24 HBV Cure: Do we Need It?
25 Histology Results Over 5 Years of Tenofovir (HBeAg+ and -) Knodell necroinflammatory score Ishak fibrosis score (Marcellin et al., Lancet 2013;381:468-75)
26 Prevention of HCC on Long- Term Tenofovir Therapy All patients (n=634) Cirrhotics (N=482) SIR = 0.50* 95% CI (0.294, 0.837) 1 st significant difference SIR = 0.45* 95% CI (0.227, 0.909) 1 st significant difference HCC incidence was reduced on TDF compared to the natural history model (REACH-B) In non-cirrhotics, the effect was visible after 2-3 years, significant after 6 years (Kim et al., EASL 2013)
27 Causes of HCC and Liver-Related Deaths in Chronic HBV Carriers Cirrhosis HBV-related carcinogenesis, related to integrated HBV sequences
28 Summary In patients with functional cure on NUC therapy (undetectable HBV DNA in the long-term), the onset of liver complications is not related to HBV persistence HBV cure is not the appropriate target to prevent severe outcomes in these patients
29 Summary Current strategies are based on early diagnosis of HCC in cirrhotic patients with controlled HBV replication The appropriate strategy is to efficiently prevent the occurrence of HCC in cirrhotic patients with controlled HBV replication (also applies to cirrhotics who cured HCV infection)
30 What Should be our Priorities?
31 Screening and Access to Care
32 HBV Vaccination
33 HCC Prevention in Cirrhotics with Controlled Infection
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35 HCV Lifecycle
36 HCV is an easyto-cure virus
37 Curing HCV Infection Treatment Potency High barrier to resistance HCV RNA level LLD
38 New HCV Drugs
39 NS3/4A Protease Inhibitors (Raney et al., J Biol Chem 2010:285: )
40 NS3/4A Protease Inhibitors 1 st -wave, 1 st -generation Telaprevir (Janssen) Boceprevir (Merck) Narrow genotypic activity Low barrier to resistance 2 nd -wave, 1 st -generation Simeprevir (Janssen) Paritaprevir/r (Abbvie) Asunaprevir (BMS) Danoprevir (Roche) Sovaprevir (Achillion) Vedroprevir (Gilead) Vaniprevir (Merck, Japan) 2 nd -generation Grazoprevir (Merck) ACH-2684 (Achillion) Pangenotypic (~) Higher barrier to resistance All genotypes except 3 Low barrier to resistance (Slide includes several investigational agents which are not approved for use in HCV by the EMA or FDA)
41 Nucleoside/Nucleotide Analogue Inhibitors of HCV RdRp Catalytic Site (Kindly provided by Dr F. Penin)
42 Sofosbuvir Acts as a Chain Terminator SOF SOF U U SOF Primer strand 5 G C C A SOF C RNA chain cannot be elongated 3 C G G U A G C G 5 Template strand
43 Non-Nucleoside Inhibitors (NNI) Thumb I BMS Palm I Dasabuvir A B D C Thumb II GS-9669 Palm II (Adapted from Dr F. Penin)
44 Non-Nucleoside Inhibitors (NNI) Thumb-1 inhibitors BMS (BMS) Thumb-2 inhibitors GS-9669 (Gilead) Palm-1 inhibitors Dasabuvir (Abbvie) Genotype 1 ~only Low barrier to resistance Genotype 1 ~only Low barrier to resistance Genotype 1 ~only Low barrier to resistance (Slide includes several investigational agents which are not approved for use in HCV by the EMA or FDA)
45 NS5A Protein NS5A Dimer Domain III Required for HCV RNA replication Cytosol Domain II Domain I Required for HCV viral particle assembly ER membrane ER lumen May be involved in the release of HCV particles
46 NS5A Inhibitors 1 st -generation Daclatasvir (BMS) Ledipasvir (Gilead) Ombitasvir (Abbvie) PPI-668 (Presidio) ACH-2928 (Achillion) GSK (GSK) BMS Samatasvir (Idenix) 2 nd -generation Elbasvir (Merck) ACH-3102 (Achillion) GS-5816 (Gilead) Pangenotypic Slightly higher barrier to resistance Genotypes 1 and 4, other genotypes variable Low barrier to resistance (Slide includes several investigational agents which are not approved for use in HCV by the EMA or FDA)
47 HCV Therapy in 2014
48 DAAs Approved in 2014 Sofosbuvir Nucleotide All genotypes Simeprevir Protease Gen 1, 4 Daclatasvir NS5A Gen 1, 3, 4, 5, 6
49 Options in 2014 IFN-based regimens Sofosbuvir + Peg-IFNα + ribavirin (all genotypes) Simeprevir + Peg-IFNα + ribavirin (genotypes 1, 4) Daclatasvir + Peg-IFNα + ribavirin (genotypes 1, 3, 4-6) IFN-free regimens Sofosbuvir + ribavirin (genotypes 2, 3) Sofosbuvir + simeprevir (genotypes 1, 4) Sofosbuvir + daclatasvir (genotypes 1, 3, 4-6)
50 P + R + Sofosbuvir-NEUTRINO Phase III, 12 weeks, Gen , % Treatment-naive 89% 96% 100% SVR12 rate (%) TOTAL (Lawitz et al., N Engl J Med 2013;368: ) N=327 N=292 N=28 Genotype 1 (89%) Genotype 4 (9%) N=7 Genotype 5, 6 (2%)
51 Sofosbuvir + Simeprevir ± RBV COSMOS Cohort 2- Gen 1, Naive and NR, F3-F % 93% 93% 93% 100% 80 SVR12 rate (%) N=80 N=27 N=14 N=24 All patients SOF+SIM+RBV SOF+SIM SOF+SIM+RBV N=15 SOF+SIM 12 weeks 24 weeks (Lawitz et al., Lancet 2014; epub ahead of print)
52 Sofosbuvir + Daclatasvir ± RBV Treatment-naive and PI failures, Genotype Weeks Treatment Naïve 100% 100% 12 Weeks Treatment Naïve 100% 95% 100% 24 Weeks PI Failures 95% SVR12 rate (%) N=14 N=15 N=41 N=41 N=21 N=20 0 SOF + DCV SOF + DCV + RBV SOF + DCV SOF + DCV + RBV SOF + DCV SOF + DCV + RBV (Sulkowski et al., N Engl J Med 2014;370: )
53 HCV Therapy in 2015 and Beyond
54 IFN-Free Combination Options Option 1 Option 2 Option 3 Protease inhibitor NS5A inhibitor Protease inhibitor 2 nd -gen protease inhibitor Nucleotide analogue NS5A inhibitor 2 nd -gen NS5A inhibitor Nonnucleoside inhibitor Non-nucleoside inhibitor ± ribavirin ± ribavirin ± ribavirin (Pawlotsky JM, Gastroenterology 2014;146: )
55 Sofosbuvir/Ledipasvir FDC ± RBV ION-1-Phase III, Gen 1, Rx-naive, 16% cirrhosis % 97% 98% 99% SVR12 rate (%) N=214 N=217 N=217 N=217 SOF/LDV SOF/LDV+RBV SOF/LDV SOF/LDV+RBV 12 weeks 24 weeks (Afdhal et al., N Engl J Med 2014;370: )
56 Sofosbuvir/Ledipasvir FDC ± RBV ION-2-Phase III, Gen 1, Rx-experienced, 20% cirrhosis % 96% 99% 99% SVR12 rate (%) N=109 N=111 N=109 N=111 SOF/LDV SOF/LDV+RBV SOF/LDV SOF/LDV+RBV 12 weeks 24 weeks (Afdhal et al., N Engl J Med 2014;370: )
57 Sofosbuvir + GS Genotype 1 Genotype 2 Genotype 3 100% 100% 96% 91% 93% % SVR12 rate (%) N=27 N=28 N=11 N=10 N=27 N=27 0 Sofosbuvir + GS-5816 (25 mg) Sofosbuvir + GS-5816 (100mg) Sofosbuvir + GS-5816 (25 mg) Sofosbuvir + GS-5816 (100mg) Sofosbuvir + GS-5816 (25 mg) Sofosbuvir + GS-5816 (100mg) (Everson et al., EASL 2014)
58 Sofosbuvir + GS Genotype 4 Genotype 5 Genotype 6 100% 100% 100% 100% 86% 80 SVR12 rate (%) N=7 N=7 N=1 N=4 N=5 0 Sofosbuvir + GS-5816 (25 mg) Sofosbuvir + GS-5816 (100mg) Sofosbuvir + GS-5816 (25 mg) Sofosbuvir + GS-5816 (25 mg) Sofosbuvir + GS-5816 (100mg) (Everson et al., EASL 2014)
59 Paritaprevir/r + Ombitasvir + Dasabuvir ± RBV Phase III, Genotype 1, Rx-naïve, No cirrhosis, 12 weeks SAPPHIRE-I PEARL-IV PEARL-III 96% 98% 95% 97% 99% 99% 90% 80 SVR12 rate (%) N=473 N=322 N=151 N=100 N=205 N=210 N=209 All 1 3D+RBV 1a 3D+RBV 1b 3D+RBV 1a 3D+RBV 1a 3D 1b 3D+RBV 1b 3D (Feld et al., N Engl J Med 2014;370: ; Ferenci et al., N Engl J Med 2014;370: )
60 Paritaprevir/r + Ombitasvir + Dasabuvir ± RBV Phase III, Genotype 1, Rx-experienced, No cirrhosis, 12 weeks SAPPHIRE-II 96% 96% 97% PEARL-II 97% 100% SVR12 rate (%) N=297 N=173 N=123 N=88 N=91 All 1 3D+RBV 1a 3D+RBV 1b 3D+RBV 1a 3D+RBV (Zeuzem et al., N Engl J Med 2014;370: ; Andreone et al., Gastroenterology 2014;147:359-65) 1b 3D
61 Paritaprevir/r + Ombitasvir + Dasabuvir ± RBV TURQUOISE-Phase III, Genotype 1, Rx-naïve and experienced, weeks % 95.9% SVR12 rate (%) N=208 N=172 3D + RBV 12 weeks 3D + RBV 24 weeks (Poordad et al., N Engl J Med 2014;370: )
62 Daclatasvir (NS5A) + Asunaprevir (PI) + BMS (NNI) - Rx-Naive, Gen % 89% 94% 94% 80 SVR12 rate (%) N=16 N=18 N=16 N= mg mg mg mg 12 weeks 24 weeks (Everson et al., Gastroenterology 2014;146:420-9)
63 Conclusions HCV is the only curable chronic viral infection Greater understanding of the HCV lifecycle has provided a new toolbox of highly effective strategies PEG-IFN-containing PEG-IFN-free ++++ Challenges remain in implementation
64 Towards HCV Eradication? An infection present in 170 million people CANNOT be eradicated by antiviral therapy without an efficient prophylactic vaccine No HCV vaccine is available or soon available Control of infection should be the goal
65 HCC Prevention in Cirrhotics with Controlled Infection
66 Follow me on
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