Ed Gane NZ Liver Transplant Unit Auckland City Hospital
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1 Clinical Management of Hepatitis C Patients Treat Now or Wait Ed Gane NZ Liver Transplant Unit Auckland City Hospital
2 SVR24 rates with PEG/RBV by HCV genotype Data from the real-world PROPHESYS cohort study Patients with GT2/3 are easier to treat with PegIFN/RBV Treatment-naive patients treated with Pegasys or PegIntron plus RBV SVR24 (%) n N HCV genotype * Patients with sufficient follow-up data. Marcellin P, et al. Hepatology 2012; 56:
3 SVR24 rates with PEG/RBV by Fibrosis Stage Patients without cirrhosis are easier to treat with PegIFN/RBV SVR24 (%) n N METAVIR fibrosis stage Ferenci P, et al. Hepatol Int 2014; 8:83 93.
4 SVR24 rates with PEG/RBV by IL28B genotype Patients with an IL28B CC genotype are easier to treat with PegIFN/RBV SVR24 (%) n N Proportion of patients with IL28B genotype Stättermayer AF, et al. Clin Gastroenterol Hepatol 2011; 9:
5 SVR24 rates with PEG/RBV by IL28B genotype Rate of SVR and CC allele frequency in diverse ethnic groups 1 Caucasian/Asian CC allele frequency patients stratified are by easier race 2 to treat with PegIFN/RBV East Asians SVR24 (%) European- Americans Hispanics African-Americans CC frequency (%) rs C allele frequency 1. Ge D, et al. Nature 2009; 461: ; 2. Jiménez-Sousa MA, et al. BMC Medicine 2013; 11:6 (supplementary information).
6 Protease Inhibitors in Clinical Development Target Agent Company Phase NS3/4a Serine Boceprevir Merck Approved Protease Telaprevir Vertex Approved Simeprevir Tibotec Approved Vaniprevir Merk I Faldaprevir Boehringer I Asunaprevir BMS ABT450 Abbott I Danoprevir Roche I MK5172 Merck SCH Merck GS 9256 Gilead GS 9451 Gilead VX-985 Vertex Phase I ACH1625 Achillon Phase I IDX-320 Idenix Phase I ACH1284 Achillon Phase I BMS BMS Phase I VX-500 Vertex Phase I PHX1766 Pfizer Phase I
7 Addition of BOC or TVR to PEG/RBV in HCV GT-1 Higher SVR rates in Treatment Naïve Patients 28% 31% SVR24 (%) n N PI = protease inhibitor. 1. Poordad F, et al. N Engl J Med 2011; 364: ; 2. Jacobson IM, et al. N Engl J Med 2011; 364:
8 Addition of BOC or TVR to PEG/RBV in HCV GT-1 Higher SVR rates in HCV Subtype 1b HCV GT1b patients are easier to treat with PI/PegIFN/RBV BOC 1 TVR 2 7% 8% SVR24 (%) SVR24 (%) n N n N P/R = peginterferon alfa/ribavirin. 1. Poordad F, et al. N Engl J Med 2011; 364: (supplementary information); 2. Jacobson IM, et al. N Engl J Med 2011; 364:
9 Addition of BOC or TVR to PEG/RBV in HCV GT-1 SVR depends on prior response to PEG/RBV SVR (%) Treatment-naive/relapser patients are easier to treat with PI/PegIFN/RBV Prior relapse 1,2 Naive patients 1,2 Prior partial response 1 3 Prior null response 1,2 1. BOC prescribing information, revised February 2014; 2. TVR prescribing information, revised October 2013; 3. Bacon BR, et al. N Engl J Med 2011; 364:
10 Real-Life Study of Boceprevir triple therapy in Asian GT-1 Nonresponders BOCEPREVIR NAMED PATIENT PROGRAMME, BNPP Eligibility Age >18y Previous treatment failure Compensated advanced fibrosis or cirrhosis Genotype 1 No contraindications for PEG-IFN/RBV PEG- IFN + BOC: 800 mg/8h; Peg-IFNα-2b: BOC 1.5 µg/kg/week; + PEG-IFNα-2b RBV: RBV to 1400 mg/day RBV Follow-up Weeks SVR12 72 SVR24 1. Fontaine H. et al. EASL Oral 60; 2. Sukeepaisarnjareon W, et al. APASL Liver Week Abstract 2392.
11 Treatment response according to type of prior IFN non-response (compare to French Boceprevir EAP) BNPP Asian Cohort, n=70/79 Thailand, Singapore, Malaysia 2 CUPIC, n=190 (boceprevir) Overall SVR = 63% Overall SVR = 41% SVR12 (%) SVR12 (%) P= /45 2/4 Relapsers Partial responders 8/21 Null responders /85 32/80 1/9 Relapsers Partial responders Null responders 1. Fontaine H. et al. EASL Oral 60; 2. Seng Gee Lim personal communication based on Sukeepaisarnjareon W, et al. APASL Liver Week Abstract `
12 Serious Adverse Events and Adverse Events (compare to French Boceprevir EAP) BNPP Asia 2 CUPIC 1 All SAEs 16.5% 51% Death 0 1.6% Sepsis 3.8% 4.2% Decompensation 2.5% 4.7% Blood transfusions 13.9% 13.7% 1. Fontaine H, et al. EASL Oral 60; 2. Seng Gee Lim personal communication based on Sukeepaisarnjareon W, et al. APASL Liver Week Abstract SAEs: serious adverse events
13 Simeprevir plus PEG/RBV in HCV GT-1 Treatment Naïve: QUEST-1 (n=394) : HCV RNA <LLQ at Wk 4 and <LOD at Wk 12 n=260 n= % 85% met RGT stopped at 24 wks 91% 80% 75% % SVR12 50% 25% 50% 21% 0% 48 wk PR TMC12PR24 Met RGT No RGT Jacobson I, et al. EASL April 2013
14 Simeprevir plus PEG/RBV in HCV GT-1 Treatment Naïve: Baseline Predictors SVR12 (%) SVR reduced by Baseline cirrhosis 85 IL28-B non-cc Q80K 75 in Subtype 1a Q80K Prevalence Nil in Subtype 1a >40% of US GT-1a <10% European GT-1a what about in Asians? 58 0 All F0 2 F3 4 METAVIR CC Non-CC IL28B GT GT1a GT1a GT1b +Q80K HCV GT1 subtype Simeprevir prescribing information, November 2013.
15 Triple Therapy cannot meet the unmet medical need in patients with HCV? 1. Poor tolerability Still requires Pegylated Interferon and ribavirin Added toxicities of the PIs Poor safety in advanced liver disease 2. Complex dosing regimen Up to 18 tablets - 8 hourly, with high-fat meal Frequent on-treatment monitoring required Response-Guided Therapy and Futility Rules 3. Limited Efficacy Null responders Subtype 1a Q80K at baseline HCV genotypes other than 1
16 HCV Non-1 GT: Almost 50% Global HCV Population Russia 4 1a 3a 1b Egypt Genotype 2 Genotype 3 Genotype 4 Genotype 6 Sources: MSD data on file. International Conquer C Coalition (I-C 3 ), Kromite. Sievert W, et al. Liver Int 2011;31(Suppl 2):61 80
17 Inhibitors of the Polymerase Complex Target Agent Phase NS5b Non-nucleoside analogue (NNA) Deleobuvir ABT-333 GS-9669 Setrobovir Filibuvir Tegobuvir ABT-072 JTK-003 TMC BMS VX-222 MK-3281 MK-8876 HCV-796 IDX375 VX759 PF I I Phase I Phase I Phase I Phase I Target Agent Phase Cyclophyllin B inhibitors Alisporivir NIM811 SYC-635 I Phase I Phase I Target Agent Phase NS5b Sofosbuvir Approved Nucleoside Mericitabine I Analogue (NA) VX-135 INX-189/BMS PSI-938 NM283 IDX184 Phase I GS-6620 Phase I IDX20963 Phase I ACH-3422 Phase I Target Agent Phase NS5a Nonnucleoside Daclatasvir I Ledipasvir I analogue ABT-267 I GS-5816 MK-8742 ACH-3102 GSK BMS82439 PPI-668 IDX719
18 IFN-free DAA therapy in HCV GT-2 or 3
19 Sofosbuvir+RBV without PEG in HCV GT2/3 Phase 3 Programme Week FISSION PEG/RBV (SOC) (n=243) SVR12 SOF+RBV (n=256) SVR12 Lawitz E, et al. N Engl J Med 2013;368: FUSION SOF+RBV (n=98) SVR12 Jacobson IM, et al. N Engl J Med 2013;368: VALENCE SOF+RBV (n=207) Zeuzem S, et al. N Engl J Med 2014; online 4 May DOI: SVR12
20 Sofosbuvir+RBV without PEG in HCV GT2/3 Phase 3 Programme (a) HCV Genotype 2 (b) HCV Genotype 3 Cure (%) Dec 2014: FDA recommends 12 weeks SOF+RBV for GT-2 24 weeks SOF+RBV for GT-3 PEG/RBV 24 wks SOF/RBV 12 wks SOF/RBV 16wks SOF/RBV 24 wks PEG/RBV 24 wks SOF/RBV 12 wks SOF/RBV 16wks SOF/RBV 24 wks Lawitz E, et al. N Engl J Med 2013;368: Jacobson IM, et al. N Engl J Med 2013;368: Zeuzem S, et al. N Engl J Med 2014; online 4 May DOI:
21 What about IFN-free DAA therapy in HCV GT-1?
22 Sofosbuvir+RBV without PEG in HCV GT1 Phase 2 studies (ELECTRON, QUANTUM, SPARE) SVR (%) Adding a second DAA with different mechanism 50 of action should enhance 40 efficacy of SOF + RBV in GT /25 21/25 13/25 26/35 0 Treatment-Naïve 12 weeks1 Treatment-naïve 1/10 14/25 26/35 13/25 Treatment-Naïve 24 weeks 2 Treatment-Naïve 24 weeks 3 1 Gane E, et al. NEJM 2013;368:34 44; 2 Osinusi A, et al. JAMA. 2013;310:804-11; 3 Lalezari J, et al. J Hepatol 2013;58:S236 22
23 Combining NS5A inhibitor Ledipasvir with a NUC NS5B polymerase inhibitor Sofosbuvir Ledipasvir Picomolar potency against HCV GT 1a and 1b 1 Once-daily, oral, 90-mg O H O N O N N N H F F H N H N N O N O H O LDV NS5A inhibitor Sofosbuvir Potent antiviral activity against HCV GT 1 6 High barrier to resistance Once-daily, oral, 400-mg tablet approved for use with other agents to treat HCV SOF Nucleotide polymerase inhibitor H 3 C H 3 C O O CH 3 O HN P O O O O N NH O CH 3 HO F Ledipasvir/Sofosbuvir FDC 2 Once daily, fixed-dose (90/400 mg) combination tablet No food effect >2000 patients treated SOF Nucleotide polymerase inhibitor LDV NS5A inhibitor 1. Lawitz E, et al. EASL 2011, poster 1219.
24 SOF/LDV FDC ± RBV in HCV GT-1 I ION-1 and ION-3: Treatment Naïve 100 SOF/LDV SOF/LDV+RBV SVR12 (%) weeks 12 weeks 24 weeks Press Release Gilead Sciences, Inc, December 18, Mangia et al. EASL 2014 Kowdley et al. EASL 2014
25 SOF/LDV FDC ± RBV in HCV GT-1 I ION-2: Treatment Experienced 100 SOF/LDV SOF/LDV+RBV SVR12 (%) weeks 24 weeks Press Release Gilead Sciences, Inc, December 18, Afdal et al. EASL 2014
26 AbbVie Triple DAA Regimen in HCV GT-1: ABT-450/r + ABT ABT-333 ± RBV (3D+RBV) ABT-450/r NS3/4A macocyclic protease inhibitor Nanomolar activity against HCV GTs 1-4 and GT6 Boosted with ritonivir Once-daily 150mg Ombitasvir (ABT-267) NS5A inhibitor Picomolar potency against GTs 1-6 Once-daily, 25-mg, co-formulated with ABT-450/r Dasabuvur (ABT-333) Non-NUC NS5B inhibitor Nanomolar activity against GT 1a and 1b Twice daily, 250mg All DAAs well tolerated in >2000 patients in Phase 1 studies and >2300 patients in Phase 3 studies 26
27 AbbVie-3D+RBV: I Studies in HCV GT-1 SAPPHIRE-1: Treatment-naive, noncirrhotic ABT-450/r+Ombitasvir+Dasabuvir+RBV for 12 wks SVR12 (%) Overall GT-1a GT-1b Press Release Gilead Sciences, Inc, December 18, Feld et al. EASL 2014
28 AbbVie-3D+RBV: I Studies in HCV GT-1 SAPPHIRE-2: Treatment-experienced, noncirrhotic ABT-450/r+Ombitasvir+Dasabuvir+RBV for 12 wks SVR12 (%) Overall GT-1a GT-1b Press Release Gilead Sciences, Inc, December 18, Zeuzem et al. EASL 2014
29 AbbVie-3D+RBV: I Studies in HCV GT-1 TURQUOISE-2: Cirrhotic ABT-450/r+Ombitasvir+Dasabuvir+RBV: 12 vs. 24 wks weeks 24 weeks SVR12 (%) Overall Responder Relapser Partial Responder Null Responder Press Release Gilead Sciences, Inc, December 18, Poordad et al. EASL 2014
30 SVR Rates in Patients With HCV GT SVR Rate (%) IFN 24 wks IFN 48 wks IFN/RBV 48 wks PEG- IFN/RBV 48 wks TVR/BOC PEG/RBV 48 wks SMV/PEG /RBV 24 wks SOF/RBV 24 wks SOF/PEG /RBV 12 wks LDV/SOF FDC 8 wks AbbVie 3D+RBV 12 wks
31 Should we treat now or wait?
32 Should we treat now or wait? Treat NOW Cure some (40-70%) Reduce stigma Prevent progression Prevent transmission Less expensive WAIT until IFN-free Cure most (>90%) Better tolerability Less contraindications Less discontinuation (<1%) Less expensive per SVR
33 Should we treat now or wait? More expensive DAAs may still be cost-effective Direct Costs of Telaprevir plus PEG/RBV for 48wks treatment = USD90,000 (55K for SOF) For S/E = 7K per pt Average cost per patient USD83,000 44% SVR in GT-1 Cost per SVR for treatment naïve = 154K Direct Costs of Sofosbuvir plus PEG/RBV for 12wks treatment = USD94,000 (84K for SOF) For S/E = Nil per pt Average cost per patient USD94,000 91% SVR in treatment naïve GT-1 Cost per SVR for treatment naïve = 104K Bichoupan K, et al. AASLD 2013, Washington DC. #244
34 Should we treat now or wait? Approved HCV treatments in Asia Boceprevir Singapore Malaysia Hong Kong Indonesia Philippines Vietnam Australia New Zealand Standard of care PEG-IFN + RBV Resource poor settings Conventional IFN + RBV Telaprevir Japan Australia Simeprevir Japan Sofosbuvir New Zealand
35 Whom should we treat now? (a) Those most likely to respond EASY TO TREAT GT2/3 GT1 IL28B CC genotype GT-1b (protease inhibitors) No cirrhosis Treatment-naïve/Relapsers Low BL viral load No comorbidities Younger age Female Lower BMI Caucasian/Asian DIFFICULT TO TREAT GT1, 4 IL28B non-cc genotype GT-1a Cirrhosis NULL Responders High BL viral load Comorbidities (e.g. HIV) Older age Male Higher BMI Black/Hispanic BMI = body mass index; BL = baseline; GT = genotype.
36 Whom should we treat now? (b) Those with highest risk for complications 1457 untreated HCV+ patients followed for 5 years Patients without severe fibrosis had NO liver-related complications/mortality/transplantation during follow-up Vergniol J, et al. Gastroenterology 2011; 141:
37 Treatment for Chronic HCV in 2014 CHRONIC HCV Fibroscan, Biopsy, Fibrotest Nil or Mild fibrosis Mod/severe fibrosis, cirrhosis GT 2 or 3 HCV genotype GT 1a or 1b IL28-β genotype CC CT or TT Await IFN-free DAAs PEG/RBV RGT 16-24wks PEG-RBV RGT 24-48wks Triple therapy (PI/PEG/RBV)
38 Treatment for Chronic HCV beyond 2016 ALL PATIENTS including HCV GT 1-6 BOC/TVR Failures Cirrhotic/decompensated HIV co-infected 1 pill/day for 8-12 wks No need for HCV GT, IL28 GT No on-treatment monitoring Community prescribing Treatment uptake Health burden
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