Treatment of hepatitis C today and tomorrow Antonio Craxì GI & Liver Unit, Di.Bi.M.I.S., University of Palermo, Italy
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1 Treatment of hepatitis C today and tomorrow Antonio Craxì GI & Liver Unit, Di.Bi.M.I.S., University of Palermo, Italy antonio.craxi@unipa.it
2 Ad Board and grants: Abbvie, Achillion, BristolMyers Squibb, Gilead, Janssen, Merck, Novartis, Roche Speaker: Abbvie, Bristol-Myers Squibb, Gilead, Janssen, Merck, Novartis, Roche
3 Flaviviridae could be as ancient as the differentiation of primate species (35 million years) - HCV has coevolved with human populations migrating out of Africa within the past,000 to 150,000 years - Current HCV genotypes appeared over the last 2,000 years - Genotypes 6 and 4 originated 700 years and 350 years ago - Subtypes 1a and 1b arose less than years ago Pybus et al Science 2001
4 HCV infects >185 million people worldwide HAJARIZADEH et al. Nat Rev Gastroenterol Hepatol 2013;10: NEGRO and ALBERTI. Liver Int 2011;31 Suppl 2:1-3 HANAFIAH et al. Hepatology 2013;57:
5 Treated/cured patients represent only a small proportion of those diagnosed Eligibility Reliability Tolerability Sensitivity North CS, et al. Gen Hosp Psych 2013;35:122 8.
6 DAAs currently approved 2013 Sofosbuvir Simeprevir Daclatasvir Nucleotide polymerase inh.all Gts (±3) NS5A inh. Protease inh.(8-12 wks), Short therapy 1, 3, 4, 5, 6 Gt 1, 4may needgt cirrhotics 24 wks - >90% SVR - Few pills, no IFN 2014 Dasabuvir - No RBV, but not for all pts Non-Nuc - Not all regimens suitable for Gt 1, 3, 4 Polymerase Gt 1-(4) Inh. decompensated pts Paritaprevir/R Ombitasvir Protease inh./ Ritonavir NS5A inh. Fixed dose combination of three DAAs ± ribavirin Sofosbuvir Triple therapy with PEG IFN and ribavirin SOF and ribavirin, no IFN Off-label combination of two DAAs ± ribavirin Ledipasvir NS5A inh Nucleotide polymerase inh. Fixed dose combination of two DAAs ± ribavirin.
7 Large body of evidence shows IFN-free therapy new combinations are highly effective in GT 1 Summary of 8 N Engl J Med studies on IFN-free therapy in GT 1 published in 2014 Regimen ION-1 LDV/SOF ± RBV ION-2 LDV/SOF ± RBV ION-3 LDV/SOF ± RBV SAPPHIRE-I PAR/r/OMB + DAS + RBV SAPPHIRE-II PAR/r/OMB + DAS + RBV PEARL-III PAR/r/OMB + DAS ± RBV PEARL-IV PAR/r/OMB + DAS ± RBV TURQUOISE-II J. Feld PAR/r/OMB + DAS + RBV PERFECTOVIR? SVR (%) Trial / Short, well-tolerated treatment regimens 8 24 weeks NB: Summary of 8 heterogeneous Phase 3 studies Included treatment-naïve and -experienced patients and cirrhotics LDV, PAR/r, OMB and DAS are investigational agents and not approved for use in HCV by the EMA/FDA Liang J, Ghany MG. N Engl J Med 2014;370: DAS: dasabuvir; LDV: ledipasvir; OMB: ombitasvir; PAR: paritaprevir; r: ritonavir
8 2014: HCV guidelines, recommendations & anti HCV drugs approval by International agencies EMA APPROVAL Olysio Olysio Sovaldi Sovaldi EASL guideline s Jan WHO guideline s Feb AASLD RECOM MENDA TIONS 1 FDA APPROVAL Sovaldi Sovaldi & & Olysio Olysio Mar Apr Daklinza Daklinza Viekirak Viekirak Exviera Harvoni Harvoni Exviera EACS guideline s May Jun Jul Aug Sept Oct Nov Dec AASLD RECOM MENDA TIONS 2 EASL RECOM MENDA TIONS Harvoni Harvoni Viekira Viekira Pack Pack
9 WHOM TO TREAT: EASL AND AASLD-IDSA RECOMMENDATIONS Indications to All treatment-naïve treatment and -experienced patients with compensated disease due to HCV should be considered for therapy (A1) Treatment is recommended for patients with chronic HCV infection (IA)
10 Clinical setting Compensated Cirrhosis Strongly recommended (A1) Highest priority (IA) Decompensate d cirrhosis not on the transplant list On clinical trial or expanded access program or within experienced centres (B1) treated by physicians with experience in treating HCV in conjunction with a liver transplantation center
11 WHOM TO TREAT: EASL AND AASLD-IDSA RECOMMENDATIONS Clinical setting F3 Strongly recommende d (A1) Highest priority (IA) F2 Justified (A2) High priority (IB) F0-F1 Indication for and timing of therapy can be Individualized (B1) Individual decision (IB)
12 RECOMMENDATIONS HCV related extrahepatic diseases & comorbidities Clinical setting Cryoglobulinemia with vasculitis HCV related immune complex Nephropathy Highest priority (IB) Treatment should be prioritized (A1) Highest priority (IIaB) Solid Organ Transplant Recipients No specific priority (A2) considered for individual decision Highest priority (IB) Haemodialysis Should be considered (B1) Consider treatment prioritization In order to yield transmission reduction benefits (IIaC) HIV No specific priority (A1) considered for individual decision High priority based on available resources(ib)
13 DAA combos reaching the clinic by Fixed dose combination of two or three DAAs Pangenotipic (± Gt3) Elbasvir Grazoprevir 2nd generation 2nd generation NS5A inh protease inh. MK 3682 (IDX 21437) Polymerase Inh. Pangenotipi c Sofosbuvir Nucleotide polymerase inh. Pangenotipi c Beclabuvir Polymerase Inh. Asunaprevir Daclatasvir Protease inh. NS5A inh. Ultra-short therapy (4-8 wks) >95% SVR for all pts. Pangenotypic One-pill regimen, no RBV ACH-3422 Suitable for all disease stages Polymerase GS nd generation NS5A inh. Pangenotipic (?) Sovaprevir (ACH-1625 Protease inh. Inh. ACH-3102 NS5A inh.
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15 SVR rates with 12 and 8-wk regimens in Gt 1, 2, 3 Part A: 12-Wk Duration Part B: 8-Wk Duration SOF + GS mg SOF + GS-5816 mg SOF + GS mg + RBV SOF + GS-5816 mg + RBV / 27 28/ 28 10/ 11 10/ /2 7 25/ 27 26/ 30 25/ 30 26/ / 31 20/ / 25 23/ 26 23/ 26 SVR12 (%) GT 1 GT 2 GT 3 Tran TT, et al. AASLD Abstract 80. GT1 GT2
16 Factors impacting response to HCV treatment: before 2015 Viral Viral factors factors Baseline viral load HCV genotype HIV/HCV co-infection DAA baseline resistance HBV/HCV co-infection Host Host factors factors Age Prior response to treatment Gender Race Genetics (IL28B, IP10, etc) Cirrhosis Transplant Obesity Diabetes/insulin resistance Hepatic decompensation Pharmacokinetics and DDIs
17 Factors impacting response to HCV treatment: after 2015 Viral Viral factors factors HCV genotype Posttreatment DAA RAVs Host Host factors factors
18 Can baseline HCV RNA inform decision to treat with LDV/SOF for 8 or 12 weeks? Similar SVR rates for 8 and 12 weeks of therapy in ION-3 If baseline HCV RNA 6 million IU/mL, treatment for 12 weeks can reduce chance of relapse LDV/SOF 8 weeks LDV/SOF 12 weeks SVR rate similar with 8 or 12 weeks 94% (202/215) 96% (208/216) Relapse rate according to baseline HCV RNA HCV RNA <6 million IU/mL 2% (2/121) 2% (2/128) HCV RNA 6 million IU/mL 10% (9/92) 1% (1/83) HCV-TARGET: 78% (253/323) of GT 1, non-cirrhotic, treatment-naïve had a baseline HCV RNA <6 million IU/mL Gilead Sciences Europe Ltd. HARVONI (ledipasvir/sofosbuvir) Summary of Product Characteristics. November 2014; Jensen D, et al. AASLD 2014; Oral #45.
19 COSMOS Cohort 2: On-treatment HCV RNA over time Ba se lin e Da y Da 2 y Da 3 y4 Mean (+/- SD) change Log10 HCV RNA (IU/mL) Week 1 Week 2 Week 3 Week 4
20 Time to Viral Suppression is not related to Achievement of SVR12 in GT1 treated with ABT-450/r/Ombitasvir+Dasabuvir +/- RBV Pooled analysis of 6 phase III Trials Aim: To evaluate the predictive value of time of first occurrence of HCVRNA TND and SVR12 Longer time to suppression associated with higher baseline HCVRNA, older age, GT1a and cirrhosis Sulkowsky M. Abst 1950 AASLD 2014
21 Is the Q80K mutation relevant for patients on SOF + SMV? Limited data but little apparent effect of Q80K for SMV in combination with SOF COSMOS: SVR12 in cohorts 1 and 2 by HCV subgenotype and baseline Q80K Cohort 2 (F3 F4 naïves/nulls)* Cohort 1 (F0 F2 nulls)* GT 1b GT 1a without Q80K 89 GT 1a with Q80K SVR12 (%) / 4 7/ 7 8/ 9 3/ 3 7/ 7 3/ 3 6/ 12/ 8/ / 4 4/ 4 5/ 6 17/ 30/ 24/ / 11/ 11/ / 7/ 4 7 4/ 4 5/ 13/ 7/ / 3 7/ 3/ / 38/ 25/ SOF + SMV SOF + SMV SOF + SMV SOF + SMV SOF + SMV SOF + SOF + SMV SOF + SMV SOF + SMV SOF + SMV + RBV + RBV ± RBV SMV + RBV + RBV ± RBV 24 weeks 12 weeks Overall Lawitz E, et al. Lancet 2014;384: weeks 12 weeks Overall *Excluding patients who discontinued for non-virological reasons
22 L159F and V321A emergence in 408 virological failures from 8 SOF and 5 LDV/SOF trials Ultra deep sequencing of NS5B (1% assay cut-off) Svarovskaia ES et al., AASLD 2014
23 Svarovskaia ES et al., AASLD
24 Krishnan, Abst 1936
25 Is Gt 1 subtype still relevant? LDV/SOF 8 weeks LDV/SOF 12 weeks 94% (202/215) 95% (206/216) GT 1a 93% (159/171) 95% (163/172) GT 1b 98% (42/43) 98% (43/44) SVR rate overall SVR according to subtype Kowdley KV, et al. N Engl J Med 2014;370:
26 Is Gt 1 subtype still relevant? RBV-free PEARL-IV1 90 * + RBV PEARL-III1 99,5 80 SVR12 (%) SVR12 (%) / / GT 1a Treatment-naïve Ferenci P, et al. N Engl J Med 2014;370: / / 210 GT 1b Treatment-naïve *RBV-free arm did not meet non-inferiority vs RBV-containing arm; Ombitasvir, paritaprevir, RTV + dasabuvir are not approved for use in HCV by the EMA; EMA: European Medicines Agency; RTV: ritonavir
27 HCV Gt 3: still a difficult genotype SOF + RBV x 24 weeks (VALENCE) LDV/SOF + RBV x 12 weeks (ELECTRON-2) SOF + DCV x 12 weeks (ALLY-3) SVR12, % /92 21/21 73/75 38/39 12/13 5/5 11/19 0 SOF + PEG-IFN + RBV x 12 weeks (TN: PROTON/ELECTRON 85/98 25/28 32/34 10/12 29/47 16/22 9/13 10/12 Treatment-experienced Non-cirrhotic LDV/SOF + RBV for 12 weeks and SOF + DCV for 12 weeks are not EMA-recommended treatment regimens for GT 3 Zeuzem S, et al. N Engl J Med 2014;370: ; Gane E, et al. EASL 2014; Oral #6; Gane E et al. NEJM 2013;368:34 44; Lawitz E et al. Lancet Infect Dis 2013;13: ; Gane E et al. AASLD 2014, Poster #LB-11; Lawitz E et al. AASLD 2013, Oral #LB-4; Nelson M et al. AASLD 2014, Oral #LB-3.
28 Factors impacting response to HCV treatment: after 2015 Viral Viral factors factors HCV genotype Posttreatment DAA RAVs Host Host factors factors Cirrhosis Post OLT status Pharmacokinetics and DDIs
29 Efficacy of SOF + SMV ± RBV in real-world settings HCV-TARGET: Prospective Observational Cohort Study: Adjusted SVR4 in GT1 HCV Pts[1] SOF + SMV TRIO: Prospective Observational Cohort Study: SVR12 in Tx-Naive GT1 HCV Pts[2] GT1 GT1a SOF + SMV + RBV SVR12 (%) n= SVR4 (%) 83 GT1b All Pts Tx-Naive Pts Tx-Exp d Pts SMV + SOF ± RBV 1. Jensen DM, et al. AASLD Abstract Dieterich D, et al. AASLD Abstract
30 LDV/SOF efficacy in compensated Gt1 cirrhosis 24 wks of LDV/SOF 24 wks of LDV/SOF + RBV 12 wks of LDV/SOF 12 wks of LDV/SOF + RBV SVR12 (%) n= Total Bourlière M, et al. AASLD Abstract Treatment Naive Treatment Experienced 22
31 SVR12 rates with LDV/SOF ± RBV by stage of cirrhosis Total Overall SVR12 Platelets (x 103/µL) FibroScan (kpa) Treatment Experienced 96% 98% 95% < 75 84% 90% 82% 75 to < 99% % 98% to < % 98% 93% % 98% 98% > 12.5 to 20 99% % 99% > 20 96% % 95% 80 Treatment Naive SVR12 (%) SVR12 rates lower among pts determined to have cirrhosis using FibroTest + APRI (89%) and among pts with a platelet count < 75,000 cells/mm3 (84%) Bourlière M, et al. AASLD Abstract 82.
32 SVR12 with PTV/RTV/OMV + DSV + RBV in Gt1 compensated cirrhosis 12 wks wks / 13/ / 59/ / 115/ / 51/ / 33/ / 102/ / 31/ CC CT TT SVR12 (%) n/n = 0 81/ 71/ Naive 28/ 23/ Relapser Partial Null Responder Responder Factor GT1a GT1b HCV Subtype IL28B Genotype P Value IL28B TT genotype.021 Previous null response to pegifn/rbv.038 GT1a HCV.046 Fried MW, et al. AASLD Abstract 81.
33 SVR12 with LDV/SOF + RBV in Gt1 patients with decompensated cirrhosis LDV/SOF + RBV 12 wks SVR12 (%) LDV/SOF + RBV 24 wks relapses 1 death 40 1 relapse 1 death 1 LTFU 1 relapse 2 deaths /52 42/47 26/30 Overall 24/27 19/22 CPT B Pts, n (%) 1 relapse 1 death 18/20 CPT C CPT B CPT C 12 Wks (n = 30) 24 Wks (n = 29) 12 Wks (n = 23) 24 Wks (n = 26) AE 29 (97) 27 (93) 23 () 26 () SAE 3 (10) 10 (34) 6 (26) 11 (42) Treatment-emergent, -related SAEs 2 (7) (8) Treatment discontinuation due to AE 0 1 (3) 0 2 (8) Flamm SL, et al. AASLD Abstract 239. Reproduced with permission.
34 SVR12 SVR12 with LDV/SOF + RBV in Gt1 post-olt patients wk LDV/SOF + RBV 24-wk LDV/SOF + RBV SVR12 (%) 80 1 relapse 2 deaths 1 consent withdrawn n/n = 0 2 relapses 1 death 1 death 1 consent withdrawn 53/ 55 55/ 56 F0-F3 25/ 26 24/ 25 CPT A 2 relapses 1 relapse 3 deaths 22/ 26 15/ 18 CPT B 3 / 5 2 / 3 CPT C In the 24-wk arm, 8 pts with CPT B and 1 pt with CPT C have not reached the follow-up Wk 12 visit MELD scores improved from baseline through follow-up Wk 4 in 15/48 pts with CPT A and 8/41 pts with CPT B disease Reddy RT, et al. AASLD Abstract 8.
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37 IFN free DAA have expanded the pool of treatable patients IFN-free combination regimens dominate the treatment landsca SOF-based regimens are effective in real-world settings Safety demonstrated in noncirrhotic and cirrhotic patients Mild Severe HCV chronic disease spectrum Currently treated Decomp - By enrolling new patients at the extreme of the spectrum - By enforcing need for mass screening for HCV
38 Who should be treated: EASL recommendations 2014 In principle, all patients with chronic HCV infection, but in a situation of limited availability: F3-F4: Priority F2: Reasonable F0-F1: Debatable Informed deferral of treatment for patients with mild disease EASL Online Recommendations on Treatment of Hepatitis C, April 2014
39 AASLD/IDSA: Patients With F3/F4 Fibrosis Have Highest Priority for HCV Treatment When constrained resources prevent treatment of all HCV infection cases, highest priority should be given to patients with advanced fibrosis (Metavir F3) or compensated cirrhosis (Metavir F4), liver transplant recipients, and patients with severe extrahepatic hepatitis C Based on available resources, treatment should be prioritized as necessary so that patients at high risk for liver-related complications and severe extrahepatic hepatitis C complications are given high priority AASLD/IDSA HCV Management Guidance. October 2014.
40 SVR associated with reduced 5-Yr risk of death and HCC in all populations SVR on IFN-based therapy was associated with substantial benefit vs no SVR 62% to 84% reduction in all-cause mortality, 90% reduction in liver transplantation, 68% to 79% reduction in HCC 5-Yr Risk of All-Cause Death by SVR SVR Pts Dead After 5 Yrs (%) General Cirrhotic Pts 1.3 HIVCoinfected Pts Hill AM, et al. AASLD Abstract Yr Risk of HCC by SVR No SVR Pts With HCC After 5 Yrs (%) General 0.9 Cirrhotic Pts HIVCoinfected Pts
41 Survival after P/R treatment in 440 patients with HCV cirrhosis, C-P A5-6 (mean follow-up 7.7 yrs) No esophageal varices before P/R Esophageal varices before P/R Patients alive (%) SVR SVR SVR SVR NoNo SVR SVR Log rank p = Log rank p = No SVR No SVR Di Marco V, submitted
42 Deaths due to HCC or liver decompensation after P/R treatment in 440 patients with HCV cirrhosis Di Marco V, submitted
43 Cost per SVR for GT1 HCV Patients GT1, TREATMENT-NAIVE COST PER SVR GT1, TREATMENT-EXPERIENCED (PI+PR-EXPERIENCED) , GT1, TREATMENT-EXPERIENCED (PR-EXPERIENCED) COST PER SVR COST PER SVR *SOF+SMV data from Phase IIb study and 12W regimen for NC, 24W regimen for CC patients as per label Younossi, AASLD, 2014, Poster # ,
44 Evaluation of Health Outcomes from LDV/SOF Treatment of Patients with Early vs. Advanced Liver Fibrosis Initiating LDV/SOF treatment at F0-F1 and F2 rather than F3-F4 reduces lifetime costs of treatment, and has a lower cost per SVR COST PER SVR LIFETIME COSTS Initiating LDV / SOF treatment in F0-F1 or F2 as opposed to F3-F4 results in substantial savings per successfully treated patient (cost per SVR) and lifetime costs. Ahmed A, AASLD, 2014, #1751
45 Hepatologist HCV
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