TREATING HEPATITIS C TODAY
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1 TREATING HEPATITIS C TODAY Nikolaos K. Gatselis Department of Medicine& Research Laboratory of Internal Medicine, Larissa Medical School, Thessaly University
2 Disclosure Research Support: Gilead, Janssen, Bayern, Roche, Abbvie, Regulus, MSD Speaker Bureau: BMS, GILEAD Travel expenses: Janssen, BMS, Novartis, Gilead, TEVA, Abbvie 2
3 The HCV therapeutic revolution
4 Goal of Therapy The goal of therapy is to cure HCV infec6on to prevent hepa6c cirrhosis, decompensa6on of cirrhosis, HCC, severe extra-hepa6c manifesta6ons and death The endpoint of therapy is undetectable HCV RNA in a sensi6ve assay (LOD <15 IU/ml) 12 weeks (SVR12) and/ or 24 weeks (SVR24) aoer the end of treatment Undetectable HCV core an.gen * 12 weeks (SVR12) and/or 24 weeks (SVR24) aoer the end of treatment is an alterna6ve endpoint of therapy if HCV RNA assays are not available or not affordable ( * according to EASL guidelines)
5 Who should be tested for HCV and who should be treated?
6 Who should be tested for anti-hcv? (I) individuals with elevated transaminases persons with illicit drug use, intravenous or intranasal (current or ever, even once) received a transfusion of blood or blood components, or underwent an organ transplant before 1992 long-term hemodialysis (ever) percutaneous/parenteral exposures in an unregulated sevng healthcare, emergency medical, and public safety workers aoer needles6cks, sharps, or mucosal exposures to HCV-infected blood HASL 2017
7 Who should be tested for anti-hcv? (II) persons who were ever incarcerated sexual partners of HCV infected persons persons with mul6ple sexual partners children born to HCV-infected mothers HIV infec6on HBV infec6on HASL 2017
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10 Who should be treated? All patients with chronic HCV infection are candidates for antiviral treatment and potentially be treated with the optimum regimen which offers higher efficacy and better safety and tolerability. UNIVERSAL ACCESS TO THERAPY
11 Prioritization for administration of DAAs moderate fibrosis or cirrhosis (Ishak: 2-6, METAVIR F2-F4, Fibroscan >7.5 kpa) HCV recurrence after liver transplantation HIV co-infection or HBV-co-infection Greek authori.es (11/2016) F3 exp. F4 LTx severe extrahepa.c manifesta.ons (?) severe extrahepatic manifestations (cryoglobulinemia, B-cell NHL) chronic hemoglobinopathies with hepatic or non-hepatic complications due to chronic hemolysis hemophiliacs and patients with other hemostasis disorders chronic renal failure (regardless of hemodialysis) patients at risk of a rapid evolution of liver disease (immunosuppression or concurrent disease) contraindication for IFNα or ribavirin (regardless of liver fibrosis stage) high risk groups for HCV transmission or exposure (active injection drug users, multiple sexual partners) HASL 2017
12 DAAs Approved Sofosbuvir Simeprevir Daclatasvir 2014 All genotypes Gen 1, 4 All genotypes 2015 Sofosbuvir/ Ledipasvir Gen 1, 4, 5, 6 Ombitasvir/ Paritaprevir /Ritonavir Gen 1, 4 Dasabuvir Gen Sofosbuvir/ Velpatasvir All genotypes Grazoprevir /Elbasvir Gen 1, 4
13 HCV treatment: Get to know your Patient HCV genotype? Presence of cirrhosis? Previous HCV therapy? Helps tailor: Treatment options Treatment duration Need for ribavirin
14 IFN-Free DAA regimens available Results from major clinical trials
15 Sofosbuvir/Ledipasvir (SOF/LDV) GT1a GT1b GT2 GT3 GT4 GT5,6 F0-F3 F4 TN 8w 8w w 12w TE 12 12w w +RBV, 24w 12w +RBV TN 12w 12w w 12w TE 12w +RBV, 24w 12w +RBV, 24w w +RBV, 24w 12w +RBV HASL 2017
16 ION-1 LDV/SOF ± RBV in HCV GT1 Naïve F0-F4 Afdhal, NEJM 2014
17 ION-2 LDV/SOF ± RBV in HCV GT1 Experienced F0-F4 Afdhal, NEJM 2014
18 Sofosbuvir + Daclatasvir (SOF + DCV) GT1a GT1b GT2* GT3 GT4 GT5,6 F0-F3 TN 12w 12w 12w 12w 12w - TE 12w 12w 12w 12w +RBV 12w +RBV, 24w - F4 TN 12w 12w 12w TE 12w +RBV, 24w 12w +RBV, 24w 12w 12-24w +RBV 12-24w +RBV 12w - 12w +RBV, 24w - *limited data HASL 2017
19 ALLY-3 DCV + SOF in Genotype 3 TN or TE, F0-F4 Nelson, Hepatology 2015
20 ALLY-3+ DCV + SOF +RBV in GT-3 with Advanced Liver Disease TN or TE, F3-F4 Leroy, Hepatology 2016
21 Ombitasvir/Paritaprevir/Ritonavir ± Dasabuvir (OBV/PTV/r ± DSV*) GT1a* GT1b* GT2 GT3 GT4 GT5,6 F0-F3 TN 12w +RBV 8w w +RBV - TE 12w +RBV 12w w +RBV - TN 12w +RBV 12w w +RBV - F4 TE 12w +RBV, 24w +RBV (nr) 12w w +RBV - HASL 2017
22 TURQUOISE-II SVR12 rate of 92-96% in 380 HCV GT-1 with Compensated Cirrhosis treated with OBV/PTV/r + DSV + RBV n=380, GT1a, GT1b, Cirrhosis (CP-A), TN, TE Poordad, NEJM 2014
23 TURQUOISE-II SVR12 rate of 92-96% in 380 HCV GT-1 with Compensated Cirrhosis treated with OBV/PTV/r + DSV + RBV n=380, GT1a, GT1b, Cirrhosis (CP-A), TN, TE Poordad, NEJM 2014
24 TURQUOISE-III OBV/PTV/r + DSV Safety and Efficacy of 12w RBV-free treatment for patients with HCV GT-1b and Cirrhosis n=60, GT1b, Cirrhosis (CP-A), TN (n=27), TE (n=33) Efficacy Safety All pa.ents completed treatment SVR12 was achieved in 100% of pa.ents 1 pa.ent experienced a serious AE of acute hypotension from DDI with nisoldipine Feld, J Hepatol 2016
25 AGATE-I & AGATE-II Studies OBV/PTV/r + RBV for HCV-GT4 infected patients AGATE-I: HCV GT4 Patients with Compensated Cirrhosis AGATE-II: Egyptian HCV GT4 Patients ± Compensated Cirrhosis Asselah, Lancet Gastroenterol Hepatol Waked, Lancet Gastroenterol Hepatol 2016
26 AGATE-I & AGATE-II Studies OBV/PTV/r + RBV for HCV-GT4 infected patients AGATE-I results AGATE-II results Overall SVR12 Asselah, Lancet Gastroenterol Hepatol Waked, Lancet Gastroenterol Hepatol 2016
27 Sofosbuvir/Velpatasvir (SOF/VEL) GT1a GT1b GT2 GT3 GT4 GT5,6 F0-F3 TN 12w 12w 12w 12w 12w 12w TE 12w 12w 12w 12w +RBV, 24w 12w 12w F4 TN 12w 12w 12w TE 12w 12w 12w 12w +RBV, 24w 12w +RBV, 24w 12w 12w 12w 12w HASL 2017
28 ASTRAL-1 SOF/VEL in HCV GT1, 2, 4, 5, or 6 TN or TE, F0-F4 Feld, NEJM 2015
29 ASTRAL-1 SOF/VEL in HCV GT1, 2, 4,,5, or 6 TN or TE, F0-F4 Feld, NEJM 2015
30 ASTRAL-3 SOF/VEL in HCV GT3 TN or TE, F0-F4 Foster, NEJM 2015
31 HASL 2017 Elbasvir/Grazoprevir (EBR/GZR) GT1a GT1b GT2* GT3 GT4 GT5,6 F0-F3 TN TE 12w* 16w +RBV** 12w* 16w +RBV** 12w w - 12w w # 16w +RBV $ - F4 TN TE 12w* 16w +RBV** 12w* 16w +RBV** 12w w - 12w w # 16w +RBV $ - *RAV- or HCVRNA 800,000 IU/ml **RAV+ or HCV RNA > 800,000 IU/ml # HCVRNA 800,000 IU/ml $ HCV RNA > 800,000 IU/ml
32 C-EDGE Treatment Naïve 12 wks of GZR/EBR in HCV GT1, 4, 6 TN, F0-F4 Zeuzem, Ann Intern Med 2015
33 GZR/EBR in HCV GT1a (naïve) EASL Special Conference, September 2016
34 Could be treatment duration shortened less than 12 weeks?
35 Attempting shorter therapies Lower cost More accessible, less medical care treatment difficult to treat populations Improved adherence, compliance Less exposure for side effects Decrease emergence of resistance
36 8-week LDV/SOF in non-cirrhotic, treatment-naïve patients: real-world confirmation of clinical data
37 Welzel, EASL Conference 2016 GARNET High SVR rated following 8w treatment with OBV/PTV/r + DSV for HCV GT-1b Patients 166 pa.ents, TN, GT1b, F0-F2 (n=151), F3 (n=15)
38 GARNET High SVR rated following 8w treatment with OBV/PTV/r + DSV for HCV GT-1b Patients 166 pa.ents, TN, GT1b, F0-F2 (n=151), F3 (n=15) Welzel, EASL Conference 2016
39 Target: 8 weeks or 12 weeks SOF/LDV 323 Qualified for 8 weeks Therapy* only 42% received 8 weeks *Qualified = TN, no-cirrhosis, HCV RNA 6,000,000 IU/ml Terrault et al, AASLD 2015
40 Hepatitis C Virus treatment in the Real-World : How well do Real Patients Respond?
41 Mauss, AASLD 2016 Variables Associated With Treatment Outcomes for HCV GT1 Infection With DAA: Data From the German Hepatitis C-Registry (DHC-R) A real-world study of 6,606 GT1 pa6ents observed for at least 40 weeks aoer ini6a6on of an6viral treatment from the German Hepa66s C Registry from 02/2014 to 06/ Overall SVR12: GT1a, 91%; GT1b, 93% No sta6s6cal difference in SVR rates between subtypes regardless of regimen used SVR12 (PP), % D/C, % Cirrho6cs, % AEs were reported by 53% Most frequent AEs: fa6gue (23%), headache (16%), nausea (7%), insomnia (6%) SAEs in 240 pts (4%) and 30 pts died (11/30 due to liver associated complica6ons) Mul.variate analysis Variable OR (95% CI) p-value An6viral regimen 1.33 ( ) <0.001 Cirrhosis 0.71 ( ) <0.003 Sex 1.52 ( ) <0.001 In this real-world cohort, SVR12 rates were equivalent to those seen in clinical trials
42 RW Safety and Effec.veness of OBV/PTV/r ± DSV ± RBV in the German Hepa..s C Registry Large RW cohort study of HCV GT1- and GT4-infected pa6ents treated with OBV/PTV/r ± DSV ± RBV Enrolled (N = 1021) Safety popula6on: ini6ated treatment (N = 1017) Effec6veness popula6on: completed treatment with post-treatment F/U data available or discon6nued treatment (N = 558) Completed follow-up (N = 543) S V R 1 2 / 2 4 (% P a tie n ts ) Baseline characteris.cs, n (%) N=1017 GT1a 261 (26) GT1b 614 (60) Unspecified, mixed or other GT1-subtype 17 (2) GT4 125 (12) Cirrhosis 228 (22) HCV treatment experienced 598 (59) G T T o ta l* G T 1 a G T 1 b G T 4 (N = 558)* G T T o ta l* G T 1 a G T 1 b G T D/C=discon6nua6on. * Includes 13 pa6ents with mixed, unknown and alterna6ve GT1-subgenotype infec6on, all of whom achieved SVR. Hinrichsen H, et al. J Hepatol 2016; 64(suppl 2):S Y e s Without cirrhosis With cirrhosis Treatment experience N o Event, n (%) Safety (N=1017) Without Cirrhosis 2D/3D no RBV (n = 436) 2D/3D with RBV (n = 353) 2D/3D no RBV (n = 44) Cirrhosis 2D/3D with RBV (n = 184) Any AE 185 (42) 201 (57) 20 (45) 119 (65) Any SAE d/c due to AE 5 (1) 8 (2) 0 8 (4) 2 (0.5) 4 (1) 0 9 (5)
43 Effectiveness and Safety of OBV/PRV/r and SOF/LDV in Patients With GT4 Chronic HCV Infection: Results from the Spanish Real World Cohort This is a retrospec6ve, non-randomized study of prospec6vely collected data from 301 TN and TE pa6ents with GT4 who were treated with OBV/PRV/r or SOF/LDV ± RBV SVR12 (%) Only pa6ents with at least SVR4 were selected for analysis (N=252) LDV/SOF + LDV/SOF LDV/SOF + LDV/SOF RBV RBV No cirrhosis Cirrhosis No cirrhosis Cirrhosis wks 24 wks 12 wks 24 wks Safety results - OBV/PRV/r 5.7% of pa6ents had a SAE 1 pa6ent had hepa6c decompensa6on (encephalopathy) No deaths Baseline albumin <3g/dL and platelets 70,000/mm3 associated with SAE development Safety results - SOF/LDV 4.6% of pa6ents had 1 SAE 1 pa6ent had hepa6c decompensa6on (ascites) No treatment discon6nua6ons No deaths No baseline factor associated with SAE development Relapsers: OBV/PRV/r, n=1; SOF/LDV, n=4 Baseline predictors of lack of response: OBV/PRV/r: Bilirubin 2 mg/dl and albumin <3 g/dl SOF/LDV: Bilirubin 2 mg/dl In pa6ents with GT4, SOF/LDV and OBV/PRV/r regimens were well tolerated, safe and effec6ve Crespo, AASLD 2016
44 How to use HCV DAAs when kidney function is impaired?
45 RUBY-I Cohort-1 OBV/PRV/r + DSV ± RBV in non- Cirrhotic HCV GT-1 pts with severe renal impairment or end-stage renal disease Cohort-2 Treatment of HCV GT-1 infection pts with severe or end-stage renal disease, including patient with cirrhosis Pockros, Gastroenterology 2016 Gane, AASLD 2016
46 RUBY-II OBV/PRV/r + DSV for CV GT-1a or GT-4 infection pts (F0-F3) with severe or end-stage renal disease, without Ribavirin These data suggest that RBV may not be necessary in some GT1a- or GT4- infected pa.ents with severe renal impairment treat with OBV/PRV/r ± DSV; however, larger trials are needed to confirm the results of this exploratory study Gane, AASLD 2016
47 C-SURFER Study GRZ/EBR in HCV GT-1 with chronic kidney disease Roth, Lancet 2015
48 Are DAA safe and tolerable?
49 Safety profiles of DAAs
50 Drug-Drug Interactions
51 Quality of Life Patient-Reported Outcomes (PROs) Younossi, AASLD 2014
52 Are DAA beneficial? Which are the long-term benefits of SVR achievement?
53 SVR is associated with reduced liverrelated and all cause mortality! LIVER RELATED MORTALITY ALL CAUSE MORTALITY van der Meer, JAMA 2012
54 Cirrhosis: Regression after antiviral treatment
55 All cirrhoses are not alike! The Laennec scoring system
56 Proportion of patient reaching delisting criteria in real life cohorts
57 Can the use of DAA impact the HCV morbidity and mortality?
58 Conclusions DAA are highly effec6ve and safe for chronic hepa66s C pa6ents Real-world data reflect efficacy in clinical trial Many op6ons and strong evidence to individualize and tailor treatment Treatment dura6on shortening is jus6fied in specific sub-popula6ons RBV is s6ll in the block to op6mize SVR rates in difficult to treat pa6ents In our therapeu6c choice, we need to take into considera6on the cost of the treatment
59 HCV population
60 Estimating the treatment cascade of chronic hepatitis B and C in Greece using a telephone survey Papatheodoridis, J Viral Hepat 2015
61 We need more than great drugs Curing the individual is now easy Curing the population will take a lot more work...
62 Thank you for your attention
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