New Hepatitis C Antivirals

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1 New Hepatitis C Antivirals Kris Stewart, BSP, MD, FRCPC Drug Therapy Conference College of Medicine, University of Saskatchewan September 23, 2016

2 Disclosures I have received research and program support grants from Gilead Sciences, Abbvie, Merck, Viiv, Vertex, Roche I have sat on the advisory boards of Gilead, Abbvie, Merck

3 Objectives Review global, national and provincial epidemiology of Hepatitis C Review virology, history and natural history of HCV. Review the history of HCV treatment. Review pharmacology of currently and soon to be available HCV regimens and their use in various patient populations. Discuss the future of HCV therapy and strategies for eradication.

4 Epidemiology Worldwide HCV prevalence* million persons 2% 3% of the world's population More than deaths are attributed to HCV infection each year liver cirrhosis hepatocellular carcinoma (HCC) Transmission is through contaminated needles Iatrogenic developing world Illicit drug use developed world *World Health Organization. Global burden of disease (GBD) for hepatitis C J Clin Pharmacol 2004;44:20-9.

5 Epidemiology Canada In 2011 and estimated people living with chronic hepatitis C* 44% unaware of their status Saskatchewan Prevalence of chronic HCV unknown but estimated at ~ Incidence in SHR 2013 was 147 with rate of 43 / ** Double national rate *RTrubnikov M, Yan P, Archibald C. Estimated Prevalence of Hepatitis C Virus infection in Canada, Canada Communicable Disease Report: Volume 40-19, December 18, ** Observatory/Documents/Reports-Publications/2014_shr_series4_hsrfull.pdf

6 History of HCV 1970s Non A non B hepatitis (NANBH) Post transfusion hepatitis High prevalence in blood supply Population unaware of risk of blood borne virus IDU, tattoos etc Hepatitis C virus was characterized and established as etiology of NANBH Began screening blood supply Risk now considered less than 1 / 5 to 7 million* *

7 HCV virology and natural history Flavi-virus which is non archive-able and has poor replicative fidelity -curable but resistance to therapies is a problem There are 6 genotypes of HCV with 3 common in North America Geno 1 (a more prevalent than b) 60% Geno 3 30% Geno 2 10%

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9 HCV virology and natural history Fibrosis is pre-cirrhotic scar of the liver which is potential reversible Evaluate with transient elastography (Fibroscan) or with lab derived calculations. (APRI, Fib-4, Fibrotest) Metavir F0 normal, F2= significant, F4 = cirrhosis (Childs Pugh A,B, C) SVR = sustained virologic response = cure SVR12 = 97% chance of cure SVR24= 99% chance of cure

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11 History of Treatment Early treatment with standard interferon in early 90 s 3 injections per week crippling side effects, cure rates < 5%. PEG interferon combined with Ribavirin mid 90 s until weeks for G1: SVR rate ~ 50% 24 weeks for G2,3: SVR rate 75 to 90% 2011 first generation Direct Activing Antivirals (DAA) Used in combination with PEG + Riba More toxic but increased cure from 50 to ~ 73% for G1.

12 History of Treatment 2013 Beginning of the interferon free era Cure rates ~ 90% in G1 on combination DAAs: SIM+ SOF 12 week regimens with minimal side effects Emerging awareness of challenges related to geno 3 infections Still requiring 24 week regimens and cure rates hardly better than PEG+Riba but 10 times as much.

13 History of Treatment 2014 First single tablet regimen versus G1 (sofosbuvir + ledipasvir: Harvoni TM ) 8 to 12 week regimens Cure rates approaching 100% in non cirrhotic patients Use of DAAs in decompensated cirrhosis and post liver transplant Harvoni TM Use of DAAs in ESRD and patients on hemodialysis Holkira TM, Zepatier TM

14 History of Treatment 2015 First pan-genotypic single tablet regimen Cure rates close to 100% in all but most challenging populations Sofosbuvir + Velpatasvir (Epcluza TM ) Future.

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18 Classes and nomenclature NS 3/4A Protease inhibitors The previrs Boceprevir, telaprevir, paritaprevir, grazeprevir NS 5A inhibitors The asvirs Ledipasvir, ombitasvir, elbasavir, velpatasvir

19 Classes and nomenclature NS 5B polymerase inhibitors The buvirs Nucleotide polymerase inhibitors Sofosbuvir Non nucleoside polymerase inhibitors Dasabuvir

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21 Clinical considerations Genotype Naïve vs Experienced Fibrosis Need F2 or greater to qualify for DAA regimens Cirrhosis or not Compensated (CP-A) vs. decompensated (CP-B) Drug Interactions Renal Function Coinfection with HIV

22 Pre treatment investigations Usual work up is to determine geno + viral load at baseline. Repeat geno if nothing recent esp if possibility for reexposure CBC, lytes, BUN, CR, HbA1C, ast, alt, alp, ggt, bili, albumen, INR Screen for HIV, other causes of liver disease Autoimmune hep, HAV, HBV, NAFLD Determine fibrosis with fibroscans and rule HCC is f3 or greater US liver and alpha feto protein

23 On treatment monitoring in general Patients on Ribavirin CBC weekly x 3 to 4 weeks then as needed Ribavirin induced hemolytic anemia Patients on DAAs At 4 weeks: CBC, lytes, Bun, CR, enzymes and functions End of Treatment: above + viral load SVR12= viral load for cure SVR24 = viral load for confirmation Or monitor more if feeling unwell.

24 Cases and treatment selection 50 year old male with DM, HCV G1b with 7.8 KPa fibrosis (F1) and viral load of 2 million. SK Health: only option is PEG +Riba, not a good option 48 wks, 50% chance of SVR Cost ~ 10K NIHB or good 3 rd party insurance : Holkira (OBV/PTV/RTV+ DSV) x 12 weeks or Harvoni (SOF+LDV) x 8 weeks. Nearly 100% chance of cure Cost ~ 45K

25 AASLD: Recommended and Alternative Regimens for GT1 Without Cirrhosis Nucleotide No nucleotide Population LDV/SOF DCV + SOF SMV + SOF GZR/EBR OBV/PTV/RTV + DSV GT1a 12 wks 12 wks 12 wks 12 wks 16 wks + RBV 12 wks + RBV GT1b 12 wks 12 wks 12 wks 12 wks 12 wks If NS5A RAVs present. Recommended Alternative AASLD/IDSA. HCV guidelines. April Slide credit: clinicaloptions.com

26 8 vs 12 Wks of LDV/SOF in Pts With GT1 HCV: HCV- TARGET and TRIO Network Treatment-naive, noncirrhotic pts with GT1 HCV HCV RNA < 6 M IU/mL in HCV-TARGET HCV-TARGET [1] TRIO Network [2] SVR12 (%) n/n = SVR12 (%) / / / / Wks 12 Wks 8 Wks 12 Wks Terrault N, et al. AASLD Abstract Curry M, et al. AASLD Abstract Slide credit: clinicaloptions.com

27 Cases and Treatment Selection 58 year old female with G1a 22 Kpa of fibrosis (F4, Childs -Pugh-B) Naïve viral load Sk Health: No treatment because of decompensation Compassionate access? NIHB or 3 rd party insurance: Sof+Ldv + Riba x 12 weeks Offer 87% chance of cure Note Holkira and Zepatier are contraindicated in CP-B and C.

28 SOF + NS5A Inhibitors ± RBV in Pts With Decompensated Cirrhosis: Efficacy SVR12, % (ITT) 12-wk SOF + LDV + RBV N = wk SOF + LDV 12-wk SOF + DCV + RBV 12-wk SOF + DCV All GT1 GT3 SVR12 among pts with other HCV GTs: 89% (n = 27) with SOF + LDV + RBV; 85% (n = 13) with SOF + DCV + RBV; 100% (n = 3) SOF + DCV Foster GR, et al. EASL Abstract O002. Reproduced with permission P <

29 ASTRAL-4: VEL/SOF FDC for HCV in Pts With Decompensated Liver Disease SOF/VEL 12 wks SOF/VEL + RBV 12 wks SOF/VEL 24 wks SVR12 (%) n/n = /90 82/87 77/90 60/68 65/68 65/71 Overall Genotype 1 Charlton MR, et al. AASLD Abstract LB-13 Slide credit: clinicaloptions.com

30 Case and Treatment Selection 24 year old coinfected male naïve with G2 Fibrosis of 7.2 Kpa (F2 by NIHB, F1 by Sk Heath) viral load of Sk Health: must use PEG + Riba x 24 wks 80-85% chance of cure, ~ 6 K NIHB, or PEG exemption from SK Health, 3 rd party insurance Sof + Riba x 12 wks 99% chance of cure, ~ 45K

31 VALENCE: SVR12 With 12 or 24 Wks of SOF + RBV in GT2 and GT3 Pts SVR12 (%) GT2 12-Wk Treatment (n = 73) No increase in AEs seen with longer duration treatment AEs seen consistent with RBV GT3 24-Wk Treatment (n = 250) n/n = 0 29/30 2/2 30/33 7/8 n/n = 0 86/92 12/13 87/100 27/45 Naive, Naive, Exp d Exp d, Naive, Naive, Exp d Exp d, Noncirrhotic Cirrhotic Noncirrhotic Cirrhotic Noncirrhotic Cirrhotic Noncirrhotic Cirrhotic SVR12 (%) Zeuzem S, et al. AASLD Abstract Graphics used with permission.

32 SOF/VEL for 12 Wks in Pts With HCV/HIV Coinfection: Efficacy and Safety Presence of NS5A RAVs (15% deep sequencing cutoff) did not affect SVR12 rates: 98% without vs 100% with NS5A RAVs Most frequent AEs: fatigue, headache, arthralgia, URTI, diarrhea, insomnia, nausea SVR12 (%) n/n 20 n/n = 0 99/ / 65 11/ 12 11/ 11 11/ 12 Total 1a 1b No Yes No Yes Genotype Cirrhosis Tx Experienced Wyles D, et al. EASL Abstract PS104. Reproduced with permission. Slide credit: clinicaloptions.com 4/ 4 80/ 85 19/ 19 71/ 75 28/ 29

33 Case and Treatment Selection 48 year old female, G3 treatment experienced (relapsed on PEG + Riba) 25 KPa fibrosis (F4, CP-B) Represents the most difficult to treat population. Sk Health/NIHB Only Sof+Riba x 24 weeks is available Cure potential probably less than 70% We need to seek compassionate access to best available therapy

34 Interim Analysis: Daclatasvir + Sofosbuvir ± RBV in GT3 HCV in European CUP Pts treated with DCV 60 mg + SOF 400 mg QD for 24 wks; RBV added or duration shortened to 12 wks per physician discretion Most common AEs: fatigue, nausea, anemia Tx-related serious AEs (n = 1 each): pancytopenia, HE, HCC, circulatory collapse SVR12 (%) n/n = / 49 29/ 33 All Pts 37/ 42 25/ 29 DCV + SOF / / / 15 12/ 14 6/ 8 DCV + SOF + RBV 100 Cirrhosis A B C Naive Exp d 12 wks 24 wks Child-Pugh Class 2/ / / / 28 Tx History 17/ / / / 42 Tx Duration 92 24/ 26 Welzel TM, et al. AASLD Abstract 37. Reproduced with permission. Slide credit: clinicaloptions.com

35 Case and Treatment Selection 51 year old man with G1a 11 Kpa of fibrosis (F2-3) Naïve Viral load 8 million ESRD on Hemodialysis (? MPGN caused ESRD)

36 Case and Treatment Selection SK Health/NIHB Holkira + Ribavirin x 12 weeks Ribavirin is tricky to use in renal failure (anemia and renal clearance) ~ 90% cure potential Might seek compassionate access to Zepatier (elbasavier + grazepravir) x 12 weeks

37 C-SURFER: Efficacy Results GZR/EBR 12 wks SVR12 (%) n/n = 0 115/ 116* Modified Full Analysis Set 115/ 122* Full Analysis Set 6/6 Cirrhotic 61/61 GT 1a HCV 54/55 GT 1b HCV 86/87 40/41 On Diabetic hemodialysis Modified analysis set: pts in pharmacokinetic substudy and pts randomized to immediate treatment who received 1 drug dose; excludes pts who died or discontinued where cause not related to study treatment. Full analysis set: all pts receiving 1 drug dose. *1 pt relapsed on each arm. 6 pts in the full analysis set discontinued unrelated to treatment: lost to follow-up (n = 2), n = 1 each for death, noncompliance, withdrawal by subject, and withdrawal by physician (owing to violent behavior). Roth D, et al. EASL Abstract LP02. Reproduced with permission.

38 Progress but still falling behind. Many effective well tolerated therapies available offering high likelihood of cure in even most difficult to treat patients. Provincial coverage badly lags what is available on market Fibrosis restrictions prevent a treatment as prevention strategy. many patients excluded from treatment

39 Progress but still falling behind There are an insufficient number of treaters and more new infections annually than individuals cured. We are headed for a tidal wave of end stage liver disease as well as on going transmission unless access to treatment is expanded and the infrastructure is improved. There is a finite amount of resources available for HCV but competition is brining prices of medications down.

40 Australian model and the hope of eradication

41 The future..(and not too far away) One pill per day for 8 weeks that is safe, easy and effective for virtually all patients. Pan genotypic Works on cirrhotic, experienced, renal failure Few drug interactions No restrictions due comprehensive agreement with pharma HCV becomes domain of primary care and in a generation ceases to be a significant health problem.

42 Questions?

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