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What are the remaining questions in Hepatitis C management?

Prof.Teerha Piratvisuth MD. NKC Institute of Gastroenterology and Hepatology Prince of Songkla University, Thailand

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What is the Optimal management for CHC decompensated cirrhosis?

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Key Considerations for CHC Decompensated Cirrhosis

▪ Treatment options are more limited than for patients without cirrhosis or with compensated cirrhosis

– SVR rates are generally lower

▪ Protease inhibitors are not recommended for CTP B

• r C

▪ Continuing role for ribavirin

– Initial low dose

▪ Extend duration to 24 wks if RBV ineligible

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SOF/VEL/VOX and G/P and not recommended in patients with decompensated cirrhosis DAA Exposure Level (relative to patients with normal hepatic function) Voxilaprevir 5-fold Pibrentasvir 11-fold

Pearlman BL. Aliment Pharmacol Ther. 2018;48:914-923

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A B C Child-Pugh class

No Yes No Yes >3.5 2.8 to 3.5 <2.8

SVR12 by Baseline Disease Severity

Cirrhosis Cohort

SVR12, %

<1.7 1.7 to 2.3 >2.3 <2.0 2.0 to 3.0 >3.0

Ascites HE Albumin, g/dL INR T bili, mg/dL

ALLY-1 SOF/DCV+RBV: SVR12 by Child-Pugh Class

Advanced cirrhosis cohort, all genotypes

HE = hepatic encephalopathy

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87 86

89 87

20 40 60 80 100

ALLY-3+

The SOLAR-1 STUDY: LDV/SOF+RBV Treatment in HCV genotype 1 or 4 with decompensated cirrhosis

SVR 12 (%)

35 12 W

Rookstroh JK. etal. Lancet HIV 2015; 2: e319–27.

RBV: initial dose of 600mg daily

24 W 12 W 24 W Treatment duration

CTP class B CTP class C

Serious Adverse event CTP 12W 24 treatment duration Class B 10% 34% Class C 26% 42%

56 52 43 48

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83 88 50 100 94 96 85 100 86 92 50 86 20 40 60 80 100 Overall GT 1 GT 3 GT 2, 4, and 6

SVR12 (%)

SOF/VEL 12 wk SOF/VEL+RBV 12 wk SOF/VEL 24 wk

SVR12

Charlton M, et al., AASLD, 2015, #LB-13

ASTRAL-4: SOF/VEL ± RBV in HCV Patients with Decompensated Liver Disease

*Patient with nondetectable drug levels at time of virologic failure.

SOF/VEL + RBV resulted in highest SVR12 in patients with decompensated liver disease

Breakthrough, n ― 1 1 ― ― ― ― 1* 1 ― ― ― Relapse, n 11 2 7 5 1 3 6 1* 4 ― ― ― Lost to follow up, n 1 ― 3 1 ― 3 ― ― ― ― ― ― Death, n 3 2 2 2 2 ― 1 ― 1 ― ― 1

75/90 82/87 77/90 60/68 65/68 65/71 7/14 11/13 6/12 GT2 4/4 GT4 4/4 GT2 4/4 GT4 2/2 GT2 3/4 GT4 2/2 GT6 1/1

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Treatment of HCV genotype 1 or 4,6 with decompensated cirrhosis CTP class B or C

Regimens Ribavirin Treatment duration Ledipasvir (60mg)/ Sofosbuvir (400mg) With low initial dose of RBV 12-24 week Sofosbuvir (400mg) / Velpatasvir (100mg) With low initial dose of RBV 12 week Daclatasvir (60mg) + Sofosbuvir (400mg) With low initial dose of RBV 12 week

ALLY-3+

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ALLY-3+

Treatment of HCV genotype 2, 3 decompensated cirrhosis

Regimens Ribavirin Treatment duration Sofosbuvir (400mg) / Velpatasvir (100mg) Low initial dose of RBV 12 week Daclatasvir (60mg) + Sofosbuvir (400mg) Low initial dose of RBV 12 week

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Treatment of CHC decompensated cirrhosis: considering risk and benefit

Improving MELD score and improve survival Delisting from Liver transplantation

Benefit Risk

Delay liver transplantation MELD purgatory Non-use HCV positive donor

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Long term clin linic ical benefits of DAAs treatment in in decompensated cir irrhosis is

• 454 cirrhotic patients with either CP (B) or decompensated cirrhosis
• Treated with DAAs 12weeks or 24 weeks : 386 SVR+ 66 no SVR and 5 LFU

Cheung MCM, Royaume-Uni, EASL 2018, Abs. LBP-009 actualisé

Successful HCV treatment was associated with significantly fewer deaths and liver cancer development

Transplant free survival Novo HCC development

% without HCC Months since DAA start

100 80 60 10 20 30 40

SVR (50 HCC/383) No SVR (17 HCC/66)

Hazard ratio 0,42 (IC 95 % : 0,21-0,88) p = 0,002

% Survival Months since DAA start

100 80 60 10 20 30 40

SVR (56 deaths/370) No SVR (20 deaths/64)

Hazard ratio 0,44 (IC 95 % : 0,23-0,84) p = 0,001

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Cheung MCM et al. EASL 2018, Abs. LBP-009

2/3 of patients alive with a baseline MELD score < 16 avoid liver transplantation.

Patients outcome according to pre-treatment baseline MELD score

Died Transplanted or

• n waitlist

Alive without transplant need MELD < 16 (n = 391) MELD 16-20 (n = 42) MELD > 20 (n = 14) 70 60 50 40 30 20 10 Patients (%)

Long term clin linic ical benefits of DAAs treatment in in decompensated cir irrhosis is

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Delis listin ing due to to cli lincal l im improvement with ith DAA Th Therapy in in HCV CV decompensated cirrh irrhosis is wati ting li list st fo for r li live ver r tr transpla lantatio ion

16 18 35 5 20 40 60 80 Delisting %

Belli LS. et al. J Hepatol 2016.

Coilly A. AASLD 2015 Pascasio M. EASL 2016 MELD < 16 MELD > 20

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CHC decompensated cirrhosis listed for Liver transplantation

HCV patient LT listed for de-compensated cirrhosis

Risk of pre LT death: Higher for MELD >18 Risk that DAAs may work at disadvantage Higher for MELD >18 Possibility of de-listing: Higher for MELD <18

Belli LS. et al. ELITA. J Hepatol 2017; 67; 585-602.

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Management of liver transplant candidate CH-C: according to MELD

CH-C decompensated cirrhosis waiting list for LT

MELD <16 MELD 16-20 MELD 21-25 MELD > 25 DAA Therapy DAA Therapy Individual consideration Risk vs Benefit Waiting list in inactive position Waiting list in active position

• Improved MELD

score > 3 points

• Improved Albumin

> 0.5 g/dL Post-LT DAA therapy Yes No

Belli LS. et al. ELITA. J Hepatol 2017; 67.

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MELD Purgatory

A lack of improvement to CPT A status MELD score <15

EI-Sherif O. et al. Gastroenterology; 154:2111-21. Merion RM. Et al. AM J Transplant 2005;5:307-313.

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BE3A Score: Predicting probability of achieving CTP class A

BE3A Score

No Encephalopathy ALT >60 IU/L Albumin >3.5 g/dL BMI < 25 No Ascites

EI-Sherif O. et al. Gastroenterology 2018; 154:2111-21.

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BE3A Score

Category Findings Score BMI <25 kg/m2 1 Encephalopathy No 1 Ascites No 1 ALT >1.5 ULN 1 Albumin >3.5 g/dL 1

ULN, upper limit of normal

EI-Sherif O. et al. Gastroenterology 2018; 154:2111-21.

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Kaplan Meier curves of achieving CPT A and death/ transplant with BE3A score

EI-Sherif O. et al. Gastroenterology 2018; 154:2111-21.

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BE BE3A sc score re in in pre redic ictin ing a chance of f achie ievin ing CP CPT T A at t 36 weeks after in init itia iatio ion of DAA therapy in in CH-C C decompensated cirrh irrhosis is

5 25 87 98.2

20 40 60 80 100

1 3 4+

% <5

EI-Sherif O. et al. Gastroenterology;2018; 154:2111-21.

BE3A Score

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What is the Optimal time to treat CHC in patients with HCC?

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A retrospective cohort study: CHC cirrhotic patients with or without HCC who failed DAA therapy

Prenner SB, et al. J Hepatol 2017;66(6):1173-1181

4% 5% 12% 21% Relapsed at 12 weeks post treatment: 48% in those with active HCC when starting DAA compared with 0% in those with no active HCC , p =0.04 Patients with inactive HCC or DAA started after tumor removal achieved high SVR similar to those without HCC

SOF/SIM 47%, SOF/LDV+RBV 37% SFO/RBV 13%

HCV G1 86%

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Th The cumula lativ ive inc incid idence of f HCC CC among CH CHC patie ients who achie ieved SVR, stratif ifie ied by cirrh irrhosis is status

Cirrhotics Without Cirrhotics

EI-Serag HB etal. Hepatology 2016; 64(1):130-137.

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When is the Optimal time to treat acute hepatitis C

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Acute HCV infection: issues need to be considered

20-40% may clear the infection spontaneously High Response to Interferon- alpha Most patients are asymptomatic Infection remains unidentified DAA therapy is very effective in chronic HCV Lack of cost-effectiveness study acute HCV infection = infection < 6 month

Maasoumy and Wedemeyer; Best Pract Res Clin Gastroenterol. 2012 Aug;26(4):401-12.

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Acute HCV infection – All-oral DAA therapy? The HepNet Acute-HCV-IV Study

Deterding et al., Lancet Infect Dis. 2017 Feb;17(2):215-222 n=20 patients n=10 centers in Germany

SOF/LDV (FDC) FU4, FU12, FU24 6 weeks 24 weeks Screening

16 16 20 20 20 20 20 20 8 14 14 20 20 20 20 5 10 10 15 15 20 20 25 25

HCV RNA < 15 IU/ml, detectable HCV RNA undetectable

number of patients (n)

Weeks 2 Weeks 4 Weeks 6 Weeks 12

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Acute HCV infection – All-oral DAA therapy? The HepNet Acute-HCV-IV Study

Deterding et al., Lancet Infect Dis. 2017 Feb;17(2):215-222 n=20 patients n=10 centers in Germany

SOF/LDV (FDC) FU4, FU12, FU24 6 weeks 24 weeks Screening

16 16 20 20 20 20 20 20 8 14 14 20 20 20 20 5 10 10 15 15 20 20 25 25

HCV RNA < 15 IU/ml, detectable HCV RNA undetectable

number of patients (n)

Weeks 2 Weeks 4 Weeks 6 Weeks 12

SVR = 100%

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Management of acute HCV infection

Persistent HCV infection Spontaneous clearance of HCV infection Acute HCV infection Chronic hepatitis C Unacceptable Monitoring for 12-16 weeks Treatment as CH-C Advise Delayed treatment Acceptable Persistent infection > 6 months SOF/VEL for 6 weeks

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Are there any patients unable to treat effectively?

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Estimated clearance time for RAVs selected upon treatment failure

Benitez-Gutierrez L. et al. Expert Opin Pharmacother 2016; 17(9): 1215-23.

NS5A Inhibitors

RAVs (%) 10% days months years

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Sofosbuvir/velpatasvir/voxilaprevir duration of therapy

Pearlman BL. Aliment Pharmacol Ther. 2018;48:914-923

Treatment‐experienced patients without cirrhosis or with compensated cirrhosis (Child‐Pugh A) Prior regimen Duration HCV genotype 1,2,3,4,5, or 6 NS5A inhibitors 12 weeks 1a or 3 Sofosbuvir without NS5A inhibitor 12 weeks

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Glecaprevir/pibrentasvir duration of therapy

Pearlman BL. Aliment Pharmacol Ther. 2018;48:914-923

Prior regimen

Duration No cirrhosis

Compensated cirrhosis (Child‐Pugh A) Treatment‐naïve HCV genotype 1,2,3,4,5, or 6 8 weeks 12 weeks Treatment‐experienced HCV genotype 1 NS5A inhibitor w/o NS3/A inhibitor 16 weeks 16 weeks 1 NS3/4A inhibitor w/o NS5A inhibitor 12 weeks 12 weeks 1,2,3,4,5, or 6 Interferon, peginterferon, ribavirin ± sofosbuvir but w/o NS3/4A or NS5A inhibitor 8 weeks 12 weeks 3 Interferon, peginterferon, ribavirin ± sofosbuvir but w/o NS3/4A or NS5A inhibitor 16 weeks 16 weeks

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CHC decompensated cirrhosis with RASs

NS5A inhibitor NS 3/4A Protease inhibitor

Protease Inhibitors, Voxilaprevir or Glecaprevir, are not recommended in patients with decompensated cirrhosis The Hong Kong Association for the Study of Liver Diseases The Hong Kong Association for the Study of Liver Diseases The Hong Kong Association for the Study of Liver Diseases The Hong Kong Association for the Study of Liver Diseases The Hong Kong Association for the Study of Liver Diseases The Hong Kong Association for the Study of Liver Diseases The Hong Kong Association for the Study of Liver Diseases

In order to Achieve HCV Elimination in 2030

How to manage with treatment barriers

How to prevent HCV re-infection The Hong Kong Association for the Study of Liver Diseases The Hong Kong Association for the Study of Liver Diseases The Hong Kong Association for the Study of Liver Diseases The Hong Kong Association for the Study of Liver Diseases The Hong Kong Association for the Study of Liver Diseases The Hong Kong Association for the Study of Liver Diseases The Hong Kong Association for the Study of Liver Diseases

• Treatment of CHC decompensated cirrhosis needs to consider

and balance between risk and benefit

• Consider the optimal strategy for CHC treatment whether

before or after liver transplantation according to MELD or BE3A score

• Due to the report of high relapsed rate after DAA therapy in

patients with HCC, starting DAA therapy after achieving inactive HCC is reasonable

• Treatment strategy for acute hepatitis C should be considered

according to the availability and national policy as well as patient agreement

• Effective and safe rescue therapy for CHC decompensated with

RAVs, particularly NS5A inhibitors, is still unmet need

Co Conclusion

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Thank you

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