HEPATITIS WEB STUDY

HEPATITIS C ONLINE

Treatment of Chronic HCV Genotype 3

Robert G. Gish MD
Staff Physician, Stanford University Medical Center Senior Medical Director, St Josephs Hospital and Medical Center, Liver Program, Phoenix, Arizona Clinical Professor of Medicine, University of Nevada, Las Vegas Medical Director, Hepatitis B Foundation Vice Chair, Executive Committee, National Viral Hepatitis Roundtable (NVHR)

Last Updated: April 27, 2014

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Treatment of Chronic HCV Genotype 3

Background and Definitions Initial Treatment and Retreatment of Prior Relapsers Retreatment of Prior Nonresponders

Issues and Controversies

Future Therapies Summary

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TREATMENT OF CHRONIC HEPATITIS C: GENOTYPE 3

Background and Definitions

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Treatment of Chronic HCV Genotype 3

Background
HCV infects ~ 5 million people in the US today
Genotype 3 is the third most common HCV genotype in US Up to 85% of patients have contraindications for interferon therapy

Major linkage to IVDA in epidemiological studies

Interferes with lipid metabolism in hepatocytes and linked with fatty liver Slightly higher risk of developing cirrhosis HCV Geno 3 is the new Geno 1 in terms of lower response rates

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Virologic Responses with HCV Therapy

Sustained Virologic Response at 12 Weeks Post Therapy (SVR12)

10,000,000 1,000,000 100,000
Treatment Post Treatment

HCV RNA IU/ml

SVR12
10,000 1,000 100 10 1
Undetectable

End of Treatment
12 Weeks

-8

-4

12

16

20

24

28

32

36

40

44

48

Treatment Week
Sustained Virologic Response (SVR12) = Undetectable HCV RNA 12 Weeks Post Treatment

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Virologic Responses with HCV Therapy

Relapser and Nonresponder (Null and Partial)

Different Types of Virologic Failure with HCV Therapy
10,000,000 1,000,000 Treatment

Nonresponder

Relapser

HCV RNA IU/ml

100,000 10,000 1,000

Null Responder

Nonresponder 100 10 1
Undetectable

Partial Responder

-8

8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80

Treatment Week

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AASLD/IDSA/IAS-USA 2014 HCV Treatment Recommendations

Criteria for Interferon Ineligible

Interferon Ineligible is defined as one or more of the following: Intolerance to interferon Autoimmune hepatitis and other autoimmune disorders Hypersensitivity to peginterferon or any of its components Decompensated hepatic disease History of depression, or clinical features consistent with depression

A baseline neutrophil count below 1500/L, a baseline platelet count below 90,000/L or baseline hemoglobin below 10 g/dL
A history of preexisting cardiac disease

Source: AASLD/IDSA/IAS-USA (www.hcvguidelines.org). Viewed April 8, 2014

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TREATMENT OF CHRONIC HEPATITIS C: GENOTYPE 3

Treatment-Nave and Prior Relapsers

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AASLD/IDSA/IAS-USA 2014 HCV Treatment Recommendations

Initial Therapy for Patients with Genotype 3 Chronic HCV

Patients with GT 3 HCV: Initial Treatment & Retreatment of Relapsers* Recommended Therapy, Regardless of Eligibility for Interferon Therapy Sofosbuvir + Ribavirin x 24 weeks Alternative Therapy, Eligible for Interferon Therapy Sofosbuvir + Peginterferon + Ribavirin x 12 weeks Not Recommended Peginterferon + Ribavirin x 24-48 weeks Monotherapy with Peginterferon, Ribavirin, or a Direct Acting Antiviral Agent Any Regimen with Telaprevir, Boceprevir, or Simeprevir
*Patients who experienced relapse after Peginterferon plus Ribavirin therapy

Source: AASLD/IDSA/IAS-USA (www.hcvguidelines.org). Viewed April 22, 2014

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Treatment-Nave & Prior Relapsers with GT3 Chronic HCV Key Studies that Support Treatment Recommendations
Sofosbuvir + Ribavirin - FISSION - POSITRON - VALENCE Sofosbuvir + Ribavirin + Peginterferon - PROTON
Sofosbuvir + Ribavirin or Sofosbuvir + Ribavirin + Peginterferon - ELECTRON

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Sofosbuvir + Ribavirin for Treatment-Nave HCV GT 2 or 3 FISSION Trial: Design

Week
0 12 24 36

N =256

Sofosbuvir + RBV (weight-based)

SVR12

N =243

Peginterferon + RBV (fixed-dose)

SVR12

Drug Dosing Sofosbuvir: 400 mg once daily Peginterferon alfa-2a: 180 g once weekly Weight-based Ribavirin (in 2 divided doses): 1000 mg/day if < 75 kg or 1200 mg/day if 75 kg Fixed-dose Ribavirin (in 2 divided doses): 800 mg/day
Source: Lawitz E, et al. N Engl J Med. 2013;368:1878-87.

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Sofosbuvir + Ribavirin for Treatment-Nave HCV GT 2 or 3 FISSION Trial: Results

SVR12 by Genotype
100

Sofosbuvir + RBV
97

PEG + RBV

Patients (%) with SVR 12

80 78 60 67 67 56 63

40
20
170/253 162/243 68/70 52/67 102/183 110/176

GT 2 and 3 (n=496)
RBV = Ribavirin; PEG = Peginterferon

GT 2 (n=137)

GT 3 (n=359)
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Source: Lawitz E, et al. N Engl J Med. 2013;368:1878-87.

Sofosbuvir + Ribavirin for HCV GT 2 or 3 (PEG not an option) POSITRON Trial: Design
Week
0 12 24

N =207

Sofosbuvir + RBV
12 weeks

SVR12

N =71

Placebo
12 weeks

SVR12

Drug Dosing Sofosbuvir: 400 mg once daily Weight-Based Ribavirin (in 2 divided doses): 1000 mg/day if < 75 kg or 1200 mg/day if 75 kg

Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.

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Sofosbuvir + Ribavirin for HCV GT 2,3 (PEG not an option) POSITRON: Results with Sofosbuvir + Ribavirin
SVR12 by HCV Genotype
100

93

Patients (%) SVR12

80

60

61

40

20 101/109 0 60/98

GT 2
Placebo arm = 0% SVR12 Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.

GT 3

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Sofosbuvir + Ribavirin for Treatment Nave & Experienced HCV GT 2 or 3

VALENCE: Treatment Arms

Week
0 12 24 36

GT 2

Sofosbuvir + RBV
(n = 73)

SVR12

GT 3

Sofosbuvir + RBV
(n = 250)

SVR12

Note: 85 patients enrolled in placebo arm

Original Study Protocol: Placebo versus 12 weeks treatment for GT 2 and 3. Amended Protocol: GT3 treatment extended from 12 to 24 weeks; Placebo arm offered alternative treatment Drug Dosing Sofosbuvir 400 mg once daily Ribavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if 75 kg Source: Zeuzem S, et al. AASLD. Nov, 2013. Abstract 1085.

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Sofosbuvir + Ribavirin for Treatment Nave & Experienced HCV GT 2 or 3

VALENCE: Results for Treatment-Nave GT 3 with 24 weeks All-Oral Therapy SVR12 for Treatment-Nave GT 3
100
Patients (%) with SVR12 93 93 92

80
60 40 20
98/105 86/92

12/13

All

Noncirrhotic

Cirrhotic

Source: Zeuzem S, et al. AASLD. Nov, 2013. Abstract 1085. Sofosbuvir (Sovaldi) Prescribing Information. Gilead Sciences.

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Sofosbuvir + Peginterferon + Ribavirin in Treatment-Naive Genotypes 1-3

PROTON Trial: Design

Week 0
SOF (200 mg) + PEG + RBV

12

24
+ RVR PEG + RBV - RVR + RVR PEG + RBV - RVR PEG + RBV PEG + RBV

48

72

n = 48

GT 1

n = 47

SOF (400 mg) + PEG + RBV

n = 26

SOF + PEG + RBV

GT 2, 3

n = 25

SOF + PEG + RBV

N =14 Drug Dosing Sofosbuvir (SOF): 400 mg once daily, except as designated in arm that received 200 mg once daily Ribavirin (RBV) weight-based and divided bid: 1000 mg/day if < 75 kg or 1200 mg/day if 75 kg Peginterferferon alfa-2a (PEG): 180 g once weekly Source: Lawitz E, et al. Lancet Infect Dis. 2013;13:401-8.

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Sofosbuvir + Ribavirin + Peginterferon in Treatment-Naive Genotypes 1-3

PROTON Trial: Results

SVR 24 by Genotype and Treatment Regimen
100

Patients (%) with SVR24

80 60

90

91

92

58 40 20 0
41/48 SOF 200 mg + PR 42/47 SOF 400 mg + PR Genotype 1 15/26 PR 23/25 SOF 400 mg + PR Genotype 2 or 3

Source: Lawitz E, et al. Lancet Infect Dis. 2013;13:401-8.

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Sofosbuvir and Ribavirin +/- Peginterferon in GT 1-3 ELECTRON Trial (Arms 1-8): Design
Week
n = 10 n=9

0
SOF + RBV

12

20

24
SVR12 SVR12 SVR12 SVR12 SVR12

SOF + RBV + PEG (week 1-4)

GT 2,3
Nave

n = 10 n = 11

SOF + RBV + PEG (week 1-8)

SOF + RBV + PEG SOF SOF + RBV + PEG SOF + RBV SOF + RBV SVR12

n = 10
n = 10

GT 1 Null GT 1 Naive

n = 10 n = 25

SVR12 SVR12

Drug Dosing N =14 Sofosbuvir (SOF): 400 mg once daily Ribavirin (RBV) weight-based and divided bid: 1000 mg/day if < 75 kg or 1200 mg/day if 75 kg Peginterferon alfa-2a (PEG): 180 g once weekly

Source: Gane EJ, et al. N Engl J Med. 2013;368:34-44.

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Sofosbuvir and Ribavirin +/- Peginterferon in GT 3 ELECTRON: Subset Analysis

SVR 12 for Treatment-Nave Genotype 3*
100 80 60 40 20
6/6 6/6
SOF 12 wks RBV 12 wks PEG wk 1-4

100

100

100

100

100

Patients with SVR12 (%)

6/6
SOF 12 wks RBV 12 wks PEG wk 1-8

7/7
SOF 12 wks RBV 12 wks PEG 12 wks

10/10
SOF 8 wks RBV 8 wks PEG 8 wks

SOF 12 wks RBV 12 wks

Treatment-Nave Genotype 3
*Data for sofosbuvir monotherapy not shown Source: Gane EJ, et al. N Engl J Med. 2013;368:34-44.

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TREATMENT OF CHRONIC HEPATITIS C: GENOTYPE 3

Retreatment of Prior Nonresponders

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AASLD/IDSA/IAS-USA 2014 HCV Treatment Recommendations Retreatment of Patients with Genotype 3 Chronic HCV
Patients with GT 3 HCV: Retreatment of Prior Nonresponders* Recommended Therapy Sofosbuvir + Ribavirin x 24 weeks Alternative Therapy Sofosbuvir + Peginterferon + Ribavirin x 12 weeks Not Recommended

Peginterferon + Ribavirin +/- [Boceprevir or Simeprevir or Telaprevir]

Monotherapy with Peginterferon, Ribavirin, or a Direct Acting Antiviral Agent Treatment of Decompensated Cirrhosis with Peginterferon
*Patients who experienced nonresponse (partial or null) with Peginterferon plus Ribavirin therapy Source: AASLD/IDSA/IAS-USA (www.hcvguidelines.org). Viewed April 22, 2014

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Treatment Experienced Nonresponders with GT3 Chronic HCV Key Studies that Support Treatment Recommendations

Sofosbuvir + Ribavirin - FUSION - VALENCE Sofosbuvir + Ribavirin + Peginterferon - LONESTAR-2

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Sofosbuvir + RBV in Treatment-Experienced HCV GT 2 or 3 FUSION Trial: Design

Week 0 12 16 24 28

N =103

Sofosbuvir + RBV
12 weeks

Placebo

SVR12

N =98

Sofosbuvir + RBV
16 weeks

SVR12

Drug Dosing Sofosbuvir: 400 mg once daily Weight-Based Ribavirin (in 2 divided doses): 1000 mg/day if < 75 kg or 1200 mg/day if 75 kg

Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.

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Sofosbuvir + RBV in Treatment-Experienced HCV GT 2 or 3 FUSION Trial: Results for GT3

SVR12 for Treatment-Experienced GT3
SOF + RBV (12 wks)
100

SOF + RBV (16 wks)

Patients (%) with SVR12

80

62
60

63

61

40

37 30 19
19/64 39/63 14/38 25/40 5/26 14/23

20

GT 3 (All)
SOF = Sofosbuvir; RBV = Ribavirin

Without Cirrhosis

With Cirrhosis Hepatitis

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Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.

Sofosbuvir + Ribavirin for Treatment Nave & Experienced HCV GT 2 or 3

VALENCE: Treatment Arms

Week
0 12 24 36

GT 2

Sofosbuvir + RBV
(n = 73)

SVR12

GT 3

Sofosbuvir + RBV
(n = 250)

SVR12

Note: 85 patients enrolled in placebo arm

Original Study Protocol: Placebo versus 12 weeks treatment for GT 2 and 3. Amended Protocol: GT3 treatment extended from 12 to 24 weeks; Placebo arm offered alternative treatment Drug Dosing Sofosbuvir 400 mg once daily Ribavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if 75 kg Source: Zeuzem S, et al. AASLD. Nov, 2013. Abstract 1085.

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Sofosbuvir + Ribavirin for Treatment Nave & Experienced HCV GT 2 or 3

VALENCE: Results for Treatment Experienced GT 3

SVR12 for Treatment-Experienced GT 3
100
Patients (%) with SVR12 80 79 60 40 20
114/145 87/100

87

60

27/45

All

Noncirrhotic

Cirrhotic

Source: Zeuzem S, et al. AASLD. Nov, 2013. Abstract 1085. Sofosbuvir (Sovaldi) Prescribing Information. Gilead Sciences.

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Sofosbuvir + PEG + RBV in Treatment-Experienced HCV GT 2 or 3

LONESTAR-2 Trial: Design

Week

12

24

GT 2 or 3

N = 47

Sofosbuvir + Peginterferon + Ribavirin

SVR12

Drug Dosing Sofosbuvir: 400 mg once daily Peginterferon alfa-2a: 180 g once weekly Ribavirin (weight-based and in 2 divided doses): 1000 mg/day if < 75 kg or 1200 mg/day if 75 kg

Source: Lawitz E, et al. 64th AASLD; Washington, DC. 2013. Abstract LB-4.

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Sofosbuvir + PEG + RBV in Treatment-Experienced HCV GT 2 or 3

LONESTAR-2 Trial: Results

SVR12 in Treatment-Experienced by HCV Genotype
100

Patients with SVR 12 (%)

96
80

89
83

60

40

20
42/47 22/23 20/24

All

GT 2

GT 3

Source: Lawitz E, et al. 64th AASLD; Washington, DC. 2013. Abstract LB-4.

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TREATMENT OF CHRONIC HEPATITIS C: GENOTYPE 3

Issues and Controversies

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Issues and Controversies

Cost of Therapy Sofosbuvir + PEG + RBV higher SVR than all oral (LONESTAR data) - Treat selected Geno 3 patients with Sofosbuvir + PEG + RBV? - Wait for FDC Ledipasvir-Sofosbuvir + RBV with 100% SVR? When to Defer Therapy - Decisions on when to warehouse? (Non) Role of IL-28b Testing Degree of Liver Fibrosis - How to stage?

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How is cost of therapy impacting treatment decisions?

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Hepatitis C Genotype 3 Estimated Medication Costs for Treatment-Nave & Prior Relapsers

Patients with GT 3 HCV: Initial Treatment & Retreatment of Relapsers Regimen and Duration Regimen Cost

Recommended Therapy Sofosbuvir + Ribavirin x 24 weeks Alternative Therapy Sofosbuvir + Peginterferon + Ribavirin x 12 weeks $97,000 $169,000

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Hepatitis C Genotype 3 Estimated Medication Costs for Retreatment of Nonresponders

Patients with GT 3 HCV: Retreatment of Nonresponders Regimen and Duration Regimen Cost

Recommended Therapy Sofosbuvir + Ribavirin x 24 weeks Alternative Therapy Sofosbuvir + Peginterferon + Ribavirin x 12 weeks $97,000 $169,000

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HCV Therapy for Genotype 3 Chronic HCV

Cost Analysis Based on Cost per SVR

Patient Characteristics Regimen Options
SOF + RBV x 24 wks SOF + PEG + RBV x 12 wks SOF + RBV x 24 wks Wait until.? SOF + RBV x 24 wks SOF + RBV x 24 wks SOF + PEG + RBV x 12 wks

SVR
93% ? 92% ? 85% 60% 83%

Cost per SVR

$194,624 ? $196,739 ? $212,941 $301,667 $126,915

Nave, no cirrhosis

Nave, cirrhosis

Treatment experienced, no cirrhosis

Treatment experienced, cirrhosis

Source for Figure: Camilla Graham, MD, MPH. Beth Israel Deaconess Medical Center Data Sources: (1) Lawitz E, et al. NEJM 2013; 368:1878-87. (2) Jacobson I, et al. NEJM 2013; 368:1867-77. (3) Antiviral Drugs Advisory Committee Meeting, FDA and Gilead reviews, 10/25/2013. (4) Package Insert, Gilead.com 12/7/2013

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Treat now or defer therapy?

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Factors Favoring Treat Now

Advanced Fibrosis (F3-F4) - Platelet count < 150,000/uL - Large spleen and/or portal vein - Esophageal varices Synthetic dysfunction

Systemic disease - Cryoglobulinemia (+RhF)

Highly motivated patients/symptoms

Patients with Increased Mortality Risk - All cause - HCC risk

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How do you treat patient that failed Sofosbuvir + Ribavirin?

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Retreatment of SOF + RBV Failure with SOF-Containing Regimens in GT 2 or 3

Study Features
Retreatment of Sofosbuvir + Ribavirin Failure: Features
Design: Open-label, study for patients with GT 2 or 3 who had failure with

sofosbuvir + ribavirin in FISSION, POSITRON, or FUSION trial

Setting: Europe, United States, and Canada Entry Criteria

- N = 107 patients with chronic HCV - HCV genotype 2 (10%) or HCV genotype 3 (90%) - Previous relapse on sofosbuvir plus ribavirin - Patients with compensated cirrhosis allowed to enroll
Regimens (patients offered 2 possible regimens)

- Sofosbuvir + Ribavirin x 24 weeks - Sofosbuvir + Peginterferon + Ribavirin x 12 weeks

Primary End-Point: SVR12

Source: Esteban R, et al. 49th EASL; April 2014. Abstract 08.

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Retreatment of SOF + RBV Failure with SOF-Containing Regimens in GT 2 or 3

Study Design
Week
0 12 24 36

N = 34

GT2 or GT3
N = 73

Sofosbuvir + PEG + RBV

SVR12

Sofosbuvir + RBV

SVR12

Drug Dosing Sofosbuvir: 400 mg once daily Peginterferon alfa-2a: 180 g once weekly Weight-based Ribavirin (in 2 divided doses): 1000 mg/day if < 75 kg or 1200 mg/day if 75 kg

Source: Esteban R, et al. 49th EASL; April 2014. Abstract 08.

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Retreatment of SOF + RBV Failure with SOF-Containing Regimens in GT 2 or 3

Results, by Genotype
SVR12 by Regimen and HCV Genotype
SOF + PEG + RBV x 12 wks 100 SOF + RBV x 24 wks

Patients (%) with SVR12

100 91

80 60 40 20 0
4/4 1/2

63 50

20/22

24/38

Genotype 2

Genotype 3
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Source: Esteban R, et al. 49th EASL; April 2014. Abstract 08.

HEPATITIS C: GENOTYPE 3

Future Treatment Options

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Future Regimens for GT-3

Ledipasvir + Sofosbuvir - Lepidasvir: NS5A replication inhibitor - Sofosbuvir: NS5B polymerase inhibitor Daclatasvir + Sofosbuvir? - Daclatasvir: NS5A replication inhibitor - Sofosbuvir: NS5B polymerase inhibitor

ABT-450/r-Ombitasvir +/- Ribavirin? - ABT-450/r: NS3 protease inhibitor with ritonavir boosting - Ombitasvir (formerly ABT-267): NS5A replication inhibitor

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Sofosbuvir-Ledipasvir +/- Ribavirin in GT 1 & 3 ELECTRON 2: Study Design

Week
GT1 Prior Sofobuvir n = 19

12

24

LDV-SOF + RBV

SVR12

GT1 CTP Class B

n = 20

LDV-SOF

SVR12

n = 25 GT3 Treatment Naive

LDV-SOF

SVR12

n = 26

LDV-SOF + RBV

SVR12

Drug Dosing Ledipasvir-sofosbuvir (90/400 mg): fixed dose combination; one pill once daily N =14 Ribavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if 75 kg Abbreviations: LDV= ledipasvir; SOF = sofosbuvir; RBV = ribavirin Source: Gane EJ, et al. 49th EASL. 2014: Abstract O6.

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Sofosbuvir-Ledipasvir +/- Ribavirin in GT 1 & 3 ELECTRON 2: Study Design

SVR 12, by GT and Treatment Regimen
100 100 100

Patients with SVR (%)

80 60 40 20
19/19 13/20
GT1 LDV-SOF CTP Class B

65

64

16/25
GT3 LDV-SOF

26/26
GT3 LDV-SOF + RBV

GT1 LDV-SOF + RBV SOF-Experienced

Treatment Naive

LDV= ledipasvir; SOF = sofosbuvir; RBV = ribavirin Source: Gane EJ, et al. 49th EASL. 2014: Abstract O6.

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Daclatasvir + Sofosbuvir +/- Ribavirin for HCV GT 1-3 A1444-040 Design: Treatment-Nave 24 Week Rx
Week
Rx Nave GT 2 / 3 n = 44
n = 16 n = 14 n = 14

12
SOF 7 days, then DCV + SOF DCV + SOF

24

36
SVR12 SVR12 SVR12

DCV + SOF + RBV

Rx Nave GT 1a/1b n = 44

n = 15 n = 14 n = 15

SOF 7 days, then DCV + SOF DCV + SOF DCV + SOF + RBV

SVR12 SVR12 SVR12

Drug Dosing Daclatasvir N =14 (DCV): 60 mg once daily Sofosbuvir (SOF): 400 mg once daily Ribavirin (RBV): GT1, given weight-based and divided bid (1000 mg/day if < 75 kg or 1200 mg/day if 75 kg) Ribavirin (RBV): GT 2 or 3 (800 mg/day)
Source: Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.

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Daclatasvir + Sofosbuvir +/- Ribavirin for HCV GT 1-3

A1444-040: Subset Analysis for Treatment-Nave GT 3

SVR12 by GT 3, by Treatment Regimen
100

100 Patients with SVR12 (%)

80

100

71
60

40

20
5/7 6/6 DCV + SOF 5/5 DCV + SOF + RBV

SOF x 7d, DCV + SOF

DCV = daclatasvir; SOF = sofosbuvir; RBV = ribavirin Source: Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.

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Summary Points for Treatment of Chronic HCV GT-3

Treat now with Sofosbuvir + Ribavirin x 24 weeks Consider IFN-based Rx in select patient who can tolerate IFN to shorten therapy, save costs and have a nominally higher SVR rate Stage patient for liver disease and systemic disease Look for signs of fatty liver and metabolic syndrome GT 3 may be the new GT 1 but high SVR rates can be seen in selected patients

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This slide deck is from the University of Washingtons Hepatitis C Online and Hepatitis Web Study projects.
Hepatitis C Online www.hepatitisc.uw.edu
Hepatitis Web Study http://depts.washington.edu/hepstudy/

Funded by a grant from the Centers for Disease Control and Prevention.

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