best of hcv from aasld...core e1 e2 p7 ns2 ns3 4a ns4b ns5a ns5b 3 an integrated safety and efficacy...

1

Best of HCV from AASLD

Victor de Lédinghen, MD, PhD Université Victor Segalen Bordeaux 2 Aquitaine, France

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New HCV Treatments

Protease inhibitors SimePREVIR AsunaPREVIR DanoPREVIR SovaPREVIR ParitaPREVIR GrazoPREVIR

NS5A inhibitors DaclatASVIR LedipASVIR OmbitASVIR ElbASVIR GS5816

NS5B inhibitors SofosBUVIR DeleoBUVIR DasaBUVIR BeclaBUVIR

Core E1 E2 P7 NS2 NS3 4A NS4B NS5A NS5B

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An Integrated Safety and Efficacy Analysis of >500 Patients with Compensated Cirrhosis Treated with

Ledipasvir/ Sofosbuvir with or without Ribavirin Marc Bourlière1, Mark S. Sulkowski2, Masao Omata3, Stefan Zeuzem4, Jordan J. Feld5, Eric Lawitz6, Patrick Marcellin7, Robert H. Hyland8, Xiao Ding8, Jenny C. Yang8, Steven J. Knox8, Phillip S. Pang8,

Mani Subramanian8, William T. Symonds8, John G. McHutchison8, Alessandra Mangia9, Edward J. Gane10, K. Rajender Reddy11, Masashi Mizokami12, Stanislas Pol13, Nezam H. Afdhal14

1.  Hôpital Saint Joseph, Marseilles, France 2.  Johns Hopkins University, Bal=more, MD 3.  Yamanashi Prefectural Hospital Organiza=on, Yamanashi, Japan 4.  Johann Wolfgang Goethe University, Frankfurt am Main, Germany 5.  Sandra Rotman Centre for Global Health, University of Toronto,

Toronto, ON, Canada 6.  Texas Liver Ins=tute, University of Texas Health Science Center,

San Antonio, TX 7.  Hôpital Beaujon, University of Paris, Paris, France 8.  Gilead Science, Inc, Foster City, CA

9.  Liver Unit, Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo, Italy

10.  New Zealand Liver Transplant Unit, Auckland City Hospital, Auckland, New Zealand

11.  University of Pennsylvania, Philadelphia, PA 12.  Research Center for Hepa==s and Immunology, Na=onal Center

for Global Health and Medicine, Chiba, Japan 13.  Department of Hepatology, Université Paris-‐René Descartes, Paris,

France 14.  Beth Israel Deaconess Medical Center, Boston, MA

Abstract #82

4

Methods

•  513 patients with GT 1, compensated cirrhosis

• Pooled data from Phase 2 and 3 LDV/SOF + RBV studies – LONESTAR, ELECTRON, ELECTRON-2, 337-0113,

ION-1, ION-2, SIRIUS

Bourlière M, et al. Abstract #82, AASLD 2014

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Baseline Demographics

Patients, % Treatment Naïve (n=161)

Treatment Experienced

(n=352)

Total (n=513)

Male 63% 68% 67% Black 8% 4% 5% Asian 17% 15% 15% GT 1a 53% 63% 60% Prior PI Failure NA 68% 47% Region US 50% 31% 37% Ex-US 50% 69% 63%


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SVR12: LDV/SOF for 12 vs 24 Weeks in Compensated Cirrhotics

96 95 98

0

20

40

60

80

100

Overall 12 Weeks 24 Weeks

SVR

12 (%

)

188/191 305/322 493/513


7

Subgroup Observations

•  Among naïve patients, 12 weeks of LDV/SOF is enough (SVR>95%).

•  Among treatment-experienced patients, 12 weeks of LDV/SOF without RBV resulted in only 90% SVR rate

•  Adding RBV or extending treatment duration increased this rate to >96%

•  Platelet count <75 x 103/uL was associated with a lower SVR rate among treatment-experienced patients with cirrhosis


8

Ledipasvir/Sofosbuvir Fixed-Dose Combination is Safe and Efficacious in Cirrhotic Patients Who Have

Previously Failed Protease-Inhibitor Based Triple Therapy

Marc Bourlière,1 Jean-Pierre Bronowicki,2 Victor de Ledinghen,3 Christophe Hézode,4 Fabien Zoulim,5 Philippe Mathurin,6 Albert Tran,7 Dominique G. Larrey,8 Vlad Ratziu,9 Laurent Alric,10 Robert H. Hyland,11

Deyuan Jiang,11 Brian Doehle,11 Phillip S. Pang,11 William T. Symonds,11 Mani Subramanian,11 John G. McHutchison, 11 Patrick Marcellin,12 François Habersetzer,13 Dominique Guyader,14 Jean-Didier Grange,15 Veronique Loustaud-Ratti,16

Lawrence Serfaty,17 Sophie Metivier,18 Vincent Leroy,19 Armando Abergel,20 Stanislas Pol21

Abstract #LB-6

1.  Hôpital Saint Joseph, Marseilles, France; 2.  CHU de Nancy-Hôpital Brabois Adulte,

Vandoeuvre-lès-Nancy, France; 3.  CHU de Bordeaux, Pessac, France; 4.  Hôpital Henri Mondor, Créteil, France; 5.  Hôpital de La Croix Rousse, Lyon, France; 6.  CHRU Lille, Lille, France; 7.  CHU de Nice, Nice, France; 8.  Hôpital Saint Eloi, Montpellier, France; 9.  Hôpital de la Pitié Salpétrière, Paris, France; 10.  Hôpital Purpan, Toulouse, France; 11.  Gilead Science, Inc., Foster City, CA;

12.  Hôpital Beaujon, Clichy, France; 13.  Hôpitaux Universitaires de Strasbourg, Strasbourg, France; 14.  Hôpital Pontchaillou, Rennes, France; 15.  Hôpital Tenon, Paris, France; 16.  Hôpital Universitaire Dupuytren, Limoges, France; 17.  Hôpital Saint Antoine, Paris, France; 18.  Hôpital Purpan, Toulouse, France; 19.  CHU de Grenoble, Grenoble, France; 20.  CHU Estaing, Clermont-Ferrand, France; 21.  Department of Hepatology, Hôpital Cochin et Université Paris-

René Descartes, Paris, France

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Study Design

• Double-blinded

•  Treatment-experienced patients with compensated cirrhosis who did not achieve SVR following sequential PEG/RBV and PI/PEG/RBV regimens

•  2 Arms – Placebo 12 weeks followed by LDV/SOF + RBV for

12 weeks

– LDV/SOF + Placebo RBV for 24 weeks

Bourlière M, et al. Abstract #LB-6, AASLD 2014

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SVR12: LDV/SOF + RBV for 12 Weeks vs LDV/SOF for 24 Weeks in GT 1 Cirrhotics Who Previously Failed PI Based Triple Therapy

96 97

0

20

40

60

80

100

LDV/SOF + RBV 12 Weeks LDV/SOF 24 Weeks

SV

R12

(%)

75/77 74/77


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Safety Summary

• Only 2 AEs occurred at a higher frequency with LDV/SOF compared with placebo (comparison during first 12 weeks of placebo-controlled double blind portion) – Headache: 21% placebo vs 35% LDV/SOF

– Fatigue: 4% placebo vs 17% LDV/SOF


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Conclusion

•  In GT 1 cirrhotics who previously failed PI based triple therapy (CUPIC patients)

– LDV/SOF + RBV for 12 weeks or

– LDV/SOF for 24 weeks


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High Efficacy of Treatment with Sofosbuvir+GS-5816 ±Ribavirin for 12 Weeks in Treatment Experienced

Patients with Genotype 1 or 3 HCV Infection

Stephen Pianko1, Steven L. Flamm2, Mitchell L. Shiffman3, Sonal Kumar4, Simone I. Strasser5, Gregory J. Dore6, John McNally7, Diana M. Brainard7, Lingling Han7, Brian Doehle7, Erik Mogalian7,

John G. McHutchison7, K. Rajender Reddy8, Stuart K. Roberts9

1.  Monash Medical Centre, Clayton, VIC, Australia 2.  Northwestern University, Chicago, IL 3.  Liver Institute of Virginia, Richmond, VA 4.  Weill Cornell Medical College, New York, NY 5.  Royal Prince Alfred Hospital, Camperdown, NSW, Australia 6.  St. Vincents Hospital, Darlinghurst, NSW, Australia 7.  Gilead Sciences, Inc., Foster City, CA 8.  University of Pennsylvania, Philadelphia, PA 9.  The Alfred, Melbourne, VIC, Australia

Abstract #197

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Background & Aims

•  Sofosbuvir (SOF) is an approved nucleotide polymerase inhibitor with activity against HCV GT 1-6

•  GS-5816 is an investigational inhibitor of the HCV NS5A protein with picomolar antiviral activity across all HCV genotypes 1-6

•  In a Phase 2 study, 12 week treatment with SOF + GS-5816 at a dose of 25 or 100 mg/day with or without RBV was found to be safe and effective

•  Evaluate safety and efficacy in treatment experienced GT 1 (PI failure) and GT 3 patients with and without cirrhosis

Pianko S, et al. Abstract #197, AASLD 2014

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SV

R12

(%)

88

100 100

0

20

40

60

80

100

SVR12: SOF/GS-5816 (100 mg) for 12 Weeks in GT 1 and GT 3 Treatment-experienced Patients With or Without Cirrhosis

Genotype 3 With Cirrhosis

(SVR 96% with RBV)

Genotype 1 PI failure

Genotype 3 No Cirrhosis


23/26 27/27 27/27

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Conclusions

• GT3 experienced patients

– Patients without cirrhosis: no RBV needed

– Patients with cirrhosis: RBV necessary

• GT1 PI failure: no RBV needed


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Integrated Efficacy Analysis of Four Phase 3 Studies in HCV Genotype 1a-Infected Patients

Treated with ABT- 450/r/Ombitasvir and Dasabuvir With or Without Ribavirin

Gregory T. Everson1, Geoffrey Dusheiko2, Eoin Coakley3, Stephen D. Shafran4, Fabien Zoulim5, Moises Diago6, Bradley Freilich7, Ravi Ravinuthala8, Suzanne Norris9, Junyuan J. Xiong3, Roger Trinh3, Tolga

Baykal3, Yan Luo3, Mark S. Sulkowski10;

1.  University of Colorado Denver, Aurora, CO; 2.  The Royal Free Hospital, London, United Kingdom; 3.  AbbVie Inc., North Chicago, IL; 4.  University of Alberta, Edmonton, AB, Canada; 5.  Hospices Civils de Lyon, Lyon, France; 6.  Hospital Quirón de Valencia, Valenci, Spain;

7.  Kansas City Gastroenterology & Hepatology, Kansas City, MO; 8.  Consultants for Clinical Research, Cincinnati, OH; 9.  St. James’s Hospital, Dublin, Ireland; 10. Johns Hopkins University, Baltimore, MD

Abstract #83

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Background

The 3D regimen includes:

•  ABT-450 - a potent NS3/4A protease inhibitor. Co-dosing of ABT-450 with ritonavir* (r; ABT-450/r) increases the peak, trough, and overall drug exposures of ABT-450

•  Ombitasvir - a potent NS5A inhibitor

•  Dasabuvir - a non-nucleoside NS5B polymerase inhibitor

Everson G, et al. Abstract #83, AASLD 2014

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Methods

• Patients infected with GT 1a in the PEARL-IV, SAPPHIRE-I, SAPPHIRE-II, or TURQUOISE-II trials

•  363/1058 (25%) of GT 1a treated patients had cirrhosis


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90.1 90.1 96.0 96.0

0

20

40

60

80

100

All Patients Treatment Naïve

Pro

porti

on o

f pat

ient

s w

ith S

VR

12 (%

)

3D + PBO

3D + RBV

Logistic regression: baseline BMI and treatment regimen (+/- RBV) were significant variables for not achieving SVR


SVR12 in GT 1a Non-cirrhotic Patients Treated with 3D Regimen for 12 Weeks (+/- RBV)

94.0 100

95.4

Relapse PR NR

12 Weeks

Prior PegIFN/RBV Response

p=0.004 p=0.006

182/202

569/593

182/202

403/420

47/ 50

36/ 36

83/ 87

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SVR12 in GT 1a Cirrhotic Patients Treated with 3D Regimen + RBV for 12 vs 24 Weeks

88.7 92.4 93.3 100

80

95.0 94.6 100 100

92.9

0

20

40

60

80

100

All Patients Treatment Naïve

Relapse Partial Responder

Null Responder

Pro

porti

on o

f pat

ient

s w

ith S

VR

12 (%

)

12 weeks

24 weeks

3D + RBV

Logistic regression: IL28B TT, prior null, North American region and history of IDU were significant variables for not achieving SVR

p=0.08 p=0.73 p=0.13

126/142

115/121

61/66

53/56

14/15

13/13

11/11

10/10

40/50

39/42

Everson G, et al. Abstract #83, AASLD 2014 Prior PegIFN/RBV Response

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Conclusions:

• GT 1a patients without cirrhosis benefit from RBV inclusion in 12 week treatment regimen (SVR12=96%)

• GT 1a patients with cirrhosis achieved SVR12 rates >90% with 3D + RBV regimen but 24 weeks should be needed in experienced patients.


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Interferon-Free Regimens of Ombitasvir and ABT-450/r With or Without Ribavirin in Patients

With HCV Genotype 4 Infection: PEARL-I Study Results

Stanislas Pol1, K. Rajender Reddy2, Tolga Baykal3, Christophe Hezode4, Tarek Hassanein5, Patrick Marcellin6, Marina Berenguer7, Katarzyna M. Fleischer-Stepniewska8, Coleen Hall3,

Christine Collins3, Regis A. Vilchez3;

1.  Groupe Hospitalier Cochin-Saint Vincent De Paul, Paris, France;

2.  University of Pennsylvania, Philadelphia, PA; 3.  AbbVie, Inc., North Chicago, IL; 4.  Hôpital Henri Mondor, Créteil, France; 5.  Southern California Liver Centers and Southern California

Research Center, Coronado,, CA;

6.  Hopital Beaujon Inserm Crb3 - U773 - Service Hepatologie, Clichy, France;

7.  Hospital Universitario La Fe, Valencia, Spain; 8.  EMC Instytut Medyczny Spolka Akcyjna, Wroclaw, Poland

Abstract #1928

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Background & Objective

•  GT4 constitutes approximately 20% of all HCV infections worldwide

•  GT4 is prevalent in the Middle East and Sub-Saharan Africa and constitutes approximately 90% of HCV infections in Egypt

•  Prevalence of GT4 is increasing in several European countries

•  Report the safety and efficacy in non-cirrhotic, treatment-naïve and treatment-experienced GT4 patients

Pol S, et al. Abstract #1928, AASLD 2014

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SVR12: Ombitasvir + ABT-450/r +/- RBV in GT4 Patients

91 100 100

0

20

40

60

80

100

Ombitasvir + ABT-450/r Ombitasvir + ABT-450/r + RBV

Ombitasvir + ABT-450/r + RBV

SV

R12

(%)

49/49 42/42 40/44

Pol S, et al. Abstract #1928, AASLD 2014

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All-oral 12-week Combination Treatment With Daclatasvir (DCV) and Sofosbuvir (SOF) in Patients Infected with

HCV Genotype (GT) 3: ALLY-3 Phase 3 Study D. R. Nelson1; J. N. Cooper2; J. P. Lalezari,3; E. Lawitz4; P. J. Pockros5; N. Gitlin6; B. Freilich7;

Z. Younes8; W. Harlan9; R. H. Ghall10; G. I. Oguchi11; P. J. Thuluvath12; G. Ortiz-Lasanta13; M. Rabinovitz14; D. Bernstein15; M. Bennett16; T. Hawkins17; N. Ravendhran8; A. M. Sheikh19;

P. Varunok; K. V. Kowdley; D. Hennicken; F. McPhee; K. Rana; E. A. Hughes22 1.  University of Florida, Gainesville, FL, United States 2.  !nova Fairfax Hospital, Falls Church, VA, United States 3.  Quest Clinical Research, San Francisco, CA, United States 4.  Texas Liver Institute, University of Texas Health Science Center,

San Antonio, TX, United States 5.  Scripps Clinic, La Jolla, CA, United States 6.  Atlanta Gastroenterology Associates, Atlanta, GA, United States 7.  Kansas City Research Institute, Kansas City, MO, United States 8.  Gastro One, Germantown, TN, United States 9.  Asheville Gastroenterology Associates, Asheville, NC, United

States 10. Texas Clinical Research Institute, Arlington, TX, United States 11. Midland Florida Clinical Research Center, DeLand, FL, United

States 12. Mercy Medical Center, Baltimore, MD, United States 13. Fundacion de Investigacion de Diego, Santurce, Puerto Rico,

United States

14. University of Pittsburgh, Pittsburgh, PA, United States 15. Hofstra North Shore-Long Island Jewish School of Medicine,

Manhasset, NY, United States 16. Medical Associates Research Group, San Diego, CA, United

States 17. Southwest CARE Center, Santa Fe, NM, United States 18. Digestive Disease Associates, Baltimore, MD, United States 19. Gastrointestinal Specialists of Georgia, Marietta, GA, United

States 20. Premier Medical Group of Hudson Valley, Poughkeepsie, NY,

United States 21. Swedish Medical Center, Seattle, WA, United States 22. Bristol-Myers Squibb Research and Development, Princeton,

NJ, United States

Abstract #LB-3

27

Background

•  HCV genotype (GT) 3 is common worldwide and remains a significant disease burden

•  GT 3 infection is associated with increased risk of fibrosis progression, steatosis, and hepatocellular carcinoma in patients with cirrhosis

•  Current therapies for patients with GT 3 infection include –  US and Europe

•  24 week sofosbuvir (SOF) + ribavirin (RBV)

•  12 week SOF + PEG/RBV

–  Europe •  24-week daclatasvir (DCV) + SOF ± RBV

Nelson D, et al. Abstract #LB-3, AASLD 2014

28

Methods

•  Two cohorts consisting of GT 3 treatment naive or treatment experienced patients received open-label DCV + SOF once daily for 12 weeks

•  21% of patients were cirrhotic


29

SVR12: DCV + SOF for 12 Weeks in GT 3 Patients

90 86

0

20

40

60

80

100

SV

R12

, %

Treatment Naive Treatment Experienced

91/101 44/51


30

SVR12: DCV + SOF for 12 Weeks in GT 3 Patients With Cirrhosis

SV

R12

, %

Overall

96 97 94

63 58 69

0

20

40

60

80

100

Present Absent

Treatment- naive

Treatment- experienced

Present Absent Present Absent

105/109 73/75 32/34 20/32 11/19 9/13


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Conclusion

• DCV + SOF for 12 weeks achieved SVR rates – 90% in treatment naïve

– 86% in treatment experienced

– 96% in non-cirrhotics

– 63% in cirrhotics (further optimization being evaluated)

• DCV + SOF was safe and well tolerated


32

All-oral fixed-dose combination therapy with daclatasvir/asunaprevir/BMS-791325, ± ribavirin, for patients with chronic HCV genotype 1 infection and compensated

cirrhosis: UNITY-2 Phase 3 SVR12 results A. Muir1; F. Poordad2; J. P. Lalezari3; G. T. Everson4; G. J. Dore5; P. Kwo6; C. Hezode7;

P. J. Pockros8; A. Tran9; A. Ramp10; R. Yang11; E. A. Hughes11; E. S. Swenson12; P. D. Yin12

1.  Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, United States.

2.  Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX, United States.

3. Quest Clinical Research, San Francisco, CA, United States. 4.  University of Colorado School of Medicine, Denver, CO,

United States. 5.  Kirby Institute , UNSW Australia, Sydney, NSW, Australia. 6.  Indiana University School of Medicine, Indianapolis, IN,

United States.

7.  Hopital Henri Mondor , University Paris-Est, Creteil, Creteil, France.

8.  Scripps Clinic, La Jolla, CA, United States. 9.  Centre Hospitalier Universitaire de Nice, Nice, France. 10. University of British Columbia, Vancouver, BC, Canada. 11. Bristol-Myers Squibb, Princeton, NJ, United States. 12. Bristol-Myers Squibb, Wallingford, CT, United States.

Abstract #LB-2

33

Background

•  All-oral DCV-TRIO regimen –  Daclatasvir (DCV)

•  NS5A inhibitor •  Approved in Europe and Japan; under review in US

–  Asunaprevir (ASV) •  NS3 protease inhibitor •  Clinical data in GT 1 and GT 4

–  Beclabuvir (BCV, BMS-791325) •  Non-nucleoside NS5B polymerase inhibitor •  Clinical data in GT 1 and GT 4

•  UNITY-2 Study –  DCV/ASV/BCV twice daily, fixed dose combo + RBV in GT 1

treatment naïve and treatment experienced compensated cirrhotics

Muir A, et al. Abstract #LB-2 , AASLD 2014

34

DCV-TRIO +/- RBV for 12 Weeks: SVR12 in GT 1 Treatment Naïve and Treatment Experienced Cirrhotic Patients

93 98

87 93

0

20

40

60

80

100

DCV TRIO DCV TRIO + RBV DCV TRIO DCV TRIO + RBV

SV

R12

(%)

53/57

________________________________

Treatment Naive ________________________________


54/55 39/45 42/45


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DCV-TRIO +/- RBV for 12 Weeks: SVR12 in GT 1a vs GT 1b

90 97

86 91 100 100

90 100

0

20

40

60

80

100

DCV TRIO DCV TRIO + RBV DCV TRIO DCV TRIO + RBV

SV

R12

(%)

36/ 40

17/ 17

________________________________

Treatment Naive ________________________________


38/ 39

30/ 35

32/ 35

15/ 15

9/ 10

10/ 10

GT 1a GT 1b


36

Conclusion

•  DCV-TRIO + RBV was safe and well tolerated with low rates of SAEs and AE discontinuations

•  RBV needed in GT1a and GT1b cirrhotic patients except GT1b naïve cirrhotic patients

•  Most commonly observed AEs with DCV-TRIO were headache, nausea, diarrhea, and fatigue


37

Efficacy and safety of MK-5172 and MK-8742 ± ribavirin in hepatitis C genotype 1 infected patients

with cirrhosis or previous null response: Final results of the C-WORTHY Study (Parts A and B)

Eric Lawitz1, Edward J. Gane2, Brian Pearlman3, Edward Tam4, Wayne Ghesquiere5, Dominique Guyader6, Laurent Alric7, Jean-Pierre Bronowicki8, Lorenzo Rossaro9, William Sievert10, Reem H. Ghalib11, Luis A.

Balart12, Fredrik Sund13, Martin Lagging14, Frank Dutko15, Anita Y. Howe15, Melissa Shaughnessy15, Peggy Hwang15, Janice Wahl15, Michael Robertson15, Barbara A. Haber15;

1.  The Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX;

2.  Auckland Clinical Studies, Grafton, Auckland, New Zealand; 3.  Atlanta Medical Center, Atlanta, GA; 4.  LAIR Centre, Vancouver, BC, Canada; 5.  Vancouver Island Health Authority, Victoria, BC, Canada; 6.  Department of Hepatology, Rennes University Hospital, Rennes

1 University, Rennes, France; 7.  CHU Purpan, Digest Dept., UMR 152, Toulouse 3 University,

Toulouse, France; 8.  INSERM U954, Centre Hospitalier Universitaire de Nancy,

Université de Lorraine, Vandoeuvre-les-Nancy, France;

9.  University of California, Davis Medical Center, Sacramento, CA; 10. Monash University and Monash Health, Melbourne, VIC,

Australia; 11. Texas Clinical Research Institute, Arlington, TX; 12. Tulane University School of Medicine, New Orleans, LA; 13. Infectious Diseases, Uppsala University, Uppsala, Sweden; 14. Institute of Biomedicine, University of Gothenburg, Gothenburg,

Sweden; 15. Merck & Co., Inc., Whitehouse Station, NJ

Abstract #196

38

Background:

•  Grazoprevir (MK-5172) is a highly potent HCV-specific NS3/4A protease inhibitor

•  Elbasvir (MK-8742) is a highly potent HCV-specific NS5A inhibitor

Treatment-naive, non-cirrhotic 12 weeks ± RBV

(n = 65) Pt. A

Treatment-naive Non-cirrhotic

8-12 weeks ± RBV (n = 94) Pt.B

Treatment-naive Cirrhotic

12-18 weeks ± RBV (n = 123) Pt.B

HIV/HCV Co-infected Non-cirrhotic

12 weeks ± RBV (n = 59) Pt.B

Null Responders Cirrhotic / Non-cirrhotic

12-18 weeks ± RBV (n = 130) Pt.B

Lawitz E, et al. Abstract #196, AASLD 2014

39

90 97 97 94 94 91 100 97

0

20

40

60

80

100

SVR

12 (%

, 95%

CI)

Treatment-naïve patients with cirrhosis

PR-Nulls with or without cirrhosis

12 Weeks 18 Weeks 12 Weeks 18 Weeks

+ RBV No RBV + RBV No

RBV + RBV No RBV + RBV No

RBV

SVR12 Rates in Cirrhotic Treatment-naïve and Null Responder GT 1 Patients


40

Summary

• SVR12 was 92% (23/25) in null responders with cirrhosis treated for 12 weeks with grazoprevir + elbasvir + RBV

• High efficacy without RBV and with only 12 weeks treatment

• Grazoprevir + elbasvir were generally safe and well tolerated


41

Conclusion

French HCV Guidelines 2015, May 29th Paris www.afef.asso.fr

best of hcv from aasld...core e1 e2 p7 ns2 ns3 4a ns4b ns5a ns5b 3 an integrated safety and efficacy...

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