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Best of HCV From AASLD 2013

Best of HCV From AASLD 2013. Michael P. Manns , MD Hannover, Germany. Jointly sponsored by the Duke University School of Medicine and the Chronic Liver Disease Foundation. Disclosures M. P. Manns, MD. Advisory Board Membership:

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Best of HCV From AASLD 2013

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  1. Best of HCVFrom AASLD 2013 Michael P. Manns, MDHannover, Germany Jointly sponsored by the Duke University School of Medicine and the Chronic Liver Disease Foundation

  2. Disclosures M. P. Manns, MD • Advisory Board Membership: Bristol-Myers Squibb, GlaxoSmithKline, Gilead, Janssen, Merck, Novartis, Roche

  3. GT 1 Interferon-Free

  4. Abstract #LB-3 SVR results of a once-daily regimen of simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in cirrhotic and non-cirrhotic HCV genotype 1 treatment-naïve and prior null responder patients: The COSMOS study Ira M. Jacobson1, Reem H. Ghalib2, Maribel Rodriguez-Torres3, Zobair M. Younossi4, Ana Corregidor5, Mark S. Sulkowski6, Edwin DeJesus7, Brian Pearlman8, Mordechai Rabinovitz9, Norman Gitlin10, Joseph K. Lim11, Paul J. Pockros12, Bart Fevery13, Tom Lambrecht14, Sivi Ouwerkerk-Mahadevan13, Katleen Callewaert13, William T. Symonds15, Gaston Picchio16, Karen Lindsay16, Maria Beumont-Mauviel13, Eric Lawitz17 1. Weill Cornell Medical College, New York, NY, United States. 2. Medicine and Gastroenterology and Hepatology, The Liver Institute, Dallas, TX, United States. 3. Fundación de Investigación, San Juan, Puerto Rico, United States. 4. Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, United States. 5. Borland-Groover Clinic, 4800 Belfort Rd, Jacksonville, FL, United States. 6. Johns Hopkins University School of Medicine, Baltimore, MD, United States. 7. Orlando Immunology Center, Orlando, FL, United States. 8. Atlanta Medical Center, Atlanta, GA, United States. 9. University of Pittsburgh Medical Center, Pittsburgh, PA, United States. 10. Atlanta Gastroenterology Association, Atlanta, GA, United States. 11. Yale School of Medicine, New Haven, CT, United States. 12. Scripps Clinic, La Jolla, CA, United States. 13. Janssen Research & Development, Beerse, Belgium. 14. Novellas Healthcare, Zellik, Belgium. 15. Gilead Sciences Inc, Foster City, CA, United States. 16. Janssen Research & Development LLC, Titusville, NJ, United States. 17. The Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX, United States.

  5. Background Simeprevir (TMC435) is an investigational, one pill, once-daily, potent oral HCV NS3/4A protease inhibitor recently approved in Japan and currently under regulatory review in North America and Europe Sofosbuvir (GS-7977) is an HCV nucleotide NS5B polymerase inhibitor also currently under regulatory review COSMOS is a Phase IIa, randomized, open-label study investigating simeprevir + sofosbuvir +/- ribavirin Interim analysis Jacobson IM, et al. Abstract #LB-3, AASLD 2013

  6. COSMOS: Study design N=14 0 4 12 24 36 48 N=24 Week N=14 SMV + SOF + RBV Post-treatment follow-up Arm 1 N=27 Enrollment ratio 2:1:2:1 Post-treatment follow-up SMV + SOF Arm 2 Post-treatment follow-up SMV + SOF + RBV Arm 3 Post-treatment follow-up SMV + SOF Arm 4 • Cohort 1: Prior null responders (METAVIR F0-F2) • Final SVR12 for all arms • Cohort 2: Treatment-naïve and prior null responders (METAVIR F3-F4) • Interim SVR4 for Arms 3 and 4 Jacobson IM, et al. Abstract #LB-3, AASLD 2013

  7. Cohort 1: Null responders (F0-2) 24 week treatment 12 week treatment 6.7 1/27 1/14 1/24 1/15 4/24 Patients (%) 13/14 26/27 19/24 14/15 SMV/SOF12 wks SMV/SOF/RBV12 wks SMV/SOF 24 wks SMV/SOF/RBV 24 wks Non-virologic failure SVR12 (SMV/SOF) SVR12 (SMV/SOF/RBV) Relapse Jacobson IM, et al. Abstract #LB-3, AASLD 2013

  8. Cohort 2: Naïve and prior null responders (F3-4): Interim analysis, SVR4 12 week treatment 1/27 1/15 SVR4 (SMV/SOF) SVR4 (SMV/SOF/RBV) Patients (%) Relapse 7/7 12/12 7/7 14/15 26/27 14/14 Jacobson IM, et al. Abstract #LB-3, AASLD 2013

  9. Most Common AEs: Cohorts 1 and 2 Combined aNo sun-protective measures were in place for this trialRBV, ribavirin; SMV, simeprevir; SOF, sofosbuvir Jacobson IM, et al. Abstract #LB-3, AASLD 2013

  10. Conclusion • Treatment with SMV + SOF ± RBV results in: • High SVR12 rates in HCV GT 1 null responder patients • High SVR4 rates in naïve and null-responder patients with METAVIR F3-F4 • Addition of RBV to SMV + SOF may not be needed to achieve high rates of SVR in this patient population • 12 weeks of treatment may confer similar SVR rates compared with 24 weeks of treatment • SMV + SOF ± RBV was generally well tolerated Jacobson IM, et al. Abstract #LB-3, AASLD 2013

  11. Abstract #211 All-oral Combination of Daclatasvir Plus Asunaprevir in Interferon Ineligible Naive/Intolerant and Nonresponder Japanese Patients Chronically Infected with HCV Genotype 1b: Results from a Phase 3 Trial Kazuaki Chayama1, Yoshiyuki Suzuki2, Kenji Ikeda2, Joji Toyota3, Yoshiyasu Karino3, Yoshiiku Kawakami1, Akio Ido4, Kazuhide Yamamoto5, Koichi Takaguchi6, Namiki Izumi7, Kazuhiko Koike8, Tetsuo Takehara9, Norifumi Kawada10, Michio Sata11, Hidetaka Miyagoshi12, Timothy Eley13, Fiona McPhee13, Wenhua Hu13, Hiroki Ishikawa12, Eric A. Hughes13, Hiromitsu Kumada2 1. Hiroshima University, Hiroshima, Japan. 2. Toranomon Hospital, Tokyo, Japan. 3. Sapporo-Kousei General Hospital, Sapporo, Japan. 4. Kagoshima University, Kagoshima, Japan. 5. Okayama University, Okayama, Japan. 6. Kagawa Prefectural Hospital, Kagawa, Japan.7. Musashino Red Cross Hospital, Tokyo, Japan. 8. University of Tokyo, Tokyo, Japan. 9. Osaka University, Osaka, Japan. 10. Osaka City University, Osaka, Japan. 11. Kurume University, Fukuoka, Japan. 12. Bristol-Myers KK, Tokyo, Japan. 13. Bristol-Myers Squibb, Princeton, NJ, United States.

  12. Virologic Response aIneligible naïve: n=100; Intolerant: n=35 bNull responders: n=48; Partial responders: n=36; Undetermined: n=3 Chayama K, et al. Abstract #211, AASLD 2013

  13. Abstract #75 Interferon- and Ribavirin-free Regimen of ABT-450/r + ABT-267 in HCV Genotype 1b-infected Treatment-naïve Patients and Prior Null Responders Eric Lawitz1, Christophe Hezode2, Peter Varunok3, Paul J. Thuluvath4, Tolga Baykal5, Mudra Kapoor5, Sandra S. Lovell5, Tianli Wang5, Tami Pilot-Matias5, Regis A. Vilchez5, Barry Bernstein5 1. The Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX, United States. 2. Assistance PubliqueHopitaux de Paris, Paris, France. 3. Premier Medical Group of the Hudson Valley, PC, Poughkeepsie, NY, United States. 4. The Institute for Digestive Health and Liver Disease at Mercy, Baltimore, MD, United States. 5. AbbVie Inc., North Chicago, IL, United States.

  14. Background and Aims ABT-450 is an HCV protease inhibitor (dosed with ritonavir 100 mg, ABT-450/r) ABT-267 is an NS5A inhibitor Both compounds have shown potent antiviral activity in vitro against HCV genotypes (GT) 1-4 and 6. Lawitz E, et al. Abstract #75, AASLD 2013

  15. PEARL-I Study Design PlannedN HCV Genotype/Regimen Treatment Experience Week 12 Week 24 BL Group 1 40 Group 2 40 Group 3 40 Group 4 40 Group 5 40 Group 6 40 Group 7 40 Group 8 40 GT4 ABT-450/r + ABT-267 Treatment-naïve GT1b ABT-450/r + ABT-267 Treatment-naïve Substudy 1: Patients Without Cirrhosis GT1b ABT-450/r + ABT-267 Null Responders GT4 ABT-450/r + ABT-267 + rbv Treatment-naïve GT4 ABT-450/r + ABT-267 Partial/Null Responders & Relapsers GT4 ABT-450/r + ABT-267 + rbv Partial/Null Responders & Relapsers Substudy 2: Patients With Compensated Cirrhosis GT1b ABT-450/r + ABT-267 Treatment-naïve GT1b ABT-450/r + ABT-267 Partial/Null Responders & Relapsers Lawitz E, et al. Abstract #75, AASLD 2013

  16. Efficacy: Treatment-Naïve Patients, ITT 100 97.6 97.6 95.2 100 80 60 Percentage of Patients (%) 40 20 42/42 41/42 41/42 40/42 0 Week 4 Week 12 (EOTR) SVR4 SVR12 Lawitz E, et al. Abstract #75, AASLD 2013

  17. Efficacy: Prior Null Responders, ITT 97.5 97.5 92.5 90.0 100 80 60 Percentage of Patients (%) 40 20 39/40 39/40 37/40 36/40 0 Week 4 SVR4 SVR12 Week 12 (EOTR) Lawitz E, et al. Abstract #75, AASLD 2013

  18. Treatment-Emergent Adverse Events (AEs) Occurring in >10% of Patients in Either Group Lawitz E, et al. Abstract #75, AASLD 2013

  19. Abstract #76 High Efficacy and Safety of the All-Oral Combination Regimen, MK-5172/MK-8742 +/- RBV for 12 Weeks in HCV Genotype 1 Infected Patients: The C-WORTHY Study Eric Lawitz1, John M. Vierling2, Abel Murillo3, Marcelo Kugelmas4, Jan Gerstoft5, Peter Winkle6, Luis A. Balart7, Peer B. Christensen8, Reem H. Ghalib9, Ronald Nahass10, Melissa Shaughnessy11, Xiao Sun11, Peggy Hwang11, Janice Wahl11, Michael Robertson11, Barbara Haber11 1. University of Texas Health Science Center, Texas Liver Institute, San Antonio, TX, United States. 2. Baylor College of Medicine, Houston, TX, United States. 3. Advanced Intervention & Pain Management Research Clinic, Miami, FL, United States. 4. South Denver Gastroenterology, PC, Englewood, CO, United States. 5. Epidemiklinikken, Rigshospitalet, Copenhagen, Denmark. 6. Anaheim Clinical Trials, Anaheim, CA, United States. 7. Tulane University Medical Center, New Orleans, LA, United States. 8. Infektionsmed. Afd Q 2 sal, Odense Universitets Hospital, Odense, Denmark.

  20. Study Design Follow-up MK-5172 (100 mg) + MK-8742 (20 mg) + RBV; G1a & G1b n=25 Follow-up MK-5172 (100 mg) + MK-8742 (50 mg) + RBV; G1a & G1b n=27 Follow-up MK-5172 (100 mg) + MK-8742 (50 mg); G1b n=13 Lawitz E, et al. Abstract #76, AASLD 2013 TW12 SVR24 SVR4 SVR8 SVR12 TW4 D1

  21. Virologic Responses 13 13 25 25 25 27 13 13 24 25 25 27 13 13 13 13 24 25 24 27 24 25 24 27 Treatment Follow-up Lawitz E, et al. Abstract #76, AASLD 2013

  22. Common Adverse Events During Treatment* * Incidence ≥10% in all arms Lawitz E, et al. Abstract #76, AASLD 2013

  23. Abstract #LB-20 Rapid and Consistent Virologic Responses in a Phase 2 Trial of a New All-Oral Combination of Faldaprevir, Deleobuvir, and PPI-668, with and without Ribavirin, in Patients with HCV Genotype-1a Infection Jacob P. Lalezari1, Laura Holland1, Eileen Glutzer1, Pamela Vig2, Mabrouk Elgadi3, Jerry O. Stern3, Richard Colonno2, Sherin Halfon2, Eric Ruby2, Ningwu Huang2, Qi Huang2, Eileen Nash2, Nathaniel A. Brown2 1. Quest Clinical Research, San Francisco, CA, United States. 2. Presidio Pharmaceuticals, San Francisco, CA, United States. 3. BoehringerIngelheim, Ridgefield, CT, United States.

  24. Objectives Primary To assess the efficacy of 12 weeks of treatment with a new three investigational drug, all-oral antiviral regimen of PPI-668 (NS5A inhibitor) added to faldaprevir (protease inhibitor, FDV) and deleobuvir (non-nucleoside NS5B inhibitor, DBV), with and without ribavirin (RBV), in patients with HCV gt-1a infection Secondary To assess the efficacy of two dose levels of DBV (600 mg BID vs. 400 mg BID), in the context of a three drug investigational regimen To assess the safety/tolerance of each of the treatment regimens Lalezari JP, et al. Abstract #LB-20, AASLD 2013

  25. Study Design Study Design and Methods Treatment Period PostTreatment Period 600 mg BID DBV + 120 mg QD FDV* + 200 mg QD 668 + RBV Cohort 1 (n=12) 400 mg BID DBV + 120 mg QD FDV* + 200 mg QD 668 + RBV Cohort 2 (n=12) 600 mg BID DBV + 120 mg QD FDV* + 200 mg QD 668 (no RBV) Cohort 3 (n=12) Day 0 Week 12 Week 16 SVR4 Week 24 SVR12 Week 36 SVR24 *FDV loading dose (240 mg) on Day 1 Lalezari JP, et al. Abstract #LB-20, AASLD 2013

  26. HCV RNA Categorical Responses • Overall, 97% of patients across all three cohorts achieved HCV RNA <LLOQ (81% <LLOD) at week 4, regardless of RBV use 1Percentage based on number of patients achieving LLOQ and LLOD at the indicated time point for each cohort 2Excludes 1 patient who discontinued at Week 5 due to viral breakthrough 3RBV-free Cohort 3 was initiated later, after efficacy and safety criteria were met in Cohorts 1 and 2 Lalezari JP, et al. Abstract #LB-20, AASLD 2013

  27. Safety Observations Lalezari JP, et al. Abstract #LB-20, AASLD 2013 • Clinical adverse events (AEs) have been similar to those previously seen in studies of FDV and DBV (skin rashes and GI side effects, mild to moderate in intensity) • Patients in the RBV-free cohort (Cohort 3) exhibited a clear predominance of mild AEs (83% indicated as “mild”) compared with mixed mild-moderate severity for RBV-containing regimens (Cohorts 1 and 2) • Grade ≥1 bilirubin elevations were common • 88% of Cohort 1 and 2 patients, less common in RBV-free Cohort 3 (46%)

  28. Abstract #215 Once Daily Sofosbuvir/Ledipasvir Fixed Dose Combination with or without Ribavirin Resulted in ≥95% Sustained Virologic Response In Patients with HCV Genotype 1, Including Patients with Cirrhosis: the LONESTAR trial Eric Lawitz1, Fred Poordad1, Robert H. Hyland2, Xiao Ding2, Christy Hebner2, Phil S. Pang2,William T. Symonds2, John G. McHutchison2, Fernando E. Membreno1 1. The Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX, United States. 2. Gilead Science, Inc, Foster City, CA, United States.

  29. Study Design Wk 8 Wk 12 Wk20 Wk24 Wk 0 SVR12 SVR12 • Treatment Naïve(Nocirrhosis) SOF/LDV SVR12 COHORT 1 (n=60) SOF/LDV + RBV SVR12 Randomized 1:1:1 SVR12 SOF/LDV • PI Failures • (50% cirrhosis) SOF/LDV COHORT 2 (n=40) Randomized 1:1 SOF/LDV + RBV Lawitz E, et al. Abstract #215, AASLD 2013 • Single center study of GT 1 patients • Broad inclusion criteria • No upper limit to age or BMI • Platelets ≥50,000/mm3

  30. Results: Demographics of Patients Who Previously Failed PI Therapy Lawitz E, et al. Abstract #215, AASLD 2013 • All patients were required to have experienced virologic failure • Patients who stopped prior therapy due to an AE were excluded

  31. SVR12 Results Patients (%) 19/20 21/21 18/19 18/19 21/21 RBV ─ + ─ ─ + Duration (week) 8 8 12 12 12 Treatment Naïve (No Cirrhosis) PI Failures (50% Cirrhosis) Lawitz E, et al. Abstract #215, AASLD 2013

  32. Patients Who Previously Failed Protease Inhibitor Therapy: With and Without Cirrhosis Patients (%) 18/19 21/21 8/8 10/10 10/11 11/11 RBV ─ + ─ + ─ + 12 Duration (week) 12 12 Overall No Cirrhosis Cirrhosis Lawitz E, et al. Abstract #215, AASLD 2013

  33. Results: Safety Summary *Peptic ulcer, spinal compression fracture; †Delirium, suicidal ideation. Lawitz E, et al. Abstract #215, AASLD 2013

  34. GT 2 and GT 3

  35. Abstract #1085 Sofosbuvir + Ribavirin for 12 or 24 Weeks for Patients with HCV Genotype 2 or 3: the VALENCE trial Stefan Zeuzem1, Geoffrey M. Dusheiko2, Riina Salupere3, Alessandra Mangia4, Robert Flisiak5, Robert H. Hyland6, Ari Illeperuma6, Evguenia S. Svarovskaia6, Diana M. Brainard6, William T. Symonds6, John G. McHutchison6, Ola Weiland7, Hendrik W. Reesink8, Peter Ferenci9, Christophe Hezode10, Rafael Esteban11 1. Johann Wolfgang Goethe University, Frankfurt, Germany. 2. Royal Free and University College School of Medicine, Royal Free Hospital, London, United Kingdom. 3. Tartu University Hospital, Tartu, Estonia. 4. "Casa SollievodellaSofferenza" Hospital, San Giovanni Rotondo, Italy. 5. Medical University of Bialystok, Bialystok, Poland. 6. Gilead Sciences, Inc., Foster City, CA, United States. 7. KarolinskaInstitutet, Karolinska University Hospital Huddinge, Stockholm, Sweden. 8. Academic Medical Center, Amsterdam, Netherlands. 9. Medical University of Vienna, Vienna, Austria. 10. Hôpital Henri Mondor, Créteil, France. 11. Hospital Universitario Val d’Hebron, Barcelona, Spain.

  36. VALENCE: Study Design SVR4, SVR12, SVR24 Wk 0 Wk 12 Wk 24 Placebo*(n = 85) Sofosbuvir + Ribavirin(n = 84)* Sofosbuvir + Ribavirin (n = 250) *Protocol amended to eliminate placebo arm and to extend treatment duration to 24 weeks for patients with genotype 3 HCV irrespective of prior treatment history. Zeuzem S, et al. Abstract #1085, AASLD 2013

  37. 212/ 250 68/73 29/30 2/2 30/33 7/8 GT 2 SOF+RBV 12 wk GT 3 SOF+RBV 24 wk Naïve, Noncirrhotic Naïve, Cirrhotic Experienced, Noncirrhotic Experienced, Cirrhotic *3 of 11 patients (27%) with HCV GT 3 who received 12 weeks of SOF+RBV achieved SVR 12. Zeuzem S, et al. Abstract #1085, AASLD 2013

  38. SVR12 in GT 3 Patients Treated for 24 Weeks 86/92 12/13 87/100 27/45 Naïve, Noncirrhotic Naïve, Cirrhotic Experienced, Noncirrhotic Experienced, Cirrhotic ZeuzemS, et al. Abstract #1085, AASLD 2013

  39. Abstract #LB-4 Sofosbuvir in Combination With PegIFN and Ribavirin for 12 Weeks Provides High SVR Rates in HCV-Infected Genotype 2 or 3 Treatment Experienced Patients with and without Compensated Cirrhosis: Results from the LONESTAR-2 Study Eric Lawitz1, 2, Fred Poordad1, 2, Diana M. Brainard3, Robert H. Hyland3, Di An3, William T. Symonds3, John G. McHutchison3, Fernando E. Membreno1, 2 1. Texas Liver Institute, San Antonio, TX, United States. 2. University of Texas Health Science Center, San Antonio, TX, United States. 3. Gilead Science, Inc, Foster City, CA, United States.

  40. Study Design Wk 0 Wk 12 Wk24 Wk36 SOF + PEG/RBV GT 2/3(N=47) SVR12 • Study population • HCV GT 2 or 3 • Failed treatment with pegylated interferon and ribavirin • Approximately 50% with compensated cirrhosis • HIV and HBV coinfected patients excluded Lawitz E, et al. Abstract #LB-4, AASLD 2013

  41. Results: SVR12 by HCV Genotype SVR12 (%) 42/47 22/23 20/24 Overall GT 2 GT 3 Lawitz E, et al. Abstract #LB-4, AASLD 2013

  42. Results: SVR12 by Cirrhosis Status SVR12 (%) 9/9 13/14 10/12 10/12 Error bars represent 95% confidence intervals. Lawitz E, et al. Abstract #LB-4, AASLD 2013

  43. Liver Transplant

  44. Abstract #216 Sustained Virological Response After Protease Inhibitor-based Therapy For Hepatitis C Recurrence After Liver Transplantation: A Multicentric European Experience Audrey Coilly1, 2, Jerome Dumortier4, Danielle Botta-Fridlund5, Marianne Latournerie6, Vincent Leroy7, Georges-Philippe Pageaux8, Emiliano G. Giostra9, Christophe Moreno10, Bruno Roche1, 3, Pascal Lebray11, Sylvie Radenne12, Anne-Catherine Saouli13, Yvon Calmus14, Laurent Alric15, Maryline Debette-Gratien16, Victor de Ledinghen17, Francois Durand18, Christophe Duvoux19, Didier Samuel1, 2, Jean-Charles Duclos-Vallee1, 3 1. Centre Hepato-Biliaire, AP-HP, Hopital Paul Brousse, Villejuif, France. 2. Unit 785, Inserm, Villejuif, France. 3. UMR-S785, Univ Paris-Sud, Villejuif, France. 4. DeptHepato-gastro-enterologie, HopitalEdouard Herriot, Lyon, France. 5. Hepato-gastro-enterologie, AP-HM Hopital de la Conception, Marseille, France. 6. Maladies du foie et de l'appareildigestif, Centre HospitalierUniversitairePontchaillou, Rennes, France. 7. Hepato-gastro-enterologie, Centre HospitalierUniversitaire de Grenoble, Grenoble, France. 8. Hepato-gastro-enterologie et Transplantation, CHU - Hopital Saint Eloi, Montpellier, France. 9. Gastro-enterologie et Hepatologie, HopitauxUniversitaire de Geneve, Geneve, Switzerland. 10. Hepato-Gastro-Enterologie, HopitalErasme - CliniquesUniversitaires de Bruxelles, Bruxelles, Belgium. 11. Hepato-gastro-enterologie, AP-HP, HopitalPitiéSalpétrière, Paris, France. 12. Hepato-gastro-enterologie, Hopital de la Croix Rousse, Lyon, France. 13. Hepato-gastro-enterologie, CHRU de Strasbourg, Strasbourg, France. 14. Chirurgie Digestive, AP-HP, Hopital Saint Antoine, Paris, France. 15. Médecine Interne, CHU Purpan, Toulouse, France. 16. Hepato-gastro-enterologie, Centre HospitalierRégionalUniversitaireDupuytren, Limoges, France. 17. Hepatogastroenterologie et Oncologie digestive, CHU de Bordeaux - Hopital Haut Leveque, Pessac, France. 18. Hepato-Gastro-Enterologie, AP-HP, HopitalBeaujon, Clichy, France. 19. Hepato-gastro-enterologie, AP-HP, Hopital Henri Mondor, Creteil, France.

  45. Patients and Methods Coilly A, et al. Abstract #216, AASLD 2013 • Study cohort • N=79 (who would have achieved SVR12) • Enrolled between March 2011 and July 2012 • In 17 liver transplant centers in France, Belgium and Switzerland • Inclusion criteria: • Genotype 1 active and chronic hepatitis C • Recurrence defined by a fibrosis stage >1 (METAVIR) or FCH • Stable immunosuppressive regimen • No HBV or HIV coinfection

  46. Study Design n=35 n=19 n=25 PegIFN/RBV PegIFN/RBV+BOC(800mg tid) Plannedtherapy duration: 48 weeks PegIFN/RBV PegIFN/RBV+TVR (750mg tid) Coilly A, et al. Abstract #216, AASLD 2013 PegIFN/RBV+TVR (750mg tid) Week-4 Week0 Week12 Week4

  47. Virological Response p=0.176 p=0.373 p=0.132 TVR BOC n=44 n=35 n=44 n=35 n=38 n=32 SVR 12 SVR 24 Coilly A, et al. Abstract #216, AASLD 2013

  48. Virological Response SVR12 according to fibrosis stage p=ns Coilly A, et al. Abstract #216, AASLD 2013

  49. Virological Response SVR12 according to genotype SVR12 according to previousresponse p=ns Coilly A, et al. Abstract #216, AASLD 2013

  50. Abstract #LB-2 Sofosbuvir and Ribavirin for the Treatment of Established Recurrent Hepatitis C Infection After Liver Transplantation:Preliminary Results of a Prospective, Multicenter Study Michael R. Charlton1, Edward J. Gane2, Michael P. Manns3, Robert S. Brown4, Michael P. Curry5,Paul Y. Kwo6, Robert J. Fontana7, Richard Gilroy8, Lewis W. Teperman9, Andrew J. Muir10,John G. McHutchison11, William T. Symonds11, Jill M. Denning11, Lindsay McNair11, Sarah Arterburn11,Norah Terrault12, Didier Samuel13, Xavier Forns14 1. Mayo Clinic, Rochester, MN, United States. 2. Auckland City Hospital, Auckland, New Zealand. 3. Hannover Medical School, Hannover, Germany. 4. Columbia University, New York, NY, United States. 5. Beth Israel Deaconess Medical Center, Boston, MA, United States. 6. Indiana School of Medicine, Indianapolis, IN, United States. 7. University of Michigan, Ann Arbor, MI, United States. 8. Kansas University Medical Center, Lawrence, KS, United States. 9. NYU Medical Center, New York , NY, United States. 10. Duke University Medical Center, Durham, NC, United States. 11. Gilead Sciences, Foster City, CA, United States. 12. University of California, San Francisco, CA, United States. 13. Université Paris-Sud, Villejuif, France. 14. The Liver Unit, Barcelona, Spain.

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