Option A - IC-HEP

Best of HCV From AASLD 2013 Darrell Crawford, MD Brisbane, Australia This activity has been supported by an independent medical education grant from Bristol Myers Squibb. 2013 IC-HEP Educational supporters include Bristol Myers Squibb and Janssen Therapeutics EMEA. Supporters do not influence IC-HEP faculty selection or educational content. 1 Abstract #LB-1 Phase 2b study of the interferon-free and ribavirin-free combination of daclatasvir, asunaprevir, and BMS-791325 for 12 weeks in treatment-nave patients with chronic HCV genotype 1 infection Gregory T. Everson1, Karen D. Sims2, Paul J. Thuluvath3, Eric Lawitz4, Tarek Hassanein5, Maribel Rodriguez-Torres6, Trevor Hawkins7, Howard Schwartz8, Vinod K. Rustgi9, Federico Hinestrosa10, James M. Levin11, Zobair M. Younossi12, Lynn R. Webster13, Timothy Eley2, Shu-Pang Huang14, Fiona McPhee15, Dennis M. Grasela2, David F. Gardiner2 1. University of Colorado Denver, Aurora, CO, United States. 2. Bristol-Myers Squibb, Hopewell, NJ, United States. 3. Mercy Medical Center, Baltimore, MD, United States. 4. The Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX, United States. 5. Southern California Liver Centers, Coronado, CA, United States. 6. Fundacin de Investigacin, San Juan, Puerto Rico, United States. 7. Southwest CARE Center, Santa Fe, NM, United States. 8. Miami Research Associates, South Miami, FL, United States. 9. Metropolitan Research, Arlington, VA, United States. 10. Orlando Immunology Center, Orlando, FL, United States. 11. Dean Foundation for Health, Research and Education, Inc, Madison, WI, United States. 12. Inova Fairfax Hospital, Center for Liver Diseases,

Falls Church, VA, United States. 13. CRI Lifetree, Salt Lake City, UT, United States. 14. Bristol-Myers Squibb, Princeton, NJ, United States. 15. Bristol-Myers Squibb, Wallingford, CT, United States. 2 Direct-Acting Antiviral Agents Daclatasvir (DCV) NS5A replication complex inhibitor with potent, pan-genotypic activity in vitro Studied in over 5500 patients Asunaprevir (ASV) NS3 protease inhibitor active against genotypes (GT) 1, 4, 5, and 6 in vitro Studied in over 2000 patients BMS-791325 Non-nucleoside, NS5B polymerase inhibitor active against GT 1, 3, 4, 5, and 6 in vitro Studied in over 500 patients Everson GT, et al. Abstract #LB-1, AASLD 2013 3 Randomized, Phase 2b Open-Label Study (AI443-014) Primary endpoint: SVR12 N = 80 DCV 30 mg BID + ASV 200 mg BID + BMS-791325 75 mg BID N = 86 DCV 30 mg BID + ASV 200 mg BID + BMS-791325 150 mg BID

Week 0 12-week follow-up 12 Additional follow-up to SVR48 24 Patients: treatment-naive, stratified by GT 1a/1b and presence of biopsy-confirmed cirrhosis (82% GT1a and 9% cirrhotics). Primary end point: HCV RNA < LLOQ 12 weeks post-treatment (SVR12) Observed analysis: breakthrough, relapse, addition of pegIFN/RBV = failure Modified intent-to-treat analysis: missing, breakthrough, relapse or addition of pegIFN/RBV = failure Everson GT, et al. Abstract #LB-1, AASLD 2013 4 Response, % of patients Efficacy Through SVR12 (Observed) 100 97.5 94.2

92.4 91.7 92.2 91.7 80 60 DCV + ASV + 325 75 mg 40 DCV + ASV + 325 150 mg 20 0 78/80 81/86 End of Treatment 73/79 77/84 SVR4 71/77

77/84 SVR12 Everson GT, et al. Abstract #LB-1, AASLD 2013 5 Safety Outcomes Event, n (%) Serious AEs AEs leading to discontinuation Grade 3/4 AEs Most frequent on-treatment AEs ( 10%) Headache Diarrhea Fatigue Nausea Grade 3/4 lab abnormalities Aspartate aminotransferase (AST) Glucose, fasting serum (high) Phosphorus, inorganic Bilirubin, total DCV + ASV + 325 75 mg N = 80 DCV + ASV + 325 150 mg N = 86 Total N = 166

1 (1.3) 1 (1.3) 0 2 (2.3) 1 (1.2) 1 (1.2) 3 (1.6) 2 (1.1) 1 (0.5) 17 (21.3) 12 (15.0) 12 (15.0) 10 (12.5) 24 (27.9) 13 (15.1) 7 (8.1) 7 (8.1) 41 (24.7) 25 (15.1) 19 (11.4) 17 (10.2) 1 (1.3) 1 (1.3) 0 0 0 1 (1.2) 1 (1.2) 1 (1.2)

1 (0.5) 2 (1.2) 1 (0.5) 1 (0.5) Everson GT, et al. Abstract #LB-1, AASLD 2013 6 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. 7

Virologic Response HCV RNA < LLOQ, n (%) Ineligible nave/Intolerant (IN/I) Patients n = 135a Nonresponder (NR) Patients n = 87b Total N = 222 RVR, Week 4 114 (84.4) 53 (60.9) 167 (75.2) cEVR, Week 12 125 (92.6) 77 (88.5) 202 (91.0) SVR4 126 (93.3) 71 (81.6)

197 (88.7) SVR12 120 (88.9) 70 (80.5) 190 (85.6) SVR24 118 (87.4) 70 (80.5) 188 (84.7) Ineligible nave: n=100; Intolerant: n=35 Null responders: n=48; Partial responders: n=36; Undetermined: n=3 a b Chayama K, et al. Abstract #211, AASLD 2013 8 Abstract #73 Once Daily Sofosbuvir/Ledipasvir Fixed Dose Combination with or without Ribavirin: the ELECTRON trial Edward J. Gane1, Catherine A. Stedman2, Robert H. Hyland3, Xiao Ding3, Evguenia S. Svarovskaia3, Phil S. Pang3, William T. Symonds3 1. Auckland Clinical Studies, Auckland, New Zealand. 2. Christchurch Clinical Studies Trust, Christchurch, New Zealand.

3. Gilead Science, Inc, Foster City, CA, United States. 9 Direct Acting Antiviral Agents Sofosbuvir/Ledipasvir FDC Once daily, oral fixed-dose (400/90 mg) combination tablet No food effect >2000 patients treated SOF Nucleotide Polymerase inhibitor LDV NS5A inhibitor GS-9669 HCV NS5B non-nucleoside inhibitor, binding at thumb site II of the polymerase Potent antiviral activity with QD dosing Nanomolar potency against GT 1a and 1b Gane EJ, et al. Abstract #73, AASLD 2013 10 Study Design F4 GT 1 Experienced F3/F4 GT 1 Nave

Randomized Randomized Wk 0 F0/F1/F2 Wk 6 Wk 12 SOF/LDV FDC (n=10) SOF/LDV FDC + RBV (n=10) SOF/LDV FDC + RBV (n=25) SVR12 SOF/LDV FDC + GS-9669 (n=25) SOF/LDV FDC + RBV (n=25) Primary endpoint: SVR12 (HCV RNA

40 30 20 10 0 Duration (wk) 100 100 100 7/10 9/9 25/25* 26/26* SOF/LDV SOF/LDV + RBV SOF/LDV + RBV SOF/LDV + GS9669 12 12 12

12 70 *From ELECTRON 2 Gane EJ, et al. Abstract #73, AASLD 2013 F4 only F3/F4 12 SVR 12 (%) SVR12 Results: Treatment Duration Genotype 1, Treatment-nave, No Cirrhosis 100 90 80 70 60 50 40 30 20 10 0 Duration (wk) 100 100 68 25/25

21/21 17/25 SOF + LDV + RBV* SOF/LDV + RBV SOF/LDV + RBV 12 8 6 *Gane et al. EASL 2013. Lawitz et al, Abstract #215, AASLD 2013 (LONESTAR) Gane EJ, et al. Abstract #73, AASLD 2013 13 Conclusions In treatment-experienced patients with advanced fibrosis/cirrhosis, either RBV or GS-9669 may enhance the efficacy of SOF/LDV given for 12 weeks The optimal duration of SOF/LDV in treatment-nave GT 1 patients, even with the addition of RBV, is more than 6 weeks Regimens of SOF/LDV alone, or with RBV or GS-9669, were safe and well tolerated Gane EJ, et al. Abstract #73, AASLD 2013

14 Abstract #75 Interferon- and Ribavirin-free Regimen of ABT-450/r + ABT-267 in HCV Genotype 1b-infected Treatment-nave 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 Publique Hopitaux 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. 15 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 16 PEARL-I Study Design Planned HCV Genotype/Regimen N BL Treatment Experience Week 12 Group 1 40 Substudy 1: Patients

Without Cirrhosis Group 2 40 Group 3 40 Group 4 40 Group 5 40 Group 6 40 Substudy 2: Group 7 40 Patients With Compensated Group 8 40 Cirrhosis Week 24 GT4 ABT-450/r + ABT-267 Treatment-nave GT1b ABT-450/r + ABT-267 Treatment-nave GT1b ABT-450/r + ABT-267 Null Responders GT4 ABT-450/r + ABT-267 + rbv Treatment-nave GT4 ABT-450/r + ABT-267 Partial/Null Responders & Relapsers GT4 ABT-450/r + ABT-267 + rbv Partial/Null Responders & Relapsers GT1b ABT-450/r + ABT-267 Treatment-nave GT1b ABT-450/r + ABT-267 Partial/Null Responders & Relapsers Lawitz E, et al. Abstract #75, AASLD 2013

17 Percentage of Patients (%) Efficacy: Treatment-Nave Patients, ITT 100 97.6 97.6 95.2 42/42 41/42 41/42 40/42 100 80 60 40 20 0 Week 4 Week 12 (EOTR) SVR4 SVR12

Lawitz E, et al. Abstract #75, AASLD 2013 18 Percentage of Patients (%) Efficacy: Prior Null Responders, ITT 100 97.5 97.5 39/40 39/40 Week 4 Week 12 (EOTR) 92.5 90.0 37/40 36/40 80 60 40 20 0

SVR4 SVR12 Lawitz E, et al. Abstract #75, AASLD 2013 19 Treatment-Emergent Adverse Events (AEs) Occurring in >10% of Patients in Either Group GT1b-infected Treatment-nave Patients (N=42) GT1b-infected Prior Null Responders (N=40) Headache 14 (33.3) 10 (25.0) Nausea 8 (19.0) 0 Dry Skin 7 (16.7) 0

Fatigue 6 (14.3) 0 Pruritus 6 (14.3) 0 Diarrhea 6 (14.3) 0 Event, n (%) Lawitz E, et al. Abstract #75, AASLD 2013 20 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.

21 Study Design Wk 0 GT 2/3 (N=47) Wk 12 SOF + PEG/RBV Wk 24 Wk 36 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 22 Results: SVR12 by HCV Genotype 100 89

96 83 SVR12 (%) 80 60 40 20 0 42/47 22/23 20/24 Overall GT 2 GT 3 Lawitz E, et al. Abstract #LB-4, AASLD 2013 23 Results: SVR12 by Cirrhosis Status No Cirrhosis SVR12 (%) 100 100

Cirrhosis 93 80 83 83 10/12 10/12 60 40 20 9/9 0 13/14 GT 2 GT 3 Error bars represent 95% confidence intervals. Lawitz E, et al. Abstract #LB-4, AASLD 2013 24 Results: Adverse Events Patients, n (%) Overall safety

Hematologic abnormalities SOF + PEG/RBV 12 weeks (N=47) AEs 45 (96) Grade 3-4 AEs 15 (32) Serious AEs 4 (9) Treatment discontinuation due to AEs 2 (4) Grade 3-4 laboratory abnormality 28 (60) Hemoglobin <10 g/dL 13 (28) Hemoglobin <8.5 g/dL 4 (9) Absolute neutrophil count <750/mm3

13 (28) Platelets <50,000/mm3 7 (15) Lawitz E, et al. Abstract #LB-4, AASLD 2013 25 Conclusions SOF + PEG/RBV for 12 weeks demonstrated high efficacy in treatment-experienced GT 2/3 patients who have historically low response rates and limited treatment options SVR rates were similar in patients with and without cirrhosis SOF + PEG/RBV was generally safe and well tolerated Safety profile consistent with PEG/RBV treatment Low discontinuation rates Lawitz E, et al. Abstract #LB-4, AASLD 2013 26 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 Sollievo della Sofferenza" Hospital, San Giovanni Rotondo, Italy. 5. Medical University of Bialystok, Bialystok, Poland. 6. Gilead Sciences, Inc., Foster City, CA, United States. 7. Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden. 8. Academic Medical Center, Amsterdam, Netherlands. 9. Medical University of Vienna, Vienna, Austria. 10. Hpital Henri Mondor, Crteil, France. 11. Hospital Universitario Val dHebron, Barcelona, Spain. 27 VALENCE: Study Design Wk 0 Wk 12 Wk 24 SVR4, SVR12, SVR24 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

28 SVR12 in GT 2 Patients Treated for 12 Weeks 100 SVR12 (%) SVR12 (%) SVR12 in GT 2 and 3 Patients* 93 85 80 100 60 40 40 20 20 0 212/ 250 GT 2 SOF+RBV 12 wk GT 3

SOF+RBV 24 wk 100 91 88 80 60 68/73 97 0 29/30 2/2 30/33 7/8 Nave, Noncirrhotic Nave, 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 29 SVR12 in GT 3 Patients Treated for 24 Weeks SVR12 (%) 100 94 92 87 80 60 60 40 20 0 86/92 12/13 87/100 27/45 Nave,

Noncirrhotic Nave, Cirrhotic Experienced, Noncirrhotic Experienced, Cirrhotic Zeuzem S, et al. Abstract #1085, AASLD 2013 30 Abstract #212 All-Oral Therapy With Sofosbuvir Plus Ribavirin For the Treatment of HCV Genotype 1, 2, and 3 Infection in Patients Co-infected With HIV (PHOTON-1) Mark S. Sulkowski1, Maribel Rodriguez-Torres2, Jacob P. Lalezari3, W. Jeffrey Fessel4, Karam Mounzer5, Margaret C. Shuhart6, Anne Luetkemeyer7, David M. Asmuth8, Anuj Gaggar9, William T. Symonds9, John G. McHutchison9, Susanna Naggie10, Douglas T. Dieterich11 1. Johns Hopkins Medical Center, Baltimore, MD, United States. 2. Fundacion De Investigacion, San Juan, Puerto Rico, United States. 3. Quest Clinical Research, San Francisco, CA, United States. 4. Kaiser Permanente, San Francisco, CA, United States. 5. Philadelphia FIGHT, Philadelphia, PA, United States. 6. Harborview Medical Center, Seattle, WA, United States. 7. San Francisco General Hospital, San Francisco, CA, United States. 8. University of California Davis Medical Center, Sacramento, CA, United States. 9. Gilead Sciences, Inc., Foster City, CA, United States. 10. Duke Clinical Research Institute, Durham, NC, United States. 11. Mount Sinai School of Medicine, New York, NY, United States.

31 Study Design Wk 0 GT 1 TN 36 Wk 12 Wk 24 Wk 36 SVR12 SOF + RBV, n=114 GT 2/3 TN SOF + RBV, n=68 GT 2/3 TE SOF + RBV, n=41 SVR12 SVR12 Broad inclusion criteria Cirrhosis permitted with no platelet cutoff Hemoglobin: 12 mg/dL (males); 11 mg/dL (females) Wide range of ART regimens allowed Undetectable HIV RNA for >8 weeks on stable ART regimen

Baseline CD4 count ART treated: CD4 T-cell count >200 cells/mm3 ART untreated: CD4 T-cell count >500 cells/mm3 Sulkowski MS, et al. Abstract #212, AASLD 2013 32 Results: Virologic Response Patients with HCV RNA

60 40 20 0 110/114 103/103 87/114 Genotype 1 SOF + RBV 24 Weeks 25/26 22/23 23/26 Genotype 2 41/41 39/40 28/42 Genotype 3 SOF + RBV 12 Weeks Sulkowski MS, et al. Abstract #212, AASLD 2013 33 Results: Safety Summary SOF + RBV Patients, % AEs

24 Weeks (n=114) 12 Weeks (n=68) 93 84 36 13 14 16 11 12 11 13 7 3 0 35 21 13 18 9 10 12 10 7 4 1 AEs in 10% of patients Fatigue Insomnia

Headache Nausea Diarrhea Irritability URI Grade 3-4 AEs Serious AEs Treatment D/C due to AEs Death Sulkowski MS, et al. Abstract #212, AASLD 2013 34 Change in HIV-1 RNA from Baseline(%) HIV Safety 600 400 200 0 -200 1 2 4 6 8 10 12

16 20 24 Treatment Period (week) 4 12 Follow-up Two patients with transient HIV viral breakthrough Both with documented nonadherance to ART No decrease in CD4 T-cell % with SOF treatment Decrease in absolute CD4 T-cell number consistent with ribavirin-mediated decrease in lymphocyte counts Sulkowski MS, et al. Abstract #212, AASLD 2013 35 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. Universit Paris-Sud, Villejuif, France. 14. The Liver Unit, Barcelona, Spain. 36 Background Reinfection of the transplanted liver is universal in patients who are serum HCV RNA-positive at the time of transplantation Recurrence of HCV is the most common cause of mortality and graft loss following transplantation 1050% of patients with recurrent infection progress to cirrhosis within 5 years 1 Once cirrhosis is established, the probability of liver graft failure is 42% within 12 months2 Current therapies for HCV treatment used after transplantation have poor tolerance, poor efficacy, severe adverse reactions, and significant interactions with immunosuppression medications 1. Berenguer M, et al. Clin Liver Dis 2007;11:35576; 2. Berenguer M, et al. Hepatology 2002;36:202-10. Charlton MR, et al. Abstract #LB-2, AASLD 2013 37 Study Design and Objectives

Week 0 12 24 36 SOF 400 mg + RBV 4001200 mg (N=40) SVR12 Patients with recurrent HCV post-liver transplant, all genotypes Low, ascending-dose RBV regimen starting at 400 mg/day, escalated based on hemoglobin levels Study objectives Primary: sustained virologic response 12 weeks post treatment with sofosbuvir + RBV in liver transplant recipients Secondary: safety, tolerability and viral kinetics Charlton MR, et al. Abstract #LB-2, AASLD 2013 38 Key Inclusion/Exclusion Criteria Inclusion criteria Liver transplant 6 and 150 months prior to enrollment Treatment-nave or experienced CPT 7 and MELD 17 Primary or secondary, liver alone or liver-kidney transplant Absence of organ rejection Exclusion criteria Current signs of decompensation Use of corticosteriods at any dose >5 mg of prednisone/day

Charlton MR, et al. Abstract #LB-2, AASLD 2013 39 Results: Virologic Response Virologic Response Rate (%) 100 100 100 77 80 60 40 20 0 40/40 39/39 27/35 Week 4 EOT* SVR 4 *1 patient still on treatment; 4 patients have not reached SVR4 visit. Charlton MR, et al. Abstract #LB-2, AASLD 2013

40 Concomitant Immunosuppression 100 Patients (%) 80 70 60 35 40 28 25 20 0 5 28/40 14/40 11/40 10/40 2/40 Tacrolimus

Mycophenolate mofetil Prednisone Cyclosporin Azathioprine No interactions reported between SOF and any immunosuppressive agents during study 4 patients increased tacrolimus dosing during SOF therapy Charlton MR, et al. Abstract #LB-2, AASLD 2013 41 Results: Grade 3 and 4 Laboratory Abnormalities n (%) SOF + RBV N=40 Overall Grade 3 10 (25) Overall Grade 4 11 (28) Lymphocytes (4 G3; 9 G4) 13 (33) Hemoglobin (G3)

8 (20) Hyperglycemia (3 G3; 1 G4) 4 (10) White blood count (G3) 3 (8) Hyperbilirubinemia (G4) 1 (3) Lipase (G4) 1 (3) Neutrophil (G3) 1 (3) AST (G3) 1 (3) Charlton MR, et al. Abstract #LB-2, AASLD 2013 42

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