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1 Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Ira M. Jacobson, Eric Lawitz, Edward J. Gane, et al. Sofosbuvir, Velpatasvir, and Voxilaprevir for 8 weeks for Chronic HCV 1
2 Table of contents POLARIS-2 Study Investigators... 3 POLARIS-3 Study Investigators... 4 Table S1. Reasons for Screen Failure: POLARIS Table S2. Reasons for Screen Failure: POLARIS Figure S1. Patient disposition: POLARIS Figure S2. Patient disposition: POLARIS Table S3. Characteristics of patients who relapsed in POLARIS Table S4. Characteristics of patients who relapsed in POLARIS Table S5. SVR12 rates in POLARIS-2 and POLARIS-3 by baseline resistance Table S6. Serious adverse events in POLARIS Table S7. Serious adverse events in POLARIS Table S8. Grade 3 and 4 adverse events in POLARIS Table S9. Grade 3 and 4 adverse events in POLARIS Table S10. Grade 3 and 4 laboratory abnormalities in POLARIS Table S11. Grade 3 and 4 laboratory abnormalities in POLARIS
3 POLARIS-2 Study Investigators Australia Stuart Roberts, Gregory Dore, Wendy Cheng, Barbara Leggett, Alexander Thompson Canada Stephen Shafran, Brian Conway, Bernard Willems, Curtis Cooper, Alnoor Ramji, Jordan Feld, Sergio Borgia, Stephen Congly France Marc Bourliere, Stanislas Pol, Didier Samuel, Victor de Ledinghen, Danielle Botta-Fridlund, Ghassan Riachi, Christophe Hezode, Fabien Zoulim, Jean-Pierre Bronowicki, François Habersetzer, Philippe Mathurin, Dominique Guyader, Jean-Didier Grange, Véronique Loustaud Ratti, Vlad Ratziu, Lawrence Serfaty, Albert Tran, Xavier Causse, Dominique Larrey, Laurent Alric, Dominique Roulot, Tarik Asselah, Armando Abergel, Vincent Leroy, Sophie Metivier Germany Peter Buggisch, Stefan Zeuzem, Thomas Berg, Tobias Goeser, Ulrich Spengler, HeinerWedemeyer New Zealand Edward Gane, Catherine Stedman Puerto Rico Grissel Ortiz-Lasanta United Kingdom Stephen Ryder, Graham Foster, Ashley Brown, Kosh Agarwal, Andrew Ustianowski, Richard Aspinall, Jane Collier, Daniel Forton United States of America Adrian DiBisceglie, Mitchell Shiffman, Myron Tong, Peter Ruane, Eugene Schiff, Michael Bennett, Robert Brown Jr., Gregory Everson, Stuart Gordon, Ilan Weisberg, Kris Kowdley, Anna Lok, David Bernstein, Sergio Rojter, Michael Charlton, Lisa Nyberg, Raymond Chung, John Vierling, Marco Lacerda, Mandana Khalili, Steven Flamm, Raymond Rubin, William Smith, Mark Sulkowski, Tram Tran, Michael Curry, James Levin, Norman Gitlin, Rajender Reddy, Kimberly Workowski, Natarajan Ravendhran, Ronald Nahass, Michael Ryan, Eric Lawitz, Ziad Younes, Arun Sanyal, Federico Hinestrosa, Mindie Nguyen, Giuseppe Morelli, Bradley Freilich, Marcelo Kugelmas, Bal Raj Bhandari, Aasim Sheikh, Thomas Sepe, Mitchell Davis, David Pound, Constance Benson, Norbert Brau, Robert Herring, Timothy Morgan, John Poulos, Charles Landis, Zeid Kayali, Mordechai Rabinovitz, Shyamasundaran Kottilil, James Cooper, Brian Pearlman, Obaid Shaikh, William Harlan III, Elizabeth Verna, Ritu Agarwal, Hays Arnold, Ira Jacobson, Paul Kwo, David Wyles 3
4 POLARIS-3 Study Investigators Australia Simone Strasser, Stuart Roberts, Gregory Dore, Stephen Pianko, Barbara Leggett, Alexander Thompson Canada Stephen Shafran, Brian Conway, Alnoor Ramji, Jordan Feld, Sergio Borgia, Stephen Congly France Marc Bourliere, Stanislas Pol, Victor de Ledinghen, Danielle Botta-Fridlund, Christophe Hezode, Fabien Zoulim, Jean-Pierre Bronowicki, François Habersetzer, Dominique Guyader, Véronique Loustaud Ratti, Lawrence Serfaty, Albert Tran, Dominique Larrey, Dominique Roulot, Tarik Asselah, Armando Abergel, Pascal Potier Germany Peter Buggisch, Stefan Zeuzem, Thomas Berg, Tobias Goeser, Ulrich Spengler, HeinerWedemeyer New Zealand Edward Gane, Catherine Stedman Puerto Rico Grisell Ortiz-Lasanta United Kingdom Stephen Ryder, Kosh Agarwal, Andrew Ustianowski, Richard Aspinall, Jane Collier, Daniel Forton United States of America Mitchell Shiffman, Peter Ruane, Eugene Schiff, Michael Bennett, Stuart Gordon, Ilan Weisberg, Kris Kowdley, Anna Lok, Sergio Rojter, Michael Charlton, Lisa Nyberg, Raymond Chung, Mandana Khalili, Raymond Rubin, Gregory Everson, Mark Sulkowski, Tram Tran, Norman Gitlin, Kimberly Workowski, Natarajan Ravendhran, Ronald Nahass, Michael Ryan, Eric Lawitz, Arun Sanyal, Mindie Nguyen, Bal Raj Bhandari, Thomas Sepe, Mitchell Davis, David Pound, Norbert Brau, Robert Herring, Timothy Morgan, John Poulos, Charles Landis, Zeid Kayali, Mordechai Rabinovitz, Shyamasundaran Kottilil, Meena Bansal, Brian Pearlman, William Harlan III 4
5 Table S1. Reasons for screen failure: POLARIS-2 5
6 Table S2. Reasons for screen failure: POLARIS-3 6
7 Figure S1. Patient disposition: POLARIS screened 173 were not randomized/enrolled 943 randomized/enrolled 502 randomized/enrolled to receive sofosbuvir-velpatasvirvoxilaprevir for 8 weeks 441 randomized to receive sofosbuvir-velpatasvir for 12 weeks 501 began treatment 440 began treatment 1 discontinued treatment due to pregnancy 3 discontinued treatment 2 due to adverse event 1 lost to follow-up 500 completed treatment 437 completed treatment 501 assessed for efficacy 440 assessed for efficacy 7
8 Figure S2. Patient disposition: POLARIS screened 95 were not randomized/enrolled 220 randomized/enrolled 110 randomized/enrolled to receive sofosbuvir-velpatasvirvoxilaprevir for 8 weeks 110 randomized to receive sofosbuvir-velpatasvir for 12 weeks 110 began treatment 109 began treatment 2 discontinued treatment 1 due to adverse event 1 due to lack of efficacy 110 completed treatment 107 completed treatment 110 assessed for efficacy 109 assessed for efficacy 8
9 Table S3. Characteristics of patients who relapsed in POLARIS-2 Age Sex Race BMI (kg/m 2 ) Genotype Sofosbuvir-velpatasvir-voxilaprevir for 8 weeks Cirrhosis IL28B HCV RNA Treatment history NS3 RASs* NS5A RASs* BL Relapse BL Relapse 46 M White a No TT 7.0 Naïve Q80K Q80K None None 61 F White a No CT 6.6 Naïve Q80K Q80K None None 62 M Black a Yes CT 7.0 Naïve Q80K Q80K None None 60 M White a Yes CT 6.6 Naïve Q80K Q80K None None 59 F White a No CT 6.6 Naïve Q80K Q80K None None 55 M White a No CT 7.2 Naïve Q80K Q80K None None 68 M White a Yes CT 6.1 Naïve Q80L Q80L None None 47 F A/W a No CT 6.0 Naïve V55A V55A None None 54 M White a No CT 6.4 Naïve Q80K None None None 60 M White a No CT 7.1 Naïve None None Q30Q/H Q30R, L31M 58 F White a Yes TT 6.8 Peg/Rbv None None None None 56 M White a No CT 6.5 Peg/Rbv None None None None 62 F White a Yes CT 7.1 Peg/Rbv None None None None 62 M Black a No TT 6.8 Naïve None None None None 63 F White b No CT 6.7 Naïve None None L31M L31M 64 M Black b Yes TT 6.6 Peg/Rbv None None L31M L31M 60 M White a No CT 5.5 Naïve None None L31M L31M 72 M White c No CC 7.2 Peg/Rbv None None T24S T24S 56 F White a No CT 6.1 Peg/Rbv None None None None 53 M White d Yes CC 7.2 Naïve None None L30R L30R 63 M White a No CT 7.1 Peg/Rbv D168D/E None None None Sofosbuvir-velpatasvir for 12 weeks 60 M PI a Yes CT 6.1 Naïve None None None Y93N 55 M White b No CC 7.2 Naïve None None L31M,Y93H L31M,Y93H 74 F White a No CT 6.4 Naïve None None None None A/W=Asian White; PI=Pacific Islander; Peg/Rbv=peginterferon + ribavirin; BL=baseline; BMI=body mass index. *Using a 15% reporting threshold. 9
10 Table S4. Characteristics of patients who relapsed in POLARIS-3 Age Sex Race BMI Genotype Cirrhosis IL28B HCV RNA Treatment history NS3 RASs* NS5A RASs* BL Relapse BL Relapse Sofosbuvir-velpatasvir-voxilaprevir for 8 weeks 56 M White a Yes CT 5.8 Peg/Rbv None None None None 59 M White a Yes CT 6.2 Naïve None None None None Sofosbuvir-velpatasvir for 12 weeks 31 M White a Yes CT 5.2 Peg/Rbv None None None Y93Y/H 61 F White a Yes CT 6.3 Peg/Rbv None None None Y93H Peg/Rbv=peginterferon + ribavirin; BL=baseline; BMI=body mass index. *Using a 15% reporting threshold. 10
11 Table S5. SVR12 rates in POLARIS-2 and POLARIS-3 by baseline resistance POLARIS-2 POLARIS-3 8 Wk of Sofosbuvir, Velpatasvir and Voxilaprevir (N=497) 12 Wk of Sofosbuvir and Velpatasvir (N=435) 8 Wk of Sofosbuvir, Velpatasvir and Voxilaprevir (N=108) 12 Wk of Sofosbuvir and Velpatasvir (N=107) No NS3 or NS5A RASs 223/228 (98) 206/208 (99) 80/82 (98) 76/78 (97) Any NS3 or NS5A RASs 234/250 (94) 217/218 (>99) 23/23 (100) 23/23 (100) NS3 Only 100/110 (91) 97/97 (100) 2/2 (100) 4/4 (100) NS5A Only 114/120 (95) 90/91 (99) 20/20 (100) 19/19 (100) NS3 and NS5A 20/20 (100) 30/30 (100) 1/1 (100) 0 RASs Not Determined for Both NS3 and NS5A 19/19 (100) 9/9 (100) 3/3 (100) 6/6 (100) *Using a 15% reporting threshold. Patients who did not have observed virologic failure (ie, those who were lost to follow-up or withdrew consent) are excluded from this analysis. 11
12 Table S6. Serious adverse events in POLARIS-2 12
13 Table S7. Serious adverse events in POLARIS-3 13
14 Table S8. Grade 3 and 4 adverse events in POLARIS-2 14
15 Table S9. Grade 3 and 4 adverse events in POLARIS-3 15
16 Table S10. Grade 3 and 4 laboratory abnormalities in POLARIS-2 16
17 Table S10. Grade 3 and 4 laboratory abnormalities in POLARIS-2 (continued) 17
18 Table S11. Grade 3 and 4 laboratory abnormalities in POLARIS-3 18
19 Table S10. Grade 3 and 4 laboratory abnormalities in POLARIS-3 (continued) 19
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