LAUSR

193 • HCV NS3/4A protease inhibitor • 50 mg per tablet • HCV NS5A next-generation inhibitor • 30 mg per tablet • HCV NS5B polymerase nucleotide inhibitor • 225 mg per tablet Ruzasvir (MK-8408) Grazoprevir (MK-5172) MK-3682 C-SURGE: MK-3682/Grazoprevir/Ruzasvir • MK3 is a three-drug regimen formulated into a fixed-dose combination tablet. The regimen is given as two tablets, once-daily, without regard to food • Triplet also called MK-3682B Lawitz E, et al. 67th AASLD; Boston, MA; November 11-15, 2016; Abst. 110. C-SURGE: Study Design • This multicenter, open-label trial randomized 94 HCV GT1infected patients who relapsed after a regimen of LDV/SOF or EBR/GZR (randomized 1:1; stratified by GT1a/1b and cirrhosis) MK-3682 + GZR + RZR + RBV† (16 weeks), n=45 MK-3682 + GZR + RZR (24 weeks), n=49 TW8 TW16 TW24 FW12 D1 SVR12 1° Endpoint Wyles D, et al. 67th AASLD; Boston, MA; November 11-15, 2016; Abst. 193. C-SURGE: Study Demographics Demographics 16 Weeks + RBV, n=44* 24 Weeks without RBV, n=49 Overall GT1 N=93* Male, n (%) 37 (84) 43 (88) 80 (86) Age, median years, (range) 61.0 (33 to 70) 60.0 (25 to 71) 60.0 (25 to 71) Race, White, n (%) 31 (71) 37 (76) 68 (73) HCV Genotype 1a, n (%) 40 (90) 40 (82) 80 (86) Non-cirrhotic, n (%) Cirrhotic, n (%) 25 (57) 19 (43) 29 (6) 20 (41) 54 (58) 39 (42) NS5A RAVs at baseline, n (%)† NS3 RAVs at baseline, n (%)‡ 32 (79) 25 (57) 46 (94) 35 (71) 78 (84) 60 (65) Baseline HCV RNA >800,00 IU/mL, n (%) 35 (80) 44 (90) 79 (85) Median baseline HCV RNA (log10 IU/mL) 6.5 6.4 6.5 Previously failed: 12 – 24 weeks of LDV/SOF 8 weeks of LDV/SOF 12 weeks of EBR/GZR 26 (59) 9 (21) 9 (21) 31 (63) 5 (10) 13 (27) 57 (61) 14 (15) 22 (24) RAVs detected by next generation sequencing performed with a 15% sensitivity threshold. * Does not include 1 patient in the 16 week + RBV arm who withdrew prior to beginning treatment. Cirrhosis = Liver biopsy at any time showing cirrhosis, Fibroscan result of >12,5kPa within 12 months of enrollment, or Fibrotest >0.75 and APRI >2 at time of enrollment † NS5A RAVs = any change from wild-type at 4 positions (28, 30, 31, or 93) ‡ NS3 RAVs = any change from wild-type at 14 positions ( 36, 54, 55, 56, 80, 107, 122, 132, 155, 156, 158, 168, 170, or 175) Wyles D, et al. 67th AASLD; Boston, MA; November 11-15, 2016; Abst. 193. C-SURGE: Results – Efficacy (Full Analysis Set) Wyles D, et al. 67th AASLD; Boston, MA; November 11-15, 2016; Abst. 193. 91 98 98 92 100 100 0 10 20 30 40 50 60 70 80 90 100 TW4 SVR4 SVR8 Pe rc en t o f P at ie nt s w ith H C V R N A <1 5 IU /m L 16 Weeks + RBV 24 Weeks without RBV C-SURGE: Efficacy (mFAS*) TW =treatment week; SVR4 = % of patients with HCV RNA <15 IU/mL at 4 weeks after end of treatment *Excludes 1 patient from the 16-week + RBV arm who withdrew after receiving 3 doses of study medication 93 100 100 92 100 100 0 10 20 30 40 50 60 70 80 90 100 TW4 SVR4 SVR8 Pe rc en ta ge o f P at ie nt s w ith H C V R N A <1 5 IU /m L 16 Weeks + RBV 24 Weeks without RBV 40 43 45 49 43 43 38 38 43 43 30 30 Wyles D, et al. 67th AASLD; Boston, MA; November 11-15, 2016; Abst. 193. C-SURGE: No Impact of Baseline NS5A or NS3 RAVs on SVR4 (Resistance Analysis Population) 100% 100% 100% 100% 100% 100% 100% 100% 0% 20% 40% 60% 80% 100% 16 Weeks + RBV 24 Weeks 16 Weeks + RBV 24 Weeks SV R 4 Patients without RAVs Patients with RAVs 35 35 3 3 28 28 10 10 31 31 12 12 24 24 19 19 Wyles D, et al. 67th AASLD; Boston, MA; November 11-15, 2016; Abst. 193. No RAVS 12/43 28% RAVs 31/43 72% No RAVS 19/43 44% RAVs 24/43 56% No RAVS 10/38 26% RAVs 28/38 74% PR EV A LE N C E NS5A NS3 16 Weeks + RBV 16 Weeks + RBV 24 Weeks 24 Weeks