*If RASs at baseline Harvoni x 12 wks 95% (83/87; ION-2) Zepatier + RBV x 12 wks Mavyret x 12 wks 92% (23/25; MAGELLAN-1)
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1 PATIENTS WITHOUT CIRRHOSIS GENOTYPE Naïve Harvoni x 8 wks (if HCV 97% (119/123; ION-3), 97% - HCV- Epclusa x 12 wks 98% (206/210; ASTRAL-1), RNA <6mill, F0-F2, No HIV) TARGET 99% (170/172; 1a Mavyret x 8 wks 99% (348/351; ENDURANCE-1) Harvoni x 12 wks 95%, Naive (179/180; ION-1, 206/216; ION-3) Zepatier x 12 wks 99% (133/135, C-EDGE TN) *if no RASs at baseline Peg/RBV experienced Epclusa x 12 wks 98% (206/210; ASTRAL-1), 99% Zepatier + RBV x 16 wks 97% (C-EDGE TE) (170/172; *if RASs at baseline Harvoni x 12 wks 95%, Exp (83/87; ION-2) Zepatier x 12 wks 99% (390/393, pooled data) Mavyret x 8 wks 99% (348/351; ENDURANCE-1) *if No RASs at baseline 1b Peg/RBV/PI experienced Epclusa x 12 wks 98% (206/210; ASTRAL-1) Zepatier + RBV x 16 wks *If RASs at baseline Harvoni x 12 wks 95% (83/87; ION-2) Zepatier + RBV x 12 wks 92% (23/25; MAGELLAN-1) *If No RASs at baseline SOF-experienced (no 97% (C-EDGE TE) 96% (C-SALVAGE) 99% (348/351; ENDURANCE-1) Epclusa + RBV x 12 wks 89% (39/44; POLARIS-4, w/o Vosevi x 12 wks 97% (35/36; POLARIS-4) RBV) NS5A-experienced Vosevi x 12 wks 97% (66/68; POLARIS-1) Mavyret x 16 wks (PI-naïve) 94% (16/17; MAGELLAN-1) Naïve Harvoni x 8 wks (if HCV RNA <6mill, F0-F2, No HIV) 97% (119/123; ION-3)97% - HCV-TARGET Epclusa x 12 wks 99% (117/118; ASTRAL-1), 97% (57/59); Mavyret x 8 wks 99% (348/351; ENDURANCE-1) Harvoni x 12 wks 95% (179/180; ION-1, 206/216; ION-3) Peg/RBV experienced Epclusa x 12 wks 99% (117/118; ASTRAL-1), 97% (57/59); Harvoni x 12 wks Mavyret x 8 wks Zepatier x 12 wks 95% (179/180; ION-1, 206/216; ION-3) 99% (348/351; ENDURANCE-1) 100%, (35/35,C-EDGE TE) Zepatier x 12 wks 98%, (129/131,C-EDGE) Peg/RBV/PI Experienced Epclusa x 12 wks 99% (117/118; ASTRAL-1) Zepatier + RBV x 12 wks 96% (C-SALVAGE) SOF-experienced (no Harvoni x 12 wks 95% (83/87; ION-2) 92% (23/25; MAGELLAN-1) 99% (348/351; ENDURANCE-1) Epclusa + RBV x 12 wks 95% (21/22; POLARIS-4, no RBV) NS5A-experienced Vosevi x 12 wks 100% (29/29; POLARIS-1) Mavyret x 16 wks (PI-naïve) 94% (16/17; MAGELLAN-1)
2 Genotype /6 Experienced (no prior SOF) Epclusa x 12 wks 100% (104/104; ASTRAL-1), 99% (133/134; ASTRAL-2), 100% (53/53; Mavyret x 8 wks 98% (193/197; SURVEYOR-2) SOF + DCV x 12 wks 100% (13/13), Ally-2, HIV/HCV SOF-Experienced 98% (193/197; SURVEYOR-2) Epclusa x 12 wks 97% (32/33; POLARIS-4) NS5A-experienced Vosevi x 12 wks 100% (5/5; POLARIS-1) Naïve Epclusa x 12 wks 98% (160/163; ASTRAL-3), 97% (86/89; prior SOF) SOF-experienced (no Mavyret x 8 wks 95% (149/157; ENDURANCE-3) Epclusa x 12 wks 94% (31/33; ASTRAL-3), 97% (86/89; Mavyret x 16 wks 95% (21/22; SURVEYOR-2) SOF + DCV x 12 wks 97% (73/75, ALLY-3) Mavyret x 16 wks 95% (21/22; SURVEYOR-2) Epclusa + RBV x 12 wks 85% (44/52; POLARIS-4, w/o Vosevi x 12 wks 96% (52/54; POLARIS-4) RBV) NS5A-experienced Vosevi x 12 wks 100% (22/22; POLARIS-1) Naïve Epclusa x 12 wks 100% (116/116; ASTRAL-1), 98% (56/57; Harvoni x 12 wks 93% (41/44, Study 1119, w/wo cirrhosis) P/R or SOF-Experienced (no prior NS5A or PI) Mavyret x 8 wks 93% (43/46; SURVEYOR-2, Part 4) Zepatier x 12 wks 97% (64/66, C-SCAPE, C-EDGE TN, C-EDGE CO INFXN, incl some cirrhotics) Epclusa x 12 wks 100% (116/116; ASTRAL-1), 98% (56/57; Harvoni x 12 wks 93% (41/44, Study 1119) Mavyret x 8 wks 93% (43/46; SURVEYOR-2, Part 4) Zepatier + RBV x 16 wks NS5A-experienced Vosevi x 12 wks 91% (20/22; POLARIS-1) P/R or SOF- prior NS5A or PI) Epclusa x 12 wks GT5: 97% (34/35; ASTRAL-1) GT6: 100% (41/41; ASTRAL-1, 9/9; Harvoni x 12 wks GT5: 93% (38/41) GT6: 96% (24/25; ELECTRON-2) NS5A-experienced Vosevi x 12 wks GT5: 100% (1/1; POLARIS-1) GT6: 100% (6/6; POLARIS-1) Mavyret x 8 wks 100% (8/8, C-EGDE TE) GT5: 100% (2/2; SURVEYOR-2, Part 4) GT6: 100% (10/10; SURVEYOR- 2, Part 4)
3 PATIENTS WITH COMPENSATED CIRRHOSIS 1a, (CP-A) GENOTYPE 1A Naïve Epclusa x 12 wks 100% (31/31; ASTRAL-1, all GT1 TN/Cirrhosis), 99% (170/172, POLARIS- 2, incl non-cirrhotic) Harvoni x 12 wks *add RBV if RAV at 28, 30, 31 or 93 99% (89/90, EXPEDITION-1) Zepatier x 12 wks *If No RASs at baseline Zepatier + RBV x 16 wks *If RASs at baseline 94% (32/35: ION-1), 96% 95% (C-EDGE TN) 97% (C-EDGE TE) Peg/RBV experienced Peg/RBV/PI experienced (no Epclusa x 12 wks 98% (41/42; ASTRAL-1, all GT1 TE/Cirrhosis, no RBV), 99% (170/172, POLARIS-2, incl non-cirrhotic) 99% (89/90, EXPEDITION-1) Zepatier x 12 wks *If No RASs at baseline Zepatier + RBV x 16 wks *If RASs at baseline Epclusa x 12 wks 98% (41/42; ASTRAL-1, all GT1 TE/Cirrhosis, no RBV) Harvoni x + RBV x 12 wks 96% (74/77; SIRIUS), 96% 94% (C-EDGE, TE) 97% (C-EDGE TE) Harvoni x + RBV x 12 wks 96% (74/77; SIRIUS), 96% Zepatier + RBV x 12 wks *If No RASs at baseline 92% (23/25; MAGELLAN-1) Zepatier + RBV x 16 wks *If RASs at baseline 96% (76/79, C-SALVAGE) 97% (C-EDGE TE) Prior SOF (no prior NS5A) 99% (89/90, EXPEDITION-1) Vosevi x 12 wks 97% (35/36; POLARIS-4, incl noncirrhotic) NS5A-experienced Vosevi x 12 wks 94% (31/33; POLARIS-1) Mavyret x 16 wks (PI-naïve) 94% (16/17; MAGELLAN-1)
4 GENOTYPE 1B 1b, (CP-A) Naïve Epclusa x 12 wks 100% (31/31; ASTRAL-1, all GT1 TN/Cirrhosis), 97% (57/59; Harvoni x 12 wks 94% (32/35: ION-1), 96% 99% (89/90, EXPEDITION-1) Zepatier x 12 wks 95% (C-EDGE TN) Peg/RBV failure Epclusa x 12 wks 98% (41/42; ASTRAL-1, all GT1 TE/Cirrhosis, no RBV), 97% (57/59; Harvoni + RBV x 12 wks 96% (74/77; SIRIUS), 96% 99% (89/90, EXPEDITION-1) Zepatier x 12 wks Peg/RBV/PI failure Epclusa x 12 wks 94% (C-EDGE TE) 98% (41/42; ASTRAL-1, all GT1 TE/Cirrhosis, no RBV) Harvoni x + RBV x 12 wks 96% (74/77; SIRIUS), 96% Zepatier + RBV x 12 wks 96% (76/79, C-SALVAGE) 92% (23/25; MAGELLAN-1) Peg/RBV/SOF or SOF/RBV failure (excludes NS5A failure) Epclusa + RBV x 12 wks 95% (21/22; POLARIS-4, incl noncirrhotics, no RBV) 99% (89/90, EXPEDITION-1) NS5A-experienced Vosevi x 12 wks 100% (16/16; POLARIS-1) Mavyret x 16 wks (PI-naïve) 94% (16/17; MAGELLAN-1)
5 (CP A) prior SOF) GENOTYPE 2 Epclusa x 12 wks 100% (29/29; ASTRAL-1, ASTRAL-2, TN/TE) 100% (31/31; EXPEDITION-1) SOF/RBV failure 100% (31/31; EXPEDITION-1) Epclusa + RBV x 12 wks 97% (32/33: POLARIS-4, incl non-cirrhotics, no RBV) NS5A-experienced Vosevi x 12 wks 100% (5/5; POLARIS-1, all were noncirrhotic) (CP A) Naive GENOTYPE 3 Epclusa 12 wks *if Y93+ add RBV 93% (40/43; ASTRAL-3, no RBV), 99% (76/77; POLARIS-3) 98% (39/40, SURVEYOR-2 Part 3) prior SOF exposure) SOF Experienced (no prior NS5A exposure) Mavyret x 16 wks 98% (39/40, SURVEYOR-2 Part 3) Epclusa +RBV x 12 wks 89% (33/37; ASTRAL-3, no RBV), 91% (29/32; POLARIS- 3, w/o RBV) Vosevi x 12 wks 98% (106/110, POLARIS-3, 8wk duration, incl some TN and noncirrhotics) Mavyret x 16 wks 98% (39/40, SURVEYOR-2 Part 3) Epclusa +RBV x 12 wks *If Y93+ consider extension Vosevi x 12 wks 96% (52/54; POLARIS-4) to 24 weeks 85% (44/52; POLARIS-4, w/o RBV) NS5A-experienced Vosevi x 12 wks *if Y93+ add RBV 93% (52/56; POLARIS-1)
6 (CP A) GENOTYPE 4 Naïve Epclusa x 12 wks 100% (27/27; ASTRAL-1), 98% (56/57; POLARIS-2, incl non-cirrhotics) 100% (16/16; EXPEDITION-1) Harvoni x + RBV x 12 wks 93% (41/44, Study 1119, Zepatier x 12 wks 97% (64/66, C-SCAPE, C-EDGE) w/wo cirrhosis, no ribavirin). Peg/RBV experienced Epclusa x 12 wks 100% (27/27; ASTRAL-1, no RBV), 98% (56/57; POLARIS-2, incl non-cirrhotics, no RBV) Harvoni x + RBV x 12 wks 93% (41/44, Study 1119, w/wo cirrhosis, no ribavirin). Zepatier + RBV x 16 wks 100% (8/8, C-EDGE TE) NS5A-experienced Vosevi x 12 wks 85% (12/14; POLARIS-1) (CP A) Experienced (No GENOTYPE 5 and 6 Epclusa x 12 weeks GT5: 100% (5/5, ASTRAL-1) GT6: 100% (6/6, ASTRAL-1) GT5: 100% (2/2; EXPEDITION-1) Harvoni x 12 wks GT6: 96% (24/25; ELECTRON- 2. Two TE pts and two w/ cirrhosis, no RBV) GT6: 100% (7/7; EXPEDITION-1) NS5A-experienced Vosevi x 12 wks GT5: 100% (1/1; POLARIS-1, all noncirrhotic) GT6: 100% (6/6; POLARIS-1, all noncirrhotic) *NS5A RASs significant for Zepatier at positions 28, 30, 31 or 93.
7 prior SOF exposure) Experienced, SOF failure (excludes NS5A failure) PATIENTS WITH DECOMPENSATED CIRRHOSIS GENOTYPE 1a or 1b Epclusa + RBV x 12 wks Harvoni x + RBV x 12 wks 1a: 94% (51/54; ASTRAL-4) 1b: 100% (14/14; ASTRAL-4) CTP B x 12wks: 87% (45/52; SOLAR-1) CTP C x 12 wks: 88% (35/40; SOLAR-1) Epclusa x 24 wks (if unable to take RBV) Harvoni x 24 wks (if unable to take RBV) Epclusa + RBV x 24 wks No Data Harvoni + RBV x 24 wks No Data GENOTYPE 2 1a: 93% (51/55; ASTRAL-4) 1b: 88% (14/16; ASTRAL-4) No Data w/o RBV CTP B x 24 wks (w/rbv): 92% (48/52; SOLAR-1) CTP C x 24 wks (w/rbv): 82% (38/46; SOLAR-1) Epclusa + RBV x 12 wks 100% (4/4; ASTRAL-4) SOF + DCV + RBV x wks 12 wks with RBV, Ally-1: CP-B 100% (2/2) CP-C 50% (1/2) GENOTYPE 3 Epclusa + RBV x 12 wks 85% (11/13; ASTRAL-4) SOF + DCV + RBV x 24 wks CP-B: 86% (12/14), w/rbv, 80% (12/15), w/o RBV, EU CUP, Welzel CP-C: 100% (2/2), w/rbv, 75% (6/8), w/o RBV, EU CUP, Welzel CP-B/C: 71% (12/17) w/o RBV, 70% (7/10) w/rbv, French Comp Access, 24 wks
8 Experienced Experienced GENOTYPE 4 Epclusa + RBV x 12 wks 100% (2/2; ASTRAL-4) Epclusa x 24 wks (if unable to take RBV) Harvoni x + RBV x 12 wks 93% (41/44, Study 1119, w/wo cirrhosis, no ribavirin). GENOTYPE 6 Harvoni x 24 wks (if unable to take RBV) 100% (2/2; ASTRAL-4) No data SOF + DCV + RBV x 24 wks CP-A/B/C: 100% (5/5), w/rbv, 100% (4/4), w/o RBV. EU CUP (SVR results did not break down by CP score) Epclusa + RBV x 12 wks No Data. Epclusa x 24 wks (if unable to take RBV) 100% (1/1; ASTRAL-4)
9 WITHOUT ribavirin PRE-HCV TREATMENT WORK UP Labs WITH ribavirin Required: HCV Genotype, HCV RNA, Liver/kidney panel, CBC, HIV, Hep A/B serologies and Baseline RAV testing (NS5A) to determine need for RBV and/or duration for: Genotype 3: naïve patients with cirrhosis and need to use Epclusa NS5A-experienced patients with cirrhosis where using Vosevi Genotype 1a: All patients if considering Zepatier Naïve patients with cirrhosis where you have to use Harvoni Consider: INR, HgbA1C, Lipid panel, vitamin A and D levels, cryoglobulins, UA, SPEP Labs Cardiac Eye exam Required: HCV Genotype, HCV RNA, Liver/kidney panel, CBC, HIV, uric Acid, Iron studies Hep A/B serologies and Baseline RAV testing (NS5A) to determine need for RBV and/or duration for: Genotype 3: naïve patients with cirrhosis and need to use Epclusa NS5A-experienced patients with cirrhosis where using Vosevi Genotype 1a: All patients if considering Zepatier Naïve patients with cirrhosis where you have to use Harvoni Consider: INR, HgbA1C, Lipid panel, vitamin A and D levels, cryoglobulins, UA, SPEP Consider Stress test based on risk factors and/or Framingham CHD risk score Not required, unless patient is Diabetic, has uncontrolled hypertension or has history of retinal problems Psychiatric If significant psych history, should have stable disease and be connected with psych providers prior to starting treatment Patients who relapse after DAA regimen: All: Repeat HCV Genotype to determine if patient had dual-strain infection or was reinfected NS5A or NS3/4A failure: 1. Order HCV Resistance testing if available for genotype (currently available for genotype 1 and 3). Recommend present DAA relapse cases at ECHO clinic.
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