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Table 2 Virologic responses according to therapeutic regimens

From: Safety and efficacy of the combination simeprevir-sofosbuvir in HCV genotype 1- and 4-mono-infected patients from the French ANRS CO22 hepather cohort

  TOTAL N = 599 Sofosbuvir + simeprevir Sofosbuvir + simeprevir + ribavirin Fisher p value CMH p value (strati-fication: 12 weeks vs 24 weeks) CMH p value (strati-fication: RBV vs no RBV)
12 weeks n = 485 24 weeks n = 51 12 weeks n = 45 24 weeks n = 18
Negative HCV RNA
 Week 12 n/N (%) 519/576 (90) 422/469 (90) 41/47 (87) 43/44 (98) 13/16 (81) 0.1312 0.2779 0.1514
 Week 24n/N (%) 60/65 (92)   44/49 (90)   16/16 (100) 0.3219 0.1869  
 Follow up week 4n/N (%) 277/570 (49) 318/341 (93) 30/31 (97) 39/40 (98) 13/13 (100) 0.7525 0.2341 0.3669
 SVR 12 (imputeda) n/N (%) 555/599 (93) 449/485 (93) 46/51 (90) 44/45 (98) 16/18 (89) 0.3742 0.3197 0.2538
 SVR 24 n/N (%) 459/473 (97) 374/385 (97) 38/40 (95) 37/38 (97) 10/10 (100) 0.7360 0.6713 0.6102
 SVR 12 in non cirrhotic patients n/N (%) 244/257 (95) 206/219 (94) 18/18 (100) 18/18 (100) 2/2 (100) 0.5937 0.2887 0.2887
 SVR 12 in cirrhotic patients n/N (%) 304/335 (91) 236/259 (91) 28/33 (85) 26/27 (96) 14/16 (88) 0.4043 0.3882 0.1293
 SVR 12 in treatment naïve patientsn/N (%) 160/173 (92) 130/141 (92) 12/13 (92) 14/14 (100) 4/5 (80) 0.3637 0.6195 0.4809
 SVR 12 in treatment experienced patients n/N (%) 395/426 (93) 319/344 (93) 34/38 (89) 30/31 (97) 12/13 (92) 0.6749 0.3874 0.3635
Last treatment
 PEG/RBV n/N (%) 365/394 (93) 300/324 (93) 32/35 (91) 24/25 (96) 9/10 (90) 0.8073 0.6462 0.6214
 First generation PI/PEG/RBV n/N (%) 30/32 (94) 19/20 (95) 2/3 (67) 6/6 (100) 3/3 (100) 0.3750 0.2637 0.1122
Response profile
 Not respondersn/N (%) 108/117 (92) 87/94 (93) 8/9 (89) 9/10 (90) 4/4 (100) 0.6151 0.9339 0.9864
 Respondersb n/N (%) 99/102 (97) 84/86 (98) 8/9 (89) 4/4 (100) 3/3 (100) 0.4040 0.5154 0.1537
 Unknown n/N (%) 188/207 (91) 148/164 (90) 18/20 (90) 17/17 (100) 5/6 (83) 0.4343 0.3647 0.5569
 SVR 12 in Cirrhotic Treatment experienced patients n/N(%) 230/258 (89) 178/200 (89) 23/27 (85) 18/19 (95) 11/12 (92) 0.8219 0.3407 0.5044
 SVR 12 in patients with genotype 1a n/N (%) 127/141 (90) 99/110 (90) 10/11 (91) 13/14 (93) 5/6 (83) 0.8660 0.9608 0.7862
 SVR 12 in patients with genotype 1b infection n/N (%) 280/297 (94) 237/251 (94) 20/22 (91) 18/18 (100) 5/6 (83) 0.2403 0.6111 0.2015
 SVR 12 in patients with genotype 4 infection n/N (%) 121/132 (92) 89/99 (90) 16/17 (94) 10/10 (100) 6/6 (100) 0.9150 0.2283 0.5850
 SVR 12 in patients with genotype 1 not subtyped n/N (%) 27/29 (93) 24/25 (96) 0/1 (0) 3/3 (100)   0.0764 0.7290 0.0005
  1. HCV Hepatitis C Virus, SVR Sustain virological response, PI Protease inhibitor, RBV Ribavirin, PEG Pegylated interferon.
  2. aimputed: missing SVR12 measurements were imputed using SVR24 measurement if available (n = 52), otherwise using SVR4 measurement (n = 6). We imputed a virological failure in patients who died before SVR12 and therefore could not be evaluated (n = 4) and in patients who were lost of follow up (n = 7) and had no measurement of the virological response after end of therapy. b responders = patients with negative HCV RNA on last treatment - includes one patient with sustained virological response who was re-infected