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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
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BMC Infectious Diseases

ISSN: 1471-2334

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