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Table 2 Primary and secondary efficacy endpoints

From: A randomized, controlled study of peginterferon lambda-1a/ribavirin ± daclatasvir for hepatitis C virus genotype 2 or 3

Parameter,  % (n/N), except where indicated 24 weeks lambda/RBV N = 353 12 weeks lambda/RBV + DCV N = 349 24 weeks alfa/RBV N = 172
SVR12a 68 (240/353) 83 (288/349) 73 (126/172)
Treatment diff. (97.5 % CI)a −6 (−14.9, 3.4) 9 (0.3, 17.6) N/A
SVR12 genotype 3 64 (109/170) 75 (123/165) 73 (59/81)
Treatment diff. (97.5 % CI)a −9 (−22.3, 4.2) 1 (−11.5, 14.3) N/A
SVR12 genotype 3 with cirrhosis 29 (4/14) 43 (6/14) 50 (4/8)
SVR12 genotype 2 72 (131/183) 90 (165/184) 74 (67/91)
Treatment diff. (97.5 % CI) −3 (−15.5, 9.9) 16 (4.2, 27.2) N/A
SVR12 genotype 2 with cirrhosis 73 (8/11) 92 (11/12) 67 (4/6)
SVR24b 66 (232/353) 82 (285/349) 72 (123/172)
Treatment diff. (97.5 % CI)a −6 (−15.5, 2.9) 10 (1.1, 18.4) N/A
RVR 64 (227/353) 86 (299/349) 58 (99/172)
eRVR 59 (210/353) 83 (288/349) 56 (97/172)
cEVR 86 (302/353) 93 (324/349) 87 (150/172)
EOTR 86 (303/353) 95 (332/349) 92 (158/172)
Virologic breakthrough 5 (16/353) 1 (2/349) 2 (3/172)
Relapse 14 (51/353) 12 (43/349) 13 (23/172)
  1. alfa peginterferon alfa-2a, cEVR complete early virologic response, CI confidence interval, DCV daclatasvir, diff. difference, EOTR end-of-treatment response, eRVR extended rapid virologic response, Lambda peginterferon Lambda-1a, N/A not available, RBV ribavirin, RVR rapid virologic response, SVR12 sustained virologic response at post-treatment Week 12, SVR24 sustained virologic response at post-treatment Week 24
  2. aLambda-alfa difference adjusted for randomization strata. Non-inferior if lower CI bound is >−10 %; superior if both non-inferior and lower CI bound is >0 %
  3. bThe study was terminated before the 24 week follow-up visit of 14 patients with SVR12, hence SVR24 data for these 14 patients are unavailable