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

SpringerPlus

Table 2 Primary and secondary efficacy endpoints

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
SVR12^a	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)
SVR24^b	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)

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
^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 %
^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