A Randomized Multicenter Study Comparing a Tacrolimus-Based Protocol with and without Steroids in HCV-Positive Liver Allograft Recipients

Table 3

Secondary study endpoints-full analysis set.

	TAC/DAC		TAC/STR
	N		N
Estimated rate of patients free of HCV recurrence*, %	67	19.1	68	13.8
Estimated rate of patients free of HCV recurrence, censored for antiviral treatment, %	67	20.2	68	13.1
Modified fibrosis staging^†, mean score (SD)	35	1.9 (1.2)	54	1.6 (0.7)
Stage 0, no. (%)		0		1 (1.7)
Stage 1, no. (%)		18 (41.9)		25 (43.1)
Stage 2, no. (%)		10 (23.3)		22 (37.9)
Stage 3, no. (%)		3 (7.0)		6 (10.3)
Stage 4, no. (%)		2 (4.7)		0
Stage 5, no. (%)		2 (4.7)		0
Stage 6, no. (%)		0		0
Modified HAI grading^‡, mean total score (SD)	35	6.7 (2.7)	54	6.5 (2.5)
Patient survival^§, %	67	83.1	68	95.5
Graft survival, %	67	80.1	68	91.1
Biopsy-proven acute rejection^¶, no. (%)	67	11 (16.4)	68	21 (30.9)
Treatment resistant, no. (%)		4 (6.0)		2 (2.9)
Treatment sensitive, no. (%)		3 (4.5)		7 (10.3)
Spontaneous resolution		4 (6.0)		14 (20.6)
Estimated freedom from biopsy-proven acute rejection^¶, %	67	78.4	68	66.1

HCV: hepatitis C virus; SD: standard deviation; HAI: histologic activity index.
*95% CI, −0.105 to 0.211%; 𝑃=0.020, Wilcoxon Gehan test.
^†Worst fibrosis staging per patient using the modified scoring system of Ishak et al. [19] in which a score of 6 is complete fibrosis. Central evaluation of nonprotocol biopsies and protocol biopsies (at 6 and 12 months) was used to assess fibrosis score.
^‡ Worst histological HCV grading per patient using the modified HAI grading [14]. Central evaluation of nonprotocol biopsies and protocol biopsies (at 6 and 12 months) was used to assess HAI grading.
^§95% CI (Greenwood formula) for the difference in 12-month patient survival was −0.227 to −0.019%, 𝑃=0.025.
^¶Local evaluation of biopsies. 𝑃=0.048, chi-square test comparing the numbers of patients.