TABLE 2.

HCV Recurrence 120 Weeks After Randomization (the ITT and PP Populations)

	ITT Population at Week 120		PP Treatment Completers Within 120 Weeks*
	Prophylaxis Arm (n = 55)	Observation Arm (n = 60)	Prophylaxis Arm (n = 25)	Observation Arm (n = 37)
Patients, n (%)†	34 (61.8)	39 (65.0)	4 (16.0)	15 (40.5)
95% confidence interval (%)	49.0-74.7	52.9-77.1	1.6-30.4	24.7-56.4
Difference (prophylaxis – observation) (%)		−3.2		−24.5
95% confidence interval for difference (%)		−20.8 to 14.4		−45.9 to −3.2
P value‡		0.725		0.041
Genotype, n/X (%)§
Type 1	25/43 (58.1)	31/48 (64.6)	3/21 (14.3)	13/30 (43.3)
Not type 1	9/12 (75.0)	7/11 (63.6)	1/4 (25.0)	2/6 (33.3)

NOTE: HCV recurrence was determined with the Batts-Ludwig system and was defined as an HAI inflammation grade ≥ 3 and/or a fibrosis score ≥ 2.

^*At any point after the baseline.

^†n refers to the number of patients with histologically confirmed HCV recurrence. The percentages are based on the number of patients in each study arm.

^‡The P values were calculated with the Cochran-Mantel-Haenszel general association test, which was used to compare the prophylaxis and observation arms. The 95% confidence intervals were calculated with normal approximation.

^§n refers to the number of patients with histologically confirmed HCV recurrence, and X refers to the number of randomized patients. The percentages are based on the number of patients in each genotype group. Genotype data were missing for 1 patient in the observation arm.