Hepatic safety in subjects with HIV-1 and hepatitis C and/or B virus: a randomized, double-blind study of maraviroc versus placebo in combination with antiretroviral agents

Figures & data

Figure 1. Subject disposition through week 48. AE, adverse event.

Table 1. Demographic and baseline characteristics

	Maraviroc (N = 70)	Placebo (N = 67)	Total (N = 137)
Age (years)
Mean (SD)	47.9 (9.0)	48.7 (7.2)	48.3 (8.1)
Range	28–75	33–62	28–75
Gender (%)
Female	10 (14.3)	10 (14.9)	20 (14.6)
Male	60 (85.7)	57 (85.1)	117 (85.4)
Race (%)^a
White	53 (75.7)	56 (83.6)	109 (79.6)
Black	14 (20.0)	10 (14.9)	24 (17.5)
Other	3 (4.3)	1 (1.5)	4 (2.9)
Co-infection status, n (%)
HBV co-infection^b	22 (31.4)	22 (32.8)	44 (32.1)
HCV co-infection^c	47 (67.1)	47 (70.1)	94 (68.6)
HBC + HCV co-infection	0	2 (3.0)	2 (1.5)
Baseline total bilirubin, n (%)^d
Normal	66 (94.3)	65 (97.0)	131 (95.6)
Grade 1	4 (5.7)	2 (3.0)	6 (4.4)
Baseline AST, n (%)^d
Normal	58 (82.9)	50 (74.6)	108 (78.8)
Grade 1	11 (15.7)	14 (20.9)	25 (18.2)
Grade 2	1 (1.4)	2 (3.0)	3 (2.2)
Grade 3	0	1 (1.5)	1 (0.7)
Baseline ALT, n (%)^d
Normal	51 (72.9)	49 (73.1)	100 (73.0)
Grade 1	16 (22.9)	14 (20.9)	30 (21.9)
Grade 2	3 (4.3)	3 (4.5)	6 (4.4)
Grade 3	0	1 (1.5)	1 (0.7)
Baseline concomitant protease inhibitor, n (%)	33 (47.1)	30 (44.8)	63 (46.0)

Note: ALT: alanine aminotransferase; AST: aspartate aminotransferase; HBV: hepatitis B virus; HCV: hepatitis C virus; SD: standard deviation.

a No Asian patients were included in this study.

b HBV co-infection defined as positive HBV surface antigen at screening.

c HCV co-infection defined as positive HCV RNA at screening.

d None of the subjects had Grades 2–4 baseline total bilirubin or Grade 4 baseline ALT or AST values.

Figure 2. Change from baseline in (A) enhanced liver fibrosis and (B) hepatic elastography through week 48.

Table 2. Adverse event summary

	All-causality	Treatment-related
	Maraviroc (N = 70)	Placebo (N = 67)	Maraviroc (N = 70)	Placebo (N = 67)
Number of AEs	244	274	38	33
AEs, n (%)	59 (84.3)	57 (85.1)	18 (25.7)	19 (28.4)
Hepatobiliary AEs, n (%)	2 (2.9)	4 (6.0)	1 (1.4)	2 (3.0)
DAIDS Grade 3 or 4 AEs, n (%)	12 (17.1)	15 (22.4)	4 (5.7)	0
SAEs, n (%)	11 (15.7)	12 (17.9)	0	0
Hepatobiliary SAEs, n (%)	1 (1.4)	0	0	0
Category C AIDS-defining illness, n (%)	0	2 (3.0)	ND	ND
Malignancy, n (%)	0	0	0	0
Discontinuations due to AEs, n (%)	8 (11.4)	2 (3.0)	4 (5.7)	2 (3.0)
Mortality, n (%)	0	2 (3.0)	0	0

Note: AE: adverse event; DAIDS: Division of AIDS; ND: not determined; SAE: serious adverse event.

Figure 3. Change from baseline in (A) total bilirubin, (B) direct bilirubin, (C) indirect bilirubin, (D) AST, and (E) ALT through week 48. ALT: alanine aminotransferase; AST: aspartate aminotransferase; SD: standard deviation.