Incidence and risk factors for liver enzyme elevation during highly active antiretroviral therapy in HIV-HCV co-infected patients: results from the Italian EPOKA-MASTER Cohort

Table 1 Patient characteristics in naïve and experienced groups

Charactertistic	Antiretroviral naïve (N = 155)		Antiretroviral experienced (N = 883)
(quantitative)	Mean	SD	Mean	SD
Age (years)	38.86	6.47	38.91	5.44
Nadir CD4+ (cells/μl)	185.02	115.79	159.99	131.80
CD4+ T-cell count at baseline (cells/μl)	206.75	133.53	357.88	233.05
HIV-RNA at baseline (copies/ml)	177,480	252,619	53,615	168,410
ALT at baseline (x10 IU/l)	6.94	4.14	7.13	4.42
AST at baseline (x10 IU/l)	6.27	3.88	5.87	3.94
CD4+ T-cell slope (cells/μl)	107.86	116.37	44.30	149.48
Exposure to DDX-drugs at baseline (days)	-	-	1,288	1,075
(qualitative)	N	%	N	%
Gender (male)	113	72.90	677	76.67
Risk factor for HIV acquisition (former IVDU)	105	67.74	684	77.46
HBsAg positivity	15	10.27	55	6.48
HDVAb positivity	4	2.96	25	2.83
Previous grade ≥III LFT elevation	15	9.68	317	35.90
Previous treatment with IFN	7	4.52	72	8.15
Concurrent use of DDX-drugs	50	32.26	526	59.57
Concurrent use of 3TC	138	89.03	618	69.99
Concurrent use of TDF	17	18.97	136	15.40
Treatment group (Single PI)	32	20.64	202	22.88
NFV	27	84.38	147	72.77
IDV	2	6.25	32	15.84
SQV	3	9.37	19	9.41
Others	-	-	4	1.98
Treatment group (Multiple PI)	50	32.26	322	36.47
LPV/r	42	84	175	54.35
IDV/r	5	10	83	25.78
SQV/r	1	2	48	14.91
Others	2	4	16	4.96
Treatment group (NNRTI)	73	47.10	359	41.62
EFV	42	57.53	165	45.96
NVP	31	42.47	194	54.04

The following abbreviations were used: SD = standard deviation; ALT = alanine amino-transferase, AST = aspartate amino-transferase; DDX = dideoxy-nucleoside analogue drugs (i.e., didanosine, stavudine, zalcitabine); IVDU = intra-venous drug use; IFN = interferon; 3TC = lamivudine, TDF = tenofovir disoproxil fumarate; PI = protease inhibitor, NFV = nelfinavir, IDV = indinavir, SQV = saquinavir, LPV/r = lopinavir/ritonavir, IDV/r = indinavir/ritonavir; SQV/r = saquinavir/ritonavir; NNRTI = non nucleoside reverse transcriptase inhibitor, EFV = efavirenz, NVP = nevirapine.
The following variables were different between drug naive and experienced patients at univariate comparison: nadir CD4+ T-cell count (P: 0.027), CD4+ T-cell count at baseline (P < 0.001), HIV-RNA at baseline (P < 0.001), CD4+ T-cell slope (P: <0.001), risk factor for HIV acquisition (P: 0.009), previous LFT elevation grade ≥III (P < 0.001), concurrent use of DDX-drugs (P < 0.001), concurrent use of 3TC (P < 0.001), use of IDV as single PI (P: 0.002), use of LPV/r (P: 0.04) or SQV/r (P: 0.009) as multiple PI, use of EFV as NNRTI (P: 0.016).
CD4+ T-cell slope was available for 146 patients in naïve group and for 844 patients in experienced group; HBsAg status was available for 146 patients in naive group and for 848 patients in experienced group; HDVAb status was available for 135 patients in naive group and for 833 patients in experienced group.

ISSN: 1471-2334