Fibrosis assessment using FibroMeter combined to first generation tests in hepatitis C

Table 1 Demographic, laboratory and histological features of patients with chronic hepatitis C of both populations

Variables	All (n = 760)	Rio population (n = 222)	Angers population (n = 538)
Females, n (%)	401 (54)	134 (60)	179 (35)
Age (yr, mean ± SD)	46 ± 11	51 ± 11	46 ± 11
AST, IU/L (mean ± SD)	67 ± 58	68 ± 52	66 ± 60
ALT, IU/L (mean ± SD)	101 ± 84	100 ± 67	101 ± 90
Platelet count, 106/mm3 (mean ± SD)	208 ± 68	203 ± 63	210 ± 70
GGT, IU/L (mean ± SD)	144 ± 171	124 ± 135	110 ± 184
APRI	1.0 ± 1.2	0.9 ± 1.2	1.1 ± 1.3
Forns		6.0 ± 1.9
FibroMeterVirus3G	0.6 ± 0.3	0.6 ± 0.3	0.6 ± 0.3
Biopsy length (mm, mean ± SD)	22 ± 9	24 ± 5	22 ± 10
METAVIR stage, n (%)
F0	22 (3)	5 (2)	17 (3)
F1	283 (37)	91 (41)	192 (36)
F2	215 (28)	55 (25)	160 (30)
F3	145 (19)	54 (24)	91 (17)
F4	95 (13)	17 (8)	78 (14)

AST: Aspartate transaminase; ALT: Alanine aminotransferase; GGT: Glutamyl transpeptidase; APRI: Aspartate transaminase to platelet ratio index.

Table 2 Rates of correct FibroMeter^Virus3G stage classification in comparison to liver biopsy in the Rio population

FibroMeter stage	METAVIR fibrosis classification						Correct fibrosis class classification according to liver biopsy (%)
	0	1	2	3	4	n
F0/F1	0	10	0	0	0	10	10/10 = 100
F1	0	6	1	0	0	7	6/7 = 86
F1[F1-F2]	3	21	4	2	0	30	25/30 = 83
F2[F1-F2]	1	26	10	4	1	42	36/42 = 86
F2[F1-F3]	1	15	12	10	0	38	37/38 = 97
F2/F3	0	9	17	12	3	41	29/41 = 71
F3[F2-F4]	0	4	8	22	6	40	36/40 = 90
F4[F3-F4]	0	0	3	4	7	14	11/14 = 79
Total	5	91	55	54	17	222	190/222 = 86

Table 3 Performance of aspartate transaminase to platelet ratio index, Forns, FibroMeter^Virus3G and combination algorithm to discriminate significant fibrosis (F0-F1 vs F2-F4) in derivation and validation population

Serum fibrosis tests	AUROC (95%CI)	Cut-off value	Se (%)	Sp (%)	PPV (%)	NPV (%)	OA (%)
Derivation population (n = 222)
FM score	0.855 (0.801-0.898)	0.61	79	81	85	74	80
APRI	0.815 (0.757-0.864)	0.51	87	53	71	76	72
		1.52	35	98	96	53	62
Forns	0.769 (0.708-0.823)	4.23	94	31	64	79	66
		6.94	41	87	81	53	61
Apri + FM			76	82	85	72	79
Forns + FM			81	75	81	75	78
Validation population (n = 538)
FM score	0.854 (0.821-0.888)	0.61	67	87	89	63	75
Apri + FM			57	88	87	57	69

¹APRI ≤ 0.5 exclude significant fibrosis;

²APRI > 1.5 predict significant fibrosis;

³Forns ≤ 4.2 exclude significant fibrosis;

⁴Forns > 6.9 predict significant fibrosis. FM: FibroMeterVirus3G; AUROC: Area under ROC curve; Se: Sensitivity; Sp: Specificity; PPV: Positive predictive value; NPV: Negative predictive value; OA: Overall accuracy; APRI: Aspartate transaminase to platelet ratio index.