Efficacy of thymosin alpha-1 and interferon alpha in treatment of chronic viral hepatitis B: A randomized controlled study

Table 1 Characteristics of the patients at entry to the study¹

Characteristics	HBeAg-positive CHB
	T-α1 group	IFN-α group	HC group
Number	29	33	30
Male: Female	26:3	27:6	21:9
Age (yr)2	45 ± 8	42 ± 11	44 ± 10
Duration of infection (yr)2	10.8 ± 5.6	9.3 ± 4.7	9.6 ± 5.5
Cirrhosis at entry	2	3	2
Previous 1FN therapy	2	0	0
Serum ALT (U/L)2	177.79 ± 58.82	189.94 ± 63.08	183.5 ± 68.32
Serum AST (U/L)	167.72 ± 34.19	154.27 ± 73.34	141.8 ± 49.85
Albumin (g/L)2	44 ± 9	47 ± 8	45 ± 8
Total bilirubin (μmol/L)	18.57 ± 9.65	17.92 ± 9.22	16.68 ± 8.72
Serum HBV DNA (copies/mL)3
< 5.0 × 105 copies/mL	10 (34%)	15 (45%)	13 (43%)
≥ 5.0 × 105 copies/mL	19 (66%)	18 (55%)	17 (57%)

¹No significant differences were observed among groups.

²Data are expressed as mean ± SD.

³Data are expressed as n (%). Normal values: ALT < 40 IU/L; AST < 40 IU/L; albumin = 35-55 g/L; total bilirubin < 17 μmol/L. ALT: Alanine aminotransferase; AST: aspartate aminotransferase; HBV: hepatitis B virus; T-α1: thymosin - α1; IFN-α: interferon -α; HC: historical control.

Table 2 Response to treatment at the end of therapy n (%)

	T-α1 (n = 29)	IFN-α (n = 33)	HC (after 6 mo of follow-up) (n = 30)
ALT normalization	11 (37.9)	16 (48.5)b	5 (16.7)
Negative HBV DNA	16 (55.2)c	22 (66.7)c	2 (6.7)
ALT normal/nagative HBeAg & HBVDNA	9 (31.0)b	15 (45.5)c	1 (3.3)

^bP < 0.01 vs HC;

^cP < 0.001 vs HC.

Table 3 Response to treatment at the end of follow-up n (%)

	T-α1 (n = 29)	IFN-α (n = 33)	HC (after 12 mo of follow-up) (n = 30)
ALT normalization	17 (58.6)cf	10 (30.3)	3 (10)
Negative HBV DNA	21 (72.4)df	13 (39.4)b	2 (6.7)
ALT normal/nagative HBeAg & HBVDNA	14 (48.3)f	9 (27.3)a	1 (3.3)
HBeAg & HBV DNA

^aP < 0.05 vs HC;

^cP < 0.05 vs IFN;

^bP<0.01 vs HC;

^dP < 0.01 vs IFN;

^fP < 0.001 vs HC.

Table 4 Response to treatment between thymosin-a1 & IFN-a groups

	At the end of therapy OR (95% CI)	At the end of follow-up OR (95% CI)
ALT normalization	0.65 (0.21, 2.01)	3.19 (1.02, 10.61)a
HBVDNA-negation	0.62 (0.19, 1.94)	3.94 (1.23, 13.69)b
HBeAg-negation	0.55 (0.17, 1.72)	2.45 (0.77, 8.23)
ALT normal/ HBeAg & HBVDNA-negation	0.55 (0.17, 1.72)	2.45 (0.77, 8.23)

^aP < 0.05,

^bP < 0.01 vs IFN-α.