Safety and efficacy of oral HD-03/ES given for six months in patients with chronic hepatitis B virus infection

Table 1 Demographic data

Characteristic		HD-03/ES
Age (yr)	Mean (SD)	33.7 (6.6)
	Median (range)	36 (20-45)
Sex	Male	22
	Female	3
Body weight (kg)	Mean (SD)	56 (10)

Table 2 Effect of six months treatment with HD-03/ES on liver function tests (mean ± SD)

Parameter	d 0	Four months	Six months
Alanine aminotransferase (ALT) (IU/L)	66.5 ± 11.1	41.6 ± 05.1	39.1 ± 5.2
Aspartate aminotransferase (AST) (IU/L)	47.5 ± 9.5	42.4 ± 10.7	40.2 ± 10.1
Serum albumin (g%)	3.5 ± 0.8	3.5 ± 0.7	3.6 ± 0.7
Serum globulin (g%)	2.9 ± 0.3	3.1 ± 0.2	3.2 ± 0.2
Total protein (g%)	6.2 ± 0.7	6.5 ± 0.7	6.5 ± 0.7
Serum bilirubin (mg%)	1.3 ± 0.6	1.2 ± 0.5	1.1 ± 0.5
Alkaline phosphatase (IU/L)	155.5 ± 9.8	140.2 ± 9.0	127.0 ± 7.5

Table 3 Biochemical and serological response to 6 mo of HD-03/ES therapy

Variable		HD-03/ES (No. of patients)
ALT normalization (%)	Four months	32%
	Six months	56%
		Positive	Negative
HBsAg	d 0	25	0
	Four months	19	6
	Six months	12	13b
HBeAg
	d 0	16	9
	Four months	11	14
	Six months	10	15a
HBV DNA	d 0	16	9
	Four months	11	14
	Six months	10	15a

^aP < 0.05; vs d 0;

^bP < 0.001 vs d 0.

Table 4 List of adverse effects

Adverse effect	HD-03/ES
Abdominal discomfort	3
Fatigue	2
Headache	1
Insomnia	1