Co-treatment with pegylated interferon alfa-2a and entecavir for hepatitis D: A randomized trial

Table 1 Baseline characteristics of study patients n (%)

	PEG-IFNα with entecavir (n = 21)	PEG-IFNα alone (n = 19)	P value
Age (mean, yr)	26.4 ± 6.4	27 ± 7.4	0.946
Gender (male:female)	16:5	15:4	1.00
Body mass index (kg/m2)	21.8 ± 3.6	23.6 ± 4.3	0.151
Hemoglobin (g/dL)	13.7 ± 1.59	13.9 ± 1.3	0.473
Total leucocyte count (× 106/L)	7.1 ± 2.0	6.7 ± 1.9	0.626
Platelets count (× 109/L)	237 ± 83	185 ± 59	0.0231
Total bilirubin (mg/dL)	0.67 ± 0.34	0.70 ± 0.38	0.828
ALT (IU/L)	87 ± 55	89 ± 41	0.379
GGT (IU/L)	49 ± 41	69 ± 72	0.255
Inflammatory grade on biopsy			0.186
0-1	5 (31)	1 (5)
2-3	16 (69)	18 (95)
Fibrosis stage on biopsy			0.105
0-2	12 (57)	6 (32)
3-4	9 (43)	13 (68)
Cirrhosis	2 (10)	6 (32)	0.120
HBeAg reactive	7 (33)	7 (37)	0.816
HDV RNA (mean log10 IU/mL)	7.5 ± 1.1	6.9 ± 1.2	0.119
HBV DNA detected	5 (24)	5 (26)	1.00
HBV DNA (mean log10 IU/mL)	1.08 ± 2.10	1.48 ± 2.70	0.656
HBsAg (mean log10 IU/mL)	4.50 ± 0.42	4.20 ± 0.64	0.068

¹Significant P value. ALT: Alanine aminotransferase; GGT: Gamma glutamyl transferase; HBeAg: Hepatitis B e antigen; HDV: Hepatitis D virus; HBV: Hepatitis B virus; HBsAg: Hepatitis B surface antigen; PEG-IFNα: Pegylated interferon alfa.

Table 2 Factors associated with hepatitis D virus RNA negativity at 24 wk post-treatment n (%)

Variable	Responders (n = 15)	Non-responders (n = 25)	P value
Age (mean, yr)	27.9 ± 8.4	25.9 ± 5.7	0.654
Gender (male:female)	12:3	19:6	1.00
Body mass index (kg/m2)	23.8 ± 4.2	21.9 ± 3.8	0.158
ALT (mean IU/L)	103 ± 44	80 ± 50	0.0331
GGT (mean IU/L)	45 ± 21	66 ± 72	0.700
Inflammatory activity on biopsy			0.493
0-1	3 (20)	3 (12)
2-3	12 (80)	22 (88)
Fibrosis on biopsy			0.412
0-2	8 (53)	10 (40)
3-4	7 (47)	15 (60)
Cirrhosis	2 (13)	6 (24)	0.686
HBeAg reactive	4 (27)	10 (40)	0.502
Baseline HDV RNA	7.01 ± 1.25	4.61 ± 1.91	0.072
Baseline HBsAg	4.38 ± 0.63	4.32 ± 0.53	0.727
Treatment arm			0.567
PEG-IFNα + entecavir (n = 21)	7 (33)	14 (67)
PEG-IFNα alone (n = 19)	8 (42)	11 (58)
Two log of HDV RNA reduction at week 24	15 (100)	6 (24)	< 0.0011
Baseline HBeAg reactive	4 (27)	10 (40)	0.502
24 wk HBsAg level	3.97 ± 1.01	4.31 ± 0.45	0.476
One log reduction of HBsAg level at 24 wk	5 (33)	4 (16)	0.255
Patients with decrease in HBsAg level at 24 wk from baseline	12 (80)	12 (48)	0.056
HBeAg reactive patients (n = 14) who seroconverted	4/4 (100)	2/10 (20)	0.0151

¹Significant P value. ALT: Alanine aminotransferase; GGT: Gamma glutamyl transferase; HBeAg: Hepatitis B e antigen; HDV: Hepatitis D virus; PEG-IFNα: Pegylated interferon alfa; HBsAg: Hepatitis B surface antigen.