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Table 1 Clinical and Laboratory Characteristics for Subjects Enrolled in both the Original and LTFU Studies

From: Sustained serological and complete responses in HBeAg-positive patients treated with Peginterferon alfa-2b: a 6-year long-term follow-up of a multicenter, randomized, controlled trial in China

 

PEG-IFN alfa-2b 1.0 μg/kg/wk 24 weeks

PEG-IFN alfa-2b 1.5 μg /kg/wk 24 weeks

PEG-IFN alfa-2b 1.5 μg /kg/wk 48 weeks

Total

p

n = 114

n = 97

n = 111

n = 322

 

Baseline

 Age (Years)

28.5 (7.5)

28.9 (6.8)

29.3 (8.1)

28.9 (7.5)

0.77

 Sex (Male)

89 (78.1)

77 (79.4)

86 (77.5)

252 (78.3)

0.94

 BMI

22.4 (2.8)

22.2 (3.2)

22.7 (3.5)

22.4 (3.2)

0.48

 HBV Genotype

    

0.83

  B

48 (42.1)

43 (44.3)

52 (46.8)

143 (44.4)

 

  C

64 (56.1)

53 (54.6)

57 (51.4)

174 (54.0)

 

 Other

2 (1.8)

1 (1.0)

2 (1.9)

5 (1.5)

 

 Total HAI Score

8.0 (3.1)

8.0 (2.9)

8.0 (3.1)

8.0 (3.0)

0.99

 ALT (*ULN)

4.1 (1.9)

4.4 (2.5)

4.0 (2.0)

4.1 (2.1)

0.41

 ALT≥3*ULN

69 (60.5)

57 (58.8)

70 (63.1)

196 (60.9)

0.67

 HBV DNA (LogIU/mL)

7.7 (0.9)

7.8 (0.7)

7.8 (0.8)

7.8 (0.8)

0.69

 HBsAg (Log10 IU/mL)

4.2 (0.7)

4.2 (0.6)

4.3 (0.6)

4.2 (0.6)

0.31

 HBeAg (Log10 IU/mL)

2.5 (0.7)

2.4 (0.7)

2.6 (0.7)

2.5 (0.7)

0.07

P05170 EOT

 ALT Normalization

33 (28.9)

36 (37.1)

49 (44.1)

118 (36.6)

0.06

 HBeAg negativity

14 (12.3)

17 (17.5)

19 (17.1)

50 (15.5)

0.49

 HBe seroconversion

14 (12.3)

17 (17.5)

19 (17.1)

50 (15.5)

0.49

 HBV-DNA < 2000

13 (11.4)

14 (14.4)

18 (16.2)

45 (14.0)

0.57

 HBsAg any decrease

87 (76.3)

66 (68.0)

86 (77.5)

239 (74.2)

0.25

P05170 EOS

 ALT Normalization

29 (25.4)

35 (36.1)

49 (44.1)

113 (35.1)

0.01

 HBeAg negativity

21 (18.4)

21 (21.6)

34 (30.6)

76 (23.6)

0.08

 HBe seroconversion

21 (18.4)

20 (20.6)

34 (30.6)

75 (23.3)

0.07

 HBV-DNA < 2000

17 (14.9)

13 (13.4)

29 (26.1)

59 (18.3)

0.03

 HBsAg any decrease

71 (62.3)

58 (59.8)

80 (72.1)

209 (64.9)

0.14

 HBe seroconversion+ALT normalization

13 (11.4)

15 (15.5)

26 (23.4)

54 (16.8)

0.05

 HBe seroconversion+DNA < 2000

10 (8.8)

9 (9.3)

20 (18.0)

39 (12.1)

0.06

LTFU^

 Duration of Follow-up

5.7 (0.4)

5.7 (0.4)

5.2 (0.3)

5.6 (0.4)

< 0.01

 ALT (*ULN)

0.9 (0.8)

0.8 (0.6)

0.8 (0.8)

0.8 (0.7)

0.21

 ALT Normalization

49 (43.0)

41 (42.3)

41 (36.9)

131 (40.7)

0.61

 HBe Negativity

45 (39.5)

43 (44.3)

45 (40.5)

133 (41.3)

0.76

HBe Seroconversion

39 (34.2)

36 (37.1)

39 (35.1)

114 (35.4)

0.91

Additional Antivirals†

49 (43.0)

41 (42.3)

53 (47.7)

143 (44.4)

0.68

  1. Data are presented as the mean (SD) or n (%); All analyses on endpoints and laboratory measurements in the original and LTFU studies were based on 322 subjects who were included in the LTFU; Including Genotype A, D or unidentified
  2. ^ Response for endpoints at LTFU was assessed as treatment response without any additional antivirals
  3. Δ Calculated as time interval between the date of long-term follow-up visit and the date of P05170 off-treatment follow-up visit as expressed by the median (SD)
  4. †Assessed as clinically significant antiviral treatment affecting clinical response assessment at LTFU before or during long-term follow-up visit; patients who were erroneously given nucleos(t)ide analogs (NA) during P05170 or initiated NAs at LTFU were excluded
  5. EOT End of Treatment, EOS End of Study, LTFU Long-Term Follow-Up
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BMC Gastroenterology

ISSN: 1471-230X

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