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Table 3 Clinical Endpoints in the Long-term Follow-up Study as Grouped by Additional NA Treatment

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 1.0mcg/kg/wk 24 weeks

PEG-IFN alfa-2b 1.5mcg/kg/wk 24 weeks

PEG-IFN alfa-2b 1.5mcg/kg/wk 48 weeks

Total

Without NAs

n = 65

Additional NAs

n = 49

Without NAs

n = 56

Additional NAs

n = 41

Without NAs

n = 58

Additional NAs

n = 53

Without NAs

n = 179

Additional NAs

n = 143

HBe Negativity

46 (70.8)

30 (61.2)

43 (76.8)

23 (56.1)

46 (79.3)

31 (58.5)

135 (75.4)

84 (58.7)

ALT Normalization

48 (73.8)

38 (77.6)

40 (71.4)

39 (95.1)

41 (70.7)

45 (84.9)

129 (72.1)

122 (85.3)

HBe(−) + ALT Normalization

36 (55.4)

26 (53.1)

35 (62.5)

22 (53.7)

38 (65.5)

29 (54.7)

109 (60.9)

77 (53.8)

SR

40 (61.5)

22 (44.9)

36 (64.3)

19 (46.3)

40 (69.0)

22 (41.5)

116 (64.8)

63 (44.1)

CR

23 (35.4)

17 (34.7)

16 (28.6)

18 (43.9)

29 (50.0)

21 (39.6)

68 (38.0)

56 (39.2)

HBsAg any decrease ^

32 (49.2)

30 (61.2)

23 (41.1)

18 (43.9)

34 (58.6)

31 (58.5)

89 (49.7)

79 (55.2)

Decompensated Liver Event*

0 (0.0)

0 (0.0)

0 (0.0)

1 (2.4)

0 (0.0)

0 (0.0)

0 (0.0)

1 (0.7)

  1. Serological response (SR) was defined as Hbe seroconversion (HBeAg negativity and HBeAb positivity)
  2. Complete clinical response (CR) was defined as Hbe seroconversion (HBeAg negativity and HBeAb positivity) and HBV-DNA less than 2000 IU/mL
  3. ^Defined as any decrease of HBsAg quantification levels at LTFU from that in the end of P05170 study observation;
  4. *1 patient had liver biopsy and clinically confirmed liver cirrhosis
  5. LTFU long-term follow-up, NA nucleos(t)ide analogs, SR serological response, CR complete response