Replacement Page 25

Table 6. Demographic and Baseline Disease Characteristics: Studies 437 and 438

 

Study GS-98-437
HBeAg+ Chronic HBV Infection

Study GS-98-438
HBeAg-/anti-HBe/HBV DNA HBV Infection
 


Placebo
N = 167

Adefovir Dipivoxil
10 mg
N = 171


Placebo
N = 61

Adefovir Dipivoxil
10 mg
N = 123

Age (years)

        

Median

35

32

45

46

Q1 to Q3

28 to 43

25 to 42

39 to 53

40 to 53

Gender

       

Males

119 (71%)

130 (76%)

50 (82%)

102 (83%)

Females

48 (29%)

41 (24%)

11 (18%)

21 (17%)

Race

        

Caucasian

60 (36%)

60 (35%)

40 (66%)

82 (67%)

Black

3 (2%)

8 (5%)

1 (2%)

5 (4%)

Asian

101 (60%)

102 (60%)

20 (33%)

36 (29%)

Other

3 (2%)

1 (< 1 %)

0%

0%

Prior HBV Therapy *

        

Interferon-a

35 (21%)

42 (25%)

28 (46%)

48 (39%)

Lamivudine

3 (2%)

1 (< 1%)

4 (7%)

10 (8%)

Other

15 (9%)

17 (10%)

7 (11%)

7 (6%)

Total Knodell HAI Score

        

Median

10

9.5

9

10

Q1 to Q3

8 to 12

8 to 11

6 to 11

8 to 12

Knodell Necro-inflammatory Score

        

Median

8

7

7

8

Q1 to Q3

7 to 10

7 to 9

5 to 10

7 to 10

Knodell Fibrosis Score

        

Median

1

1

1

1

Q1 to Q3

1 to 3

1 to 3

1 to 3

1 to 3

Cirrhosis

13 (8%)

12 (7%)

6 (10%)

14 (11%)

HBV-DNA (log10 copies/mL)

        

Median

8.33

8.40

7.05

7.10

Q1 to Q3

7.5 to 8.76

7.69 to 8.87

6.24 to 7.67

6.35 to 7.53

ALT (IU/L)

        

Median

94

95

100

93

Q1 to Q3

69 to159

65 to 165

72 to 161

69 to 165

ALT ( x ULN)

        

Median

2.4

2.3

2.4

2.3

Q1 to Q3

1.7 to 3.9

1.6 to 3.9

1.7 to 3.9

1.7 to 3.8

* Prior HBV-medications for the purpose of this analysis was classed as interferon alpha only as the number of patients taking other prior medications was low per protocol exclusion criteria.

Source: GS-98-437 ICSR, Table 11-2, 11-3, 11-4; GS-98-438 ICSR, Table 11-2, 11-3