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Table 1 Laboratory toxicities during scheduled follow-up in the TDF-FTC arm by previous exposure to HBV

From: Liver and renal safety of tenofovir disoproxil fumarate in combination with emtricitabine among African women in a pre-exposure prophylaxis trial

 

HBsAb negative (N=804)

HBsAb positive (N=215)

 
 

No. of events

No. of women

% of women

Person years

Rate (per 100) person-years

No. of events

No. of women

% of women

Person years

Rate (per 100) person-years

Difference (P-value)#

ALT or AST

Grade 1 or higher

238

180

22.4

449.4

40.05

91

68

31.6

123.4

55.09

9.2 (0.007)

Grade 2 or higher

24

21

2.6

525.0

4.00

12

12

5.6

152.0

7.90

3.0 (0.047)

Grade 3 or higher

6

6

0.7

532.6

1.13

2

2

0.9

156.6

1.28

0.2 (0.678)

Grade 4

1

1

0.1

535.8

0.19

1

1

0.5

157.2

0.64

0.3 (0.378)

PHO G2+ and creatininemia

Grade 1 or higher

11

10

1.2

532.5

1.88

2

2

0.9

156.4

1.28

-0.3 (1.0000)

Grade 2 or higher

0

0

0.0

535.8

0.00

1

1

0.5

156.7

0.64

0.5 (0.2110)

Grade 3 or higher

0

0

0.0

535.8

0.00

1

1

0.5

156.7

0.64

0.5 (0.2110)

Grade 4

0

0

0.0

535.8

0.00

0

0

0.0

157.4

0.00

0 (-)

  1. #Difference in the proportions of participants experiencing toxicities.