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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.