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Table 4 Efficacy and safety parameters (mean values ±standard deviation, median) at M6, M12 and M24 after initiation (baseline) of a RPV/TDF/FTC co-formulation among cART-naïve and cART-experienced patients

From: Rilpivirine use in the Swiss HIV cohort study: a prospective cohort study

 

Baseline

M6 ††

M12 †††

M24 ††††

P value over time*

Viral load (copies/mL), n (%)

     

 cART-naïve

     

  <50

2 (4.2)¥

45 (93.8)

41 (97.6)

26 (100)

<0.001

  > = 50

46 (95.8)

3 (6.2)

1 (2.4)

0 (0)

 

 cART-experienced

     

  <50

549 (92.6)

562 (96.2)

514 (97.5)

380 (96.7)

0.002

  > = 50

44 (7.4)

22 (3.8)

13 (2.5)

13 (3.3)

 

CD4 count (cells/mm3), ±SD, median

     

 cART-naïve

478 (±176, 473)

622 (±204, 602)

621 (±201, 581)

704 (±248, 649)

0.004

 cART-experienced

650 (±273, 620)

676 (±285, 643)

681 (±286, 633)

697 (±363, 660)

0.001

ALAT (UI/L), ±SD, median

     

 cART-naïve

31 (±18, 28)

31 (±16, 30)

31 (±16, 28)

30 (±14, 32)

0.578

 cART-experienced

39 (±49, 29)

38 (±42, 29)

35 (±25, 29)

36 (±63, 28)

0.284

Creatinine (μmmol/L), ±SD, median

     

 cART-naïve

94 (±82, 82)

88 (±15, 86)

88 (±15, 86)

91 (±13, 89)

0.887

 cART-experienced

78 (±16, 77)

85 (±18, 85)

86 (±18, 86)

85 (±21, 83)

<0.001

eGFR (mL/min/1.73m2), ±SD, median

     

 cART-naïve

98 (±25, 100)

90 (±20, 89)

91 (±21, 91)

90 (±26, 86)

0.008

 cART-experienced

100 (±25, 96)

90 (±28, 86)

88 (±23, 85)

89 (±26, 87)

<0.001

Cholesterol (mmol/L), ±SD, median

     

 cART-naïve

4.7 (±1.0, 4.8)

4.5 (±1.0, 4.4)

4.5 (±1.0, 4.4)

NA

0.270

 cART-experienced

5.1 (±1.0, 5.0)

4.7 (±1.0, 4.6)

4.7 (1.0, 4.6)

NA

<0.001

Triglycerides (mmol/L), ±SD, median

     

 cART-naïve

1.5 (±1.1, 1.2)

1.5 (±1.1, 1.3)

1.5 (±0.9, 1.4)

1.3 (±0.6, 1.2)

0.347

 cART-experienced

1.6 (±1.3, 1.3)

1.4 (±0.9, 1.2)

1.4 (±0.9, 1.2)

1.4 (±0.9, 1.2)

<0.001

HDL-cholesterol (mmol/L), ±SD, median

     

 cART-naïve

1.2 (±0.4, 1.2)

1.2 (±0.3, 1.2)

1.1 (±0.3, 1.2)

NA

0.195

 cART-experienced

1.3 (±0.4, 1.3)

1.3 (±0.3, 1.2)

1.2 (±0.3, 1.2)

NA

<0.001

BMI (kg/m2), ±SD, median

     

 cART-naïve

23.6 (±5.6, 22.6)

24.2 (±3.8, 23.7)

24.2 (±3.9, 23.8)

22.9 (±1.0, 22.9)

0.006

 cART-experienced

24.9 (±5.3, 24.4)

24.7 (±4.0, 24.3)

24.7 (±3.9, 24.3)

24.8 (±4.6, 24.0)

0.096

  1. Missing data (ASAT 37/48 available in naïve patients, 565/596 in experienced; ALAT 37/48 available in naïve patients, 576/596 in experienced; creatinine and eGFR 33/48 available in naïve patients, 463/596 in experienced; triglycerides 36/48 available in naïve patients, 540/596 in experienced; cholesterol 36/48 available in naïve patients, 542/596 in experienced; HDL 36/48 available in naïve patients, 530/596 in experienced; weight 48/48 available in naïve patients, 574/596 in experienced; waist and hip 48/48 available in naïve patients, 563/596 in experienced; BMI 48/48 available in naïve patients, 574/596 in experienced)
  2. ††Missing data (ASAT/ALAT/Cholesterol 48/48 available in naïve patients, 583/596 in experienced; creatinine/eGFR/triglycerides 48/48 available in naïve patients, 578/596 in experienced; HDL/weight/BMI 48/48 available in naïve patients, 582/596 in experienced; waist and hip 48/48 available in naïve patients, 580/596 in experienced)
  3. †††Missing data (ASAT/ALAT 42/48 available in naïve patients, 527/596 in experienced; creatinine 42/48 available in naïve patients, 521/596 in experienced; eGFR 41/48 available in naïve patients, 517/596 in experienced; triglycerides 41/48 available in naïve patients, 522/596 in experienced; cholesterol 41/48 available in naïve patients, 526/596 in experienced; HDL 41/48 available in naïve patients, 525/596 in experienced; weight 44/48 available in naïve patients, 513/596 in experienced; waist 44/48 available in naïve patients, 511/596 in experienced; hip 44/48 available in naïve patients, 510/596 in experienced; BMI 44/48 available in naïve patients, 513/596 in experienced)
  4. ††††Missing data (ALAT 15/48 available in naïve patients, 239/596 in experienced; creatinine 14/48 available in naïve patients, 236/596 in experienced; eGFR 14/48 available in naïve patients, 235/596 in experienced; triglycerides 14/48 available in naïve patients, 232/596 in experienced; cholesterol 0/48 available in naïve patients, 0/596 in experienced; HDL 0/48 available in naïve patients, 0/596 in experienced; weight 4/48 available in naïve patients, 158/596 in experienced; waist 4/48 available in naïve patients, 151/596 in experienced; hip 4/48 available in naïve patients, 151/596 in experienced; BMI 4/48 available in naïve patients, 158/596 in experienced)
  5. *P-values from generalized estimating equation (for viral load) and linear multilevel models (CD4, ALAT, creatinine, eGFR, cholesterol, triglycerides, HDL-cholesterol and BMI) comparing data at M6, M12 and M24 to baseline among cART-naïve and cART-experienced patients separately, after adjustment for main confounders
  6. RPV/TDF/FTC rilpivirine/tenofovir/emtricitabine, cART combined antiretroviral treatment, ASAT aspartate aminotransferase, ALAT alanine aminotransferase, eGFR glomerular filtration rate, HDL high-density lipoprotein, BMI body mass index
  7. ¥Two cART-naïve patients started treatment with an HIV-RNA <50 copies/mL: one because of anxiety related to HIV-infection, the other was taking a combination of tenofovir and emtricitabine intermittently without his physician knowledge