Table 1.
Patients’ Characteristics in the Pharmacokinetics Analysis
Parameter | Cohort, n = 57 n (%) or Median (Range) |
---|---|
Demographic data | |
Sex ratio M/F | 24/33 |
Age at birth (GA weeks + daysa) | 34 (28.7–39.4) |
28 w – 29 w + 6 d | 4 (7) |
30 w – 33 w + 6 d | 23 (40.3) |
34 w – 36 w + 6 d | 18 (31.6) |
≥37 GA | 12 (21.1) |
Postnatal age at first visitb (months) | 0.6 (0.2–2.9) |
Body weight at first visitb (kg) | 2.1 (0.9–4.7) |
Height at first visitb (cm) | 45.1 (34–55.5) |
Intrauterine growthc | |
10th–90th percentile | 38 (66.7) |
<10th percentile | 8 (14) |
<3rd percentile | 11 (19.3) |
Postnatal age throughout the study (months) | 2.3 (0.2–7.3) |
Postmenstrual age throughout the study (months) | 10.1 (7.2–15.8) |
Body weight throughout the study (kg) | 3.7 (0.9–9.3) |
Height throughout the study (cm) | 50.1 (34–73) |
Clinical data | |
Ethnicity (Black/colored/other) | 39/17/1 |
Infants born to HIV-infected mother | 34 (59.6) |
Treated with lopinavir | 1 (1.8) |
Treated with nevirapine | 32 (56.1) |
Treated with lamivudine | 2 (3.5) |
Treated with zidovudine | 25 (43.9) |
Treated with rifampicin | 4 (7) |
Biological data for all visits | |
Serum creatinine (mg/dL) | 0.42 (0.2–0.85) |
Hemoglobin (g/dL) | 9.6 (7.6–12.6) |
ALT (IU/L) | 10 (3–30) |
Pharmacological data | |
Samples per patient | 12 (2–14) |
No. of occasions per patient | 6 (1–7) |
Daily dosing regimen (mg/kg) | 10.3 (2.9–38.3) |
Treated with oral suspension | 44 (77.2) |
Treated with tablet | 28 (49.1) |
Pharmacogenomics data (NAT2 genotype) | |
Slow metabolizer | 10 (17.5) |
Intermediate metabolizer | 26 (45.6) |
Fast metabolizer | 7 (12.3) |
Unknown classification | 4 (7) |
Missing data | 10 (17.5) |
Abbreviations: ALT, alanine aminotransferase; GA, gestational age; HIV, human immunodeficiency virus; NAT2, N-acetyl transferase 2.
In sum, 28 weeks equal to 6.5 months, 30 weeks equal to 7 months, 34 weeks equal to 8 months, and 37 weeks equal to 8.6 months (term).
For 39 patients, the first visit was at birth.
Using the Fenton chart.