Table 1:
Demographic, clinical, and laboratory characteristics of women on isoniazid and efavirenz during pregnancy and at postpartum.
| Characteristics (median and range, or n and %) | Participants in isoniazid PK analysis | Participants in efavirenz PK analysis | ||
|---|---|---|---|---|
| Pregnancy (n=420) | Postpartum (n=637) | Pregnancy (n=712) | Postpartum (n=670) | |
| Age (years) | 29 (18 – 45) | 29 (19 – 42) | 29 (18–45) | 29 (18–45) |
| Weight (kg) | 68 (39 – 167) | 62 (38 – 165) | 67 (42 – 164) | 61 (37 – 114) |
| Body mass index (kg/m2) | 27 (18 – 61) | 24 (16 – 45) | 27 (18 – 61) | 25 (16 – 49) |
| Gestation/postnatal age (weeks) at PK sampling time | 26 (14 – 34) | 16 (7 – 23) | 26 (14 – 34) | 16 (7 – 23) |
| Baseline Viral load (copies/mL) | <40 (<40 – 237000) | <40 (<40 – 465000) | <40 (<40 – 237000) | <40 (<40 – 465000) |
| Drug regimen | ||||
| On isoniazid | 420 (100%) | 637 (100%) | 352 (49%) | 540 (80%) |
| On efavirenz | 371 (88%) | 563 (88%) | 712 (100%) | 670 (100%) |
| On nevirapine | 11 (3%) | 47 (8%) | - | - |
| On lopinavir/ritonavir | 5 (1%) | 5 (1%) | - | - |
| On atazanavir/ritonavir | 2 (0%) | 2 (0%) | - | - |
| Days on EFV at PK sampling time | 125 (18 – 3800) | 264 (1 – 4228) | 125 (18 – 3800) | 408 (1 – 4228) |
| Drug metabolizing genotype | NAT 2 acetylation status | CYP2B6 metabolizer status | ||
| Rapid | 52 (12%) | 70 (11%) | 168 (24%) | 146 (22%) |
| Intermediate | 140 (33%) | 202 (32%) | 299 (42%) | 264 (40%) |
| Slow | 159 (39%) | 199 (31%) | 118 (16%) | 102 (15%) |
| Ultra-slow | - | - | 1 (0%) | 2 (0%) |
| Missing | 69 (16%) | 166 (26%) | 126 (18%) | 156 (23%) |
| CYP2A6 metabolizer status | ||||
| Normal | 501 (70%) | 439 (65%) | ||
| Intermediate | 81 (11%) | 71 (11%) | ||
| Slow | 4 (1%) | 4 (1%) | ||
| Missing | 126 (18%) | 156 (23%) | ||
210 women had isoniazid profiles during both pregnancy and postpartum.
596 women had efavirenz profiles available during both pregnancy and postpartum.