Table 1.
Characteristics of the study population and pregnancy outcomes, presented as median (range) or number of subjects (%).
| Once Daily Dosing N=32 | Twice Daily Dosing N=34 | Combined N=66 | |
|---|---|---|---|
| Race/Ethnicity: | |||
| Black Non-Hispanic | 17 (53.1%) | 12 (35.3%) | 29 (44%) |
| Hispanic/Latina (any race) | 12 (37.5%) | 14 (41.2%) | 26 (39%) |
| White Non-Hispanic | 2 (6.3%) | 4 (11.8%) | 6 (9%) |
| Asian/Pacific Islander | 0 | 3 (8.8%) | 3 (5%) |
| More than 1 race | 1 (3%) | 1 (3%) | 2 (3%) |
| Age at 3rd trimester visit (yrs) | 27.6 (19.3 - 44.9) | 27.0 (18.4- 43.7) | 27.4 (18.4 - 44.9) |
| Weight at 3rd trimester visit (kg) | 91.9 (60.5 - 155) | 76.0 (53.8- 204.1) | 81.0 (53.8 – 204.1) |
| Gestational age at 2nd trimester visit (months) | 24.6 (20.7 – 27.3) | 25.7 (20.3-26.7) | 24.9 (20.3-27.3) |
| Gestational age at 3rd trimester visit (months) | 33.7 (30.0-37.1) | 34.3 (27.4-41.0) | 34.1 (27.4-41.0) |
| Weeks after delivery at postpartum PK visit | 7.1 (3.6-12.9) | 7.0 (2.3-14.1) | 7.0 (2.3-14.1) |
| Other ARVs: | |||
| tenofovir | 17 (54%) | 18 (53%) | 35 (53%) |
| emtricitabine | 16 (53%) | 16 (47%) | 32 (48%) |
| lamivudine | 14 (47%) | 13 (37%) | 27 (41%) |
| zidovudine | 14 (47%) | 11 (32%) | 25 (38%) |
| abacavir | 5 (17%) | 3 (9%) | 8 (12%) |
| raltegravir | 1 (3%) | 10 (29%) | 2 (3%) |
| etravirine | 0 | 2 (6%) | 2 (3%) |
| didanosine | 1 (3%) | 1 (3%) | 2 (3%) |
| efavirenz | 1 (3%) | 0 | 1 (1%) |
| maraviroc | 0 | 1 (3%) | 1 (1%) |
| enfuvirtide | 0 | 1 (3%) | 1 (2%) |
| Duration of darunavir therapy at 3rd trimester visit (weeks) | 27 (6 – 121) | 17 (2 - 252) | 21 (2 - 252) |
| HIV-1 RNA at delivery (copies/mL) | <50 (<50 - 35,313) | 51 (<50 - 66,142) | <50 (<50 - 66,142) |
| HIV-1 RNA at delivery (copies/mL) | |||
| ≤ 50 copies/mL | 19/30 (63%) | 14/28 (50%) | 33/58 (57%) |
| ≤ 400 copies/mL | 28/30 (93%) | 22/28 (79%) | 50/58 (86%) |
| Infant Gestational Age at Birth (weeks) | 38.4 (31.9 - 41.1) | 38.6 (35.0 - 42.4) | 38.6 (31.9 - 42.4) |
| Infant Weight at Birth (gm) | 2792 (1800 - 4401) | 3090 (2245 - 4560) | 3023 (1800 - 4560) |