TABLE 3.
Births with antiretroviral therapy exposure during pregnancy in HIV infected women.
| Variable | Total ever exposed in utero |
Definitive and entire first trimester exposure |
Ambiguous/partial first trimester exposure |
First trimester non-exposure |
Unknown/uncertain exposure time (Excluded) |
Self-reported as ‘Before pregnancy’ without exposure dates |
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| N | %* | N | %† | N | %‡ | N | %§ | N | %¶ | N | %†† | |
| Total births in HIV-infected women | 4063 | - | - | - | - | - | - | - | - | - | - | - |
| No ART exposure reported | 131 | 3.2 | - | - | - | - | - | - | - | - | - | - |
| Number exposed to ART regimen | 3932* | 96.8 | 486 | 12.4 | 667 | 17.0 | 1541 | 39.2 | 1238 | 31.5 | 74 | 1.9 |
| ART regimens switched during pregnancy | 219 | 5.4‡‡ | - | - | - | - | - | - | - | - | - | - |
| Twin babies exposed to ART regimen | 85 | 2.1 | - | - | - | - | - | - | - | - | - | - |
| Number exposed to ART regimen (excluding those who switched and excluding twin births) | 3632 | 89.4 | 380 | 10.4 | 653 | 18.0 | 1494 | 41.1 | 1105 | 30.4 | 56 | 1.5 |
| Regimens (excluding those who switched and twin births) | ||||||||||||
| TDF/FTC/EFV | 3391 | - | 261 | 7.7 | 641 | 18.9 | 1473 | 43.4 | 1016 | 30.0 | 43 | 1.3 |
| TDF/3TC/EFV | 57 | - | 30 | 52.6 | 0 | 0.0 | 3 | 5.3 | 24 | 42.1 | 1 | 1.8 |
| TDF/FTC/NVP | 75 | - | 45 | 60.0 | 4 | 5.3 | 5 | 6.7 | 21 | 29.0 | 3 | 4.0 |
| D4T/3TC/NVP | 8 | - | 5 | 62.5 | 0 | 0.0 | 0 | 0.0 | 3 | 37.5 | 1 | 12.5 |
| Other EFV-based regimens** | 17 | - | 15 | 88.2 | 0 | 0.0 | 1 | 5.9 | 1 | 5.9 | 3 | 17.6 |
| Other NVP-based regimens*** | 13 | - | 8 | 61.5 | 1 | 7.7 | 0 | 0.0 | 4 | 30.8 | 2 | 15.4 |
| PI-based regimens**** | 30 | - | 7 | 46.7 | 4 | 13.3 | 4 | 13.3 | 15 | 50.0 | 0 | 0.0 |
| Missing/Unknown regimens | 41 | - | 9 | 22.0 | 3 | 7.3 | 8 | 19.5 | 21 | 51.2 | 3 | 7.3 |
, ART initiated before reported LMP and continued on the specific regimen throughout the first 15 weeks of pregnancy; in the absence of known LMP, ART initiated at least 12 months before delivery or in the absence of any dates, exposure self-reported by the woman as being initiated before pregnancy (i.e. last column: ‘Self-reported as ‘Before pregnancy’ without exposure dates’).
, Cases excluded from birth risk analysis because date of ART onset was reported to be between 2 weeks prior to LMP and LMP+15 weeks.
, First trimester unexposed birth outcomes where ART was initiated at least 15 weeks after first date of the last menstrual period.
, Cases excluded: where date of ART onset was unknown; LMP date was unknown (and ART onset was reported as < 12 months prior to infant’s date of birth) or where there was discordance between reported dates of exposure and woman’s reporting of whether treatment was initiated before or during the pregnancy.
, Cases that were classified as ‘Exposed’ based on the woman’s self-reported timing of ART exposure as being ‘before pregnancy’ but where LMP or onset date was not reported. These cases are included as Definitive and entire first trimester exposures.
, Regimen was switched in 2 twin pregnancies.
, Of 4063 HIV-exposed births, 3932 were exposed to ART in utero;
D4T/3TC/EFV or AZT/3TC/EFV;
AZT/3TC/NVP or NVP/3TC/TDF;
TDF/3TC/LPV/r; TDF/FTC/LPV/r; AZT/3TC/LPV/r; TDF/3TC/ATV/r; AZT/3TC/ATV/r; TDF/FTC/ATV/r.