Antenatal Atazanavir: A Retrospective Analysis of Pregnancies Exposed to Atazanavir

Table 1

Birth outcome data for pregnancies exposed to an atazanavir (ATV) containing regimen. Data are presented based on the indication for atazanavir use.

		Indication for atazanavir use*
		Preconception		First-line		Switch
Total pregnancies**			89		27		29
ATV discontinued	, %; (95% CI)^‡‡		5, 5.6%; (1.8–12.6%)		3, 11.1%; (2.4–29.1%)		3, 10.3%; (2.2–27.4%)
Gastrointestinal side effects***	, %; (95% CI)		23, 25.8%; (16.5–35.1%)		15, 55.6%; (35.5–75.6%)		10, 34.5%; (16.1–52.9%)
New-onset transaminitis^†	, %; (95% CI)		1, 1.1%; (0.02%–6.1%)		3, 11.0%; (2.4–29.1%)		0^††, 0%; (0–14.2%)
Singleton deliveries^†††	, %; (95% CI)		80, 97.6%; (91.5–99.7%)		23, 95.8%; (78.9–99.9%)		26, 100%; (86.8–100%)
Twin deliveries^†††	, %; (95% CI)		2, 2.4%; (0.3–8.5%)		1, 4.2%; (0.1–21.1%)		0; (0–13.2%)
Gestation <37 weeks	, %; (95% CI)		9, 11.7%; (5.5–21.0%)		2, 9.1%; (1.1–29.2%)		2, 7.7%; (1.0–25.1%)
Birth weight (grams)	Median; (IQR)		3160; (2870–3360)		3030; (2720–3255)		3030; (2670–3480)
Low birth weight (<2500 grams)	, %; (95% CI)		6, 9.2%; (3.5–19.0%)		3, 14.3%; (3.0–36.3%)		3, 13.0%; (2.7–33.6%)
Neonatal bilirubin; (μmol/litre)	Median; (IQR)		70.5; (45.0–107.0)		76; (54.3–112.3)		70.5; (49.8–88.8)
HIV viral load <50 (copies/mL)	, %; (95% CI)		74, 89.3%; (80.4–94.9%)		23, 56.5%; (34.8–76.0%)		25, 72.0%; (49.7–87.0%)

Indication for ATV use: “preconception,” if already taking an atazanavir-containing regimen at the time of last menstrual period (LMP); “switch,” if atazanavir was commenced during this pregnancy in a woman already taking combination antiretroviral therapy (cART); “first-line,” if a first-line atazanavir-based regimen was initiated after the LMP.
Total pregnancies: number of pregnancies with data available for each of the listed outcomes.
Gastrointestinal side effects: nausea, vomiting, or diarrhoea.
Transaminitis: AIDS Clinical Trial Group grade 1–4 transaminitis.
Transaminitis in the “switch” exposure group presented for 24 women with normal transaminase levels at the time of switch.
^††† refers to the number of live singleton/twin births in women who continued atazanavir until the time of delivery. % refers to the proportion of live births that were singleton or twin respectively.
: the number of events.
95% CI: 95% confidence interval calculated with robust standard errors.
: the number of cases with data available.
Birth weight and gestation data are only presented for singleton deliveries.
IQR: interquartile range.