Infectious Diseases in Obstetrics and Gynecology / 2014 / Article / Tab 1

Research Article

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*
PreconceptionFirst-lineSwitch

Total pregnancies**892729
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.

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