Table 3.
Associations of First Trimester Exposure to Specific Antiretrovirals with Specific Anomalies
| ARV Exposure/Type of Anomaly | Defect Rate | Unadjusted Models | Adjusted Models* | |
|---|---|---|---|---|
|
|
|
|||
| Exposed | Unexposed | OR (95% CI) | OR (95% CI) | |
| Atazanavir (ATV) | ||||
| Cardiac | 7/222 (3.2%) | 33/2295 (1.4%) | 2.23 (0.98, 5.11) | 2.02 (0.88, 4.64) |
| Musculoskeletal | 11/222 (5.0%) | 46/2295 (2.0%) | 2.55 (1.30, 5.00) | 2.57 (1.30, 5.08) |
| Skin | 3/222 (1.4%) | 6/2296 (0.3%) | 5.23 (1.30, 21.0) | 6.01 (1.43, 25.3) |
| Ritonavir (RTV, as booster) | ||||
| Cardiac | 16/635 (2.5%) | 24/1882 (1.3%) | 2.00 (1.06, 3.79) | 1.83 (0.96, 3.49) |
| Musculoskeletal | 22/635 (3.5%) | 35/1882 (1.9%) | 1.89 (1.10, 3.25) | 1.79 (1.02, 3.14) |
| Lopinavir/RTV (LPV/RTV) | ||||
| Cardiac | 6/341 (1.8%) | 34/2176 (1.6%) | 1.13 (0.47, 2.71) | 0.79 (0.40, 2.34) |
| Musculoskeletal | 11/341 (3.2%) | 46/2176 (2.1%) | 1.54 (0.79, 3.01) | 1.40 (0.70, 2.83) |
| Zidovudine (ZDV) | ||||
| Male Genital | 8/726 (1.1%) | 6/1791 (0.3%) | 3.31 (1.15, 9.59) | 3.18 (1.10, 9.22) |
| Lamivudine (3TC) | ||||
| Male Genital | 8/797 (1.0%) | 6/1720 (0.3%) | 2.90 (1.00, 8.38) | 2.77 (0.96, 8.03) |
| Didanosine and Stavudine (ddI+d4T) | ||||
| Cardiac | 0/7 (0%) | 40/2510 (1.6%) | N/A | N/A |
| Musculoskeletal | 1/7 (14.3%) | 56/2510 (2.2%) | 7.30 (0.86, 61.7) | 8.29 (0.96, 71.8) |
ARV=antiretroviral, OR=odds ratio, CI=confidence interval
*
Models adjusted for: any anomaly low maternal CD4 count (< 250 cells/mm3) early in pregnancy and birth cohort; cardiac anomaly birth cohort; musculoskeletal anomaly low maternal CD4 count early in pregnancy and first trimester maternal alcohol consumption; skin anomaly low maternal CD4 count early in pregnancy; male genital anomaly maternal age >35 years at delivery.