Table 5.
Adjusted Odds Ratios of Laboratory Serious Adverse Events
| Hemoglobina |
Absolute Neutrophil Count |
Total Lymphocyte Count |
Glucose |
|||||
|---|---|---|---|---|---|---|---|---|
| Covariate | OR (95% CI) | P Value | OR (95% CI) | P Value | OR (95% CI) | P Value | OR (95% CI) | P Value |
| Study visit | <.001 | <.001 | .28 | .02 | ||||
| Within first 7 days after birth | Reference | Reference | Reference | Reference | ||||
| 2 weeks of age | 0.95 (.60–1.50) | 0.80 (.48–1.35) | NAc | 0.20 (.07–.63) | ||||
| 6 weeks of age | 0.09 (.05–.16)b | 1.07 (.45–2.55) | 0.90 (.58–1.40) | 0.11 (.01–1.10) | ||||
| 4 months of age | … | 0.16 (.05–.54) | 0.56 (.31–1.01) | 0.10 (.01–.94) | ||||
| 6 months of age | … | 0.06 (.02–.23) | 0.90 (.57–1.44) | 0.03 (.00–.36) | ||||
| Maternal CD4 count at study entry (cells/mm3) | .05 | .07 | ||||||
| >350 | Reference | Reference | ||||||
| ≤350 | 1.39 (1.00–1.92) | 1.40 (.97–2.01) | ||||||
| Maternal plasma HIV-1 RNA concentration at study entry (copies/mL) | .01 | |||||||
| ≤1400 | Reference | |||||||
| >400 | 1.63 (1.10–2.41) | |||||||
| Maternal clinical class at study entry | .23 | |||||||
| A | Reference | |||||||
| B | 0.93 (.51–1.70) | |||||||
| C | 1.42 (.94–2.15) | |||||||
| Maternal antiretroviral regimen of longest duration during pregnancyd | .02 | |||||||
| PI-containing regimen | Reference | |||||||
| NNRTI-containing regimen | 1.43 (.75–2.71) | |||||||
| NRTI(s) only | 1.90 (1.21–2.97) | |||||||
| Infant preterm birth | .006 | .001 | ||||||
| No | Reference | Reference | ||||||
| Yes | 1.79 (1.18–2.73) | 1.90 (1.28–2.83) | ||||||
| Infant was currently receiving antiretroviral(s) at study visit | .008 | |||||||
| No | Reference | |||||||
| Yes | 1.99 (1.20–3.31) | |||||||
| Cumulative duration of infant receipt of antiretroviral(s) by study visit (weeks) | 1.16 (1.01–1.32) | .04 | 1.01 (.66–1.55) | .97 | ||||
| Infant received TMP/SMX before the date of study visit | ||||||||
| No | Reference | |||||||
| Yes | 0.43 (.19–.95) | .04 | ||||||
| Cumulative duration of TMP/SMX receipt by study visit (weeks) | 1.09 (.99–1.19) | .07 | ||||||
Variables with a P value < .1 from the bivariable model for each laboratory outcome were retained in the final multivariable models and were presented in this table.
Abbreviations: CI, confidence interval; HIV, human immunodeficiency virus type 1; NNRTI, nonnucleoside reverse transcriptase inhibitor; NRTI, nucleoside/nucleotide reverse transcriptase inhibitor; OR, odds ratio; PI, protease inhibitor; TMP/SMX, trimethoprim/sulfamethoxazole.
aNone of the infants with hemoglobin severe adverse events received TMP/SMX before the date of hemoglobin assay; therefore, the TMP/SMX exposure variable was excluded during the model fitting procedure.
bHemoglobin assay results at the 6-week, 4-month, and 6-month study visits were collapsed due to the sparseness of event counts (1 at 4 months, 0 at 6 months).
cThere is no standard cut-off value for infants at 2 weeks of age [43]; therefore, total lymphocyte count measurements at this time point were excluded from the analysis.
dThe antiretroviral regimen was classified into 3 mutually exclusive categories following the hierarchy: PI-containing regimen > NNRTI-containing regimen > NRTI-only regimen > NRTI + other regimen. One woman who received NRTI + other regimen was excluded from the analysis.