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Lower Newborn Bone Mineral Content Associated
With Maternal Use of Tenofovir Disoproxil Fumarate
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CROI 2014
Abstract Body
Background: The impact of maternal tenofovir disoproxil fumarate (TDF) use on infant bone mass has not been well studied. Methodology: Two groups of HIV-exposed, uninfected newborns >36 weeks gestational age [GA] were enrolled in this substudy of the US multisite Pediatric HIV AIDS Cohort Study. The TDF group included infants whose mothers used ≥8 weeks of TDF in the 3rd trimester; the nonTDF group included infants whose mothers used no TDF during the pregnancy. Within 4 weeks of birth, a whole body (WB) dual-energy X-ray absorptiometry (DXA) scan was obtained to measure WB bone mineral content (BMC) with head (WBWH) and less head (WBLH). Standardized analysis of scans was performed centrally. Maternal demographic/clinical data were prospectively collected. Infant weight/length were measured within 72 hours of birth. Target sample size was 75 (63 evaluable) per group to detect WBWH BMC difference between groups of 7% or 0.5 standard deviation (SD) with 80% power. Differences in covariates by TDF group were evaluated by Chi-square and Wilcoxon test. Linear regression models were fit to evaluate BMC by TDF group, adjusted and unadjusted for potential confounders.
Results: 74 TDF and 69 nonTDF group infants from 14 sites had evaluable DXA scans. Maternal TDF use varied by site (p<.001). Compared to the nonTDF group, TDF group mothers were more likely to be married (31% vs 22%, p=.035) and use boosted protease inhibitors (bPI) (86% vs 64%, p=.005); the groups were similar on demographics, infant weight (p=.159) and length (p= .21) z-scores and GA (p=.60). Among mothers with values available in 3rd trimester for CD4 (63 in TDF;44 in nonTDF) and viral load [VL] (62 in TDF; 50 in nonTDF), similar proportions of TDF and nonTDF group mothers had CD4 ≥ 250 (94% and 93%, respectively) and VL < 400 copies/mL (90% and 90%, respectively). The unadjusted mean infant WBWH BMC was significantly lower in the TDF group (56g vs 64g, p=.002, 12.2%, 0.5 SD) as was the mean WBLH BMC (33 g vs 36g, p=.038, 8.3%, 0.3 SD). These differences persisted after adjusting individually for site; maternal bPI use, age, smoking, and pre-pregnancy body mass index; and infant GA, race/ethnicity, age at DXA and length. Maternal CD4 and VL during the 3rd trimester were not correlated with WBWH BMC (p=.44 and p=.13, respectively) or WBLH BMC (p=.29 and p=.34, respectively). Adjusted for site, maternal bPI use, age, and smoking, and infant body length, race/ethnicity and age at DXA, the mean WBWH BMC and mean WBLH BMC were lower in the TDF group than in the nonTDF group by 6.3g (p = .004) and 2.6 g (p = .056), respectively.
Conclusions: Maternal TDF use is associated with a significant reduction in neonatal BMC that persists after adjustment for other factors. The duration and clinical significance of this finding merit evaluation in longitudinal studies.
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