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BACKGROUND We assessed bone and kidney outcomes in infants randomized post-delivery as mother-infant pairs within the IMPAACT PROMISE trial to maternal TDF-based ART (mART) or infant nevirapine prophylaxis (iNVP) to… Click to show full abstract
BACKGROUND We assessed bone and kidney outcomes in infants randomized post-delivery as mother-infant pairs within the IMPAACT PROMISE trial to maternal TDF-based ART (mART) or infant nevirapine prophylaxis (iNVP) to prevent breastfeeding HIV transmission. METHODS Infants were co-enrolled in the P1084s substudy on randomization day and followed through Week 74. Lumbar spine bone mineral content (LS-BMC) was assessed at entry (6-21 days of life) and Week 26 by dual-energy x-ray absorptiometry. Creatinine clearance (CrCl) was calculated at entry and Weeks 10, 26, and 74. Student t-tests compared mean LS-BMC and CrCl at Week 26 and mean change from entry between arms. RESULTS Of 400 enrolled infants, mean (standard deviation (sd); n) for entry LS-BMC was 1.68g (0.35; n=363) and CrCl was 64.2mL/min/1.73m2 (24.6; n=357). At Week 26, 98% of infants were breastfeeding and 96% were on their assigned HIV prevention strategy. Mean (sd) Week 26 LS-BMC was 2.64g (0.48) for mART and 2.77g (0.44) for iNVP; mean difference (95% confidence interval (CI)) -0.13g (-0.22, -0.04), P=0.007, n=375/398 (94%). Mean absolute (-0.14g (-0.23, -0.06)) and percent (-10.88% (-18.53, -3.23)) increase in LS-BMC from entry was smaller for mART than iNVP. At Week 26, mean (sd) CrCl was 130.0mL/min/1.73m2 (34.9) for mART vs. 126.1mL/min/1.73m2 (30.0) for iNVP; mean difference (95% CI) 3.8 (-3.0, 10.7), P=0.27, n=349/398 (88%). CONCLUSION Week 26 mean LS-BMC was lower in infants in the mART group compared with the iNVP group. However, this difference (∼0.23g) was less than the one-half sd considered potentially clinically relevant. No infant renal safety concerns were observed.