Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial

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dc.contributor.authorBaltrusaitis, Kristin
dc.contributor.authorMakanani, Bonus
dc.contributor.authorTierney, Camlin
dc.contributor.authorFowler, Mary G
dc.contributor.authorMoodley, Dhayendre
dc.contributor.authorTheron, Gerhard
dc.contributor.authorNyakudya, Lynette H
dc.contributor.authorTomu, Musunga
dc.contributor.authorFairlie, Lee
dc.contributor.authorGeorge, Kathleen
dc.contributor.authorHeckman, Barbara
dc.contributor.authorKnowles, Kevin
dc.contributor.authorBrowning, Renee
dc.contributor.authorSiberry, George K
dc.contributor.authorTaha, Taha E
dc.contributor.authorStranix-Chibanda, Lynda
dc.date.accessioned2022-10-24T11:13:33Z
dc.date.available2022-10-24T11:13:33Z
dc.date.issued2022-07-20
dc.date.updated2022-07-24T03:11:43Z
dc.description.abstractBackground Tenofovir disoproxil fumarate (TDF) in combination with other antiretroviral (ARV) drugs has been in clinical use for HIV treatment since its approval in 2001. Although the effectiveness of TDF in preventing perinatal HIV infection is well established, information about renal safety during pregnancy is still limited. Trial design The IMPAACT PROMISE study was an open-label, strategy trial that randomized pregnant women to one of three arms: TDF based antiretroviral therapy (ART), zidovudine (ZDV) based ART, and ZDV alone (standard of care at start of enrollment). The P1084s substudy was a nested, comparative study of renal outcomes in women and their infants. Methods PROMISE participants (n = 3543) were assessed for renal dysfunction using calculated creatinine clearance (CrCl) at study entry (> 14 weeks gestation), delivery, and postpartum weeks 6, 26, and 74. Of these women, 479 were enrolled in the P1084s substudy that also assessed maternal calcium and phosphate as well as infant calculated CrCl, calcium, and phosphate at birth. Results Among the 1338 women who could be randomized to TDF, less than 1% had a baseline calculated CrCl below 80 mL/min. The mean (standard deviation) maternal calculated CrCl at delivery in the TDF-ART arm [147.0 mL/min (51.4)] was lower than the ZDV-ART [155.0 mL/min (43.3); primary comparison] and the ZDV Alone [158.5 mL/min (45.0)] arms; the mean differences (95% confidence interval) were − 8.0 mL/min (− 14.5, − 1.5) and − 11.5 mL/min (− 18.0, − 4.9), respectively. The TDF-ART arm had lower mean maternal phosphate at delivery compared with the ZDV-ART [− 0.14 mg/dL (− 0.28, − 0.01)] and the ZDV Alone [− 0.17 mg/dL (− 0.31, − 0.02)] arms, and a greater percentage of maternal hypophosphatemia at delivery (4.23%) compared with the ZDV-ART (1.38%) and the ZDV Alone (1.46%) arms. Maternal calcium was similar between arms. In infants, mean calculated CrCl, calcium, and phosphate at birth were similar between arms (all CIs included 0). Conclusions Although mean maternal calculated CrCl at Delivery was lower in the TDF-ART arm, the difference between arms is unlikely to be clinically significant. During pregnancy, the TDF-ART regimen had no observed safety concerns for maternal or infant renal function. Trial Registration: NCT01061151 on 10/02/2010 for PROMISE (1077BF). NCT01066858 on 10/02/2010 for P1084s.en_US
dc.identifier.apacitationBaltrusaitis, K., Makanani, B., Tierney, C., Fowler, M. G., Moodley, D., Theron, G., ... Stranix-Chibanda, L. (2022). Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial. <i>BMC Infectious Diseases</i>, 22(1), 634. http://hdl.handle.net/11427/36874en_ZA
dc.identifier.chicagocitationBaltrusaitis, Kristin, Bonus Makanani, Camlin Tierney, Mary G Fowler, Dhayendre Moodley, Gerhard Theron, Lynette H Nyakudya, et al "Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial." <i>BMC Infectious Diseases</i> 22, 1. (2022): 634. http://hdl.handle.net/11427/36874en_ZA
dc.identifier.citationBaltrusaitis, K., Makanani, B., Tierney, C., Fowler, M.G., Moodley, D., Theron, G., Nyakudya, L.H. & Tomu, M. et al. 2022. Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial. <i>BMC Infectious Diseases.</i> 22(1):634. http://hdl.handle.net/11427/36874en_ZA
dc.identifier.ris TY - Journal Article AU - Baltrusaitis, Kristin AU - Makanani, Bonus AU - Tierney, Camlin AU - Fowler, Mary G AU - Moodley, Dhayendre AU - Theron, Gerhard AU - Nyakudya, Lynette H AU - Tomu, Musunga AU - Fairlie, Lee AU - George, Kathleen AU - Heckman, Barbara AU - Knowles, Kevin AU - Browning, Renee AU - Siberry, George K AU - Taha, Taha E AU - Stranix-Chibanda, Lynda AB - Background Tenofovir disoproxil fumarate (TDF) in combination with other antiretroviral (ARV) drugs has been in clinical use for HIV treatment since its approval in 2001. Although the effectiveness of TDF in preventing perinatal HIV infection is well established, information about renal safety during pregnancy is still limited. Trial design The IMPAACT PROMISE study was an open-label, strategy trial that randomized pregnant women to one of three arms: TDF based antiretroviral therapy (ART), zidovudine (ZDV) based ART, and ZDV alone (standard of care at start of enrollment). The P1084s substudy was a nested, comparative study of renal outcomes in women and their infants. Methods PROMISE participants (n = 3543) were assessed for renal dysfunction using calculated creatinine clearance (CrCl) at study entry (> 14 weeks gestation), delivery, and postpartum weeks 6, 26, and 74. Of these women, 479 were enrolled in the P1084s substudy that also assessed maternal calcium and phosphate as well as infant calculated CrCl, calcium, and phosphate at birth. Results Among the 1338 women who could be randomized to TDF, less than 1% had a baseline calculated CrCl below 80 mL/min. The mean (standard deviation) maternal calculated CrCl at delivery in the TDF-ART arm [147.0 mL/min (51.4)] was lower than the ZDV-ART [155.0 mL/min (43.3); primary comparison] and the ZDV Alone [158.5 mL/min (45.0)] arms; the mean differences (95% confidence interval) were − 8.0 mL/min (− 14.5, − 1.5) and − 11.5 mL/min (− 18.0, − 4.9), respectively. The TDF-ART arm had lower mean maternal phosphate at delivery compared with the ZDV-ART [− 0.14 mg/dL (− 0.28, − 0.01)] and the ZDV Alone [− 0.17 mg/dL (− 0.31, − 0.02)] arms, and a greater percentage of maternal hypophosphatemia at delivery (4.23%) compared with the ZDV-ART (1.38%) and the ZDV Alone (1.46%) arms. Maternal calcium was similar between arms. In infants, mean calculated CrCl, calcium, and phosphate at birth were similar between arms (all CIs included 0). Conclusions Although mean maternal calculated CrCl at Delivery was lower in the TDF-ART arm, the difference between arms is unlikely to be clinically significant. During pregnancy, the TDF-ART regimen had no observed safety concerns for maternal or infant renal function. Trial Registration: NCT01061151 on 10/02/2010 for PROMISE (1077BF). NCT01066858 on 10/02/2010 for P1084s. DA - 2022-07-20 DB - OpenUCT DP - University of Cape Town IS - 1 J1 - BMC Infectious Diseases KW - HIV/AIDS KW - Antiretroviral therapy KW - Renal function KW - Pregnancy KW - Prevention of perinatal HIV transmission LK - https://open.uct.ac.za PY - 2022 T1 - Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial TI - Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial UR - http://hdl.handle.net/11427/36874 ER - en_ZA
dc.identifier.urihttps://doi.org/10.1186/s12879-022-07608-8
dc.identifier.urihttp://hdl.handle.net/11427/36874
dc.identifier.vancouvercitationBaltrusaitis K, Makanani B, Tierney C, Fowler MG, Moodley D, Theron G, et al. Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial. BMC Infectious Diseases. 2022;22(1):634. http://hdl.handle.net/11427/36874.en_ZA
dc.language.isoenen_US
dc.language.rfc3066en
dc.publisher.departmentDepartment of Public Health and Family Medicineen_US
dc.publisher.facultyFaculty of Health Sciencesen_US
dc.rights.holderThe Author(s)
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_US
dc.sourceBMC Infectious Diseasesen_US
dc.source.journalissue1en_US
dc.source.journalvolume22en_US
dc.source.pagination634en_US
dc.source.urihttps://bmcinfectdis.biomedcentral.com/
dc.subjectHIV/AIDSen_US
dc.subjectAntiretroviral therapyen_US
dc.subjectRenal functionen_US
dc.subjectPregnancyen_US
dc.subjectPrevention of perinatal HIV transmissionen_US
dc.titleMaternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trialen_US
dc.typeJournal Articleen_US
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