Background:  The German Guidelines recommend the treatment of pregnant HIV-infected women with ART started 4 weeks prior to delivery. Tenofovir (TDF) is increasingly used in prenatal ART of pregnant HIV-infected women at our center. TDF has low teratogenicity (FDA classification, class B). Therefore its use is a suitable antiretroviral agent during pregnancy. Side effects of TDF consist predominantly of nephrotoxicity and interference with bone metabolism. We initiated a prospective- controlled study to determine whether renal function was impaired of HIV-exposed children whose mothers were treated with TDF during pregnancy.

Methods:  Since January 2005 we followed 20 children whose mothers received TDF/zidovudine (AZT) during pregnancy in order to evaluate the effects of TDF on the child’s renal function (study cohort). A control group consisted of 20 HIV-exposed children whose mothers were treated with ART excluding TDF (n = 7 AZT/lamivudine [3TC] and nevirapine [NVP]; n = 4 AZT/3TC and lopinavir [LPV]/ritonavir [r]; n = 3 no ART; n = 3 other ART excluding TDF). Cystatin C (which correlates with the glomerular filtration rate more precisely than creatinine methods during childhood), urea, calcium, phosphate, and creatinine were determined at regular intervals from the neonatal period until the age of 2 years (ideally 1.5, 3, 6, 12, and 24 months after birth). The results of the study group were compared with the controls.

Results:  All individuals were followed for 24 months:  neither elevation of cystatin C nor urea was observed in the study cohort (n = 20), as well as in the controls (n = 20).

Conclusions:  We therefore conclude that the use of TDF during pregnancy has no impact on the renal function of the children after birth and during early childhood.