Impact of Tenofovir Disoproxil Fumarate Use During Pregnancy on Maternal Bone Mineral Density.

BACKGROUND

: There is limited information on the effects of tenofovir disoproxil fumarate (TDF) on bone mineral density (BMD) of women exposed to it during pregnancy, despite increasingly widespread use among pregnant women with HIV or hepatitis B virus (HBV).

METHODS

: The Tenofovir in Pregnancy (TiP) study was a phase II randomized controlled trial to assess the safety of a regimen containing TDF (in combination with lamivudine and lopinavir/ritonavir), starting from 14 weeks gestation, in pregnant women with HIV/HBV co-infection in Guangxi, China. Maternal spinal and hip BMD were assessed by Dual X-ray absorptiometry (DXA) scans at delivery and at 6 months postpartum.

RESULTS

: Fifteen TDF-exposed and 16 TDF-unexposed women had evaluable BMD measurements at delivery. TDF-exposed women were similar at baseline to unexposed women on mean age (28.8 vs 27.8 years), gestational age at delivery (38.1 vs. 38.4 weeks), and body mass index (21.2 vs 22.3 kg/m2). Using a repeated measures mixed-effects model including all study visits, the mean difference in BMD between TDF-exposed and unexposed women at lumbar spine was 0.02 g/cm2 (95% CI = −0.05, 0.09) and at femur neck was 0 (95% CI, −0.09, 0.09), adjusted for relevant covariates (age, BMI, CD4+ T cell count and log10 HIV viral load).

CONCLUSIONS

: Women with HIV/HBV co-infection exposed to TDF during the second and third trimester of pregnancy had no detectable difference in BMD at delivery and at 6 months postpartum, compared to women not exposed to TDF.