Children of women who used tenofovir disoproxil fumarate, or TDF, to prevent transmission of hepatitis B to their child did not have lower bone mineral density compared with children who were exposed to placebo, according to findings from a randomized controlled trial published in Clinical Infectious Diseases.
“TDF is often part of drug combinations that HIV-infected pregnant women take for their own health and the prevention of perinatal HIV transmission,” study researcher Gonzague Jourdain, MD, PhD, from the French National Research Institute for Sustainable Development, told Infectious Diseases in Children. “According to previous studies conducted in pregnant women with HIV infection, it was suspected that maternal TDF use during pregnancy and lactation may adversely affect bone mineral density in both mothers and infants. However, bone mineral density may be altered due to concomitant antiretroviral drugs, HIV infection and related inflammation.”
To investigate the effect of TDF use on maternal and infant bone mineral density (BMD), Jourdain and colleagues conducted a secondary analysis of the iTAP study, which included 168 pregnant women in Thailand with chronic HBV. The women received either TDF or placebo beginning at 28 weeks’ gestational age and discontinued treatment 2 months after birth.
According to the researchers, 140 mothers and 137 infants were included in the BMD analysis.
When scans of TDF-exposed mothers were compared with those of mothers who received placebo, Jourdain and colleagues found no statistically significant differences in hip BMD (mean difference = 0.008 g/cm2 [95% CI, –0.028 to 0.044 g/cm2]) or lumbar spine BMD (mean difference = 0.010 g/cm2 [95% CI, –0.026 to 0.046 g/cm2]). In addition, there were no statistically significant differences in lumbar spine scans between infants who received TDF and those who received placebo (mean difference = –0.006 g/cm2 [95% CI, –0.019 to 0.007 g/cm2]).
“Although TDF is not formally indicated by the U.S. FDA for the prevention of mother-to-child transmission of HBV, the findings of our study provide reassuring information that supports the guidelines from several associations for the study of liver diseases, including the American Association for the Study of Liver Diseases, recommending TDF as the preferred therapy in women with high HBV replication,” Jourdain said. – by Katherine Bortz
Disclosures: Jourdain reports receiving research funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development through grant U01HD071889. Please see the study for all other authors’ relevant financial disclosures.