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In Utero Tenofovir Exposure May Not Affect Infant Bones
By Reuters Staff
August 14, 2018
NEW YORK (Reuters Health) - A new pilot study suggests prenatal tenofovir exposure does not have a significant effect on infant bone mineral content (BMC) or bone mineral density (BMD).
Six-month-olds whose mothers were on the antiviral drug showed a trend toward lower BMC and BMD, although the difference was not statistically significant, Dr. Athena P. Kourtis of the Centers for Disease Control and Prevention (CDC) in Atlanta and her colleagues found.
"Our findings are overall reassuring and provide support for the current WHO and NIH recommendations that include TDF in the preferred regimens for HIV-infected and HIV/HBV co-infected pregnant women," they conclude in The Pediatric Infectious Disease Journal, online July 31.
The Tenofovir in Pregnancy study, a phase 2 trial, enrolled 35 pregnant women coinfected with HIV and hepatitis B virus (HBV), below the target sample size of 80. Participants were randomized to tenofovir/lamivudine/lopinavir-ritonavir or zidovudine/lamivudine/lopinavir-ritonavir.
At birth, BMC was 10% lower in tenofovir-exposed infants than in unexposed infants, and 6% lower at six months of age. BMD was 4% lower at birth and 3% lower at six months in the exposed infants compared to the unexposed infants.
The study's small sample size meant it did not have the power to detect statistically significant differences between exposed and unexposed infants, the authors note.
"Notwithstanding the small sample size, recently reported initial findings from larger trials in HIV/HBV co-infected and HBV-monoinfected women seem to confirm our findings," they conclude.
The CDC, the Guanxi Provincial Center for Disease Control and Prevention, and Gilead Sciences, Inc., through a grant to the CDC foundation, funded the study.
Dr. Kourtis was not available for an interview by press time.
SOURCE: https://bit.ly/2vVlkg4
Pediatr Infect Dis J 2018. |
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