Tenofovir alafenamide prevents mother-to-infant HBV transmission
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Tenofovir alafenamide therapy was safe, well-tolerated and prevented the transmission of hepatitis B virus from pregnant mothers to infants, according to research presented at The Liver Meeting Digital Experience.
Currently, few data exist investigating the safety and effectiveness of tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) administration among pregnant women with chronic HBV despite being indicated for use during pregnancy in China, Qing-Lei Zeng, MD, associate professor at The First Affiliated Hospital of Zhengzhou University, said during the presentation. In a multicenter study, researchers aimed to investigate the safety and effectiveness of TAF therapy in preventing mother-to-child HBV transmission.
Enrolled mothers received either TAF (n = 103) or TDF (n = 104) according to patient preference and all infants received immunoprophylaxis. For mothers, Zeng and colleagues evaluated perinatal adverse events, complications, ALT flare and changes in kidney function at delivery, postpartum month 3 and postpartum month 6. Infant safety assessments included evaluation of structural defects at birth, Apgar scores and abnormal conditions from birth to 7 months. At therapy initiation, they noted a mean gestational age of 1 week, an alanine aminotransferase level of 112.5 U/L and an HBV DNA level of 4.6 log10 IU/mL. Mothers and infants were closely monitored until at least 7 months postpartum; the longest follow-up timepoint was postpartum month 18.
During a mean treatment duration of 96.1 weeks among mothers dosed with TAF and 98.7 weeks among mothers dosed with TDF, researchers observed good tolerability. The most common adverse event was nausea which occurred in 29.1% and 31.7% of mothers and the most common maternal complication was premature rupture of membranes (12.6% and 13.5%). After initiating TAF at week 12, one mother underwent induced abortion at gestational week 23 due to fetal cleft lip and palate; the researchers noted the lip and palate develop by 6 to 10 weeks of embryogenesis. They further observed no congenital defects among infants as well as normal physical and neurological development through follow-up; the mother-to-child transmission rate reduced to 0%.
“The TAF and TDF groups had comparable safety and effectiveness for active HBV mothers during about 2 years of treatment,” Zeng concluded. “Treatment with TAF can serve as an alternative option for mothers with active chronic HBV.”
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Zeng QL. Tenofovir alafenamide used throughout pregnancy in Chinese active chronic hepatitis b mothers: A multicenter prospective study. Presented at: The Liver Meeting Digital Experience; Oct. 12-15, 2021 (virtual meeting).
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