Phase 4 TAF vs TDF Pregnancy Study, NCT07542951
ClinicalTrials.gov Studies
Summary
The NIH has registered a Phase 4 clinical trial (NCT07542951) comparing Tenofovir alafenamide (TAF) versus Tenofovir disoproxil fumarate (TDF) for antiviral therapy in pregnant women with chronic hepatitis B. The study will evaluate HBV mother-to-child transmission rates, birth defect incidence, adverse events, and newborn growth and development. Participants will receive daily drug treatment throughout pregnancy with clinic visits every 4 weeks during pregnancy and every 12 weeks postpartum.
What changed
This entry adds a new Phase 4 clinical trial registration (NCT07542951) to ClinicalTrials.gov. The study compares TAF and TDF antiviral therapy in pregnant women with chronic hepatitis B across four primary endpoints: HBV vertical transmission rate, birth defect incidence, adverse events, and newborn development indices.
Pharmaceutical companies manufacturing either TAF or TDF formulations and healthcare providers conducting hepatitis B treatment in pregnancy should note this comparative safety and efficacy study. Results may inform clinical practice guidelines for antiviral use in this patient population.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
TAF vs TDF During the Pregancy
Phase 4 NCT07542951 Kind: PHASE4 Apr 21, 2026
Abstract
The goal of this clinical trial is to learn the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy antiviral therapy for chronic hepatitis B pregnant women.
The main questions it aims to answer are:
The rate of HBV mother-to-child transmission between the TAF and TDF groups. The incidence of birth defects in newborns between the TAF and TDF groups. What medical problems do participants have when taking drug TAF or TDF? The growth and development indices of newborns between the TAF and TDF groups.
Participants will:
Take drug TAF or TDF every day during the pregnacy. Visit the clinic once every 4 weeks for checkups and tests during the pregnancy and every 12 weeks postpartum.
Conditions: Hepatitis B Virus Infection; Pregnant Women
Interventions: TAF
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