Safety and Efficacy of TAF to Prevent MTCT of HBV in Middle/Late Pregnancies With High HBV DNA Load

Launched by XINGFEI PAN · Jul 18, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a medication called tenofovir alafenamide (TAF) to see if it can help prevent the transmission of Hepatitis B virus (HBV) from pregnant women to their babies. The study focuses on pregnant women who are 24 to 28 weeks along and have a high level of the virus in their blood. Participants will be randomly assigned to receive either TAF or another medication called tenofovir disoproxil fumarate (TDF), which is currently used but has some potential side effects for infants. The goal is to determine how safe and effective TAF is during pregnancy, as well as to monitor the health of both the mothers and their babies.

To be eligible for this trial, women must be between 20 and 40 years old, have been diagnosed with Hepatitis B for at least six months, and have a high level of the virus. They must not have any other serious health issues or complications related to pregnancy. Participants can expect to take the assigned medication daily and will be followed closely for two years to monitor their health and that of their babies, looking at things like any potential birth defects and the overall well-being of both mother and child. This trial is important because it aims to find safer and more effective ways to protect infants from Hepatitis B during pregnancy.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Age of 20-40 years.
• • Positive for HBsAg ≥6 months.
• • HBV DNA load of ≥ 2×10\^5 IU/ml.
• • Gestation 24-28 weeks .
• • Pregnancies are orally administrated with TAF (25mg/day) or TDF (300mg/day) from 24-28 weeks of gestation.
• • The good compliance of patients.
• Exclusion Criteria:
• • Patients with antibodies against HIV, HCV, HDV, or other forms of chronic liver disease.
• • Evidence of hepatocellular carcinoma, decompensated liver disease, auto-immune hepatitis, or significant renal, cardiovascular, respiratory or neurological comorbidity.
• • Concurrent treatment with nephrotoxic drugs, glucocorticoids, cytotoxic drugs, nonsteroidal anti-inflammatory drugs, or immune modulators.
• • Ultra-sonographic evidence of fetal deformity, abnormal fetal development or placental abnormality.
• • Clinical signs of threatened miscarriage.
• • History of complication of pregnancy.
• • History of nucleoside analogues (NA) treatment.