Abstract
BackgroundTenofovir alafenamide fumarate has been used in late pregnancy; however, no data exist regarding its safety and effectiveness in early and middle pregnancy for mothers with hepatitis B virus infection.AimsTo design a prospective study to investigate the efficacy and safety of TAF in pregnant women with chronic HBV infection during early-middle pregnancy.MethodsPregnant women with active chronic hepatitis B who received tenofovir alafenamide fumarate during early and middle pregnancy were enrolled and followed up until 6 months postpartum. Infants received immunoprophylaxis. The primary endpoint was the safety of mothers and infants. The secondary endpoints were maternal hepatitis B virus DNA reduction at delivery and mother-to-child transmission rate.ResultsAmong 98 mothers enrolled, 31 initiated tenofovir alafenamide fumarate in early pregnancy, and 57 in middle pregnancy. The mean (± standard deviation) age was 29.00 (±3.81) years. At delivery, 100% (98/98) of the mothers achieved hepatitis B virus DNA levels <200,000 IU/L. Ninety-eight infants were born, and none had congenital defects or malformations. All infants received hepatitis B virus immunoprophylaxis. The mother-to-child transmission rate was 0%. Growth parameters including body weight, height, and head circumference were comparable to the national standards for physical development. No severe adverse effects were reported in either mothers or infants. No severe liver function damage occurred in any of the mothers.ConclusionsInitiating tenofovir alafenamide fumarate in early and middle pregnancy appears safe for both mothers and infants, and it is effective for controlling maternal disease as well as interrupting mother-to-child transmission.
Highlights
There were an estimated 257 million chronic hepatitis B virus (HBV) carriers worldwide in 2015, and 887,000 people died due to HBV-related complications, which mostly included end-stage liver diseases such as cirrhosis and hepatocellular carcinoma [1]
Pregnant mothers with chronic HBV infection in early and middle pregnancy were included if they fulfilled the following eligibility criteria: [1] they were aged above 20 years; [2] they had active chronic hepatitis B (CHB), classified as alanine aminotransferase (ALT)≥2 upper limit of normal value (ULN) more than two times during 1 month and HBV DNA >100,000 IU/ml [16]; [3] they were in early pregnancy, defined as
Drug compliance to Tenofovir alafenamide fumarate (TAF) was assessed by the attending physician at each visit and the medication possession ratio (MPR) was calculated as the total number of days of medication supply divided by the time interval [21]
Summary
There were an estimated 257 million chronic hepatitis B virus (HBV) carriers worldwide in 2015, and 887,000 people died due to HBV-related complications, which mostly included end-stage liver diseases such as cirrhosis and hepatocellular carcinoma [1]. An estimated 4.5 million women with chronic HBV infection give birth annually, with the largest number living in Africa and Western Pacific regions [2]. Mother-to-child transmission (MTCT) is the most common route of HBV transmission, and is the key target for controlling HBV infection. Standardised management of mothers and infants is an effective measure to control MTCT of HBV [3, 4]. Tenofovir alafenamide fumarate has been used in late pregnancy; no data exist regarding its safety and effectiveness in early and middle pregnancy for mothers with hepatitis B virus infection
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