Immediate postpartum cessation of tenofovir did not increase risk of virological or clinical relapse in highly viremic pregnant mothers with chronic hepatitis B infection

Abstract

<h3>Background</h3><p>Peripartum prophylaxis (PP) with tenofovir disoproxil fumarate (TDF) is the standard-of-care to prevent mother-to-child transmission (MTCT) of chronic hepatitis B (CHB) infection in highly-viremic mothers. We investigated the maternal and infant outcomes in a large Chinese cohort of TDF-treated CHB pregnant subjects.</p><h3>Methods</h3><p>In this prospective study, treatment-naïve non-cirrhotic highly-viremic (hepatitis B virus [HBV] DNA ≥200,000 IU/mL) CHB mothers were treated with TDF at 24-28 weeks of pregnancy. In accordance with Chinese CHB guidelines, TDF was stopped at delivery or ≥4 weeks postpartum. Serum HBV DNA and alanine aminotransferase (ALT) were monitored every 6-8 weeks to determine virological relapse (VR). Infants received standard neonatal immunization and HBV serology were checked at 7-12 months of age.</p><h3>Results</h3><p>Among 330 subjects recruited (median age 30, 82.7% HBeAg+, median HBV DNA 7.82 log IU/mL), TDF was stopped at delivery in 66.4% and ≥4 weeks in 33.6%. VR was observed in 98.3%, among which 11.6% were retreated with TDF. Timing of TDF cessation did not alter the risk of VR (99.0% vs. 96.9%), clinical relapse (19.5% vs. 14.3%) or retreatment (12.3% vs. 10.2%) (all p>0.05). Similar proportion of patients developed ALT flare 5x (2.1% vs 1.0%, p=0.464) and 10x (0.5% vs 0%, p=0.669) above upper limit of normal respectively, in early withdrawal and late withdrawal group. No infants developed HBsAg-positivity.</p><h3>Conclusion</h3><p>PP-TDF and neonatal immunization were highly effective to prevent MTCT of HBV in highly-viremic mothers. Timing of cessation of PP-TDF did not affect the risk of VR or retreatment.</p>