TITLE: Safety of Tenofovir Disoproxil Fumarate (TDF) treatment for the entire pregnancy in mothers with active chronic hepatitis B or cirrhosis
AUTHORS (FIRST NAME, LAST NAME): Calvin Pan1, Min Liu2, Haodong Cai2, Wei Yi2
INSTITUTIONS (ALL): 1. Division of Gastroenterology and Hepatology, NYU Langone Medical Center, NYU School of Medicine, Flushing, NY, United States.
2. Ditan Hospital, Beijing, China.
ABSTRACT BODY: Background:
Antiviral therapy may be used during pregnancy to control maternal disease. Data are lacking on TDF treatment throughout pregnancy in mothers with active chronic hepatitis B (CHB). We evaluate the safety and efficacy of TDF therapy in such mothers and their infant outcomes.
We retrospectively enrolled CHB mothers who received TDF (300 mg/day) throughout their pregnancy between 1/2011-5/2013 and assessed mother-infant outcomes. All infants received appropriate immunoprophylaxis.
Among 48 mothers enrolled, 43 initiated TDF prior to pregnancy, and 5 were switched from nucleoside at the first trimester; 28 mother delivered 29 newborns (mean TDF fetal exposure 37.6±3.0 weeks), 3 experienced fetal loss at the first trimester (1 got pregnant again on TDF), and 18 had not reached full term yet. All subjects had active CHB (1 cirrhosis). The mean age was 30.7±3.2 years; 87.5% mothers were HBeAg positive, 93.8% mothers were nucleoside experience (39 lamivudine resistance; 3 telbivudine resistance). TDF was well tolerated with no viral rebound/breakthrough or alanine aminotransferase (ALT) flare during treatment. Three mothers (6.1%) had spontaneous abortion at the first trimester. Maternal and fetal adverse events are shown on Table 1. Most adverse events were mild in severity and considered unrelated to TDF. A higher percentage of mothers achieved HBV DNA 9. Among the 19 infants that have since reached the age of 7 months, 18 were tested and all were HBsAg(-).
TDF treatment for the entire pregnancy period is safe and well-tolerated in pregnant women with active CHB. A majority of mothers in this study maintained complete virological response with normalized ALT and none had antiviral resistance or signs of disease progression. There were no congenital abnormalities related to TDF nor HBV infection among their infants for up to 7 months of follow up.
Very encouraging results. In a very high HBV endemic country, all HBV mothers are desperate to stop vertical transmission to their babies. Gilead is conducting a large clinical trial in China on the use TDF during pregnancy.
Thank you for sharing.
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