Most new hepatitis B virus (HBV) infections are acquired perinatally. In this study, pregnant women with HBsAg and HBeAg will receive tenofovir disoproxil fumarate during the last trimester of pregnancy and for two months following delivery. Their infants will receive hepatitis B (HB) immunization, starting with a first dose soon after birth. We hypothesize that the risk of mother-to-child transmission of HBV will be lower than 2%. The results of the study will help define policy to manage HBV infected pregnant women to prevent perinatal transmission.
This is a prospective multi-center, multi-country (Thailand and Lao PDR), open-label, single arm clinical trial in HBsAg and HBeAg positive pregnant women (from 28 weeks until one year postpartum) and their infants (until 18 months of age). Pregnant women with HBsAg and HBeAg will receive tenofovir disoproxil fumarate 300 mg once daily from 28 weeks of pregnancy until two months postpartum. Their infants will receive hepatitis B (HB) immunization, starting with the first dose soon after birth. The study aims to show that substituting maternal antiviral treatment for infant HBIg can be favorably considered in settings where HBIg plus vaccine has been used as well as in settings where only vaccine is used. A significant improvement over the standard HBIg + vaccine strategy would be that adding an antiviral strategy results in less than 2% transmission. A total of 499 women and their infants will be enrolled in public hospitals in Thailand and Lao PDR. The study will be monitored by a Data and Safety Monitoring Board (DSMB) at least annually.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
504
Tenofovir disoproxil fumarate (TDF), one 300 mg tablet once a day from 28 weeks' gestation through two months postpartum
Champasak Hospital
Champasak, Laos
Luang Prabang Provincial Hospital
Luang Prabang, Laos
Sayaboury Hospital
Sainyabuli, Laos
Savannakhet Provincial hospital
Savannakhet, Laos
103 Hospital
Vientiane, Laos
Mahosot Hospital
Vientiane, Laos
Mother and Newborn Hospital
Vientiane, Laos
Setthathirath Hospital
Vientiane, Laos
Chiang Kham Hospital
Chiang Kham, Changwat Phayao, Thailand
Nopparat Rajathanee Hospital
Bangkok, Thailand
...and 10 more locations
Infant hepatitis B infection status
HBsAg positive confirmed by PCR detection of HBV DNA.
Time frame: Six months of age
Maternal HBV DNA changes
Description of the effect of tenofovir disoproxil fumarate on maternal HBV DNA levels
Time frame: From enrollment until end of study treatment scheduled 2 months after delivery
Infant levels of anti-HBs antibodies
Levels of anti-HBs antibodies in infants in the absence of HBIg administration at birth
Time frame: At 1, 2, 4, 6, and 12 months of age
HBV infection status in all infants regardless of maternal response to study treatment
HBsAg positive confirmed by PCR detection of HBV DNA in all infants, i.e. including those born to women with unsatisfactory virological response to study treatment
Time frame: At 6 months of age
Serious adverse events
Occurrence of maternal serious adverse events (ICH SAEs) including DAIDS grade 4 signs and symptoms regardless of their relatedness to the study treatment
Time frame: From enrollment until 12 months postpartum
Serious adverse events
Occurrence of infant serious adverse events (ICH SAEs) including DAIDS grade 4 signs and symptoms regardless of their relatedness to the study treatment
Time frame: From birth until 12 months of age
Preterm live births
Proportion of neonates born alive before 37 weeks of pregnancy
Time frame: Delivery
Low birth weight
Proportion of neonates born alive with birth weight of 2,499 g or less, regardless of gestational age
Time frame: Delivery
Active or previous transient infection in children
Detection of anti-HBc antibodies among all infants
Time frame: At 18 months of age
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