The Safety of Anti-viral Therapy in Preventing HBV MTCT in Pregnant Women After Discontinuation
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Mother-to-child transmission (MTCT) is the most common mode of perpetuating chronic hepatitis
      B virus (HBV) infection in endemic countries. Many studies have demonstrated antepartum
      anti-viral therapy (AVT) is a advisable option to reduce mother-to-child transmission and the
      risk of vaccination breakthrough in infants who received passive-active immunoprophylaxis.
      However, several controversies over antiviral treatment have not been resolved, that is,
      optimal duration, effect of postpartum therapy, and risk of postpartum alanine
      aminotransferase (ALT) flare after withdrawal. Will the risk of postpartum hepatitis flares
      increase after short-term AVT in late pregnancy for maternal HBV infection is discontinued?
      Is there any correlation between postpartum hepatitis flares and withdrawal time? Will the
      proportion of postpartum flares be reduced if extending the duration of AVT after delivery?
      There is an urgent need in this area. This study mainly investigated the safety of antiviral
      therapy in preventing HBV mother-to-child transmission in pregnant women after
      discontinuation.
    

Detailed description: 
      Between June 2015 and December 2017, 111 mothers were enrolled during their visit to the
      Department of Gynecology and Obstetrics or the Department of Infectious Diseases of the Third
      Affiliated Hospital of Sun Yat-Sen University in Guangzhou, Guangdong province, China.
      Pregnant women fulfilling the inclusion and exclusion criteria were offered participation in
      the study. All pregnant women who opted for AVT need to sign a consent form and started on
      oral telbivudine (LDT) 600 mg or tenofovir disoproxil fumarate (TDF) 300 mg (as per patients'
      wishes) daily between gestational weeks 24 and 28. Serum levels of HBV DNA, HBsAg, HBsAb,
      HBeAg, HBeAb, liver function tests, haematology and renal biochemistry were measured at
      baseline(i.e. at screening), every 4 weeks after treatment begins, at the time of delivery,
      and at 1, 2, 3, 6, 12 month postpartum. After delivery, treatment with LDT or TDF was
      immediately withdrew to the patients with an intention of breastfeeding, while the other
      patients, without desire of breastfeeding, would subsequently extend antiviral treatment
      duration to postpartum 6 weeks. All infants were vaccinated with genetically engineered HBV
      vaccine 20 ug according to a standard vaccination regimen (i.e. within 12h of birth, at week
      4 and at week 24) and 200 IU doses of hepatitis B immunoglobulin immediately (within 2h)
      after birth and at day 15. The infant's HBV serologic status and HBV DNA were tested at birth
      (before immunization) and again at 7 months. The investigators discussed the postpartum liver
      function after withdrawal and evaluated the impact of extending the postpartum duration of
      AVT administered for the prevention of perinatal transmission.
    

Intervention name(s): Telbivudine 600mg; Tenofovir disoproxil fumarate 300mg
Intervention type(s): Drug; Drug
Intervention description(s): Pregnant mothers who opted for antiviral therapy would start on oral LDT 600 mg daily between gestational weeks 24 and 28.; Pregnant mothers who opted for antiviral therapy would start on oral TDF 300 mg daily between gestational weeks 24 and 28.
Other intervention name(s): Sebivo; Viread
Intervention MeSH terms: Tenofovir; Telbivudine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Pregnant mothers who opt for antiviral therapy will start on oral LDT 600 mg or TDF 300 mg (as per patients' wishes) daily between gestational weeks 24 and 28. Antiviral therapy will be discontinued in intrapartum or at postpartum 6 weeks.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hepatitis B virus; exacerbation; antiviral agents; pregnancy; flare