title: Clinical course of 161 untreated and tenofovir-treated chronic hepatitis B pregnant patients in a low hepatitis B virus endemic region.
abstract: Hepatitis B immunoprophylaxis failure is linked to high maternal viraemia. There is limited North American data on hepatitis B outcomes in pregnancy. Pregnant hepatitis B carriers were enrolled January 2011-December 2014 and offered tenofovir in the 3rd trimester if hepatitis B virus (HBV)-DNA was >7-log IU/mL. Outcomes were determined in treated vs untreated patients. In total, 161 women with 169 pregnancies (one twin, 170 infants; median age 32 years), 18% (29/161) HBeAg+ and median HBV-DNA 2.51 log IU/mL (IQR 1.66-3.65; range 0.8-8.1) were studied. 14.3% (23/161) received tenofovir due to high viral load (16/23, median 74 days, IQR 59-110) or due to liver disease (7/23). In 10/16 treated due to high viraemia, with confirmed adherence, follow-up HBV-DNA showed a 5.49 log decline (P = 0.003). In treatment naïve mothers, median alanine aminotransferase (ALT) increased from 17 IU/L (IQR 12-24) to 29 (IQR 18-36) post-partum (P = 1.5e-7). In seven highly viraemic mothers who declined therapy (HBV-DNA >8-log IU/mL); median ALT increased ~3X from baseline (P < 0.01). 26% (44/169) had Caesarean section with no difference in treated vs untreated subjects. No tenofovir-treated mothers had renal dysfunction. Data were available on 167/170 infants; in 50.8% (85/167) who completed immunoprophylaxis, 98.8% (84/85, including 12 exposed to tenofovir in utero) were HBV immune. One infant born to an HBeAg+ mother with HBV-DNA >8-log IU/mL failed immunoprophylaxis. In this prospective Canadian cohort study, most untreated mothers experienced mild HBV flares. Tenofovir in pregnancy is well tolerated and reduces viral load prior to parturition.
authors.affiliation: Calgary Liver Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
authors.forename: G
authors.initials: G
authors.lastname: Samadi Kochaksaraei
authors.affiliation: Medical Disorders in Pregnancy, Division of Internal Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
authors.forename: E
authors.initials: E
authors.lastname: Castillo
authors.affiliation: Alberta Health, Government of Alberta, Edmonton, AB, Canada.
authors.forename: M
authors.initials: M
authors.lastname: Osman
authors.affiliation: Alberta Health, Government of Alberta, Edmonton, AB, Canada.
authors.forename: K
authors.initials: K
authors.lastname: Simmonds
authors.affiliation: Alberta Health, Government of Alberta, Edmonton, AB, Canada.
authors.forename: A N
authors.initials: AN
authors.lastname: Scott
authors.affiliation: Calgary Liver Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
authors.forename: J I
authors.initials: JI
authors.lastname: Oshiomogho
authors.affiliation: Calgary Liver Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
authors.forename: S S
authors.initials: SS
authors.lastname: Lee
authors.affiliation: Calgary Liver Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
authors.forename: R P
authors.initials: RP
authors.lastname: Myers
authors.affiliation: Department of Paediatrics, Alberta Children's Hospital, Calgary, AB, Canada.
authors.forename: S R
authors.initials: SR
authors.lastname: Martin
authors.affiliation: Calgary Liver Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
authors.forename: C S
authors.initials: CS
authors.lastname: Coffin
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D002170:Canada; D015331:Cohort Studies; D005260:Female; D006514:Hepatitis B Surface Antigens / Q000097:blood; D017325:Hepatitis B Vaccines / Q000627:therapeutic use*; D006515:Hepatitis B virus / Q000276:immunology / Q000302:isolation & purification; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000517:prevention & control / Q000635:transmission / Q000821:virology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000517:prevention & control* / Q000821:virology; D011446:Prospective Studies; D000068698:Tenofovir / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects; D014766:Viremia / Q000188:drug therapy* / Q000821:virology
chemical_list: D000998:Antiviral Agents; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D000068698:Tenofovir; D000410:Alanine Transaminase
keywords: chronic hepatitis B; perinatal transmission; pregnancy; tenofovir disoproxil fumarate