@article{fdi:010067755,
  title = {{P}revention of mother-to-child transmission of hepatitis {B} virus : a phase {III}, placebo-controlled, double-blind, randomized clinical trial to assess the efficacy and safety of a short course of tenofovir disoproxil fumarate in women with hepatitis {B} virus e-antigen},
  author = {{J}ourdain, {G}onzague and {N}go-{G}iang-{H}uong, {N}icole and {C}ressey, {T}. {R}. and {H}ua, {L}. and {H}arrison, {L}. and {T}ierney, {C}. and {S}alvadori, {N}icolas and {D}ecker, {L}uc and {T}raisathit, {P}. and {S}irirungsi, {W}. and {K}hamduang, {W}. and {B}owonwatanuwong, {C}. and {P}uthanakit, {T}. and {S}iberry, {G}. {K}. and {W}atts, {D}. {H}. and {M}urphy, {T}. {V}. and {A}chalapong, {J}. and {H}ongsiriwon, {S}. and {K}linbuayaem, {V}. and {T}hongsawat, {S}. and {C}hung, {R}. {T}. and {P}ol, {S}. and {C}hotivanich, {N}.},
  editor = {},
  language = {{ENG}},
  abstract = {{B}ackground: {C}hronic hepatitis {B} virus ({HBV}) infection is complicated by cirrhosis and liver cancer. {I}n {T}hailand, 6-7 % of adults are chronically infected with {HBV}. {T}he risk of mother-to-child transmission ({MTCT}) of {HBV} has been estimated to be about 12 % when mothers have a high hepatitis {B} viral load, even if infants receive passive-active prophylaxis with {HBV} immunoglobulin ({HBI}g) and initiate the hepatitis {B} vaccine series at birth. {W}e designed a study to assess the efficacy and safety of a short course of maternal tenofovir disoproxil fumarate ({TDF}) among women with a marker of high viral load for the prevention of {MTCT} of {HBV}. {M}ethods: {T}he study is a phase {III}, multicenter (17 sites in {T}hailand), placebo-controlled, double-blind, randomized 1: 1, two-arm clinical trial of {TDF} 300 mg once daily versus placebo among pregnant women from 28 weeks' gestation through 2-month post-partum. {A}ll infants receive {HBI}g at birth, and a hepatitis {B} ({HB}) vaccination series according to {T}hai guidelines: birth, and age 1, 2, 4 and 6 months. {P}articipant women at study entry must be age >= 18 years, hepatitis {B} surface antigen ({HB}s{A}g) and e-antigen ({HB}e{A}g) positive, have alanine aminotransferase ({ALT}) level < 30 {IU}/{L} at screening (confirmed < 60 {IU}/{L} pre-entry), negative hepatitis {C} serology, creatinine clearance > 50 m{L}/min, and no history of anti-{HBV} antiviral treatment. {T}he target sample size of 328 mother/infant pairs assumed 156 evaluable cases per arm to detect a >= 9 % difference in {MTCT} transmission (3 % experimental arm versus 12 % placebo arm) with 90 % power. {M}others and infants are followed until 12 months after delivery. {T}he primary infant endpoint is detection of {HB}s{A}g, confirmed by detection of {HBV} {DNA} at six months of age. {S}econdary endpoints are maternal and infant adverse events, acute exacerbations of maternal hepatitis {B} disease ({ALT} > 300 {IU}/ {L}, defined as a "flare") following discontinuation of study treatment, infant {HBV} infection status and growth up to 12 months of age. {D}iscussion: {T}he results of this randomized trial will clarify the efficacy and safety of a short course of antiviral treatment to prevent mother-to-child transmission of {HBV} and inform international guidelines.},
  keywords = {{THAILANDE}},
  booktitle = {},
  journal = {{BMC} {I}nfectious {D}iseases},
  volume = {16},
  numero = {},
  pages = {art. 393 [6 p.]},
  ISSN = {1471-2334},
  year = {2016},
  DOI = {10.1186/s12879-016-1734-5},
  URL = {https://www.documentation.ird.fr/hor/fdi:010067755},
}