@article{fdi:010071494,
  title = {{T}enofovir versus placebo to prevent perinatal transmission of hepatitis {B}},
  author = {{J}ourdain, {G}onzague and {N}go-{G}iang-{H}uong, {N}icole and {H}arrison, {L}. and {D}ecker, {L}uc and {T}ierney, {C}. and {S}alvadori, {N}. and {C}ressey, {T}.{R}. and {S}irirungsi, {W}. and {A}chalapong, {J}. and {Y}uthavisuthi, {P}. and {K}anjanavikai, {P}. and {N}a {A}yudhaya, {O}.{P}. and {S}iriwachirachai, {T}. and et al.},
  editor = {},
  language = {{ENG}},
  abstract = {{BACKGROUND}: {P}regnant women with an elevated viral load of hepatitis {B} virus ({HBV}) have a risk of transmitting infection to their infants, despite the infants’ receiving hepatitis {B} immune globulin. {METHODS}: {I}n this multicenter, double-blind clinical trial performed in {T}hailand, we randomly assigned hepatitis {B} e antigen ({HB}e{A}g)–positive pregnant women with an alanine aminotransferase level of 60 {IU} or less per liter to receive tenofovir disoproxil fumarate ({TDF}) or placebo from 28 weeks of gestation to 2 months post partum. {I}nfants received hepatitis {B} immune globulin at birth and hepatitis {B} vaccine at birth and at 1, 2, 4, and 6 months. {T}he primary end point was a hepatitis {B} surface antigen ({HB}s{A}g)–positive status in the infant, confirmed by the {HBV} {DNA} level at 6 months of age. {W}e calculated that a sample of 328 women would provide the trial with 90% power to detect a difference of at least 9 percentage points in the transmission rate (expected rate, 3% in the {TDF} group vs. 12% in the placebo group). {I}n this multicenter, double-blind clinical trial performed in {T}hailand, we randomly assigned hepatitis {B} e antigen ({HB}e{A}g)–positive pregnant women with an alanine aminotransferase level of 60 {IU} or less per liter to receive tenofovir disoproxil fumarate ({TDF}) or placebo from 28 weeks of gestation to 2 months post partum. {I}nfants received hepatitis {B} immune globulin at birth and hepatitis {B} vaccine at birth and at 1, 2, 4, and 6 months. {T}he primary end point was a hepatitis {B} surface antigen ({HB}s{A}g)–positive status in the infant, confirmed by the {HBV} {DNA} level at 6 months of age. {W}e calculated that a sample of 328 women would provide the trial with 90% power to detect a difference of at least 9 percentage points in the transmission rate (expected rate, 3% in the {TDF} group vs. 12% in the placebo group). {RESULTS}: {F}rom {J}anuary 2013 to {A}ugust 2015, we enrolled 331 women; 168 women were randomly assigned to the {TDF} group and 163 to the placebo group. {A}t enrollment, the median gestational age was 28.3 weeks, and the median {HBV} {DNA} level was 8.0 log10 {IU} per milliliter. {A}mong 322 deliveries (97% of the participants), there were 319 singleton births, two twin pairs, and one stillborn infant. {T}he median time from birth to administration of hepatitis {B} immune globulin was 1.3 hours, and the median time from birth to administration of hepatitis {B} vaccine was 1.2 hours. {I}n the primary analysis, none of the 147 infants (0%; 95% confidence interval [{CI}], 0 to 2) in the {TDF} group were infected, as compared with 3 of 147 (2%; 95% {CI}, 0 to 6) in the placebo group ({P} = 0.12). {T}he rate of adverse events did not differ significantly between groups. {T}he incidence of a maternal alanine aminotransferase level of more than 300 {IU} per liter after discontinuation of the trial regimen was 6% in the {TDF} group and 3% in the placebo group ({P} = 0.29). {CONCLUSIONS}: {I}n a setting in which the rate of mother-to-child {HBV} transmission was low with the administration of hepatitis {B} immune globulin and hepatitis {B} vaccine in infants born to {HB}e{A}g-positive mothers, the additional maternal use of {TDF} did not result in a significantly lower rate of transmission. ({F}unded by the {E}unice {K}ennedy {S}hriver {N}ational {I}nstitute of {C}hild {H}ealth and {H}uman {D}evelopment; {C}linical{T}rials.gov number, {NCT}01745822.)},
  keywords = {{INFECTION} ; {TRANSMISSION} ; {VIRUS} ; {GROSSESSE} ; {TRAITEMENT} {MEDICAL} ; {EFFICACITE} ; {IMMUNITE} ; {ANTIGENE} ; {HEPATITE} {B} ; {TRANSMISSION} {MERE} {ENFANT} ; {THAILANDE}},
  booktitle = {},
  journal = {{N}ew {E}ngland {J}ournal of {M}edicine},
  volume = {378},
  numero = {10},
  pages = {911--923},
  ISSN = {0028-4793},
  year = {2018},
  DOI = {10.1056/{NEJM}oa1708131},
  URL = {https://www.documentation.ird.fr/hor/fdi:010071494},
}