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Tenofovir versus Placebo to Prevent Perinatal Transmission of Hepatitis B
Gonzague Jourdain1, Nicole Ngo-Giang-Huong1, Linda Harrison1
1From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).
Background:
Pregnant 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:
In this multicenter, double-blind clinical trial performed in Thailand, we randomly assigned hepatitis B e antigen (HBeAg)-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. Infants received hepatitis B immune globulin at birth and hepatitis B vaccine at birth and at 1, 2, 4, and 6 months. The primary end point was a hepatitis B surface antigen (HBsAg)-positive status in the infant, confirmed by the HBV DNA level at 6 months of age. We 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:
From January 2013 to August 2015, we enrolled 331 women; 168 women were randomly assigned to the TDF group and 163 to the placebo group. At enrollment, the median gestational age was 28.3 weeks, and the median HBV DNA level was 8.0 log10 IU per milliliter. Among 322 deliveries (97% of the participants), there were 319 singleton births, two twin pairs, and one stillborn infant. The 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. In 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). The rate of adverse events did not differ significantly between groups. The 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:
In 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 HBeAg-positive mothers, the additional maternal use of TDF did not result in a significantly lower rate of transmission. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT01745822 .).
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