Prevention 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

BMC Infectious Diseases

Volumn 16, Issue 1, 2016, Pages

  Jourdain, Gonzague ^a,b,c   Ngo Giang Huong, Nicole ^a,b,c   Cressey, Tim R ^a,b,c,d   Hua, Lei ^e   Harrison, Linda ^e   Tierney, Camlin ^e   Salvadori, Nicolas ^a,b   Decker, Luc ^a,b   Traisathit, Patrinee ^b   Sirirungsi, Wasna ^b   Khamduang, Woottichai ^b   Bowonwatanuwong, Chureeratana ^f   Puthanakit, Thanyawee ^g   Siberry, George K ^h   Watts, Diane Heather ⁱ   Murphy, Trudy V ^j   Achalapong, Jullapong ^k   Hongsiriwon, Suchat ^f   Klinbuayaem, Virat ^l   Thongsawat, Satawat ^m   Chung, Raymond T ⁿ   Pol, Stanislas ^o   Chotivanich, Nantasak ^f   more..

^a Institute of research for development Thailand   (Thailand)

^b CHIANG MAI UNIVERSITY   (Thailand)

^c HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^d UNIVERSITY OF LIVERPOOL   (United Kingdom)

^e CENTER FOR BIOSTATISTICS IN AIDS RESEARCH   (United States)

^f CHONBURI HOSPITAL   (Thailand)

^g CHULALONGKORN UNIVERSITY   (Thailand)

^h EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

ⁱ U S DEPARTMENT OF STATE   (United States)

^j CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^k CHIANGRAI PRACHANUKROH HOSPITAL   (Thailand)

^l Sanpatong Hospital   (Thailand)

^m Faculty of Medicine Chiang Mai University   (Thailand)

ⁿ MASSACHUSETTS GENERAL HOSPITAL   (United States)

^o Department of Internal Medicine ^*  (France)

more..

Author keywords

Hepatitis B; Hepatitis B e antigen; Hepatitis B surface antigen; Mother to child transmission; Pregnancy; Thailand

Indexed keywords

ALANINE AMINOTRANSFERASE; HEPATITIS B ANTIBODY; HEPATITIS B SURFACE ANTIGEN; HEPATITIS B(E) ANTIGEN; PLACEBO; TENOFOVIR DISOPROXIL; VIRUS DNA; ANTIVIRUS AGENT; BIOLOGICAL MARKER; HEPATITIS B HYPERIMMUNE GLOBULIN; HEPATITIS B VACCINE; IMMUNOGLOBULIN; TENOFOVIR;

ARTICLE; CONTROLLED STUDY; CREATININE CLEARANCE; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; HEPATITIS B; HUMAN; MULTICENTER STUDY; MULTICENTER STUDY (TOPIC); PHASE 3 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL (TOPIC); PREGNANT WOMAN; RANDOMIZED CONTROLLED TRIAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SHORT COURSE THERAPY; THAILAND; VERTICAL TRANSMISSION; VIRUS LOAD; ADULT; ANTIBIOTIC PROPHYLAXIS; BLOOD; CLINICAL TRIAL; GESTATIONAL AGE; INFANT; MOTHER; PREGNANCY; PREGNANCY COMPLICATION; PREVENTION AND CONTROL; PROCEDURES; TRANSMISSION; VIROLOGY;

ADULT; ALANINE TRANSAMINASE; ANTIBIOTIC PROPHYLAXIS; ANTIVIRAL AGENTS; BIOMARKERS; DOUBLE-BLIND METHOD; FEMALE; GESTATIONAL AGE; HEPATITIS B; HEPATITIS B E ANTIGENS; HEPATITIS B SURFACE ANTIGENS; HEPATITIS B VACCINES; HUMANS; IMMUNOGLOBULINS; INFANT; INFECTIOUS DISEASE TRANSMISSION, VERTICAL; MOTHERS; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; TENOFOVIR; THAILAND; VIRAL LOAD;

EID: 84981186408     PISSN: None     EISSN: 14712334     Source Type: Journal    
DOI: 10.1186/s12879-016-1734-5     Document Type: Article

References (13)

1. WHO. Prevention, care and treatment of persons with chronic hepatitis B infection. Guidelines [Internet]. WHO; 2015 [cited 2016 Feb 29]. Available from: http://apps.who.int/iris/bitstream/10665/154590/1/9789241549059_eng.pdf
2. Lee C, Gong Y, Brok J, Boxall EH, Gluud C. Effect of hepatitis B immunisation in newborn infants of mothers positive for hepatitis B surface antigen: systematic review and meta-analysis. BMJ. 2006;332:328-36.
3. Xu W-M, Cui Y-T, Wang L, Yang H, Liang Z-Q, Li X-M, et al. Lamivudine in late pregnancy to prevent perinatal transmission of hepatitis B virus infection: a multicentre, randomized, double-blind, placebo-controlled study. J Viral Hepat. 2009;16:94-103.
4. Han G-R, Cao M-K, Zhao W, Jiang H-X, Wang C-M, Bai S-F, et al. A prospective and open-label study for the efficacy and safety of telbivudine in pregnancy for the prevention of perinatal transmission of hepatitis B virus infection. J Hepatol. 2011;55:1215-21.
5. Wen W-H, Chang M-H, Zhao L-L, Ni Y-H, Hsu H-Y, Wu J-F, et al. Mother-to-infant transmission of hepatitis B virus infection: significance of maternal viral load and strategies for intervention. J Hepatol. 2013;59:24-30.
6. Oon CJ, Chen WN. Current aspects of hepatitis B surface antigen mutants in Singapore. J Viral Hepat. 1998;5 Suppl 2:17-23.
7. Carman WF, Zanetti AR, Karayiannis P, Waters J, Manzillo G, Tanzi E, et al. Vaccine-induced escape mutant of hepatitis B virus. Lancet. 1990;336:325-9.
8. Chen H-L, Lee C-N, Chang C-H, Ni Y-H, Shyu M-K, Chen S-M, et al. Efficacy of maternal tenofovir disoproxil fumarate in interrupting mother-to-infant transmission of hepatitis B virus. Hepatology. 2015;62:375-86.
9. Brown RS, McMahon BJ, Lok ASF, Wong JB, Ahmed AT, Mouchli MA, et al. Antiviral therapy in chronic hepatitis B viral infection during pregnancy: a systematic review and meta-analysis. Hepatology. 2016;63:319-33.
10. Terrault NA, Bzowej NH, Chang K-M, Hwang JP, Jonas MM, Murad MH. AASLD guidelines for treatment of chronic hepatitis B. Hepatology. 2016;63:261-83.
11. World Health Organization. Hepatitis B and breastfeeding [Internet]. World Health Organization; 1996 [cited 2012 Jul 9]. Available from: http://www.who.int/maternal_child_adolescent/documents/pdfs/hepatitis_b_and_breastfeeding.pdf
12. Guidelines for the Prevention, Care and Treatment of Persons with Chronic Hepatitis B Infection [Internet]. Geneva: World Health Organization; 2015 [cited 2016 Jun 9]. Available from: http://www.ncbi.nlm.nih.gov/books/NBK305553/
13. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events [Internet]. National Institute of Allergy and Infectious Diseases, National Institutes of Health; 2004. Available from: http://rsc.tech-res.com/document/safetyandpharmacovigilance/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf