Tenofovir to prevent hepatitis B transmission in mothers with high viral load

New England Journal of Medicine

Volumn 374, Issue 24, 2016, Pages 2324-2334

  Pan, Calvin Q ^a,b   Duan, Zhongping ^b   Dai, Erhei ^c   Zhang, Shuqin ^d   Han, Guorong ^e   Wang, Yuming ^f   Zhang, Huaihong ^g   Zou, Huaibin ^b   Zhu, Baoshen ^c   Zhao, Wenjing ^d   Jiang, Hongxiu ^e  

^a NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b CAPITAL MEDICAL UNIVERSITY   (China)

^c HEBEI MEDICAL UNIVERSITY   (China)

^d Department of Scientific Research   (China)

^e SOUTHEAST UNIVERSITY   (China)

^f THIRD MILITARY MEDICAL UNIVERSITY   (China)

^g Center Hospital of Nanyang   (China)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; CREATINE KINASE; HEPATITIS B(E) ANTIGEN; TENOFOVIR DISOPROXIL; VIRUS DNA; ANTIVIRUS AGENT; TENOFOVIR;

ABDOMINAL PAIN; ADULT; ANTIVIRAL THERAPY; ARTICLE; CONTROLLED STUDY; COUGHING; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DYSPEPSIA; FATIGUE; FEMALE; FETUS; FETUS WASTAGE; HEADACHE; HEART PALPITATION; HEPATITIS B; HUMAN; IMMUNOPROPHYLAXIS; INFANT; INFECTION PREVENTION; INSOMNIA; JAUNDICE; MAJOR CLINICAL STUDY; MULTICENTER STUDY; PREECLAMPSIA; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; SEROCONVERSION; STILLBIRTH; UPPER RESPIRATORY TRACT INFECTION; VERTICAL TRANSMISSION; VIRUS LOAD; VIRUS TRANSMISSION; BLOOD; CHINA; CLINICAL TRIAL; CONGENITAL DISORDER; GENETICS; HEPATITIS B VIRUS; HEPATITIS B, CHRONIC; INTENTION TO TREAT ANALYSIS; NEWBORN; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; PREVENTION AND CONTROL; THIRD TRIMESTER PREGNANCY; VIROLOGY; YOUNG ADULT;

ADULT; ALANINE TRANSAMINASE; ANTIVIRAL AGENTS; CHINA; CONGENITAL ABNORMALITIES; CREATINE KINASE; DNA, VIRAL; FEMALE; HEPATITIS B E ANTIGENS; HEPATITIS B VIRUS; HEPATITIS B, CHRONIC; HUMANS; INFANT, NEWBORN; INFECTIOUS DISEASE TRANSMISSION, VERTICAL; INTENTION TO TREAT ANALYSIS; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; PREGNANCY TRIMESTER, THIRD; TENOFOVIR; VIRAL LOAD; YOUNG ADULT;

EID: 84974851752     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1508660     Document Type: Article

References (37)

1. European Association for the Study of the Liver. EASL clinical practice guidelines: management of chronic hepatitis B virus infection. J Hepatol 2012;57:167-85.
2. Pan CQ, Zhang JX. Natural history and clinical consequences of hepatitis B virus infection. Int J Med Sci 2005;2:36-40.
3. Pan CQ, Hu KQ, Tsai N. Long-term therapy with nucleoside/nucleotide analogues for chronic hepatitis B in Asian patients. Antivir Ther 2013;18:841-52.
4. Hepatitis B fact sheet no. 204. Geneva: World Health Organization, July 2015 (http://www.who.int/mediacentre/factsheets/fs204/en/).
5. Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection. Geneva: World Health Organization, March 2015 (http://apps.who.int/iris/bitstream/10665/154590/1/9789241549059-eng.pdf?ua=1).
6. Stevens CE, Beasley RP, Tsui J, Lee W-C. Vertical transmission of hepatitis B antigen in Taiwan. N Engl J Med 1975;292:771-4.
7. Xu DZ, Yan YP, Choi BC, et al. Risk factors and mechanism of transplacental transmission of hepatitis B virus: a case-control study. J Med Virol 2002;67:20-6.
8. Wong VC, Lee AK, Ip HM. Transmission of hepatitis B antigens from symptom free carrier mothers to the fetus and the infant. Br J Obstet Gynaecol 1980;87:958-65.
9. Beasley RP, Trepo C, Stevens CE, Szmuness W. The e antigen and vertical transmission of hepatitis B surface antigen. Am J Epidemiol 1977;105:94-8.
10. Lee C, Gong Y, Brok J, Boxall EH, Gluud C. Hepatitis B immunisation for newborn infants of hepatitis B surface antigen-positive mothers. Cochrane Database Syst Rev 2006;2:CD004790.
11. Centers for Disease Control and Prevention. Hepatitis B vaccination recommendations for infants, children, and adolescents. December 2005 (http://www.cdc.gov/hepatitis/hbv/vaccchildren.htm).
12. Zou H, Chen Y, Duan Z, Zhang H, Pan C. Virologic factors associated with failure to passive-active immunoprophylaxis in infants born to HBsAg-positive mothers. J Viral Hepat 2012;19(2):e18-25.
13. Zhang H, Pan CQ, Pang Q, Tian R, Yan M, Liu X. Telbivudine or lamivudine use in late pregnancy safely reduces perinatal transmission of hepatitis B virus in real-life practice. Hepatology 2014;60:468-76.
14. Xu WM, Cui YT, Wang L, 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.
15. Wiseman E, Fraser MA, Holden S, et al. Perinatal transmission of hepatitis B virus: an Australian experience. Med J Aust 2009;190:489-92.
16. Pan CQ, Zou H-B, Chen Y, et al. Cesarean section reduces perinatal transmission of hepatitis B virus infection from hepatitis B surface antigen-positive women to their infants. Clin Gastroenterol Hepatol 2013;11:1349-55.
17. Pan CQ, Han GR, Jiang HX, et al. Telbivudine prevents vertical transmission from HBeAg-positive women with chronic hepatitis B. Clin Gastroenterol Hepatol 2012;10:520-6.
18. del Canho R, Grosheide PM, Schalm SW, de Vries RR, Heijtink RA. Failure of neonatal hepatitis B vaccination: the role of HBV-DNA levels in hepatitis B carrier mothers and HLA antigens in neonates. J Hepatol 1994;20:483-6.
19. Perumalswami PV, Factor SH, Kapelusznik L, et al. Hepatitis Outreach Network: a practical strategy for hepatitis screening with linkage to care in foreignborn communities. J Hepatol 2013;58:890-7.
20. Han GR, Cao MK, Zhao W, 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.
21. Pan CQ, Mi LJ, Bunchorntavakul C, et al. Tenofovir disoproxil fumarate for prevention of vertical transmission of hepatitis B virus infection by highly viremic pregnant women: a case series. Dig Dis Sci 2012;57:2423-9.
22. Greenup AJ, Tan PK, Nguyen V, et al. Efficacy and safety of tenofovir disoproxil fumarate in pregnancy to prevent perinatal transmission of hepatitis B virus. J Hepatol 2014;61:502-7.
23. Chen HL, Lee CN, Chang CH, et al. Efficacy of maternal tenofovir disoproxil fumarate in interrupting mother-to-infant transmission of hepatitis B virus. Hepatology 2015;62:375-86.
24. Pan CQ, Trinh H, Yao A, Bae H, Lou L, Chan S. Efficacy and safety of tenofovir disoproxil fumarate in Asian-Americans with chronic hepatitis B in community settings. PLoS One 2014;9(3):e89789.
25. Marcellin P, Heathcote EJ, Buti M, et al. Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. N Engl J Med 2008;359:2442-55.
26. Pan CQ, Chan S, Trinh H, Yao A, Bae H, Lou L. Similar efficacy and safety of tenofovir in Asians and non-Asians with chronic hepatitis B. World J Gastroenterol 2015;21:5524-31.
27. Mast EE, Margolis HS, Fiore AE, et al. A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP) part 1: immunization of infants, children, and adolescents. MMWR Recomm Rep 2005;54(RR-16):1-31.
28. Rapicetta M, D'Ugo E, Argentini C, et al. New perspectives for hepatitis B vaccines and immunization. Vaccine 2009;27:3271-5.
29. Benaboud S, Pruvost A, Coffie PA, et al. Concentrations of tenofovir and emtricitabine in breast milk of HIV-1-infected women in Abidjan, Cote d'Ivoire, in the ANRS 12109 TEmAA Study, Step 2. Antimicrob Agents Chemother 2011;55:1315-7.
30. Keeffe EB, Dieterich DT, Han SH, et al. A treatment algorithm for the management of chronic hepatitis B virus infection in the United States: 2008 update. Clin Gastroenterol Hepatol 2008;6:1315-41.
31. Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. Rockville, MD: Food and Drug Administration, September 2007 (http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm091977.pdf).
32. Park JS, Pan C. Current recommendations of managing HBV infection in preconception or pregnancy. Front Med 2014;8:158-65.
33. Pan CQ, Lee HM. Antiviral therapy for chronic hepatitis B in pregnancy. Semin Liver Dis 2013;33:138-46.
34. Pan CQ, Duan ZP, Bhamidimarri KR, et al. An algorithm for risk assessment and intervention of mother to child transmission of hepatitis B virus. Clin Gastroenterol Hepatol 2012;10:452-9.
35. Wu Q, Huang H, Sun X, et al. Telbivudine prevents vertical transmission of hepatitis B virus from women with high viral loads: a prospective long-term study. Clin Gastroenterol Hepatol 2015;13:1170-6.
36. Rysgaard CD, Morris CS, Drees D, et al. Positive hepatitis B surface antigen tests due to recent vaccination: a persistent problem. BMC Clin Pathol 2012;12:15.
37. The Antiretroviral Pregnancy Registry - interim report. 1 January 1989 through 31 July 2015 (issued December 2015) (http://www.apregistry.com/forms/interim-report.pdf).