Efficacy of maternal tenofovir disoproxil fumarate in interrupting mother-to-infant transmission of hepatitis B virus.

Abstract

UNLABELLED:

The efficacy and safety of maternal tenofovir disoproxil fumarate (TDF) in reducing mother-to-infant hepatitis B virus (HBV) transmissions is not clearly understood. We conducted a prospective, multicenter trial and enrolled 118 hepatitis B surface antigen (HBsAg)- and hepatitis B e antigen-positive pregnant women with HBV DNA ≥7.5 log10 IU/mL. The mothers received no medication (control group, n = 56, HBV DNA 8.22 ± 0.39 log10 IU/mL) or TDF 300 mg daily (TDF group, n = 62, HBV DNA 8.18 ± 0.47 log10 IU/mL) from 30-32 weeks of gestation until 1 month postpartum. Primary outcome was infant HBsAg at 6 months old. At delivery, the TDF group had lower maternal HBV DNA levels (4.29 ± 0.93 versus 8.10 ± 0.56 log10 IU/mL, P < 0.0001). Of the 121/123 newborns, the TDF group had lower rates of HBV DNA positivity at birth (6.15% versus 31.48%, P = 0.0003) and HBsAg positivity at 6 months old (1.54% versus 10.71%, P = 0.0481). Multivariate analysis revealed that the TDF group had lower risk (odds ratio = 0.10, P = 0.0434) and amniocentesis was associated with higher risk (odds ratio 6.82, P = 0.0220) of infant HBsAg positivity. The TDF group had less incidence of maternal alanine aminotransferase (ALT) levels above two times the upper limit of normal for ≥3 months (3.23% versus 14.29%, P = 0.0455), a lesser extent of postpartum elevations of ALT (P = 0.007), and a lower rate of ALT over five times the upper limit of normal (1.64% versus 14.29%, P = 0.0135) at 2 months postpartum. Maternal creatinine and creatinine kinase levels, rates of congenital anomaly, premature birth, and growth parameters in infants were comparable in both groups. At 12 months, one TDF-group child newly developed HBsAg positivity, presumably due to postnatal infection and inefficient humoral responses to vaccines.

CONCLUSIONS:

Treatment with TDF for highly viremic mothers decreased infant HBV DNA at birth and infant HBsAg positivity at 6 months and ameliorated maternal ALT elevations. (Hepatology 2015;62:375-386.

• Authors: Huey-Ling Chen, Chien-Nan Lee, Chin-Hao Chang, Yen-Hsuan Ni, Ming-Kwang Shyu, Shih-Ming Chen, Jen-Jan Hu, Hans Hsienhong Lin, Lu-Lu Zhao, Shu-Chi Mu, Ming-Wei Lai, Chyi-Long Lee, Hsien-Ming Lin, Ming-Song Tsai, Jenn-Jeih Hsu, Ding-Shinn Chen, K Arnold Chan, Mei-Hwei Chang, Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV (PreMIT Study), Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV PreMIT Study
• Journal: Hepatology (Baltimore, Md.) (Hepatology) Vol. 62 Issue 2 Pg. 375-86 (Aug 2015) ISSN: 1527-3350 [Electronic] United States
• PMID: 25851052 (Publication Type: Controlled Clinical Trial, Journal Article)
• Copyright: © 2015 by the American Association for the Study of Liver Diseases.

Chemical References

• DNA, Viral
• Organophosphonates
• Tenofovir
• Adenine

Topics

• Adenine (analogs & derivatives, therapeutic use)
• Adult
• DNA, Viral (analysis)
• Female
• Follow-Up Studies
• Gestational Age
• Hepatitis B virus (drug effects)
• Hepatitis B, Chronic (diagnosis, drug therapy, transmission)
• Humans
• Infant, Newborn
• Infectious Disease Transmission, Vertical (prevention & control)
• Male
• Maternal Age
• Multivariate Analysis
• Organophosphonates (therapeutic use)
• Patient Selection
• Pregnancy
• Pregnancy Complications, Infectious (drug therapy, prevention & control)
• Pregnancy Outcome
• Prospective Studies
• Reference Values
• Risk Assessment
• Taiwan
• Tenofovir
• Treatment Outcome
• Viral Load (drug effects)
• Young Adult