title: Efficacy and safety of telbivudine treatment: an open-label, prospective study in pregnant women for the prevention of perinatal transmission of hepatitis B virus infection.
abstract: We evaluated the efficacy and safety of telbivudine (LdT, 600 mg/day) vs control patients (no treatment) in decreasing vertical transmission of HBV, in HBeAg-positive mothers (HBVDNA >6log(10) copies/mL). HBeAg-positive pregnant women either in the second or third trimester were recruited in a prospective, case-control, open-label study, at the Second Affiliated Hospital of the Southeast University, China (February 2008-December 2010). Efficacy (month 7: HBVDNA (+), HBsAg (+) infants) in either the overall group or the treated group and control group was analysed using student's t-test. Infants were followed for at least 1 year. 362 women received LdT (second trimester n = 257; third trimester n = 105) and 92 were untreated. Before delivery, the mean maternal HBVDNA was 2.73, 2.47, 3.34 and 7.94 log10 copies/mL in the overall, second and third trimester treated and control groups, respectively (P < 0.001). At birth, 11.8% of babies overall (43/365), 13.5% (35/259) of those treated in the second trimester, 7.5% of those treated in the third trimester (8/106) and 20.7% (19/92) of untreated infants were HBsAg positive. At month 7, none of the LdT-treated infant had detectable HBVDNA, while eight infants from control mothers were HBsAg positive. Vertical transmission was 0% in LdT treated and 9.3% (8/86) in the control groups (P < 0.001). No difference in the vertical transmission rate was found in mothers treated in the second or third trimester. LdT treatment was safe for mothers and infants, and no congenital deformities were reported.
authors: Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the Southeast University, Nanjing, China.
authors: G-R
authors: GR
authors: Han
authors: Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the Southeast University, Nanjing, China.
authors: H-X
authors: HX
authors: Jiang
authors: Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the Southeast University, Nanjing, China.
authors: X
authors: X
authors: Yue
authors: Department of Gynecology and Obstetrics, School of Medicine, Southeast University, Nanjing, China.
authors: Y
authors: Y
authors: Ding
authors: Department of Infectious Diseases, The Second Affiliated Hospital of the Southeast University, Nanjing, China.
authors: C-M
authors: CM
authors: Wang
authors: Department of Infectious Diseases, The Second Affiliated Hospital of the Southeast University, Nanjing, China.
authors: G-J
authors: GJ
authors: Wang
authors: Department of Infectious Diseases, The Second Affiliated Hospital of the Southeast University, Nanjing, China.
authors: Y-F
authors: YF
authors: Yang
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D016022:Case-Control Studies; D002681:China; D004279:DNA, Viral / Q000097:blood; D005260:Female; D006509:Hepatitis B / Q000635:transmission*; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008137:Longitudinal Studies; D008297:Male; D011247:Pregnancy; D011446:Prospective Studies; D000077712:Telbivudine; D013936:Thymidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D000077712:Telbivudine; D013936:Thymidine
keywords: HBV infection; pregnancy; telbivudine; vertical transmission