title: [Long-term efficacy and safety of telbivudine in the treatment of childbearing patients with chronic hepatitis B].
abstract: OBJECTIVE
  To observe the long-term efficacy and safety of telbivudine (LdT) for pregnant women with chronic hepatitis B (CHB) and their children born from the treatment period.
  
  
  METHODS
  A total of 118 pregnant women with CHB were enrolled in the study and provided informed consent for participation. The women opted for participation in the treatment group (7 =73; LdT 600 mg once daily, starting in early pregnancy and continued until after delivery) or in the control group (n =45; no LdT treatment). All newborns were given active and passive immunization upon birth and tested for serum hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), anti-hepatitis B core antibody (anti-HBc), anti-hepatitis B surface antibody (anti-HBs) and HBV DNA at 0, 1, 7 and 12 months of age. The Paediatrics Neuropsychological Development Scale for Children aged 0 - 6 (5 items) established by the Capital Institute was used to test the children; in addition, the children were evaluated by observation for action ability (fine and gross motor skills), adaptability, language ability and social behaviour. Total IQ was estimated as a developmental quotient (DQ) by using the equation: points from the 5 scale items actual age in months * 100.
  
  
  RESULTS
  The LdT group included 69 women with successful pregnancies, 1 case of miscarriage and 3 cases that were lost to follow-up. The control group included 34 women with successful pregnancies, 4 cases of miscarriage, 1 case with fatal outcome, and 6 cases of no pregnancy. Compared to the control group, the LdT group had a significantly higher successful pregnancy rate (x² =4.86 in the LdT group, P < 0.05). In addition, the LdT group had a significantly higher rate of term delivery (53 cases vs. 34 cases, x² = 6.38, P < 0.05). The neonates born to the women in the LdT group included 53 cases of weakly-negative HBsAg at birth and 1 case at 1 month old, as well as negativity for HBV DNA, and HBsAg remaining weakly positive at 6 months old; the intrauterine infection rate was 1.8% and no case of deformity occurred.Among the 34 neonates in the control group, 6 showed HBsAg positivity at 1 month old, and the HBsAg positivity remained for all 6 at 6 months old; the intrauterine infection rate was 16.6%, which was significantly higher than that of the LdT group (x² = 5.10, P < 0.05). The neonates in the LdT group had a significantly higher anti-HBs production rate at 1 year old than those in the control group (98.1% (52/53 vs. 82.4% (28/34). X² = 4.87, P < 0.05). The neonates in the LdT group showed normal growth and development for all 53 cases of young children, and IQ levels of excellent for 3 cases, smart for 8 cases, normal for 40 cases, and low for 2 cases. The neonates in the control group showed normal growth and development for all 34 cases of young children, and IQ levels of excellent for 2 cases, smart for 4 cases, normal for 27 cases, and low for 1 case.
  
  
  CONCLUSIONS
  Childbearing chronic HBV patients treated with LdT had higher rates of successful pregnancy, blocking of intrauterine infection and anti-HBs reduction compared to their untreated counterparts. The children bom to LdT-treated women showed no difference in long-term growth and development and total IQ from the children born to the untreated women with chronic HBV.
authors.affiliation: The 118 Hospital Liver Diseases Research Center of Nanjing Military, Wenzhou 325000, China.
authors.forename: Yuejin
authors.initials: Y
authors.lastname: Zhou
authors.forename: Jinli
authors.initials: J
authors.lastname: Zheng
authors.forename: Huajiang
authors.initials: H
authors.lastname: Pan
authors.forename: Chenghong
authors.initials: C
authors.lastname: Lu
mesh_terms: D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D000077712:Telbivudine; D013936:Thymidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D000077712:Telbivudine; D013936:Thymidine