Prospective cohort study on the efficacy and safety of telbivudine used throughout pregnancy in blocking mother‐to‐child transmission of hepatitis B virus

Abstract

Women with chronic hepatitis B should maintain nucleotide analogue treatment to prevent disease progression during pregnancy. The aim of this study was to prospectively evaluate the efficacy and safety of telbivudine used throughout pregnancy for preventing hepatitis B virus (HBV) mother-to-child transmission (MTCT). From January 2012 to June 2014, women who were receiving telbivudine therapy and became pregnant were enrolled in group A at 28 weeks of gestation. Pregnant women with an HBV DNA level >10 IU/mL were enrolled in either group B (telbivudine started at 28 weeks of gestation) or group C (control group without treatment). MTCT was defined as infants who were positive for serum hepatitis B surface antigen at 7 months after birth. There were 41, 179 and 177 pregnant women (397 infants) enrolled in groups A, B and C, respectively. The HBV DNA load at 28 weeks of gestation and delivery was 1.50 ± 0.62 vs 1.45 ± 0.61, 8.05 ± 0.37 vs 4.24 ± 0.89 and 7.94 ± 0.62 vs 7.86 ± 0.73 log IU/mL in groups A, B and C, respectively. The rate of MTCT in group C was 4.60%, which was significantly higher than the rates in groups A and B (0% and 0.6%, respectively) (P = .043). The difference between group A and group B was not significant. The rates of neonatal congenital abnormalities were 2.4%, 0.6% and 2.3% in groups A, B and C, respectively, and there were no significant differences (P = .140). Telbivudine used throughout pregnancy may be safe and effective for mothers and infants, but it may not enhance the efficacy of an HBV MTCT block compared with treatment starting at 28 weeks of gestation (NCT02253485).

Efficacy and safety of antiviral treatment on blocking the mother‐to‐child transmission of hepatitis B virus: A meta‐analysis

“…Of the 32 RCTs that enrolled 4189 pregnant women, 17 studies evaluated the effect of LAM, 15 studies evaluated LdT, 3 studies evaluated TDF, and 3 studies evaluated both LAM and LdT . Of the 27 non‐RCT studies enrolling 5039 pregnant women, 10 evaluated LAM, 18 evaluated LdT, 3 studies evaluated TDF, 2 evaluated both LAM and LdT, and another 2 studies evaluated both LAM and TDF . The characteristics of pregnant women and newborns in the 59 studies are summarized in Table .…”

Efficacy and safety of antiviral therapy for HBV in different trimesters of pregnancy: systematic review and network meta-analysis

“…Among the selected studies, 3 RCTs [7-9] and 12 non-RCTs [10,[16][17][18][19][20][21][22][23][24][25][26] compared treatment started in the third trimester versus control, 7 non-RCTs compared the timing of second trimester versus control [27][28][29][30][31][32][33], 3 non-RCTs compared first trimester versus control [14,34,35], 4 non-RCTs compared second and third trimester versus control respectively [11,[36][37][38], 3 non-RCTs compared first, second trimester versus control respectively [39][40][41]; 2 non-RCTs compared first, third trimester versus control respectively [12,42], 1 non-RCTs compared first, second trimester, third trimester versus control respectively [13]. No randomized controlled trials were conducted for the treatment that was applied during first or second trimester except for several non-RCTs.…”

“…Emerging data suggest the application of antiviral therapy in the third trimester is able to prevent immunoprophylaxis failure [7][8][9][10] to a great extent. Currently, only scarce studies showed the rates of MTCT appeared similar under the utilization of agents during second and third trimester [11], but the events of HBV transmission were still reported even if their mothers obtained a treatment in late pregnancy [12,13]. The well efficacy and safety in preventing MTCT have been clearly investigated among highly viremic HBV of mothers that started antiviral therapy in the first or second trimesters [12,14].…”

“…Currently, only scarce studies showed the rates of MTCT appeared similar under the utilization of agents during second and third trimester [11], but the events of HBV transmission were still reported even if their mothers obtained a treatment in late pregnancy [12,13]. The well efficacy and safety in preventing MTCT have been clearly investigated among highly viremic HBV of mothers that started antiviral therapy in the first or second trimesters [12,14]. Therefore, it's necessary to identify a more effective and safe period for initiating antiviral treatment (AVT) in pregnancy to completely prevent HBV transmission.…”

Efficacy of antiviral therapy during the second or the third trimester for preventing mother-to-child hepatitis B virus transmission: a systematic review and meta-analysis

“…Compared to the acute hepatitis B infection, CHB is more likely to result in severe long-term life-threatening complications, including cirrhosis and hepatocellular carcinoma. In 2015, 887,000 deaths were reported and attributed to HBV complications 9 . Therefore, preventing MTCT could effectively decrease deaths related to CHB.…”