Efficacy and safety of telbivudine and tenofovir disoproxil fumarate in preventing hepatitis B vertical transmission: A real‐life practice

Abstract

Mother‐to‐child transmission (MTCT) is a major obstacle in the elimination of hepatitis B virus (HBV) infection. Telbivudine (LdT) and tenofovir disoproxil fumarate (TDF) are the two most common antiviral medicines for preventing MTCT. However, the efficacy and safety of LdT and TDF in preventing HBV vertical transmission during the second to third trimester have not been compared rigorously. Therefore, we carried out a prospective multicentre cohort study of chronic hepatitis B in mothers with HBV DNA > 106 IU/mL, receiving LdT or TDF during the second to third trimester. Among the 893 mothers enrolled, 857 (LdT/TDF/untreated group (NTx) = 396/325/136) completed consecutive follow‐up with 854 infants (LdT/TDF/NTx = 395/323/136). LdT and TDF treatment resulted in a similar decrease of HBV DNA in mothers at delivery. Multivariate analysis indicated that only HBsAg titre at the baseline correlated with viral DNA decrease (P = 0.015). With intention‐to‐treat analysis, MTCT rates in the LdT, TDF and NTx group were 4.41%, 2.42% and 22.08%, respectively. An increasing vertical transmission rate was found to be closely associated with higher HBsAg titre, 5.32% and 17.65% infection rate was estimated in infants born to mothers with HBsAg > 4 and >5 log10 IU/mL, respectively. No serious side effects were reported in either mothers or infants. LdT and TDF treatments were well tolerated and showed comparable efficacy in reducing MTCT. Higher risk of MTCT was shown in pregnant women with HBsAg > 4 log10IU/mL.

Telbivudine therapy for gravidas with chronic hepatitis B infection and patients at risk of renal impairment

“…Additionally, only 1 child was HBsAg(+) by 1 year age, and an intention-to-treat analysis indicated an MTCT rate of 4.01% with LdT treatment. 27 Similar to our findings, subsequent studies demonstrated that LdT antiviral treatment could effectively reduce MTCT, whereas MTCT occurred in 2.8%-14.7% patients in the untreated control groups. 24 the differences in the efficacy of LdT administration during the first trimester (early pregnancy group) and the second or third trimesters of pregnancy (middle pregnancy group) in preventing MTCT.…”

“…Our group enrolled 312 CHB gravidas who hadn't accepted LdT starting at 24 weeks of gestation; 51.0% (159/312) displayed undetectable HBV DNA at delivery. Additionally, only 1 child was HBsAg(+) by 1 year age, and an intention‐to‐treat analysis indicated an MTCT rate of 4.01% with LdT treatment . Similar to our findings, subsequent studies demonstrated that LdT antiviral treatment could effectively reduce MTCT, whereas MTCT occurred in 2.8%‐14.7% patients in the untreated control groups .…”

“…Recently, a long‐term, prospective study from the same group that conducted a 5‐year continuous follow‐up of infants exposed to LdT during pregnancy showed few differences in the infants' growth (mean head circumference, weight and height values) compared with standard Chinese values; furthermore, there were few differences in development (eg incidence of congenital abnormality and Denver Developmental Screening Test results) . Additionally, in our investigation, pregnancy complications and postnatal development of infants born to mothers exposed to LdT were similar to those from mothers exposed to TDF and the general population in China . LdT has been reported to be associated with myopathy, neuropathy and lactic acidosis.…”

“…Additionally, LdT showed more profound inhibition of HBV DNA replication compared with LAM (RR = 1.8, 95% CI: 1.3‐2.6). Furthermore, our real‐world study including 312 gravidas who accepted LdT vs 223 gravidas who accepted TDF indicated that the depression of the HBV viral titre, percentage of mothers with undetectable HBV DNA at delivery and rate of MTCT were all comparable between the LdT and TDF groups . In a prospective survey following infants born to CHB gravidas who accepted LdT, all 214 infants were free of HBV infection from birth up to 5 years of age …”

Mother‐to‐child transmission of hepatitis B: What more needs to be done to eliminate it around the world?

“…The risk of HBV MTCT is closely related to high HBV DNA levels, and the risk of immunoprophylaxis failure starts to increase when HBV DNA levels exceed 200 000 IU/mL. Data mainly from Asia have confirmed the efficacy and safety of peripartum antiviral therapy using tenofovir disoproxil (TDF) in addition to BDV and HBIG to control HBV MTCT in mothers with high risk of HBV MTCT . The 2016 study by Pan and colleagues from China provides strong evidence to support the efficacy of this strategy .…”