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

Han, Guorong; Jiang, Hongxiu; Yue, Xin; Ding, Yang; Wang, C.-M.; Wang, G.-J.; Yang, Yue

doi:10.1111/jvh.12379

Cited by 53 publications

(41 citation statements)

References 20 publications

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“…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 .…”

Section: Resultsmentioning

confidence: 99%

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

Song

Yang

Wang

et al. 2018

Journal of Viral Hepatitis

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Summary Nucleo(t)side analogues (NAs) have been administered as adjunctive therapy to interrupt the mother‐to‐child transmission (MTCT) of hepatitis B virus (HBV). The efficacy and safety of this method remain controversial. A meta‐analysis was conducted to evaluate the efficacy and safety of NAs treatment during pregnancy. The differences among different agents and initiation trimesters were analysed. A total of 9228 mother‐infant pairs in 59 studies (32 RCTs and 27 non‐RCTs) were included in this meta‐analysis. NAs significantly reduced the risk of MTCT, as indicated by seropositivity of hepatitis B surface antigen (HBsAg) (risk ratio (RR) = 0.51, 95% confidence interval (CI) 0.45‐0.57) and HBV DNA in newborns (RR = 0.22, 95% CI 0.18‐0.26). No differences in the efficacy of interrupting HBV MTCT were evident among lamivudine, telbivudine and tenofovir disoproxil fumarate. NA was more effective when administered from the second than from the third trimester as indicated by HBV DNA (RR: the second vs the third 0.08 vs 0.22, P = 0.010), but this effect was not evident as indicated by HBsAg (RR: the second vs the third 0.46 vs 0.53, P = 0.596). Antiviral treatment initiated from the second trimester did not confer a higher risk of safety problems in the newborns compared with treatment from the third trimester, as indicated by weight (P = 0.064), length (P = 0.491) and malformation rate (P = 0.635) of newborns. Conclusions Lamivudine, telbivudine and tenofovir disoproxil fumarate are equally effective in blocking HBV MTCT. Antiviral treatment can be applied from the second trimester, without obvious safety concerns.

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Section: Resultsmentioning

confidence: 99%

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

Song

Yang

Wang

et al. 2018

Journal of Viral Hepatitis

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“…Although telbivudine (LdT) is the first drug to be assigned to Pregnancy Category B and it is generally considered safe for the treatment of CHB during pregnancy . In recent years, there have been reports of pregnant women treated with LdT during the third trimester of pregnancy to block mother‐to‐infant transmission (MTIT) of HBV ; however, there are very few reports about the safety of LdT treatment for the whole pregnancy. The present study aims to evaluate the safety of LdT treatment for chronic HBV infection during the whole pregnancy, to provide a reference for chronic HBV‐infected fertile women on how to block MTIT of HBV.…”

Section: Introductionmentioning

confidence: 99%

Safety of telbivudine treatment for chronic hepatitis B for the entire pregnancy

Cai

2013

Journal of Viral Hepatitis

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Orally administered nucleus(t)ide analogues (NA) have brought about a simple, safe and effective therapeutic approach for chronic hepatitis B (CHB). However, treatment duration is long and some female patients become pregnant during treatment. In recent years, there have been gradually increasing reports on the safety of telbivudine (LdT) treatment for chronic hepatitis B virus (HBV) infection in the third trimester of pregnancy to block mother-to-infant transmission (MTIT) of HBV; however, the safety of LdT treatment for chronic HBV infection for the entire pregnancy has not been reported. The aim of the present study was to evaluate the safety of LdT treatment for chronic HBV infection for the entire pregnancy and provide a reference for HBV-infected fertile women on how to block MTIT of HBV. Eighty-six pregnant women who received LdT treatment either before or in early pregnancy were enrolled in the study. Adverse events were prospectively observed for the entire pregnancy and perinatal period, and short-term and long-term follow-up of infants was conducted, monitoring the abnormalities of infants and blocking rate of MTIT with LdT treatment. Eighty-six pregnant women treated with LdT had a total of 89 pregnancies: 6 (6.7%) had early embryonic death or spontaneous abortion, 1 (1.1%) had ectopic pregnancy and three had a second pregnancy after initial abortion. Fifty-one mothers completed pregnancy: one had induction of labour at 24 weeks of pregnancy for cleft lip and palate of the foetus and 50 delivered 52 full-term live infants. One infant had right ear accessories, and the total occurrence of congenital abnormality was 3.8%. Thirty-nine infants were followed up for more than 6 months and completed all examinations for MTIT. None of the infants were HBsAg positive, resulting in a 100% success rate of blocking MTIT. All mothers maintained good liver function during the third trimester of pregnancy; 86% maintained complete virological response (HBV DNA <500 copies/mL) prior to delivery, and none developed progression of liver disease. Factors leading to increased adverse effects and drug resistance were not found. LdT treatment is safe and effective in chronic HBV-infected pregnant mothers for the entire pregnancy.

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“…Although practice guidelines do not recommend the use of telbivudine as a first‐line agent for the treatment of CHB, the European Association for the Study of the Liver and the Asian‐Pacific Association for the Study of the Liver guidelines recommend telbivudine as one of the two preferred drugs to be used for the prevention of perinatal and intrauterine HBV transmission in the last trimester of pregnancy in HBsAg‐positive women with high levels of viremia (serum HBV DNA > 10 6‐7 IU/mL) . Several studies showed that maternal treatment with telbivudine when compared with no treatment or placebo during the third trimester of pregnancy was effective in reducing vertical transmission of HBV infection . A meta‐analysis of seven clinical trials involving 644 pregnant women demonstrated that telbivudine use during late pregnancy was effective in interrupting mother‐to‐child transmission in newborns .…”

Section: Safety Profile Of Telbivudinementioning

confidence: 99%

Telbivudine therapy for chronic hepatitis B: A journey to identify super‐responders and to optimize treatment using the roadmap model

Kao

Asselah

Dou

et al. 2017

J of Gastro and Hepatol

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Hepatitis B virus (HBV) infection is one of the most serious health problems worldwide with a high risk for cirrhosis and liver cancer. Several antiviral agents have been approved for the treatment of chronic hepatitis B, leading to a rapid reduction in HBV DNA and normalization of serum alanine aminotransferase levels. Telbivudine, a potent inhibitor of HBV replication, has been shown to be well tolerated. Because of the emergence of drug resistance, optimization strategies for telbivudine therapy have been shown to improve patient responses. Optimal baseline characteristics in so-called super-responders have been used to predict the virological response. Baseline HBV DNA levels < 9 log 10 copies/mL (2 × 10 8 IU/mL) or alanine aminotransferase levels of more than or equal to twofold the upper limit of normal in HBeAg-positive patients and HBV DNA < 7 log 10 copies/mL (2 × 10 6 IU/mL) in HBeAg-negative patients were strong predictors for virological response. In addition, the roadmap model, based on early virological response at week 24 of therapy, is considered as a powerful tool to identify patients at risk of treatment failure (HBV DNA ≥ 300 copies/mL, i.e. 60 IU/mL) and to reduce the risk of antiviral resistance. When considering pre-treatment characteristics and on-treatment responses, telbivudine may provide physicians with a wide choice of options to effectively treat patients with chronic hepatitis B, especially those with or at risk of renal impairment, or women of childbearing age.

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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

Cited by 53 publications

References 20 publications

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

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

Safety of telbivudine treatment for chronic hepatitis B for the entire pregnancy

Telbivudine therapy for chronic hepatitis B: A journey to identify super‐responders and to optimize treatment using the roadmap model

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