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

M, Liu; Cai, Haodong; Yi, Wei

doi:10.1111/jvh.12066

Cited by 52 publications

(54 citation statements)

References 24 publications

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“…However, most of these reports concern patients treated with telbivudine during the second or third trimesters of pregnancy to prevent transmission of HBV from the mothers with high viral load to their infants (16,17,18,19). To the best of our knowledge, there have been a very few reports on the safe use of telbivudine throughout the whole pregnancy, beginning from the first trimester (9,20). Treatment is challenging in women of childbearing potential.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Telbivudine in Chronic Hepatitis B Treatment Throughout the Entire Pregnancy

Baysal¹,

Kaya²,

Aksöz³

et al. 2016

vhd

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ÖZObjective: Women of childbearing potential treated for chronic hepatitis B virus (HBV) infection may experience exacerbations during or after pregnancy. Infants may also acquire HBV infection through perinatal route. Currently, there is no antiviral agent approved for use in pregnancy. This makes it difficult to decide whether treatment should be withdrawn immediately or continued in women who become pregnant while on HBV antiviral therapy. The present study aims to establish the safety and, as a second measure, the efficacy of telbivudine in patients who became pregnant while they were on telbivudine treatment for chronic HBV infections and were maintained on the treatment throughout pregnancy. Materials and Methods: Between 2010 and 2013, twentyone patients, who became pregnant while receiving telbivudine treatment for chronic HBV infection and continued the treatment, were evaluated retrospectively. Results: The mean age of the patients was 28.9±6.3 years (range: 18-41 years). All patients were hepatitis B envelope antigen-negative. The mean pre-treatment hepatic activity index was 9.4±1.6 (range: 7-13), and fibrosis and serum HBV, DNA measurements were 3.2±0.8 (range: 2-5) and 3.5x10 5 ±2.8x10 5 IU/mL, respectively. No drug-related side effects were seen in any of the patients. All infants had normal birth weights and no abnormalities were observed in any of them. At the end of week 28, none of the infants was hepatitis B surface antigen-positive. Conclusion:The use of telbivudine from the first trimester of pregnancy appears to be safe both for the mother and fetus and

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Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Telbivudine in Chronic Hepatitis B Treatment Throughout the Entire Pregnancy

Baysal¹,

Kaya²,

Aksöz³

et al. 2016

vhd

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“…A number of studies suggest that it is effective and safe in pregnancy [36][37][38], though long-term data are lacking.…”

Section: Third Trimester Management To Prevent Mtctmentioning

confidence: 98%

Management of HBV in Pregnancy

Kelly¹,

Peters²

2015

Curr Hepatology Rep

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Hepatitis B in pregnancy must include diagnosis and management of the pregnant woman as well as modalities to decrease mother to child transmission (MTCT). MTCT remains the most important mode of hepatitis B virus (HBV) transmission, although effective strategies exist to reduce this risk. Universal screening for HBV can identify women with previously unrecognized infection and allow for targeted therapy to prevent MTCT. All children of HBV-infected mothers should receive passive active immunoprophylaxis with hepatitis B immune globulin (HBIG) and HBV vaccination within 12 h of birth. With such measures, the risk of transmission can be decreased to less than 1 % in women with low viral loads. Immunoprophylaxis failures occur in as many as 15 % of children born to mothers with high viral loads at the time of delivery (>6 log copies/ml or >200,000 IU/ml), and therefore, additional treatment in the third trimester is warranted in this group. Antiviral therapy with lamivudine, tenofovir, or telbivudine in the third trimester can decrease MTCT to less than 5 % and should be used in women with high viral loads in the third trimester. Postpartum flares of liver disease are common, and therefore, careful monitoring is warranted in women who stop therapy. The decision to breastfeed while on antiviral therapy should be individualized, but current evidence suggests that it is safe.

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“…It is structurally similar to lamivudine and has similar resistance profile, is well tolerated and has no doselimiting side effects [38] . The overall rate of drug resistance development is 22% in HBeAg-positive patients and 9% in HBeAg-negative carriers [39] . Although it is more potent than lamivudine and adenovir, it is cross-resistant with lamivudine and has a considerable risk of drug resistance development [40] .…”

Section: Telbivudinementioning

confidence: 99%

Current and future antiviral drug therapies of hepatitis B chronic infection

Koumbi¹

2015

WJH

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Despite significant improvement in the management of chronic hepatitis B virus (HBV) it remains a public health problem, affecting more than 350 million people worldwide. The natural course of the infection is dynamic and involves a complex interplay between the virus and the host's immune system. Currently the approved therapeutic regimens include pegylated-interferon (IFN)-α and monotherapy with five nucleos(t)ide analogues (NAs). Both antiviral treatments are not capable to eliminate the virus and do not establish longterm control of infection after treatment withdrawal. IFN therapy is of finite duration and associates with low response rates, liver decompensating and numerous side effects. NAs are well-tolerated therapies but have a high risk of drug resistance development that limits their prolonged use. The imperative for the development of new approaches for the treatment of chronic HBV infection is a challenging issue that cannot be over-sided. Research efforts are focusing on the identification and evaluation of various viral replication inhibitors that target viral replication and a number of immunomodulators that aim to restore the HBV specific immune hyporesponsiveness without inducing liver damage. This review brings together our current knowledge on the available treatment and discusses potential therapeutic approaches in the battle against chronic HBV infection. Core tip: Despite significant improvement in the management of chronic hepatitis B virus (HBV) it remains a public health problem. Current therapeutic regimens include pegylated-interferon (IFN)-α and nucleos(t)ide analogues (NAs). Both treatments do not eradicate the virus and have numerous limitations. IFN therapy is of finite duration and has low response rates while longterm NA therapies have a high risk of drug resistance. The development of new therapeutic approaches is imperative. This review brings together current treatments and the ongoing research efforts on evaluating potential therapeutic strategies that target the suppression of HBV replication the restoration of the weak immune responses against HBV.

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

Cited by 52 publications

References 24 publications

Efficacy and Safety of Telbivudine in Chronic Hepatitis B Treatment Throughout the Entire Pregnancy

Efficacy and Safety of Telbivudine in Chronic Hepatitis B Treatment Throughout the Entire Pregnancy

Management of HBV in Pregnancy

Current and future antiviral drug therapies of hepatitis B chronic infection

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