Tenofovir Alafenamide for Pregnant Chinese Women With Active Chronic Hepatitis B: A Multicenter Prospective Study

Data on long-term tenofovir alafenamide (TAF) therapy for pregnant women with active chronic hepatitis B (CHB) (immune clearance and reactivation phases, currently and previously diagnosed) and their infants are lacking. Pregnant women with active CHB treated with TAF and tenofovir disoproxil fumara...

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Published inClinical gastroenterology and hepatology Vol. 20; no. 12; pp. 2826 - 2837.e9
Main Authors Zeng, Qing-Lei, Zhang, Hong-Xu, Zhang, Ji-Yuan, Huang, Shuo, Li, Wei-Zhe, Li, Guang-Ming, Pan, Ya-Jie, Feng, Ying-Hua, Li, Zhi-Qin, Zhang, Guo-Fan, Xu, Jiang-Hai, Lin, Wan-Bao, Xu, Guang-Hua, Liu, Na, Zhang, Guo-Qiang, Li, Guo-Tao, Li, Wei, Zeng, Yan-Li, Song, Ning, Wang, Meng, Zhang, Da-Wei, Chen, Zhi-Min, Cui, Guang-Lin, Li, Juan, Lv, Jun, Liu, Yan-Min, Liang, Hong-Xia, Sun, Chang-Yu, Zhou, Yi-Hua, Yu, Zu-Jiang, Wang, Fu-Sheng
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LanguageEnglish
Published United States Elsevier Inc 01.12.2022
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Abstract Data on long-term tenofovir alafenamide (TAF) therapy for pregnant women with active chronic hepatitis B (CHB) (immune clearance and reactivation phases, currently and previously diagnosed) and their infants are lacking. Pregnant women with active CHB treated with TAF and tenofovir disoproxil fumarate (TDF) were enrolled in this multicenter prospective study, and infants received immunoprophylaxis. The primary outcomes were rates of adverse (safety) events in pregnant women and defects in infants and fetuses. The secondary outcomes were virologic responses in pregnant women, infants’ safety, hepatitis B surface antigen (HBsAg) status, and growth conditions. One hundred three and 104 pregnant women were enrolled and 102 and 104 infants were born in the TAF and TDF groups, respectively. In the TAF group, the mean age, gestational age, alanine aminotransferase level, and viral loads at treatment initiation were 29.3 years, 1.3 weeks, 122.2 U/L, and 5.1 log10 IU/mL, respectively. TAF was well-tolerated, and the most common adverse event was nausea (29.1%) during a mean of 2 years of treatment. Notably, 1 (1.0%) TAF-treated pregnant woman underwent induced abortion due to noncausal fetal cleft lip and palate. No infants in either group had birth defects. In the TAF group, the hepatitis B e antigen seroconversion rate was 20.7% at postpartum month 6, infants had normal growth parameters, and no infants were positive for HBsAg at 7 months. The TDF group had comparable safety and effectiveness profiles. TAF administered throughout or beginning in early pregnancy is generally safe and effective for pregnant women with active CHB and their infants. [Display omitted]
AbstractList Data on long-term tenofovir alafenamide (TAF) therapy for pregnant women with active chronic hepatitis B (CHB) (immune clearance and reactivation phases, currently and previously diagnosed) and their infants are lacking.BACKGROUND & AIMSData on long-term tenofovir alafenamide (TAF) therapy for pregnant women with active chronic hepatitis B (CHB) (immune clearance and reactivation phases, currently and previously diagnosed) and their infants are lacking.Pregnant women with active CHB treated with TAF and tenofovir disoproxil fumarate (TDF) were enrolled in this multicenter prospective study, and infants received immunoprophylaxis. The primary outcomes were rates of adverse (safety) events in pregnant women and defects in infants and fetuses. The secondary outcomes were virologic responses in pregnant women, infants' safety, hepatitis B surface antigen (HBsAg) status, and growth conditions.METHODSPregnant women with active CHB treated with TAF and tenofovir disoproxil fumarate (TDF) were enrolled in this multicenter prospective study, and infants received immunoprophylaxis. The primary outcomes were rates of adverse (safety) events in pregnant women and defects in infants and fetuses. The secondary outcomes were virologic responses in pregnant women, infants' safety, hepatitis B surface antigen (HBsAg) status, and growth conditions.One hundred three and 104 pregnant women were enrolled and 102 and 104 infants were born in the TAF and TDF groups, respectively. In the TAF group, the mean age, gestational age, alanine aminotransferase level, and viral loads at treatment initiation were 29.3 years, 1.3 weeks, 122.2 U/L, and 5.1 log10 IU/mL, respectively. TAF was well-tolerated, and the most common adverse event was nausea (29.1%) during a mean of 2 years of treatment. Notably, 1 (1.0%) TAF-treated pregnant woman underwent induced abortion due to noncausal fetal cleft lip and palate. No infants in either group had birth defects. In the TAF group, the hepatitis B e antigen seroconversion rate was 20.7% at postpartum month 6, infants had normal growth parameters, and no infants were positive for HBsAg at 7 months. The TDF group had comparable safety and effectiveness profiles.RESULTSOne hundred three and 104 pregnant women were enrolled and 102 and 104 infants were born in the TAF and TDF groups, respectively. In the TAF group, the mean age, gestational age, alanine aminotransferase level, and viral loads at treatment initiation were 29.3 years, 1.3 weeks, 122.2 U/L, and 5.1 log10 IU/mL, respectively. TAF was well-tolerated, and the most common adverse event was nausea (29.1%) during a mean of 2 years of treatment. Notably, 1 (1.0%) TAF-treated pregnant woman underwent induced abortion due to noncausal fetal cleft lip and palate. No infants in either group had birth defects. In the TAF group, the hepatitis B e antigen seroconversion rate was 20.7% at postpartum month 6, infants had normal growth parameters, and no infants were positive for HBsAg at 7 months. The TDF group had comparable safety and effectiveness profiles.TAF administered throughout or beginning in early pregnancy is generally safe and effective for pregnant women with active CHB and their infants.CONCLUSIONSTAF administered throughout or beginning in early pregnancy is generally safe and effective for pregnant women with active CHB and their infants.
Data on long-term tenofovir alafenamide (TAF) therapy for pregnant women with active chronic hepatitis B (CHB) (immune clearance and reactivation phases, currently and previously diagnosed) and their infants are lacking. Pregnant women with active CHB treated with TAF and tenofovir disoproxil fumarate (TDF) were enrolled in this multicenter prospective study, and infants received immunoprophylaxis. The primary outcomes were rates of adverse (safety) events in pregnant women and defects in infants and fetuses. The secondary outcomes were virologic responses in pregnant women, infants’ safety, hepatitis B surface antigen (HBsAg) status, and growth conditions. One hundred three and 104 pregnant women were enrolled and 102 and 104 infants were born in the TAF and TDF groups, respectively. In the TAF group, the mean age, gestational age, alanine aminotransferase level, and viral loads at treatment initiation were 29.3 years, 1.3 weeks, 122.2 U/L, and 5.1 log10 IU/mL, respectively. TAF was well-tolerated, and the most common adverse event was nausea (29.1%) during a mean of 2 years of treatment. Notably, 1 (1.0%) TAF-treated pregnant woman underwent induced abortion due to noncausal fetal cleft lip and palate. No infants in either group had birth defects. In the TAF group, the hepatitis B e antigen seroconversion rate was 20.7% at postpartum month 6, infants had normal growth parameters, and no infants were positive for HBsAg at 7 months. The TDF group had comparable safety and effectiveness profiles. TAF administered throughout or beginning in early pregnancy is generally safe and effective for pregnant women with active CHB and their infants. [Display omitted]
Background & AimsData on long-term tenofovir alafenamide (TAF) therapy for pregnant women with active chronic hepatitis B (CHB) (immune clearance and reactivation phases, currently and previously diagnosed) and their infants are lacking. MethodsPregnant women with active CHB treated with TAF and tenofovir disoproxil fumarate (TDF) were enrolled in this multicenter prospective study, and infants received immunoprophylaxis. The primary outcomes were rates of adverse (safety) events in pregnant women and defects in infants and fetuses. The secondary outcomes were virologic responses in pregnant women, infants’ safety, hepatitis B surface antigen (HBsAg) status, and growth conditions. ResultsOne hundred three and 104 pregnant women were enrolled and 102 and 104 infants were born in the TAF and TDF groups, respectively. In the TAF group, the mean age, gestational age, alanine aminotransferase level, and viral loads at treatment initiation were 29.3 years, 1.3 weeks, 122.2 U/L, and 5.1 log 10 IU/mL, respectively. TAF was well-tolerated, and the most common adverse event was nausea (29.1%) during a mean of 2 years of treatment. Notably, 1 (1.0%) TAF-treated pregnant woman underwent induced abortion due to noncausal fetal cleft lip and palate. No infants in either group had birth defects. In the TAF group, the hepatitis B e antigen seroconversion rate was 20.7% at postpartum month 6, infants had normal growth parameters, and no infants were positive for HBsAg at 7 months. The TDF group had comparable safety and effectiveness profiles. ConclusionsTAF administered throughout or beginning in early pregnancy is generally safe and effective for pregnant women with active CHB and their infants.
Data on long-term tenofovir alafenamide (TAF) therapy for pregnant women with active chronic hepatitis B (CHB) (immune clearance and reactivation phases, currently and previously diagnosed) and their infants are lacking. Pregnant women with active CHB treated with TAF and tenofovir disoproxil fumarate (TDF) were enrolled in this multicenter prospective study, and infants received immunoprophylaxis. The primary outcomes were rates of adverse (safety) events in pregnant women and defects in infants and fetuses. The secondary outcomes were virologic responses in pregnant women, infants' safety, hepatitis B surface antigen (HBsAg) status, and growth conditions. One hundred three and 104 pregnant women were enrolled and 102 and 104 infants were born in the TAF and TDF groups, respectively. In the TAF group, the mean age, gestational age, alanine aminotransferase level, and viral loads at treatment initiation were 29.3 years, 1.3 weeks, 122.2 U/L, and 5.1 log IU/mL, respectively. TAF was well-tolerated, and the most common adverse event was nausea (29.1%) during a mean of 2 years of treatment. Notably, 1 (1.0%) TAF-treated pregnant woman underwent induced abortion due to noncausal fetal cleft lip and palate. No infants in either group had birth defects. In the TAF group, the hepatitis B e antigen seroconversion rate was 20.7% at postpartum month 6, infants had normal growth parameters, and no infants were positive for HBsAg at 7 months. The TDF group had comparable safety and effectiveness profiles. TAF administered throughout or beginning in early pregnancy is generally safe and effective for pregnant women with active CHB and their infants.
Author Xu, Jiang-Hai
Li, Guo-Tao
Liu, Yan-Min
Pan, Ya-Jie
Li, Wei
Lin, Wan-Bao
Wang, Meng
Zhang, Ji-Yuan
Zhang, Hong-Xu
Zeng, Yan-Li
Zhang, Guo-Qiang
Zeng, Qing-Lei
Cui, Guang-Lin
Li, Guang-Ming
Li, Zhi-Qin
Zhang, Da-Wei
Song, Ning
Wang, Fu-Sheng
Huang, Shuo
Li, Juan
Xu, Guang-Hua
Sun, Chang-Yu
Zhou, Yi-Hua
Liang, Hong-Xia
Chen, Zhi-Min
Liu, Na
Lv, Jun
Li, Wei-Zhe
Feng, Ying-Hua
Zhang, Guo-Fan
Yu, Zu-Jiang
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Issue 12
Keywords anti-HBs
eGFR
Chronic Hepatitis B
Effectiveness
HBeAg
ALT
HBsAg
Mother-to-Child Transmission
LMP
Pregnancy
Tenofovir Alafenamide
TDF
TAF
Safety
CHB
MTCT
Tenofovir Disoproxil Fumarate
HBV
WHO
estimated glomerular filtration rate
hepatitis B virus
alanine aminotransferase
hepatitis B e antigen
World Health Organization
hepatitis B surface antigen
last menstrual period
anti-hepatitis B surface antibody
Language English
License This is an open access article under the CC BY-NC-ND license.
Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.
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Snippet Data on long-term tenofovir alafenamide (TAF) therapy for pregnant women with active chronic hepatitis B (CHB) (immune clearance and reactivation phases,...
Background & AimsData on long-term tenofovir alafenamide (TAF) therapy for pregnant women with active chronic hepatitis B (CHB) (immune clearance and...
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SubjectTerms Adenine - adverse effects
Adult
Antiviral Agents - adverse effects
China
Chronic Hepatitis B
Cleft Lip - chemically induced
Cleft Lip - drug therapy
Cleft Palate - chemically induced
Cleft Palate - drug therapy
Effectiveness
Female
Gastroenterology and Hepatology
Hepatitis B - diagnosis
Hepatitis B Surface Antigens
Hepatitis B, Chronic - drug therapy
Humans
Infant, Newborn
Mother-to-Child Transmission
Pregnancy
Pregnant Women
Prospective Studies
Safety
Tenofovir - adverse effects
Tenofovir Alafenamide
Tenofovir Disoproxil Fumarate
Title Tenofovir Alafenamide for Pregnant Chinese Women With Active Chronic Hepatitis B: A Multicenter Prospective Study
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https://dx.doi.org/10.1016/j.cgh.2021.12.012
https://www.ncbi.nlm.nih.gov/pubmed/34902570
https://www.proquest.com/docview/2610075717
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