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 in | Clinical gastroenterology and hepatology Vol. 20; no. 12; pp. 2826 - 2837.e9 |
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Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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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.
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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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Wei-Zhe organization: Department of Infectious Diseases and Hepatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province – sequence: 6 givenname: Guang-Ming surname: Li fullname: Li, Guang-Ming organization: Department of Hepatology, The Sixth People’s Hospital of Zhengzhou City, Zhengzhou, Henan Province – sequence: 7 givenname: Ya-Jie surname: Pan fullname: Pan, Ya-Jie organization: Department of Infectious Diseases and Hepatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province – sequence: 8 givenname: Ying-Hua surname: Feng fullname: Feng, Ying-Hua organization: Department of Hepatology, The Sixth People’s Hospital of Kaifeng City, Kaifeng, Henan Province – sequence: 9 givenname: Zhi-Qin surname: Li fullname: Li, Zhi-Qin organization: Department of Infectious Diseases and Hepatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province – sequence: 10 givenname: Guo-Fan surname: Zhang fullname: Zhang, Guo-Fan organization: Department of Infectious Diseases, The First Affiliated Hospital of Nanyang Medical College, Nanyang, Henan Province – sequence: 11 givenname: Jiang-Hai surname: Xu fullname: Xu, Jiang-Hai organization: Department of Hepatology, The Fifth People’s Hospital of Anyang City, Anyang, Henan Province – sequence: 12 givenname: Wan-Bao surname: Lin fullname: Lin, Wan-Bao organization: Department of Infectious Diseases, Xinyang Central Hospital, Xinyang, Henan Province – sequence: 13 givenname: Guang-Hua surname: Xu fullname: Xu, Guang-Hua organization: Department of Infectious Diseases, The Affiliated Hospital of Yan’an University, Yan’an, Shaanxi Province – sequence: 14 givenname: Na surname: Liu fullname: Liu, Na organization: Department of Infectious Diseases, The Affiliated Hospital of Yan’an University, Yan’an, Shaanxi Province – sequence: 15 givenname: Guo-Qiang surname: Zhang fullname: Zhang, Guo-Qiang organization: Department of Infectious Diseases, Luoyang Central Hospital, Luoyang, Henan Province – sequence: 16 givenname: Guo-Tao surname: Li fullname: Li, Guo-Tao organization: Department of Infectious Diseases, Luoyang Central Hospital, Luoyang, Henan Province – sequence: 17 givenname: Wei surname: Li fullname: Li, Wei organization: Department of Infectious Diseases, Henan Provincial People’s Hospital, Zhengzhou, Henan Province – sequence: 18 givenname: Yan-Li surname: Zeng fullname: Zeng, Yan-Li organization: Department of Infectious Diseases, Henan Provincial People’s Hospital, Zhengzhou, Henan Province – sequence: 19 givenname: Ning surname: Song fullname: Song, Ning organization: Center for Reproductive Medicine, Henan Key Laboratory of Reproduction and Genetics, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province – sequence: 20 givenname: Meng surname: Wang fullname: Wang, Meng organization: Department of Hematology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province – sequence: 21 givenname: Da-Wei surname: Zhang fullname: Zhang, Da-Wei organization: Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing – sequence: 22 givenname: Zhi-Min surname: Chen fullname: Chen, Zhi-Min organization: Department of Obstetrics, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province – sequence: 23 givenname: Guang-Lin surname: Cui fullname: Cui, Guang-Lin organization: Department of Clinical Laboratory, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province – sequence: 24 givenname: Juan surname: Li fullname: Li, Juan organization: Department of Infectious Diseases and Hepatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province – sequence: 25 givenname: Jun surname: Lv fullname: Lv, Jun organization: Department of Infectious Diseases and Hepatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province – sequence: 26 givenname: Yan-Min surname: Liu fullname: Liu, Yan-Min organization: Department of Infectious Diseases and Hepatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province – sequence: 27 givenname: Hong-Xia surname: Liang fullname: Liang, Hong-Xia organization: Department of Infectious Diseases and Hepatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province – sequence: 28 givenname: Chang-Yu surname: Sun fullname: Sun, Chang-Yu organization: Department of Infectious Diseases and Hepatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province – sequence: 29 givenname: Yi-Hua surname: Zhou fullname: Zhou, Yi-Hua organization: Department of Experimental Medicine and Jiangsu Key Laboratory for Molecular Medicine, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing, Jiangsu 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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 |
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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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