Efficacy of maternal tenofovir disoproxil fumarate in interrupting mother‐to‐infant transmission of hepatitis B virus
The efficacy and safety of maternal tenofovir disoproxil fumarate (TDF) in reducing mother‐to‐infant hepatitis B virus (HBV) transmissions is not clearly understood. We conducted a prospective, multicenter trial and enrolled 118 hepatitis B surface antigen (HBsAg)– and hepatitis B e antigen–positive...
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| Veröffentlicht in: | Hepatology (Baltimore, Md.) Md.), 2015-08, Vol.62 (2), p.375-386 |
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| creator | Chen, Huey‐Ling Lee, Chien‐Nan Chang, Chin‐Hao Ni, Yen‐Hsuan Shyu, Ming‐Kwang Chen, Shih‐Ming Hu, Jen‐Jan Lin, Hans Hsienhong Zhao, Lu‐Lu Mu, Shu‐Chi Lai, Ming‐Wei Lee, Chyi‐Long Lin, Hsien‐Ming Tsai, Ming‐Song Hsu, Jenn‐Jeih Chen, Ding‐Shinn Chan, K. Arnold Chang, Mei‐Hwei Hwa, Hsiao‐Lin Su, Yi‐Ning Shih, Jin‐Chung Chao, Kuang‐Han Wu, Jia‐Feng Hsu, Hong‐Yuan Liu, Chun‐Jen Su, Tung‐Hung Lin, Chin‐Chuan Lin, Pei‐Ying Yang, Wen‐Rong Yang, Chun‐Kuang Chang, Yin‐Kuang Chen, Kuo‐Hu Lin, Yu‐Hung Chen, Heng‐Ju Pan, Hun‐Shan Lau, Beng‐Huat Cheng, Po‐Jen Chang, Yao‐Lung Chiueh, Ho‐Yen Wang, Tzu‐Hao Lo, Liang‐Ming Hsieh, Chia‐Lin Cheng, Shao‐Wen Lin, Lung‐Huang She, Bo‐Qing Koh, King‐Jun Hung, Yi‐Li Peng, Fu‐Shiang Lin, Yu‐Cheng Wu, Tzee‐Chung Chen, Chih‐Yao Chen, Chie‐Pein Huang, Jian‐Pei Yeung, Chun‐Yan Lin, Chen‐Ju Chiu, Wei‐Tsung Wang, Duo‐Sheng Lin, Wen‐Terng Hwang, Kwei‐Shuai Huang, Ching‐Feng |
| description | The efficacy and safety of maternal tenofovir disoproxil fumarate (TDF) in reducing mother‐to‐infant hepatitis B virus (HBV) transmissions is not clearly understood. We conducted a prospective, multicenter trial and enrolled 118 hepatitis B surface antigen (HBsAg)– and hepatitis B e antigen–positive pregnant women with HBV DNA ≥7.5 log10 IU/mL. The mothers received no medication (control group, n = 56, HBV DNA 8.22 ± 0.39 log10 IU/mL) or TDF 300 mg daily (TDF group, n = 62, HBV DNA 8.18 ± 0.47 log10 IU/mL) from 30‐32 weeks of gestation until 1 month postpartum. Primary outcome was infant HBsAg at 6 months old. At delivery, the TDF group had lower maternal HBV DNA levels (4.29 ± 0.93 versus 8.10 ± 0.56 log10 IU/mL, P |
| doi_str_mv | 10.1002/hep.27837 |
| format | Article |
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Arnold ; Chang, Mei‐Hwei ; Hwa, Hsiao‐Lin ; Su, Yi‐Ning ; Shih, Jin‐Chung ; Chao, Kuang‐Han ; Wu, Jia‐Feng ; Hsu, Hong‐Yuan ; Liu, Chun‐Jen ; Su, Tung‐Hung ; Lin, Chin‐Chuan ; Lin, Pei‐Ying ; Yang, Wen‐Rong ; Yang, Chun‐Kuang ; Chang, Yin‐Kuang ; Chen, Kuo‐Hu ; Lin, Yu‐Hung ; Chen, Heng‐Ju ; Pan, Hun‐Shan ; Lau, Beng‐Huat ; Cheng, Po‐Jen ; Chang, Yao‐Lung ; Chiueh, Ho‐Yen ; Wang, Tzu‐Hao ; Lo, Liang‐Ming ; Hsieh, Chia‐Lin ; Cheng, Shao‐Wen ; Lin, Lung‐Huang ; She, Bo‐Qing ; Koh, King‐Jun ; Hung, Yi‐Li ; Peng, Fu‐Shiang ; Lin, Yu‐Cheng ; Wu, Tzee‐Chung ; Chen, Chih‐Yao ; Chen, Chie‐Pein ; Huang, Jian‐Pei ; Yeung, Chun‐Yan ; Lin, Chen‐Ju ; Chiu, Wei‐Tsung ; Wang, Duo‐Sheng ; Lin, Wen‐Terng ; Hwang, Kwei‐Shuai ; Huang, Ching‐Feng</creator><creatorcontrib>Chen, Huey‐Ling ; Lee, Chien‐Nan ; Chang, Chin‐Hao ; Ni, Yen‐Hsuan ; Shyu, Ming‐Kwang ; Chen, Shih‐Ming ; Hu, Jen‐Jan ; Lin, Hans Hsienhong ; Zhao, Lu‐Lu ; Mu, Shu‐Chi ; Lai, Ming‐Wei ; Lee, Chyi‐Long ; Lin, Hsien‐Ming ; Tsai, Ming‐Song ; Hsu, Jenn‐Jeih ; Chen, Ding‐Shinn ; Chan, K. Arnold ; Chang, Mei‐Hwei ; Hwa, Hsiao‐Lin ; Su, Yi‐Ning ; Shih, Jin‐Chung ; Chao, Kuang‐Han ; Wu, Jia‐Feng ; Hsu, Hong‐Yuan ; Liu, Chun‐Jen ; Su, Tung‐Hung ; Lin, Chin‐Chuan ; Lin, Pei‐Ying ; Yang, Wen‐Rong ; Yang, Chun‐Kuang ; Chang, Yin‐Kuang ; Chen, Kuo‐Hu ; Lin, Yu‐Hung ; Chen, Heng‐Ju ; Pan, Hun‐Shan ; Lau, Beng‐Huat ; Cheng, Po‐Jen ; Chang, Yao‐Lung ; Chiueh, Ho‐Yen ; Wang, Tzu‐Hao ; Lo, Liang‐Ming ; Hsieh, Chia‐Lin ; Cheng, Shao‐Wen ; Lin, Lung‐Huang ; She, Bo‐Qing ; Koh, King‐Jun ; Hung, Yi‐Li ; Peng, Fu‐Shiang ; Lin, Yu‐Cheng ; Wu, Tzee‐Chung ; Chen, Chih‐Yao ; Chen, Chie‐Pein ; Huang, Jian‐Pei ; Yeung, Chun‐Yan ; Lin, Chen‐Ju ; Chiu, Wei‐Tsung ; Wang, Duo‐Sheng ; Lin, Wen‐Terng ; Hwang, Kwei‐Shuai ; Huang, Ching‐Feng ; Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV (PreMIT Study) ; Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV PreMIT Study ; Taiwan Study Group for the Prevention of Mother‐to‐Infant Transmission of HBV (PreMIT Study)</creatorcontrib><description>The efficacy and safety of maternal tenofovir disoproxil fumarate (TDF) in reducing mother‐to‐infant hepatitis B virus (HBV) transmissions is not clearly understood. We conducted a prospective, multicenter trial and enrolled 118 hepatitis B surface antigen (HBsAg)– and hepatitis B e antigen–positive pregnant women with HBV DNA ≥7.5 log10 IU/mL. The mothers received no medication (control group, n = 56, HBV DNA 8.22 ± 0.39 log10 IU/mL) or TDF 300 mg daily (TDF group, n = 62, HBV DNA 8.18 ± 0.47 log10 IU/mL) from 30‐32 weeks of gestation until 1 month postpartum. Primary outcome was infant HBsAg at 6 months old. At delivery, the TDF group had lower maternal HBV DNA levels (4.29 ± 0.93 versus 8.10 ± 0.56 log10 IU/mL, P < 0.0001). Of the 121/123 newborns, the TDF group had lower rates of HBV DNA positivity at birth (6.15% versus 31.48%, P = 0.0003) and HBsAg positivity at 6 months old (1.54% versus 10.71%, P = 0.0481). Multivariate analysis revealed that the TDF group had lower risk (odds ratio = 0.10, P = 0.0434) and amniocentesis was associated with higher risk (odds ratio 6.82, P = 0.0220) of infant HBsAg positivity. The TDF group had less incidence of maternal alanine aminotransferase (ALT) levels above two times the upper limit of normal for ≥3 months (3.23% versus 14.29%, P = 0.0455), a lesser extent of postpartum elevations of ALT (P = 0.007), and a lower rate of ALT over five times the upper limit of normal (1.64% versus 14.29%, P = 0.0135) at 2 months postpartum. Maternal creatinine and creatinine kinase levels, rates of congenital anomaly, premature birth, and growth parameters in infants were comparable in both groups. At 12 months, one TDF‐group child newly developed HBsAg positivity, presumably due to postnatal infection and inefficient humoral responses to vaccines. Conclusions: Treatment with TDF for highly viremic mothers decreased infant HBV DNA at birth and infant HBsAg positivity at 6 months and ameliorated maternal ALT elevations. (Hepatology 2015;62:375–386</description><identifier>ISSN: 0270-9139</identifier><identifier>EISSN: 1527-3350</identifier><identifier>DOI: 10.1002/hep.27837</identifier><identifier>PMID: 25851052</identifier><identifier>CODEN: HPTLD9</identifier><language>eng</language><publisher>United States: Wolters Kluwer Health, Inc</publisher><subject>Adenine - analogs & derivatives ; Adenine - therapeutic use ; Adult ; Antigens ; Deoxyribonucleic acid ; DNA ; DNA, Viral - analysis ; Female ; Follow-Up Studies ; Gestational Age ; Hepatitis ; Hepatitis B ; Hepatitis B virus ; Hepatitis B virus - drug effects ; Hepatitis B, Chronic - diagnosis ; Hepatitis B, Chronic - drug therapy ; Hepatitis B, Chronic - transmission ; Hepatology ; Humans ; Infant, Newborn ; Infectious Disease Transmission, Vertical - prevention & control ; Liver cirrhosis ; Male ; Maternal Age ; Multivariate Analysis ; Organophosphonates - therapeutic use ; Patient Selection ; Pregnancy ; Pregnancy Complications, Infectious - drug therapy ; Pregnancy Complications, Infectious - prevention & control ; Pregnancy Outcome ; Prospective Studies ; Reference Values ; Risk Assessment ; Taiwan ; Tenofovir ; Treatment Outcome ; Viral Load - drug effects ; Young Adult</subject><ispartof>Hepatology (Baltimore, Md.), 2015-08, Vol.62 (2), p.375-386</ispartof><rights>2015 by the American Association for the Study of Liver Diseases</rights><rights>2015 by the American Association for the Study of Liver Diseases.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5577-a7fbe5ca092dedc508ad1712d9313982282cc928e75f0a94b8a3eedd670e9a303</citedby><cites>FETCH-LOGICAL-c5577-a7fbe5ca092dedc508ad1712d9313982282cc928e75f0a94b8a3eedd670e9a303</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fhep.27837$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fhep.27837$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25851052$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chen, Huey‐Ling</creatorcontrib><creatorcontrib>Lee, Chien‐Nan</creatorcontrib><creatorcontrib>Chang, Chin‐Hao</creatorcontrib><creatorcontrib>Ni, Yen‐Hsuan</creatorcontrib><creatorcontrib>Shyu, Ming‐Kwang</creatorcontrib><creatorcontrib>Chen, Shih‐Ming</creatorcontrib><creatorcontrib>Hu, Jen‐Jan</creatorcontrib><creatorcontrib>Lin, Hans Hsienhong</creatorcontrib><creatorcontrib>Zhao, Lu‐Lu</creatorcontrib><creatorcontrib>Mu, Shu‐Chi</creatorcontrib><creatorcontrib>Lai, Ming‐Wei</creatorcontrib><creatorcontrib>Lee, Chyi‐Long</creatorcontrib><creatorcontrib>Lin, Hsien‐Ming</creatorcontrib><creatorcontrib>Tsai, Ming‐Song</creatorcontrib><creatorcontrib>Hsu, Jenn‐Jeih</creatorcontrib><creatorcontrib>Chen, Ding‐Shinn</creatorcontrib><creatorcontrib>Chan, K. Arnold</creatorcontrib><creatorcontrib>Chang, Mei‐Hwei</creatorcontrib><creatorcontrib>Hwa, Hsiao‐Lin</creatorcontrib><creatorcontrib>Su, Yi‐Ning</creatorcontrib><creatorcontrib>Shih, Jin‐Chung</creatorcontrib><creatorcontrib>Chao, Kuang‐Han</creatorcontrib><creatorcontrib>Wu, Jia‐Feng</creatorcontrib><creatorcontrib>Hsu, Hong‐Yuan</creatorcontrib><creatorcontrib>Liu, Chun‐Jen</creatorcontrib><creatorcontrib>Su, Tung‐Hung</creatorcontrib><creatorcontrib>Lin, Chin‐Chuan</creatorcontrib><creatorcontrib>Lin, Pei‐Ying</creatorcontrib><creatorcontrib>Yang, Wen‐Rong</creatorcontrib><creatorcontrib>Yang, Chun‐Kuang</creatorcontrib><creatorcontrib>Chang, Yin‐Kuang</creatorcontrib><creatorcontrib>Chen, Kuo‐Hu</creatorcontrib><creatorcontrib>Lin, Yu‐Hung</creatorcontrib><creatorcontrib>Chen, Heng‐Ju</creatorcontrib><creatorcontrib>Pan, Hun‐Shan</creatorcontrib><creatorcontrib>Lau, Beng‐Huat</creatorcontrib><creatorcontrib>Cheng, Po‐Jen</creatorcontrib><creatorcontrib>Chang, Yao‐Lung</creatorcontrib><creatorcontrib>Chiueh, Ho‐Yen</creatorcontrib><creatorcontrib>Wang, Tzu‐Hao</creatorcontrib><creatorcontrib>Lo, Liang‐Ming</creatorcontrib><creatorcontrib>Hsieh, Chia‐Lin</creatorcontrib><creatorcontrib>Cheng, Shao‐Wen</creatorcontrib><creatorcontrib>Lin, Lung‐Huang</creatorcontrib><creatorcontrib>She, Bo‐Qing</creatorcontrib><creatorcontrib>Koh, King‐Jun</creatorcontrib><creatorcontrib>Hung, Yi‐Li</creatorcontrib><creatorcontrib>Peng, Fu‐Shiang</creatorcontrib><creatorcontrib>Lin, Yu‐Cheng</creatorcontrib><creatorcontrib>Wu, Tzee‐Chung</creatorcontrib><creatorcontrib>Chen, Chih‐Yao</creatorcontrib><creatorcontrib>Chen, Chie‐Pein</creatorcontrib><creatorcontrib>Huang, Jian‐Pei</creatorcontrib><creatorcontrib>Yeung, Chun‐Yan</creatorcontrib><creatorcontrib>Lin, Chen‐Ju</creatorcontrib><creatorcontrib>Chiu, Wei‐Tsung</creatorcontrib><creatorcontrib>Wang, Duo‐Sheng</creatorcontrib><creatorcontrib>Lin, Wen‐Terng</creatorcontrib><creatorcontrib>Hwang, Kwei‐Shuai</creatorcontrib><creatorcontrib>Huang, Ching‐Feng</creatorcontrib><creatorcontrib>Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV (PreMIT Study)</creatorcontrib><creatorcontrib>Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV PreMIT Study</creatorcontrib><creatorcontrib>Taiwan Study Group for the Prevention of Mother‐to‐Infant Transmission of HBV (PreMIT Study)</creatorcontrib><title>Efficacy of maternal tenofovir disoproxil fumarate in interrupting mother‐to‐infant transmission of hepatitis B virus</title><title>Hepatology (Baltimore, Md.)</title><addtitle>Hepatology</addtitle><description>The efficacy and safety of maternal tenofovir disoproxil fumarate (TDF) in reducing mother‐to‐infant hepatitis B virus (HBV) transmissions is not clearly understood. We conducted a prospective, multicenter trial and enrolled 118 hepatitis B surface antigen (HBsAg)– and hepatitis B e antigen–positive pregnant women with HBV DNA ≥7.5 log10 IU/mL. The mothers received no medication (control group, n = 56, HBV DNA 8.22 ± 0.39 log10 IU/mL) or TDF 300 mg daily (TDF group, n = 62, HBV DNA 8.18 ± 0.47 log10 IU/mL) from 30‐32 weeks of gestation until 1 month postpartum. Primary outcome was infant HBsAg at 6 months old. At delivery, the TDF group had lower maternal HBV DNA levels (4.29 ± 0.93 versus 8.10 ± 0.56 log10 IU/mL, P < 0.0001). Of the 121/123 newborns, the TDF group had lower rates of HBV DNA positivity at birth (6.15% versus 31.48%, P = 0.0003) and HBsAg positivity at 6 months old (1.54% versus 10.71%, P = 0.0481). Multivariate analysis revealed that the TDF group had lower risk (odds ratio = 0.10, P = 0.0434) and amniocentesis was associated with higher risk (odds ratio 6.82, P = 0.0220) of infant HBsAg positivity. The TDF group had less incidence of maternal alanine aminotransferase (ALT) levels above two times the upper limit of normal for ≥3 months (3.23% versus 14.29%, P = 0.0455), a lesser extent of postpartum elevations of ALT (P = 0.007), and a lower rate of ALT over five times the upper limit of normal (1.64% versus 14.29%, P = 0.0135) at 2 months postpartum. Maternal creatinine and creatinine kinase levels, rates of congenital anomaly, premature birth, and growth parameters in infants were comparable in both groups. At 12 months, one TDF‐group child newly developed HBsAg positivity, presumably due to postnatal infection and inefficient humoral responses to vaccines. Conclusions: Treatment with TDF for highly viremic mothers decreased infant HBV DNA at birth and infant HBsAg positivity at 6 months and ameliorated maternal ALT elevations. (Hepatology 2015;62:375–386</description><subject>Adenine - analogs & derivatives</subject><subject>Adenine - therapeutic use</subject><subject>Adult</subject><subject>Antigens</subject><subject>Deoxyribonucleic acid</subject><subject>DNA</subject><subject>DNA, Viral - analysis</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Gestational Age</subject><subject>Hepatitis</subject><subject>Hepatitis B</subject><subject>Hepatitis B virus</subject><subject>Hepatitis B virus - drug effects</subject><subject>Hepatitis B, Chronic - diagnosis</subject><subject>Hepatitis B, Chronic - drug therapy</subject><subject>Hepatitis B, Chronic - transmission</subject><subject>Hepatology</subject><subject>Humans</subject><subject>Infant, Newborn</subject><subject>Infectious Disease Transmission, Vertical - prevention & control</subject><subject>Liver cirrhosis</subject><subject>Male</subject><subject>Maternal Age</subject><subject>Multivariate Analysis</subject><subject>Organophosphonates - therapeutic use</subject><subject>Patient Selection</subject><subject>Pregnancy</subject><subject>Pregnancy Complications, Infectious - drug therapy</subject><subject>Pregnancy Complications, Infectious - prevention & control</subject><subject>Pregnancy Outcome</subject><subject>Prospective Studies</subject><subject>Reference Values</subject><subject>Risk Assessment</subject><subject>Taiwan</subject><subject>Tenofovir</subject><subject>Treatment Outcome</subject><subject>Viral Load - drug effects</subject><subject>Young Adult</subject><issn>0270-9139</issn><issn>1527-3350</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkcFuFSEUhompsdfqoi_QkHSji2kPcBlgWZurNWnSLup6wmXA0szAFRjbu_MRfEafRK5TXZg0Tchh8-XLOf-P0CGBEwJAT2_t5oQKycQLtCCcioYxDntoAVRAowhT--h1zncAoJZUvkL7lEtOgNMF2q6c80abLY4Oj7rYFPSAiw3Rxe8-4d7nuEnxwQ_YTaNOlcA-1FfJNG2KD1_xGMutTb9-_CyxDh-cDgWXpEMefc4-hp277qiLLz7jD7iKp_wGvXR6yPbt43-Avnxc3ZxfNJdXnz6fn102hnMhGi3c2nKjQdHe9oaD1D0RhPaK1cMkpZIao6i0gjvQarmWmlnb960AqzQDdoDezd56xrfJ5tLVrYwdBh1snHJHBHAQrVL8ebRVUvFWiLaix_-hd3HaZTdTsOQt2wnfz5RJMedkXbdJvqa47Qh0u-q6Gkv3p7rKHj0ap_Vo-3_k364qcDoD936w26dN3cXqelb-BtYApoo</recordid><startdate>201508</startdate><enddate>201508</enddate><creator>Chen, Huey‐Ling</creator><creator>Lee, Chien‐Nan</creator><creator>Chang, Chin‐Hao</creator><creator>Ni, Yen‐Hsuan</creator><creator>Shyu, Ming‐Kwang</creator><creator>Chen, Shih‐Ming</creator><creator>Hu, Jen‐Jan</creator><creator>Lin, Hans Hsienhong</creator><creator>Zhao, Lu‐Lu</creator><creator>Mu, Shu‐Chi</creator><creator>Lai, Ming‐Wei</creator><creator>Lee, Chyi‐Long</creator><creator>Lin, Hsien‐Ming</creator><creator>Tsai, Ming‐Song</creator><creator>Hsu, Jenn‐Jeih</creator><creator>Chen, Ding‐Shinn</creator><creator>Chan, K. Arnold</creator><creator>Chang, Mei‐Hwei</creator><creator>Hwa, Hsiao‐Lin</creator><creator>Su, Yi‐Ning</creator><creator>Shih, Jin‐Chung</creator><creator>Chao, Kuang‐Han</creator><creator>Wu, Jia‐Feng</creator><creator>Hsu, Hong‐Yuan</creator><creator>Liu, Chun‐Jen</creator><creator>Su, Tung‐Hung</creator><creator>Lin, Chin‐Chuan</creator><creator>Lin, Pei‐Ying</creator><creator>Yang, Wen‐Rong</creator><creator>Yang, Chun‐Kuang</creator><creator>Chang, Yin‐Kuang</creator><creator>Chen, Kuo‐Hu</creator><creator>Lin, Yu‐Hung</creator><creator>Chen, Heng‐Ju</creator><creator>Pan, Hun‐Shan</creator><creator>Lau, Beng‐Huat</creator><creator>Cheng, Po‐Jen</creator><creator>Chang, Yao‐Lung</creator><creator>Chiueh, Ho‐Yen</creator><creator>Wang, Tzu‐Hao</creator><creator>Lo, Liang‐Ming</creator><creator>Hsieh, Chia‐Lin</creator><creator>Cheng, Shao‐Wen</creator><creator>Lin, Lung‐Huang</creator><creator>She, Bo‐Qing</creator><creator>Koh, King‐Jun</creator><creator>Hung, Yi‐Li</creator><creator>Peng, Fu‐Shiang</creator><creator>Lin, Yu‐Cheng</creator><creator>Wu, Tzee‐Chung</creator><creator>Chen, Chih‐Yao</creator><creator>Chen, Chie‐Pein</creator><creator>Huang, Jian‐Pei</creator><creator>Yeung, Chun‐Yan</creator><creator>Lin, Chen‐Ju</creator><creator>Chiu, Wei‐Tsung</creator><creator>Wang, Duo‐Sheng</creator><creator>Lin, Wen‐Terng</creator><creator>Hwang, Kwei‐Shuai</creator><creator>Huang, Ching‐Feng</creator><general>Wolters Kluwer Health, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TM</scope><scope>7TO</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>201508</creationdate><title>Efficacy of maternal tenofovir disoproxil fumarate in interrupting mother‐to‐infant transmission of hepatitis B virus</title><author>Chen, Huey‐Ling ; Lee, Chien‐Nan ; Chang, Chin‐Hao ; Ni, Yen‐Hsuan ; Shyu, Ming‐Kwang ; Chen, Shih‐Ming ; Hu, Jen‐Jan ; Lin, Hans Hsienhong ; Zhao, Lu‐Lu ; Mu, Shu‐Chi ; Lai, Ming‐Wei ; Lee, Chyi‐Long ; Lin, Hsien‐Ming ; Tsai, Ming‐Song ; Hsu, Jenn‐Jeih ; Chen, Ding‐Shinn ; Chan, K. Arnold ; Chang, Mei‐Hwei ; Hwa, Hsiao‐Lin ; Su, Yi‐Ning ; Shih, Jin‐Chung ; Chao, Kuang‐Han ; Wu, Jia‐Feng ; Hsu, Hong‐Yuan ; Liu, Chun‐Jen ; Su, Tung‐Hung ; Lin, Chin‐Chuan ; Lin, Pei‐Ying ; Yang, Wen‐Rong ; Yang, Chun‐Kuang ; Chang, Yin‐Kuang ; Chen, Kuo‐Hu ; Lin, Yu‐Hung ; Chen, Heng‐Ju ; Pan, Hun‐Shan ; Lau, Beng‐Huat ; Cheng, Po‐Jen ; Chang, Yao‐Lung ; Chiueh, Ho‐Yen ; Wang, Tzu‐Hao ; Lo, Liang‐Ming ; Hsieh, Chia‐Lin ; Cheng, Shao‐Wen ; Lin, Lung‐Huang ; She, Bo‐Qing ; Koh, King‐Jun ; Hung, Yi‐Li ; Peng, Fu‐Shiang ; Lin, Yu‐Cheng ; Wu, Tzee‐Chung ; Chen, Chih‐Yao ; Chen, Chie‐Pein ; Huang, Jian‐Pei ; Yeung, Chun‐Yan ; Lin, Chen‐Ju ; Chiu, Wei‐Tsung ; Wang, Duo‐Sheng ; Lin, Wen‐Terng ; Hwang, Kwei‐Shuai ; Huang, Ching‐Feng</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5577-a7fbe5ca092dedc508ad1712d9313982282cc928e75f0a94b8a3eedd670e9a303</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adenine - analogs & derivatives</topic><topic>Adenine - therapeutic use</topic><topic>Adult</topic><topic>Antigens</topic><topic>Deoxyribonucleic acid</topic><topic>DNA</topic><topic>DNA, Viral - analysis</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Gestational Age</topic><topic>Hepatitis</topic><topic>Hepatitis B</topic><topic>Hepatitis B virus</topic><topic>Hepatitis B virus - drug effects</topic><topic>Hepatitis B, Chronic - diagnosis</topic><topic>Hepatitis B, Chronic - drug therapy</topic><topic>Hepatitis B, Chronic - transmission</topic><topic>Hepatology</topic><topic>Humans</topic><topic>Infant, Newborn</topic><topic>Infectious Disease Transmission, Vertical - prevention & control</topic><topic>Liver cirrhosis</topic><topic>Male</topic><topic>Maternal Age</topic><topic>Multivariate Analysis</topic><topic>Organophosphonates - therapeutic use</topic><topic>Patient Selection</topic><topic>Pregnancy</topic><topic>Pregnancy Complications, Infectious - drug therapy</topic><topic>Pregnancy Complications, Infectious - prevention & control</topic><topic>Pregnancy Outcome</topic><topic>Prospective Studies</topic><topic>Reference Values</topic><topic>Risk Assessment</topic><topic>Taiwan</topic><topic>Tenofovir</topic><topic>Treatment Outcome</topic><topic>Viral Load - drug effects</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chen, Huey‐Ling</creatorcontrib><creatorcontrib>Lee, Chien‐Nan</creatorcontrib><creatorcontrib>Chang, Chin‐Hao</creatorcontrib><creatorcontrib>Ni, Yen‐Hsuan</creatorcontrib><creatorcontrib>Shyu, Ming‐Kwang</creatorcontrib><creatorcontrib>Chen, Shih‐Ming</creatorcontrib><creatorcontrib>Hu, Jen‐Jan</creatorcontrib><creatorcontrib>Lin, Hans Hsienhong</creatorcontrib><creatorcontrib>Zhao, Lu‐Lu</creatorcontrib><creatorcontrib>Mu, Shu‐Chi</creatorcontrib><creatorcontrib>Lai, Ming‐Wei</creatorcontrib><creatorcontrib>Lee, Chyi‐Long</creatorcontrib><creatorcontrib>Lin, Hsien‐Ming</creatorcontrib><creatorcontrib>Tsai, Ming‐Song</creatorcontrib><creatorcontrib>Hsu, Jenn‐Jeih</creatorcontrib><creatorcontrib>Chen, Ding‐Shinn</creatorcontrib><creatorcontrib>Chan, K. Arnold</creatorcontrib><creatorcontrib>Chang, Mei‐Hwei</creatorcontrib><creatorcontrib>Hwa, Hsiao‐Lin</creatorcontrib><creatorcontrib>Su, Yi‐Ning</creatorcontrib><creatorcontrib>Shih, Jin‐Chung</creatorcontrib><creatorcontrib>Chao, Kuang‐Han</creatorcontrib><creatorcontrib>Wu, Jia‐Feng</creatorcontrib><creatorcontrib>Hsu, Hong‐Yuan</creatorcontrib><creatorcontrib>Liu, Chun‐Jen</creatorcontrib><creatorcontrib>Su, Tung‐Hung</creatorcontrib><creatorcontrib>Lin, Chin‐Chuan</creatorcontrib><creatorcontrib>Lin, Pei‐Ying</creatorcontrib><creatorcontrib>Yang, Wen‐Rong</creatorcontrib><creatorcontrib>Yang, Chun‐Kuang</creatorcontrib><creatorcontrib>Chang, Yin‐Kuang</creatorcontrib><creatorcontrib>Chen, Kuo‐Hu</creatorcontrib><creatorcontrib>Lin, Yu‐Hung</creatorcontrib><creatorcontrib>Chen, Heng‐Ju</creatorcontrib><creatorcontrib>Pan, Hun‐Shan</creatorcontrib><creatorcontrib>Lau, Beng‐Huat</creatorcontrib><creatorcontrib>Cheng, Po‐Jen</creatorcontrib><creatorcontrib>Chang, Yao‐Lung</creatorcontrib><creatorcontrib>Chiueh, Ho‐Yen</creatorcontrib><creatorcontrib>Wang, Tzu‐Hao</creatorcontrib><creatorcontrib>Lo, Liang‐Ming</creatorcontrib><creatorcontrib>Hsieh, Chia‐Lin</creatorcontrib><creatorcontrib>Cheng, Shao‐Wen</creatorcontrib><creatorcontrib>Lin, Lung‐Huang</creatorcontrib><creatorcontrib>She, Bo‐Qing</creatorcontrib><creatorcontrib>Koh, King‐Jun</creatorcontrib><creatorcontrib>Hung, Yi‐Li</creatorcontrib><creatorcontrib>Peng, Fu‐Shiang</creatorcontrib><creatorcontrib>Lin, Yu‐Cheng</creatorcontrib><creatorcontrib>Wu, Tzee‐Chung</creatorcontrib><creatorcontrib>Chen, Chih‐Yao</creatorcontrib><creatorcontrib>Chen, Chie‐Pein</creatorcontrib><creatorcontrib>Huang, Jian‐Pei</creatorcontrib><creatorcontrib>Yeung, Chun‐Yan</creatorcontrib><creatorcontrib>Lin, Chen‐Ju</creatorcontrib><creatorcontrib>Chiu, Wei‐Tsung</creatorcontrib><creatorcontrib>Wang, Duo‐Sheng</creatorcontrib><creatorcontrib>Lin, Wen‐Terng</creatorcontrib><creatorcontrib>Hwang, Kwei‐Shuai</creatorcontrib><creatorcontrib>Huang, Ching‐Feng</creatorcontrib><creatorcontrib>Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV (PreMIT Study)</creatorcontrib><creatorcontrib>Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV PreMIT Study</creatorcontrib><creatorcontrib>Taiwan Study Group for the Prevention of Mother‐to‐Infant Transmission of HBV (PreMIT Study)</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Hepatology (Baltimore, Md.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chen, Huey‐Ling</au><au>Lee, Chien‐Nan</au><au>Chang, Chin‐Hao</au><au>Ni, Yen‐Hsuan</au><au>Shyu, Ming‐Kwang</au><au>Chen, Shih‐Ming</au><au>Hu, Jen‐Jan</au><au>Lin, Hans Hsienhong</au><au>Zhao, Lu‐Lu</au><au>Mu, Shu‐Chi</au><au>Lai, Ming‐Wei</au><au>Lee, Chyi‐Long</au><au>Lin, Hsien‐Ming</au><au>Tsai, Ming‐Song</au><au>Hsu, Jenn‐Jeih</au><au>Chen, Ding‐Shinn</au><au>Chan, K. Arnold</au><au>Chang, Mei‐Hwei</au><au>Hwa, Hsiao‐Lin</au><au>Su, Yi‐Ning</au><au>Shih, Jin‐Chung</au><au>Chao, Kuang‐Han</au><au>Wu, Jia‐Feng</au><au>Hsu, Hong‐Yuan</au><au>Liu, Chun‐Jen</au><au>Su, Tung‐Hung</au><au>Lin, Chin‐Chuan</au><au>Lin, Pei‐Ying</au><au>Yang, Wen‐Rong</au><au>Yang, Chun‐Kuang</au><au>Chang, Yin‐Kuang</au><au>Chen, Kuo‐Hu</au><au>Lin, Yu‐Hung</au><au>Chen, Heng‐Ju</au><au>Pan, Hun‐Shan</au><au>Lau, Beng‐Huat</au><au>Cheng, Po‐Jen</au><au>Chang, Yao‐Lung</au><au>Chiueh, Ho‐Yen</au><au>Wang, Tzu‐Hao</au><au>Lo, Liang‐Ming</au><au>Hsieh, Chia‐Lin</au><au>Cheng, Shao‐Wen</au><au>Lin, Lung‐Huang</au><au>She, Bo‐Qing</au><au>Koh, King‐Jun</au><au>Hung, Yi‐Li</au><au>Peng, Fu‐Shiang</au><au>Lin, Yu‐Cheng</au><au>Wu, Tzee‐Chung</au><au>Chen, Chih‐Yao</au><au>Chen, Chie‐Pein</au><au>Huang, Jian‐Pei</au><au>Yeung, Chun‐Yan</au><au>Lin, Chen‐Ju</au><au>Chiu, Wei‐Tsung</au><au>Wang, Duo‐Sheng</au><au>Lin, Wen‐Terng</au><au>Hwang, Kwei‐Shuai</au><au>Huang, Ching‐Feng</au><aucorp>Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV (PreMIT Study)</aucorp><aucorp>Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV PreMIT Study</aucorp><aucorp>Taiwan Study Group for the Prevention of Mother‐to‐Infant Transmission of HBV (PreMIT Study)</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy of maternal tenofovir disoproxil fumarate in interrupting mother‐to‐infant transmission of hepatitis B virus</atitle><jtitle>Hepatology (Baltimore, Md.)</jtitle><addtitle>Hepatology</addtitle><date>2015-08</date><risdate>2015</risdate><volume>62</volume><issue>2</issue><spage>375</spage><epage>386</epage><pages>375-386</pages><issn>0270-9139</issn><eissn>1527-3350</eissn><coden>HPTLD9</coden><abstract>The efficacy and safety of maternal tenofovir disoproxil fumarate (TDF) in reducing mother‐to‐infant hepatitis B virus (HBV) transmissions is not clearly understood. We conducted a prospective, multicenter trial and enrolled 118 hepatitis B surface antigen (HBsAg)– and hepatitis B e antigen–positive pregnant women with HBV DNA ≥7.5 log10 IU/mL. The mothers received no medication (control group, n = 56, HBV DNA 8.22 ± 0.39 log10 IU/mL) or TDF 300 mg daily (TDF group, n = 62, HBV DNA 8.18 ± 0.47 log10 IU/mL) from 30‐32 weeks of gestation until 1 month postpartum. Primary outcome was infant HBsAg at 6 months old. At delivery, the TDF group had lower maternal HBV DNA levels (4.29 ± 0.93 versus 8.10 ± 0.56 log10 IU/mL, P < 0.0001). Of the 121/123 newborns, the TDF group had lower rates of HBV DNA positivity at birth (6.15% versus 31.48%, P = 0.0003) and HBsAg positivity at 6 months old (1.54% versus 10.71%, P = 0.0481). Multivariate analysis revealed that the TDF group had lower risk (odds ratio = 0.10, P = 0.0434) and amniocentesis was associated with higher risk (odds ratio 6.82, P = 0.0220) of infant HBsAg positivity. The TDF group had less incidence of maternal alanine aminotransferase (ALT) levels above two times the upper limit of normal for ≥3 months (3.23% versus 14.29%, P = 0.0455), a lesser extent of postpartum elevations of ALT (P = 0.007), and a lower rate of ALT over five times the upper limit of normal (1.64% versus 14.29%, P = 0.0135) at 2 months postpartum. Maternal creatinine and creatinine kinase levels, rates of congenital anomaly, premature birth, and growth parameters in infants were comparable in both groups. At 12 months, one TDF‐group child newly developed HBsAg positivity, presumably due to postnatal infection and inefficient humoral responses to vaccines. Conclusions: Treatment with TDF for highly viremic mothers decreased infant HBV DNA at birth and infant HBsAg positivity at 6 months and ameliorated maternal ALT elevations. (Hepatology 2015;62:375–386</abstract><cop>United States</cop><pub>Wolters Kluwer Health, Inc</pub><pmid>25851052</pmid><doi>10.1002/hep.27837</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0270-9139 |
| ispartof | Hepatology (Baltimore, Md.), 2015-08, Vol.62 (2), p.375-386 |
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| subjects | Adenine - analogs & derivatives Adenine - therapeutic use Adult Antigens Deoxyribonucleic acid DNA DNA, Viral - analysis Female Follow-Up Studies Gestational Age Hepatitis Hepatitis B Hepatitis B virus Hepatitis B virus - drug effects Hepatitis B, Chronic - diagnosis Hepatitis B, Chronic - drug therapy Hepatitis B, Chronic - transmission Hepatology Humans Infant, Newborn Infectious Disease Transmission, Vertical - prevention & control Liver cirrhosis Male Maternal Age Multivariate Analysis Organophosphonates - therapeutic use Patient Selection Pregnancy Pregnancy Complications, Infectious - drug therapy Pregnancy Complications, Infectious - prevention & control Pregnancy Outcome Prospective Studies Reference Values Risk Assessment Taiwan Tenofovir Treatment Outcome Viral Load - drug effects Young Adult |
| title | Efficacy of maternal tenofovir disoproxil fumarate in interrupting mother‐to‐infant transmission of hepatitis B virus |
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