Y. Lim, Chun‐Yen Lin, J. Heo, H. Bae, W. Chuang, T. Tsang, C. Fournier, A. Hui, H. Trinh, Carol Yee Kwan Chan, Susanna K. Tan, Yang Zhao, J. Flaherty, V. Suri, A. Gaggar, Dianna M Brainard, S. Ryder, H. Janssen
{"title":"病毒性抑制的慢性乙型肝炎(CHB)肝功能损害患者从富马酸替诺福韦二氧丙酯(TDF)和/或其他口服抗病毒药物(OAVS)切换到替诺福韦alafenamide (TAF):来自2期的最终2年疗效和安全性结果","authors":"Y. Lim, Chun‐Yen Lin, J. Heo, H. Bae, W. Chuang, T. Tsang, C. Fournier, A. Hui, H. Trinh, Carol Yee Kwan Chan, Susanna K. Tan, Yang Zhao, J. Flaherty, V. Suri, A. Gaggar, Dianna M Brainard, S. Ryder, H. Janssen","doi":"10.1136/gutjnl-2021-iddf.81","DOIUrl":null,"url":null,"abstract":"(HBV DNA <LLOQ x 6 months, <20 IU/mL at screening) with moderate or severe RI or with ESRD on HD at screening while receiving TDF and/or other OAVs for 48 weeks were enrolled and switched to TAF for 96 weeks. Safety assessments including adverse events (AEs), changes in bone BMD and renal (eGFRCG, serum phosphorus serum creatinine except in ESRD patients) parameters, viral suppression, serological and biochemical responses were serially assessed. Results Of 93 patients (mod-severe RI 78; ESRD on HD 15), most (74%) were male and Asian (77%), 51% 65 y, 83% HBeAg-negative, 34% cirrhosis, and median ALT 17 U/L. Up to 24% had osteoporosis at hip and/or spine, with most having comorbidities. Twelve (13%; 11 mod-severe RI and 1 ESRD) patients discontinued the study early (5-withdrew consent, 3-deaths [none treatment-related], 2-AE, 2investigator decision). Viral suppression (HBV DNA<20IU/ mL) was maintained in all patients remaining on treatment (i.e. missing equals excluded); a high proportion had target not detected. Overall, TAF was well tolerated with no Grade 3 ,4 or serious AEs related to study treatment. Relative to baseline levels, switching to TAF resulted in small median% increases in hip/spine BMD in those with moderate to severe RI, and small median decreases in ESRD patients. 2 patients with mod-severe RI had a bone fracture (ankle, rib). Median eGFRCG increased while urinary markers of proximal tubular function progressively decreased in mod-severe RI patients. Conclusions Renally-impaired CHB patients, including ESRD patients on HD, who were switched to TAF from TDF and/or other OAVs maintained high rates of viral suppression, and bone and renal parameters remained stable or slightly improved after 2 years of treatment.","PeriodicalId":9921,"journal":{"name":"Chinese Journal of Clinical Hepatology","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2021-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"IDDF2021-ABS-0079 Switching from tenofovir disoproxil fumarate (TDF) and/or other oral antivirals (OAVS) to tenofovir alafenamide (TAF) in virally suppressed chronic hepatitis B (CHB) patients with hepatic impairment: final 2-year efficacy and safety results from a phase 2\",\"authors\":\"Y. Lim, Chun‐Yen Lin, J. Heo, H. Bae, W. Chuang, T. Tsang, C. Fournier, A. Hui, H. Trinh, Carol Yee Kwan Chan, Susanna K. Tan, Yang Zhao, J. Flaherty, V. Suri, A. Gaggar, Dianna M Brainard, S. Ryder, H. Janssen\",\"doi\":\"10.1136/gutjnl-2021-iddf.81\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"(HBV DNA <LLOQ x 6 months, <20 IU/mL at screening) with moderate or severe RI or with ESRD on HD at screening while receiving TDF and/or other OAVs for 48 weeks were enrolled and switched to TAF for 96 weeks. Safety assessments including adverse events (AEs), changes in bone BMD and renal (eGFRCG, serum phosphorus serum creatinine except in ESRD patients) parameters, viral suppression, serological and biochemical responses were serially assessed. Results Of 93 patients (mod-severe RI 78; ESRD on HD 15), most (74%) were male and Asian (77%), 51% 65 y, 83% HBeAg-negative, 34% cirrhosis, and median ALT 17 U/L. Up to 24% had osteoporosis at hip and/or spine, with most having comorbidities. Twelve (13%; 11 mod-severe RI and 1 ESRD) patients discontinued the study early (5-withdrew consent, 3-deaths [none treatment-related], 2-AE, 2investigator decision). Viral suppression (HBV DNA<20IU/ mL) was maintained in all patients remaining on treatment (i.e. missing equals excluded); a high proportion had target not detected. Overall, TAF was well tolerated with no Grade 3 ,4 or serious AEs related to study treatment. Relative to baseline levels, switching to TAF resulted in small median% increases in hip/spine BMD in those with moderate to severe RI, and small median decreases in ESRD patients. 2 patients with mod-severe RI had a bone fracture (ankle, rib). Median eGFRCG increased while urinary markers of proximal tubular function progressively decreased in mod-severe RI patients. Conclusions Renally-impaired CHB patients, including ESRD patients on HD, who were switched to TAF from TDF and/or other OAVs maintained high rates of viral suppression, and bone and renal parameters remained stable or slightly improved after 2 years of treatment.\",\"PeriodicalId\":9921,\"journal\":{\"name\":\"Chinese Journal of Clinical Hepatology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2021-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Chinese Journal of Clinical Hepatology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1136/gutjnl-2021-iddf.81\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Chinese Journal of Clinical Hepatology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1136/gutjnl-2021-iddf.81","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
IDDF2021-ABS-0079 Switching from tenofovir disoproxil fumarate (TDF) and/or other oral antivirals (OAVS) to tenofovir alafenamide (TAF) in virally suppressed chronic hepatitis B (CHB) patients with hepatic impairment: final 2-year efficacy and safety results from a phase 2
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