Clinical Efficacy and Safety of Long-Term Treatment of Tenofovir Alafenamide vs Tenofovir Disoproxil Fumarate for Chronic Hepatitis B in Vietnam.

IF 3 3区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Clinical and Translational Gastroenterology Pub Date : 2024-10-01 DOI:10.14309/ctg.0000000000000749
Thao Huynh Phuong Nguyen, Quynh Thi Huong Bui, Thong Duy Vo
{"title":"Clinical Efficacy and Safety of Long-Term Treatment of Tenofovir Alafenamide vs Tenofovir Disoproxil Fumarate for Chronic Hepatitis B in Vietnam.","authors":"Thao Huynh Phuong Nguyen, Quynh Thi Huong Bui, Thong Duy Vo","doi":"10.14309/ctg.0000000000000749","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Hepatitis B virus (HBV) infection is a contagious condition posing a major public health risk in various nations, including Vietnam. In 2019, the Ministry of Health introduced tenofovir alafenamide (TAF) to treat patients with chronic HBV infection and reduce the long-term toxicity of tenofovir disoproxil fumarate (TDF). This study aimed to assess the effectiveness and safety of these 2 medications in individuals with hepatitis B e antigen (HBeAg)-positive chronic HBV.</p><p><strong>Methods: </strong>This retrospective cohort study included data collected from the medical records of patients with chronic HBV who visited the Liver Clinic at University Medical Center Ho Chi Minh City between 2018 and 2020.</p><p><strong>Results: </strong>After 2 years of treatment, the proportion of HBeAg loss in the TAF group was twice that of the TDF group (22.4% vs 11.2%), indicating a statistically significant difference in the probability of HBeAg loss (adjusted hazard ratio = 2.22; 95% confidence interval [CI] 1.43-3.42; P < 0.01). In addition, there was a statistically significant difference in the rate and ability of antiviral response between patients treated with TAF and TDF (65% vs 54.5%, respectively; adjusted hazard ratio = 1.34; 95% CI 1.08-1.69; P < 0.01). A total of 93.9% of patients achieved the goal of restoring alanine aminotransferase to normal, a higher percentage compared with the 81.2% in the TDF group, and the likelihood of achieving normal alanine aminotransferase levels with TAF was greater compared with those on TDF (adjusted hazard ratio = 1.67; 95% CI 1.38-2.01; P < 0.01). Moreover, there was a statistically significant difference in the variation in renal function between the TAF and TDF groups. Serum creatinine levels in the TAF group increased less than those in the TDF group by 0.03 mg/dL every 6 months (95% CI -0.04 to -0.01, P < 0.01), and the estimated glomerular filtration rate in the TAF group was higher than that in the TDF group every 6 months by 2.78 mL/min/1.73 m 2 (95% CI 0.98-4.57, P < 0.01). However, there was no statistically significant difference in the likelihood of HBeAg seroconversion between patients with chronic hepatitis B treated with TAF or TDF (adjusted hazard ratio = 1.79; 95% CI 0.91-3.53; P = 0.09), nor in the risk of adverse events between the 2 groups (adjusted odds ratio = 1.34; 95% CI 0.88-2.05; P = 0.17). In addition, although the HBsAg concentration in the TAF group was lower than in the TDF group by an average of 0.05 log 10 IU/mL every 6 months (95% CI -0.15 to 0.05), this difference also did not reach statistical significance ( P = 0.35).</p><p><strong>Discussion: </strong>TAF has been demonstrated to achieve some therapeutic efficacy goals and reduce nephrotoxicity better than TDF. However, no differences were found in seroconversion or adverse events between the patient groups.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.0000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11500786/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical and Translational Gastroenterology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.14309/ctg.0000000000000749","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Introduction: Hepatitis B virus (HBV) infection is a contagious condition posing a major public health risk in various nations, including Vietnam. In 2019, the Ministry of Health introduced tenofovir alafenamide (TAF) to treat patients with chronic HBV infection and reduce the long-term toxicity of tenofovir disoproxil fumarate (TDF). This study aimed to assess the effectiveness and safety of these 2 medications in individuals with hepatitis B e antigen (HBeAg)-positive chronic HBV.

Methods: This retrospective cohort study included data collected from the medical records of patients with chronic HBV who visited the Liver Clinic at University Medical Center Ho Chi Minh City between 2018 and 2020.

Results: After 2 years of treatment, the proportion of HBeAg loss in the TAF group was twice that of the TDF group (22.4% vs 11.2%), indicating a statistically significant difference in the probability of HBeAg loss (adjusted hazard ratio = 2.22; 95% confidence interval [CI] 1.43-3.42; P < 0.01). In addition, there was a statistically significant difference in the rate and ability of antiviral response between patients treated with TAF and TDF (65% vs 54.5%, respectively; adjusted hazard ratio = 1.34; 95% CI 1.08-1.69; P < 0.01). A total of 93.9% of patients achieved the goal of restoring alanine aminotransferase to normal, a higher percentage compared with the 81.2% in the TDF group, and the likelihood of achieving normal alanine aminotransferase levels with TAF was greater compared with those on TDF (adjusted hazard ratio = 1.67; 95% CI 1.38-2.01; P < 0.01). Moreover, there was a statistically significant difference in the variation in renal function between the TAF and TDF groups. Serum creatinine levels in the TAF group increased less than those in the TDF group by 0.03 mg/dL every 6 months (95% CI -0.04 to -0.01, P < 0.01), and the estimated glomerular filtration rate in the TAF group was higher than that in the TDF group every 6 months by 2.78 mL/min/1.73 m 2 (95% CI 0.98-4.57, P < 0.01). However, there was no statistically significant difference in the likelihood of HBeAg seroconversion between patients with chronic hepatitis B treated with TAF or TDF (adjusted hazard ratio = 1.79; 95% CI 0.91-3.53; P = 0.09), nor in the risk of adverse events between the 2 groups (adjusted odds ratio = 1.34; 95% CI 0.88-2.05; P = 0.17). In addition, although the HBsAg concentration in the TAF group was lower than in the TDF group by an average of 0.05 log 10 IU/mL every 6 months (95% CI -0.15 to 0.05), this difference also did not reach statistical significance ( P = 0.35).

Discussion: TAF has been demonstrated to achieve some therapeutic efficacy goals and reduce nephrotoxicity better than TDF. However, no differences were found in seroconversion or adverse events between the patient groups.

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
越南慢性乙型肝炎长期治疗替诺福韦-阿拉非那胺与富马酸替诺福韦二吡呋酯的临床疗效和安全性。
导言:乙型肝炎病毒(HBV)感染是一种传染性疾病,在包括越南在内的多个国家构成重大公共卫生风险。2019 年,越南卫生部推出了替诺福韦-阿拉非那胺(TAF),用于治疗慢性 HBV 感染患者,并降低富马酸替诺福韦二吡呋酯(TDF)的长期毒性。本研究旨在评估这两种药物对 HBeAg 阳性慢性 HBV 感染者的有效性和安全性:这项回顾性队列研究包括从2018年至2020年期间在胡志明市大学医学中心肝病门诊就诊的慢性HBV患者病历中收集的数据:治疗两年后,TAF组的HBeAg丢失比例是TDF组的两倍(22.4% vs. 11.2%),表明HBeAg丢失的概率存在显著统计学差异(调整后危险比=2.22;95% CI 1.43至3.42;P <0.01)。此外,接受 TAF 和 TDF 治疗的患者的抗病毒应答率和应答能力也有显著统计学差异(分别为 65% 对 54.5%;调整后危险比 = 1.34;95% CI 1.08 至 1.69;P < 0.01)。93.9%的患者实现了ALT恢复正常的目标,这一比例高于TDF组的81.2%,与服用TDF的患者相比,服用TAF的患者实现ALT水平正常的可能性更大(调整后危险比=1.67;95% CI 1.38至2.01;p <0.01)。此外,TAF组和TDF组之间的肾功能差异也有统计学意义。TAF组的血清肌酐水平每6个月比TDF组低0.03 mg/dL (95% CI -0.04 to -0.01,p < 0.01),TAF组的eGFR每6个月比TDF组高2.78 mL/min/1.73 m2 (95% CI 0.98 to 4.57,p < 0.01)。然而,接受 TAF 或 TDF 治疗的慢性乙型肝炎患者发生 HBeAg 血清转换的可能性没有显著统计学差异(调整后危险比 = 1.79;95% CI 0.91 至 3.53;p = 0.09),两组患者发生不良事件的风险也没有显著统计学差异(调整后几率比 = 1.34;95% CI 0.88 至 2.05;p = 0.17)。此外,虽然TAF组的HBsAg浓度比TDF组平均每6个月低0.05 log10 IU/mL(95% CI -0.15至0.05),但这一差异也未达到统计学意义(P = 0.35):讨论:事实证明,TAF比TDF更能达到某些疗效目标并减少肾毒性。然而,在血清转换或不良事件方面,两组患者之间没有发现差异。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
Clinical and Translational Gastroenterology
Clinical and Translational Gastroenterology GASTROENTEROLOGY & HEPATOLOGY-
CiteScore
7.00
自引率
0.00%
发文量
114
审稿时长
16 weeks
期刊介绍: Clinical and Translational Gastroenterology (CTG), published on behalf of the American College of Gastroenterology (ACG), is a peer-reviewed open access online journal dedicated to innovative clinical work in the field of gastroenterology and hepatology. CTG hopes to fulfill an unmet need for clinicians and scientists by welcoming novel cohort studies, early-phase clinical trials, qualitative and quantitative epidemiologic research, hypothesis-generating research, studies of novel mechanisms and methodologies including public health interventions, and integration of approaches across organs and disciplines. CTG also welcomes hypothesis-generating small studies, methods papers, and translational research with clear applications to human physiology or disease. Colon and small bowel Endoscopy and novel diagnostics Esophagus Functional GI disorders Immunology of the GI tract Microbiology of the GI tract Inflammatory bowel disease Pancreas and biliary tract Liver Pathology Pediatrics Preventative medicine Nutrition/obesity Stomach.
期刊最新文献
The Effects of Testosterone Replacement Therapy in Adult Men with Metabolic Dysfunction associated Steatotic Liver Disease: A Systematic Review and Meta-analysis. Size of Pelvic Outlet as a Potential Risk Factor for Fecal Incontinence: A Population-Based Exploratory Analysis. Association of Childhood Abuse with Incident Inflammatory Bowel Disease. Proportion and characteristics of Helicobacter pylori-negative gastric mucosa-associated lymphoid tissue lymphoma: A systematic review and meta-analysis. A multi-institutional study on Ultrasound image analysis for staging HBV-derived liver fibrosis: a potential non-invasive alternative to liver stiffness measurement.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1