Dolutegravir/Lamivudine for Maintenance of Virological Suppression in Persons with Historical Suspected or Confirmed Resistance to Lamivudine: Week 48 Results of a Single-Arm, Open-Label, Multicentre, Phase IIA Clinical Trial

杜鲁特格拉维尔 拉米夫定 医学 临床试验 打开标签 病毒学 临床研究阶段 内科学 病毒载量 人类免疫缺陷病毒(HIV) 病毒 抗逆转录病毒疗法 乙型肝炎病毒
作者
Rosa de Miguel Buckley,María Lagarde,José Luís Blanco,Adriana Pinto-Martínez,Rocío Montejano,Ángela Gutiérrez,Roser Navarro-Soler,Esperanza Cañas‐Ruano,Alexy Inciarte,Luz Martín‐Carbonero,Arkaitz Imaz,Cristina Hernández Gutiérrez,Antonio Ocampo,Pedro Gil Divasson,Rafaël Delgado,Federico Pulido,José Ramón Arribas
出处
期刊:Clinical Infectious Diseases [Oxford University Press]
标识
DOI:10.1093/cid/ciaf100
摘要

We investigated the efficacy of dolutegravir/lamivudine for maintenance treatment for people with HIV and previous lamivudine resistance. Open-label, single arm, multicentric clinical trial including virologically suppressed PWH with historical lamivudine resistance (confirmed by genotypic testing or suspected based on clinical history), no integrase resistance and CD4+ >200 cells/mm3 whose ART was changed to dolutegravir/lamivudine if the M184V/I mutation was not detected in baseline proviral DNA population sequencing. Proviral DNA next-generation sequencing (NGS) was retrospectively performed in baseline samples. Primary endpoint was proportion of participants with HIV-1 RNA viral load (VL) ≥50 copies/mL at 48 weeks in the intention-to-treat-exposed (ITT-e) population using the Food and Drug Administration snapshot algorithm. 121 participants enrolled, 114 with a prior genotype with M184V/I, mean virological suppression of 9 years. 24 (19·8%) had the M184V/I in baseline proviral DNA NGS (>5% threshold). At 48 weeks, 4 participants had a VL ≥50 copies/mL (3·3%, 95% CI: 0·9%-8·2%, FDA-Snapshot ITT-e): 1 confirmed virologic withdrawal, 1 precautionary virologic withdrawal and 2 discontinued from study treatment for other reasons with last VL ≥ 50 copies/mL; none had M184V/I in baseline proviral DNA NGS and there was no emergent integrase resistance. 90·1% participants (109/121) had a VL<50 copies/mL (95% CI: 83·3%-94·8%) and there were no data for 6·6 % (8/121 participants) at 48 weeks. After excluding lamivudine mutations in proviral DNA by population sequencing, dolutegravir/lamivudine effectively maintained virological suppression in PWH with CD4+ >200 cells/mm3 and history of lamivudine resistance. Notably, no treatment-emergent resistance was observed.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
无花果应助王星星采纳,获得10
2秒前
superfatcat完成签到,获得积分10
2秒前
苏雅霏完成签到 ,获得积分10
3秒前
EED发布了新的文献求助10
4秒前
5秒前
5秒前
cindywu发布了新的文献求助10
7秒前
科研通AI2S应助Huang_being采纳,获得10
7秒前
7秒前
8秒前
量子星尘发布了新的文献求助10
8秒前
HCB1发布了新的文献求助10
9秒前
9秒前
ShuXU完成签到,获得积分10
11秒前
11秒前
Pom完成签到,获得积分10
11秒前
gujiguji发布了新的文献求助10
13秒前
科研通AI2S应助HCB1采纳,获得10
13秒前
HOME发布了新的文献求助30
14秒前
阿俊发布了新的文献求助10
14秒前
16秒前
Richard发布了新的文献求助10
16秒前
FashionBoy应助sanyecai采纳,获得10
19秒前
19秒前
20秒前
科目三应助gujiguji采纳,获得10
20秒前
advance发布了新的文献求助10
22秒前
23秒前
23秒前
小二郎应助科研通管家采纳,获得10
23秒前
在水一方应助科研通管家采纳,获得10
23秒前
丘比特应助科研通管家采纳,获得10
23秒前
朱建军应助科研通管家采纳,获得30
24秒前
李健应助科研通管家采纳,获得10
24秒前
科目三应助anan采纳,获得30
24秒前
所所应助科研通管家采纳,获得10
24秒前
酷波er应助科研通管家采纳,获得10
24秒前
英姑应助科研通管家采纳,获得10
24秒前
慕青应助科研通管家采纳,获得10
24秒前
大个应助科研通管家采纳,获得30
24秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
‘Unruly’ Children: Historical Fieldnotes and Learning Morality in a Taiwan Village (New Departures in Anthropology) 400
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3988920
求助须知:如何正确求助?哪些是违规求助? 3531290
关于积分的说明 11253247
捐赠科研通 3269903
什么是DOI,文献DOI怎么找? 1804830
邀请新用户注册赠送积分活动 882027
科研通“疑难数据库(出版商)”最低求助积分说明 809052