文献检索文档翻译深度研究
Suppr Zotero 插件Zotero 插件
邀请有礼套餐&价格历史记录

新学期,新优惠

限时优惠:9月1日-9月22日

30天高级会员仅需29元

1天体验卡首发特惠仅需5.99元

了解详情
不再提醒
插件&应用
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
高级版
套餐订阅购买积分包
AI 工具
文献检索文档翻译深度研究
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2025

在研究 GS-01-934 中,比较恩曲他滨、替诺福韦酯富马酸二吡呋酯和依非韦伦与拉米夫定/齐多夫定和依非韦伦在抗逆转录病毒初治受试者中 144 周的 HIV-1 耐药性发展。

Development of HIV-1 drug resistance through 144 weeks in antiretroviral-naïve subjects on emtricitabine, tenofovir disoproxil fumarate, and efavirenz compared with lamivudine/zidovudine and efavirenz in study GS-01-934.

机构信息

Gilead Sciences, Inc., Foster City, California 94404, USA.

出版信息

J Acquir Immune Defic Syndr. 2009 Oct 1;52(2):209-21. doi: 10.1097/QAI.0b013e3181b05f7c.


DOI:10.1097/QAI.0b013e3181b05f7c
PMID:19644384
Abstract

Study 934 was an open-label, randomized Phase III study of emtricitabine + tenofovir DF + efavirenz (FTC + TDF + EFV) compared with lamivudine + zidovudine + efavirenz (3TC + ZDV + EFV) in antiretroviral therapy-naïve HIV-1 infected subjects. Baseline genotyping revealed the presence of primary nonnucleoside reverse transcriptase inhibitor resistance (NNRTI-R) in 22 of 509 enrolled patients (4.3%, 11 subjects in each group). The 487 subjects without baseline NNRTI-R formed the primary efficacy population (modified intent-to-treat population). Through 144 weeks, 50 of 487 modified intent-to-treat subjects (FTC + TDF + EFV, n = 19; 3TC + ZDV + EFV, n = 31) were analyzed for resistance development after virologic failure. NNRTI-R, primarily the K103N mutation, was the most common form of resistance that developed in both groups. No subject on FTC + TDF + EFV developed the K65R mutation. Significantly fewer subjects on FTC + TDF + EFV compared with 3TC + ZDV + EFV developed the M184V/I mutation (two versus 10, respectively, P = 0.021). Thymidine analog mutations developed in two subjects on 3TC + ZDV + EFV. Subjects with baseline NRTI genotypic resistance (TAMs, n = 13) or non-B HIV-1 subtypes (n = 28) showed no evidence of reduced treatment responses in either group. Nine of 22 patients with baseline NNRTI-R experienced virologic failure (FTC + TDF + EFV, n = 4; 3TC + ZDV + EFV, n = 5); seven of nine developed M184V/I and/or additional NNRTI-R, but none developed K65R. Baseline NNRTI-R was significantly associated with virologic failure in both groups (P < 0.001).

摘要

研究 934 是一项开放性、随机的 III 期研究,比较了恩曲他滨+替诺福韦酯+依法韦仑(FTC+TDF+EFV)与拉米夫定+齐多夫定+依法韦仑(3TC+ZDV+EFV)在初治 HIV-1 感染患者中的疗效。基线基因分型显示,509 名入组患者中有 22 名(4.3%,每组各 11 名)存在原发性非核苷类逆转录酶抑制剂耐药(NNRTI-R)。487 名无基线 NNRTI-R 的患者构成主要疗效人群(修改后的意向治疗人群)。在 144 周时,对 487 名修改后的意向治疗患者(FTC+TDF+EFV,n=19;3TC+ZDV+EFV,n=31)中的 50 名患者进行了病毒学失败后的耐药性发展分析。NNRTI-R,主要是 K103N 突变,是两组中最常见的耐药形式。FTC+TDF+EFV 组无 K65R 突变。与 3TC+ZDV+EFV 组相比,FTC+TDF+EFV 组中 M184V/I 突变的发生率明显较低(分别为 2 例和 10 例,P=0.021)。3TC+ZDV+EFV 组中有 2 例患者出现胸苷类似物突变。基线核苷类逆转录酶抑制剂基因型耐药(TAMs,n=13)或非 B 型 HIV-1 亚型(n=28)的患者在两组中均无治疗反应降低的证据。基线 NNRTI-R 的 22 名患者中有 9 名发生病毒学失败(FTC+TDF+EFV,n=4;3TC+ZDV+EFV,n=5);其中 7 名患者出现 M184V/I 和/或其他 NNRTI-R,但均未出现 K65R。两组中基线 NNRTI-R 均与病毒学失败显著相关(P<0.001)。

相似文献

[1]
Development of HIV-1 drug resistance through 144 weeks in antiretroviral-naïve subjects on emtricitabine, tenofovir disoproxil fumarate, and efavirenz compared with lamivudine/zidovudine and efavirenz in study GS-01-934.

J Acquir Immune Defic Syndr. 2009-10-1

[2]
Tenofovir disoproxil fumarate, emtricitabine, and efavirenz versus fixed-dose zidovudine/lamivudine and efavirenz in antiretroviral-naive patients: virologic, immunologic, and morphologic changes--a 96-week analysis.

J Acquir Immune Defic Syndr. 2006-12-15

[3]
The emergence of drug resistant HIV variants at virological failure of HAART combinations containing efavirenz, tenofovir and lamivudine or emtricitabine within the UK Collaborative HIV Cohort.

J Infect. 2013-9-20

[4]
Tenofovir disoproxil fumarate, emtricitabine, and efavirenz compared with zidovudine/lamivudine and efavirenz in treatment-naive patients: 144-week analysis.

J Acquir Immune Defic Syndr. 2008-1-1

[5]
Drug-resistance development differs between HIV-1-infected patients failing first-line antiretroviral therapy containing nonnucleoside reverse transcriptase inhibitors with and without thymidine analogues.

HIV Med. 2013-10

[6]
96-week resistance analyses of the STaR study: rilpivirine/emtricitabine/tenofovir DF versus efavirenz/emtricitabine/tenofovir DF in antiretroviral-naive, HIV-1-infected subjects.

HIV Clin Trials. 2015

[7]
Characterization of HIV-1 drug resistance development through week 48 in antiretroviral naive subjects on rilpivirine/emtricitabine/tenofovir DF or efavirenz/emtricitabine/tenofovir DF in the STaR study (GS-US-264-0110).

J Acquir Immune Defic Syndr. 2014-3-1

[8]
Simplification of antiretroviral therapy to a single-tablet regimen consisting of efavirenz, emtricitabine, and tenofovir disoproxil fumarate versus unmodified antiretroviral therapy in virologically suppressed HIV-1-infected patients.

J Acquir Immune Defic Syndr. 2009-6-1

[9]
Resistance profiles of emtricitabine and lamivudine in tenofovir-containing regimens.

J Antimicrob Chemother. 2012-2-26

[10]
Different evolution of genotypic resistance profiles to emtricitabine versus lamivudine in tenofovir-containing regimens.

J Acquir Immune Defic Syndr. 2010-11

引用本文的文献

[1]
HIV-1 Transcription Inhibition Using Small RNA-Binding Molecules.

Pharmaceuticals (Basel). 2023-12-25

[2]
The Potential of to Ameliorate the Adverse Effects of Highly Active Antiretroviral Therapy (HAART).

Nutrients. 2022-7-27

[3]
Identification of Modulators of HIV-1 Proviral Transcription from a Library of FDA-Approved Pharmaceuticals.

Viruses. 2020-9-23

[4]
Epidemiologic and viral predictors of antiretroviral drug resistance among persons living with HIV in a large treatment program in Nigeria.

AIDS Res Ther. 2020-2-17

[5]
Emergence of resistance mutations in simian immunodeficiency virus (SIV)-infected rhesus macaques receiving non-suppressive antiretroviral therapy (ART).

PLoS One. 2018-2-21

[6]
Zidovudine/Lamivudine vs. Abacavir/Lamivudine vs. Tenofovir/Emtricitabine in fixed-dose combinations as initial treatment for HIV patients: a systematic review and network meta-analysis.

Colomb Med (Cali). 2017-6-30

[7]
Clinical Outcomes of Tenofovir Zidovudine-based Regimens Among People Living with HIV/AIDS: a Two Years Retrospective Cohort Study.

Open AIDS J. 2017-1-23

[8]
How Much Do We Know about Drug Resistance Due to PrEP Use? Analysis of Experts' Opinion and Its Influence on the Projected Public Health Impact.

PLoS One. 2016-7-8

[9]
Global epidemiology of drug resistance after failure of WHO recommended first-line regimens for adult HIV-1 infection: a multicentre retrospective cohort study.

Lancet Infect Dis. 2016-5

[10]
Prevalence of Primary HIV Drug Resistance in Thailand Detected by Short Reverse Transcriptase Genotypic Resistance Assay.

PLoS One. 2016-2-1

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

推荐工具

医学文档翻译智能文献检索