Efficacy and safety of lower dose tenofovir disoproxil fumarate and efavirenz versus standard dose in HIV-infected, antiretroviral-naive adults: a multicentre, randomized, noninferiority trial.

Content Provider	Europe PMC
Author	Chen, Jun Chen, Rong Shen, Yinzhong Wei, Hongxia Wang, Xicheng Zhang, Renfang Hu, Zhiliang Xie, Ronghui Huang, Qiong Wang, Jiangrong Liu, Li Qi, Tangkai Wang, Zhenyan Song, Wei Tang, Yang Sun, Jianjun Lu, Hongzhou
Copyright Year	2020
Abstract	Reduced doses of antiretroviral (ARV) drugs may lower toxicity while preserving efficacy. We aimed to evaluate the efficacy of reduced doses of both tenofovir disoproxil fumarate (TDF) and efavirenz for the treatment of HIV-1 infection. In this open-label, non-inferiority trial, HIV-1-infected antiretroviral-naive adults were randomly assigned to receive either a lower dose anti-retroviral regimen comprised of TDF (200 mg), efavirenz (400 mg), and standard dose lamivudine (300 mg) or the standard dose regimen. The primary endpoint was the proportion of participants with HIV-1 RNA≤ 50 copies/mL at week 48 using a non-inferiority margin of –10%. At week 48, 79 of 92 (85.9%) participants in the lower dose regimen group and 78 of 92 (84.8%) in the standard dose regimen group achieved HIV-1 RNA≤ 50 copies/mL (treatment difference 1.1%, 95% CI −9.1 to 11.3) in the intention-to-treat analysis. Drug-related adverse events occurred more frequently in the participants receiving the standard dose regimen compared with the lower dose one (63.0% vs 80.4%). Changes in estimated glomerular filtration rate and bone mineral density were comparable between the two groups. The non-inferior efficacy and better safety profile of the lower dose ARV regimen support its use as alternative initial therapy for HIV-1 infected patients.
Page Count	8
Journal	Emerging Microbes & Infections
Volume Number	9
PubMed Central reference number	PMC7241516
Issue Number	1
PubMed reference number	32267205
e-ISSN	22221751
DOI	10.1080/22221751.2020.1752609
Language	English
Publisher	Taylor & Francis
Publisher Date	2020-12-01
Access Restriction	Open
Rights License	This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. © 2020 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group, on behalf of Shanghai Shangyixun Cultural Communication Co., Ltd
Subject Keyword	HIV tenofovir disoproxil fumarate efavirenz low dose non-inferiority
Content Type	Text
Resource Type	Article
Subject	Immunology Infectious Diseases Virology Drug Discovery Microbiology Epidemiology Parasitology