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Week 96 resistance analyses of the once-daily, single-tablet regimen (STR) darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in adults living with HIV-1 from the phase 3 randomized AMBER and EMERALD trials.

Author: BaughBryan, De MeyerSandra, GhysAnne, JezorwskiJohn, LathouwersErkki, MohsineEl Ghazi, Van LanduytErika, WeinsteigerShirley

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

This study examined the resistance profiles of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in two clinical trials (AMBER and EMERALD) after 96 weeks of treatment. The results indicate that D/C/F/TAF has a high barrier to resistance, with few emerging mutations. Even with pre-existing resistance mutations, D/C/F/TAF demonstrated sustained virologic suppression.
Paper Details　
Original Abstract of the Article :
In AMBER and EMERALD, darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg demonstrated high virological response and low virological failure (VF) through week 96. Week 96 resistance analyses are presented. Post-baseline samples for genotyping/phenotyping were analy...See full text at original site
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引用元：
https://doi.org/10.1002/jmv.26721

データ提供：米国国立医学図書館（NLM）

A Robust Resistance Barrier for a Once-Daily, Single-Tablet Regimen

The desert of HIV treatment is vast, with ongoing research aimed at developing more effective and convenient regimens. This study investigates the resistance profile of a once-daily, single-tablet regimen (STR) containing darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) for HIV-1 infection. The research analyzes resistance patterns observed in two phase 3 clinical trials (AMBER and EMERALD), assessing the regimen's ability to maintain virological suppression and prevent the emergence of drug resistance.

Navigating the Desert of HIV Treatment

The study's findings demonstrate that D/C/F/TAF exhibits a high barrier to resistance, with no emergence of darunavir, primary protease inhibitor (PI), or tenofovir resistance-associated-mutations (RAMs) observed over 96 weeks. These results highlight the regimen's ability to maintain virological suppression and minimize the risk of developing drug resistance.

Embracing Convenience and Efficacy

This research underscores the significant advantages of D/C/F/TAF as a convenient and effective treatment option for HIV-1 infection. Its robust resistance profile and once-daily, single-tablet formulation offer a valuable oasis in the desert of HIV treatment, empowering individuals to manage their condition effectively and improve their quality of life.

Dr.Camel's Conclusion

The desert of HIV treatment is a demanding landscape, requiring effective and convenient solutions. This study reveals D/C/F/TAF as a promising oasis, offering a robust resistance profile and a simplified regimen. This innovative approach brings hope and empowerment to individuals living with HIV, offering a path to better health and well-being. Like a camel navigating the desert, we must continue to seek advancements in HIV treatment, creating a more hospitable landscape for those living with this complex condition.

Date :
  1. Date Completed 2021-10-08
  2. Date Revised 2023-10-11
Further Info :

Pubmed ID

33300183

DOI: Digital Object Identifier

10.1002/jmv.26721

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Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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