Evidence map›Paper›PMID 31516033›Full record

Trial reportAIDS research and human retroviruses2020

Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials.

Erkki Lathouwers, Eric Y Wong, Kimberley Brown, Bryan Baugh, Anne Ghys, John Jezorwski, El Ghazi Mohsine, Erika Van Landuyt, Magda Opsomer, Sandra De Meyer and 1 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in AIDS research and human retroviruses, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.9field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02269917 phase3completednot on this map

A Phase 3, Randomized, Active-controlled, Open-label Study to Evaluate the Efficacy, Safety and Tolerability of Switching to a Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once-daily Single-tablet Regimen Versus Continuing the Current Regimen Consisting of a Boosted Protease Inhibitor (bPI) Combined With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in Virologically-suppressed, Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects

TypeinterventionalSponsorJanssen R&D IrelandRan2015 to 2020Enrolled1,149ConditionsHuman Immunodeficiency Virus Type 1ArmsD/C/F/TAF, Boosted Protease Inhibitor (bPI), FTC/TDF
NCT02431247 phase3completednot on this map

A Phase 3, Randomized, Active-controlled, Double-blind Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed Dose Combination Regimen Versus a Regimen Consisting of Darunavir/Cobicistat Fixed Dose Combination Coadministered With Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 Infected Subjects

TypeinterventionalSponsorJanssen Sciences Ireland UCRan2015 to 2020Enrolled725ConditionsImmunodeficiency Virus Type 1, HumanArmsDarunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC, DRV/COBI FDC, FTC/TDF FDC, D/C/F/TAF FDC - Matching Placebo, FTC/TDF FDC Matching Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 13 citations in OpenAlex.

  1. Target identification and assessment in the era of AI.Nature reviews. Drug discovery · 2026
    Review
  2. Article
  3. Observational
  4. Simplifying ARV Therapy in the Setting of Resistance.Current infectious disease reports · 2019
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 2 countries.

Erkki LathouwersJanssen Pharmaceutica NV, Beerse, Belgium.
Eric Y WongJanssen Scientific Affairs, LLC, Titusville, New Jersey.
Kimberley BrownJanssen Pharmaceutica NV, Beerse, Belgium.
Bryan BaughJanssen Research & Development LLC, Raritan, New Jersey.
Anne GhysJanssen Pharmaceutica NV, Beerse, Belgium.
John JezorwskiJanssen Research & Development, Pennington, New Jersey.
El Ghazi MohsineJanssen Pharmaceutica NV, Beerse, Belgium.
Erika Van LanduytJanssen Pharmaceutica NV, Beerse, Belgium.
Magda OpsomerJanssen Pharmaceutica NV, Beerse, Belgium.
Sandra De MeyerJanssen Pharmaceutica NV, Beerse, Belgium.
AMBER and EMERALD Study Groups
Janssen (Belgium) · BEJanssen (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is being investigated in two Phase III trials, AMBER (NCT02431247; treatment-naive adults) and EMERALD (NCT02269917; treatment-experienced, virologically suppressed adults). Week 48 AMBER and EMERALD resistance analyses are presented. Postbaseline samples for genotyping/phenotyping were analyzed from protocol-defined virologic failures (PDVFs) with viral load (VL) ≥400 copies/mL at failure/later time points.

Indexed as

Drug Resistance, ViralAdenineAdultAlanineAnti-HIV AgentsCobicistatDarunavirDrug Administration ScheduleDrug CombinationsEmtricitabineHIV-1HIV InfectionsHumansReverse Transcriptase InhibitorsTabletsTenofovirAdenineAlanineAnti-HIV AgentsCobicistatDarunavirDrug CombinationsEmtricitabineReverse Transcriptase InhibitorsTabletsTenofovirtenofovir alafenamidearchived RAMsdarunavir/cobicistat/emtricitabine/TAFdeep sequencingefficacyresistancesingle-tablet regimen

Identifiers

PMID31516033
PMCPMC6944133
OpenAlexW2972707496

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.