Evidence map›Paper›PMID 31879782›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2020

Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in a Rapid-Initiation Model of Care for Human Immunodeficiency Virus Type 1 Infection: Primary Analysis of the DIAMOND Study.

Gregory D Huhn, Gordon Crofoot, Moti Ramgopal, Joseph Gathe, Robert Bolan, Donghan Luo, Richard Bruce Simonson, Richard E Nettles, Carmela Benson, Keith Dunn

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03227861 (A Phase 3, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
2.9field-weighted citation impact, top 8% 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.

NCT03227861 phase3completednot on this map

A Phase 3, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed-dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects Receiving Care in a Test and Treat Model of Care

TypeinterventionalSponsorJanssen Scientific Affairs, LLCRan2017 to 2019Enrolled109ConditionsHIV-1ArmsDRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 42 citations in OpenAlex.

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  15. Redefining therapeutic success in HIV patients: an expert view.The Journal of antimicrobial chemotherapy · 2021
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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

10 authors at 5 institutions in 1 country.

Gregory D HuhnRuth M. Rothstein CORE Center, Chicago, Illinois, USA.
Gordon CrofootCrofoot Research Center, Houston, Texas, USA.
Moti RamgopalMidway Immunology and Research Center, Fort Pierce, Florida, USA.
Joseph GatheTherapeutic Concepts, Houston, Texas, USA.
Robert BolanLos Angeles LGBT Center, Los Angeles, California, USA.
Donghan LuoJanssen Research & Development, LLC, Titusville, New Jersey, USA.
Richard Bruce SimonsonJanssen Scientific Affairs, LLC, Titusville, New Jersey, USA.
Richard E NettlesJanssen Scientific Affairs, LLC, Titusville, New Jersey, USA.
Carmela BensonJanssen Scientific Affairs, LLC, Titusville, New Jersey, USA.
Keith DunnJanssen Scientific Affairs, LLC, Titusville, New Jersey, USA.
Janssen (United States) · USJanssen Scientific Affairs (United States)Los Angeles LGBT Center · USMidway College · USRuth M. Rothstein CORE Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMost guidelines recommend rapid treatment initiation for patients with newly diagnosed human immunodeficiency virus type 1 (HIV-1) infection, but prospective US data are limited. The DIAMOND (NCT03227861) study using darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is a phase 3 prospective study evaluating efficacy/safety of a single-tablet regimen in a rapid-initiation model of care.

methodsAdults aged ≥18 years began D/C/F/TAF ≤14 days from diagnosis without screening/baseline results; as results became available, participants not meeting predefined safety/resistance stopping rules continued. Primary endpoint was virologic response (HIV-1 RNA <50 copies/mL; intent-to-treat; US Food and Drug Administration [FDA] snapshot) at week 48; participant satisfaction was measured via the HIV Treatment Satisfaction Questionnaire status version (HIVTSQs).

resultsOf 109 participants, 87% were male, 32% black/African American, median (range) age was 28 (range, 19-66) years, 25% of participants had HIV-1 RNA ≥100 000 copies/mL, 21% had CD4+ cell count <200 cells/µL, and 31% enrolled ≤48 hours from diagnosis. At week 48, 97 (89%) participants completed the study and 92 (84%) achieved HIV-1 RNA <50 copies/mL (FDA snapshot). There were no protocol-defined virologic failures; incidences of adverse events (AEs) and adverse drug reactions (33%) were low, no serious AEs were study drug related, and 1 (<1%) participant discontinued due to study drug related AE(s). The overall HIVTSQs score at week 48 was 58 (maximum: 60).

conclusionsAt week 48, a high proportion of participants starting D/C/F/TAF achieved HIV-1 RNA <50 copies/mL and very few discontinued therapy. D/C/F/TAF was well tolerated, no participants discontinued due to baseline resistance stopping criteria, and high treatment satisfaction among participants was recorded. CLINICAL TRIALS REGISTRATION: NCT03227861.

Indexed as

Anti-HIV AgentsHIV-1HIV InfectionsAdenineAdolescentAdultAgedAlanineCobicistatDarunavirDiamondDrug CombinationsEmtricitabineFemaleHumansMaleAdenineAlanineAnti-HIV AgentsCobicistatDarunavirDiamondDrug CombinationsEmtricitabineTenofovirtenofovir alafenamidedarunavirD/C/F/TAFHIV-1rapid initiationsingle-tablet regimen

Identifiers

PMID31879782
PMCPMC7819515
OpenAlexW2996920874

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.