Evidence map›Paper›PMID 30985556›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2019

Switching to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) Maintains HIV-1 Virologic Suppression Through 48 Weeks: Results of the DRIVE-SHIFT Trial.

Margaret Johnson, Princy Kumar, Jean-Michel Molina, Giuliano Rizzardini, Pedro Cahn, Markus Bickel, Josep Mallolas, Yan Zhou, Cristiana Morais, Sushma Kumar and 5 more

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

Trial report in Journal of acquired immune deficiency syndromes (1999), 2019. 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 47 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 1 pooled it
6.6field-weighted citation impact, top 2% 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.

NCT02397096 phase3completednot on this map

A Phase III Multicenter, Open-Label, Randomized Study to Evaluate a Switch to MK-1439A in HIV-1-Infected Subjects Virologically Suppressed on a Regimen of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2015 to 2023Enrolled673ConditionsHIV-1 InfectionArmsDoravirine, Tenofovir, Lamivudine, Baseline regimen of ritonavir- or cobicistat-boosted protease inhibitor, Baseline regimen of cobicistat-boosted elvitegravir, Baseline regimen of a non-nucleoside reverse transcriptase inhibitor, Baseline regimen of two nucleoside reverse transcriptase inhibitors
NCT04665375 phase4terminatednot on this mapstarted 2021, after this paper: background citation

Can the Weight Gain Associated With Use of Integrase Strand Inhibitors be Halted or Reversed With a Switch to Doravirine/Lamivudine/Tenofovir DF in Patients Living With HIV? (DeLiTE)

TypeinterventionalSponsorUniversity Health Network, TorontoRan2021 to 2024Enrolled4ConditionsHiv, Weight GainArmsDOR/3TC/TDF
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 1 synthesis or guideline pooled it, 92 citations in OpenAlex.

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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

15 authors at 7 institutions in 7 countries.

Margaret JohnsonDepartment of HIV Medicine, Royal Free Hospital, London, United Kingdom.
Princy KumarDivision of Infectious Diseases and Travel Medicine, Medstar Georgetown University Hospital, Washington, DC.
Jean-Michel MolinaUniversity of Paris Diderot, Hôpital Saint-Louis, Paris, France.
Giuliano RizzardiniDepartment of Infectious Diseases, ASST Fatebenefratelli Sacco Hospital, Milan, Italy.
Pedro CahnFundación Huésped and Buenos Aires University, Buenos Aires, Argentina.
Markus BickelInfektiologikum, Center for Infectious Diseases, Frankfurt, Germany.
Josep MallolasHIV Unit, Infectious Diseases Service, Hospital Clinic, Barcelona, Spain.
Yan ZhouMerck & Co., Inc., Kenilworth, NJ.
Cristiana MoraisMerck & Co., Inc., Kenilworth, NJ.
Sushma KumarMerck & Co., Inc., Kenilworth, NJ.
Peter SklarMerck & Co., Inc., Kenilworth, NJ.
George J HannaMerck & Co., Inc., Kenilworth, NJ.
Carey HwangMerck & Co., Inc., Kenilworth, NJ.
Wayne GreavesMerck & Co., Inc., Kenilworth, NJ.
DRIVE-SHIFT Study Group
Merck & Co., Inc., Rahway, NJ, USA (United States) · USFundación Huésped · ARHôpital Saint-Louis · FRHospital Clínic de Barcelona · ESMedStar Georgetown University Hospital · USThe Royal Free Hospital · GBUniversity of the Witwatersrand · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDoravirine is a novel, nonnucleoside reverse transcriptase inhibitor with demonstrated efficacy in treatment-naive adults with HIV-1.

methodsIn this open-label, active-controlled, noninferiority trial, adults with HIV-1 virologically suppressed for ≥6 months on 2 nucleoside reverse transcriptase inhibitors plus a boosted protease inhibitor, boosted elvitegravir, or a non-nucleoside reverse transcriptase inhibitor were randomized (2:1) to switch to once-daily, single-tablet doravirine 100 mg with lamivudine 300 mg and tenofovir disoproxil fumarate 300 mg (DOR/3TC/TDF) or to continue their current therapy (Baseline Regimen) for 24 weeks. The primary endpoint was the proportion of participants with HIV-1 RNA <50 copies/mL (defined by the FDA Snapshot approach), with the primary comparison between DOR/3TC/TDF at week 48 and Baseline Regimen at week 24 and a secondary comparison between the groups at week 24 (noninferiority margin, -8%).

resultsSix hundred seventy participants (447 DOR/3TC/TDF, 223 Baseline Regimen) were treated and included in the analyses. At week 24, 93.7% on DOR/3TC/TDF vs 94.6% on Baseline Regimen had HIV-1 RNA <50 copies/mL [difference -0.9 (-4.7 to 3.0)]. At week 48, 90.8% on DOR/3TC/TDF had HIV-1 RNA <50 copies/mL, demonstrating noninferiority vs Baseline Regimen at week 24 [difference -3.8 (-7.9 to 0.3)]. In participants on ritonavir-boosted protease inhibitor at entry, mean reductions in fasting LDL-C and non-HDL-C at week 24 were significantly greater for DOR/3TC/TDF vs Baseline Regimen (P < 0.0001). Adverse events occurred in 68.9% on DOR/3TC/TDF and 52.5% on Baseline Regimen by week 24, leading to treatment discontinuation in 2.5% and 0.4%, respectively.

conclusionsSwitching to once-daily DOR/3TC/TDF is a generally well-tolerated option for maintaining viral suppression in patients considering a change in therapy. REGISTRATION: ClinicalTrials.gov NCT02397096.

Indexed as

AdultAgedAnti-Retroviral AgentsEquivalence Trials as TopicFemaleHIV-1HumansLamivudineMaleMiddle AgedProtease InhibitorsPyridonesQuinolonesRitonavirTenofovirTreatment OutcomeAnti-Retroviral AgentsdoravirineelvitegravirLamivudineProtease InhibitorsPyridonesQuinolonesRitonavirTenofovirTriazoles

Identifiers

PMID30985556
PMCPMC6905402
OpenAlexW2938502016

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.