Evidence map›Paper›PMID 30184165›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2019

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate is Non-inferior to Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-naive Adults With Human Immunodeficiency Virus-1 Infection: Week 48 Results of the DRIVE-AHEAD Trial.

Chloe Orkin, Kathleen E Squires, Jean-Michel Molina, Paul E Sax, Wing-Wai Wong, Otto Sussmann, Richard Kaplan, Lisa Lupinacci, Anthony Rodgers, Xia Xu and 8 more

3 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 80 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed, 3 pooled it
12.0field-weighted citation impact, top 1% 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.

NCT02403674 phase3completednot on this map

A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A Once-Daily Versus ATRIPLA™ Once-Daily in Treatment-Naïve HIV-1 Infected Subjects

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2015 to 2023Enrolled734ConditionsHuman Immunodeficiency Virus (HIV)ArmsDoravirine, Tenofovir, Lamivudine, ATRIPLA™, Placebo
NCT04669678 phase4completednot on this mapstarted 2021, after this paper: background citation

An Observational Pharmacokinetic Study to Evaluate Drug-drug Interactions Between Doravirine-containing ART and Hormonal Contraceptives Among Women Living With HIV in South Africa.

TypeinterventionalSponsorUniversity of Alabama at BirminghamRan2021 to 2024Enrolled110ConditionsHIV Infections, Contraception, Drug-drug InteractionArmsEtonogestrel (ETG) implant, Intramuscular depo-medroxyprogesterone acetate (IM DMPA), Sub-cutaneous medroxyprogesterone acetate (SC MPA), Non-hormonal intrauterine device (IUD)
NCT06602622 phase4recruitingnot on this mapstarted 2024, after this paper: background citation

Change in Body Weight and BMI in PWH Virologically Suppressed Who Maintain a Second-generation INSTI Regimen Compared to Those Who Switch to DOR/3TC/TDF At 48 Weeks

TypeinterventionalSponsorInstituto Mexicano del Seguro SocialRan2024 to 2025Enrolled108ConditionsHIV, HIV Associate Weight Loss, HIV-1 Infection, Integrase Inhibitors, HIVArmsIntegrase inhibitor, Doravirine + tenofovir DF + lamivudine
3 · Its place in the literature

Who cites it

80 citing papers in PubMed, 3 syntheses or guidelines pooled it, 162 citations in OpenAlex.

  1. Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV - CDC Recommendations, United States, 2025.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2025
    Guideline
  2. Pooled it
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20 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 7 institutions in 5 countries.

Chloe OrkinQueen Mary University.
Kathleen E SquiresThomas Jefferson University, Philadelphia, Pennsylvania.
Jean-Michel MolinaUniversity of Paris Diderot, Hôpital Saint-Louis, Assitance Publique Hôpitaux de Paris, France.
Paul E SaxBrigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Wing-Wai WongTaipei Veterans General Hospital, Taiwan.
Otto SussmannAsistencia Cientifica de Alta Complejidad SAS, Bogota, Colombia.
Richard KaplanDesmond Tutu HIV Foundation, Cape Town, South Africa.
Lisa LupinacciMerck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.
Anthony RodgersMerck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.
Xia XuMerck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.
Gina LinMerck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.
Sushma KumarMerck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.
Peter SklarMerck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.
Bach-Yen NguyenMerck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.
George J HannaMerck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.
Carey HwangMerck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.
Elizabeth A MartinMerck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.
DRIVE-AHEAD Study Group
Merck & Co., Inc., Rahway, NJ, USA (United States) · USBrigham and Women's Hospital · USDesmond Tutu HIV Foundation · ZARoyal London Hospital · GBTaipei Veterans General Hospital · TWThomas Jefferson University · USUniversité Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Doravirine (DOR), a novel non-nucleoside reverse-transcriptase inhibitor (NNRTI), is active against wild-type Human Immunodeficiency Virus (HIV)-1 and the most common NNRTI-resistant variants, and has a favorable and unique in vitro resistance profile. Methods: DRIVE-AHEAD is a phase 3, double-blind, non-inferiority trial. Antiretroviral treatment-naive adults with ≥1000 HIV-1 RNA copies/mL were randomized (1:1) to once-daily, fixed-dose DOR at 100 mg, lamivudine at 300 mg, and tenofovir disoproxil fumarate (TDF) at 300 mg (DOR/3TC/TDF) or to efavirenz at 600 mg, emtricitabine at 200 mg, and TDF at 300 mg (EFV/FTC/TDF) for 96 weeks. The primary efficacy endpoint was the proportion of participants with <50 HIV-1 RNA copies/mL at week 48 (Food and Drug Administration snapshot approach; non-inferiority margin 10%). Results: Of the 734 participants randomized, 728 were treated (364 per group) and included in the analyses. At week 48, 84.3% (307/364) of DOR/3TC/TDF recipients and 80.8% (294/364) of EFV/FTC/TDF recipients achieved <50 HIV-1 RNA copies/mL (difference 3.5%, 95% CI, -2.0, 9.0). DOR/3TC/TDF recipients had significantly lower rates of dizziness (8.8% vs 37.1%), sleep disorders/disturbances (12.1% vs 25.2%), and altered sensorium (4.4% vs 8.2%) than EFV/FTC/TDF recipients. Mean changes in fasting low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C) were significantly different between DOR/3TC/TDF and EFV/FTC/TDF (-1.6 vs +8.7 mg/dL and -3.8 vs +13.3 mg/dL, respectively). Conclusions: In HIV-1 treatment-naive adults, DOR/3TC/TDF demonstrated non-inferior efficacy to EFV/FTC/TDF at week 48 and was well tolerated, with significantly fewer neuropsychiatric events and minimal changes in LDL-C and non-HDL-C compared with EFV/FTC/TDF. Clinical Trials Registration: NCT02403674.

Indexed as

AdolescentAdultAgedAged, 80 and overAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveDouble-Blind MethodFemaleHIV-1HIV InfectionsHumansMaleMiddle AgedReverse Transcriptase InhibitorsRNA, ViralTreatment OutcomeAnti-HIV AgentsReverse Transcriptase InhibitorsRNA, Viral

Identifiers

PMID30184165
PMCPMC6355823
OpenAlexW2889157553

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.