Evidence map›Paper›PMID 35544387›Full record

Trial reportThe New England journal of medicine2022

Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection.

Sorana Segal-Maurer, Edwin DeJesus, Hans-Jurgen Stellbrink, Antonella Castagna, Gary J Richmond, Gary I Sinclair, Krittaecho Siripassorn, Peter J Ruane, Mezgebe Berhe, Hui Wang and 8 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04150068 (A Phase 2/3 Study to Evaluate the Safety and Efficacy of Long-Acting Capsid Inhibitor GS-6207 in Combination With an Optimized Background Regimen in Heavily Treatment Experienced People Living With HIV-1 Infection With Multidrug Resistance), which is not on this map. Cited by 168 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
168citing papers in PubMed, 1 pooled it
25.7field-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.

NCT04150068 phase2 / phase3active not recruitingnot on this map

A Phase 2/3 Study to Evaluate the Safety and Efficacy of Long-Acting Capsid Inhibitor GS-6207 in Combination With an Optimized Background Regimen in Heavily Treatment Experienced People Living With HIV-1 Infection With Multidrug Resistance

TypeinterventionalSponsorGilead SciencesRan2019 to 2027Enrolled72ConditionsHIV-1-infectionArmsOral Lenacapavir, Oral Lenacapavir Placebo, Subcutaneous Lenacapavir, Failing ARV Regimen, Optimized Background Regimen (OBR)
3 · Its place in the literature

Who cites it

168 citing papers in PubMed, 1 synthesis or guideline pooled it, 280 citations in OpenAlex.

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  10. Mechanisms of HIV-1 assembly, release and maturation.Nature reviews. Microbiology · 2026
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108 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 11 institutions in 6 countries.

Sorana Segal-MaurerFrom NewYork-Presbyterian Queens, Flushing, NY (S.S.-M.); Orlando Immunology Center, Orlando (E.D.), and Fort Lauderdale (G.J.R.) - both in Florida; Infektionsmedizinisches Centrum Hamburg, Hamburg, Germany (H.-J.S.); Vita-Salute University, San Raffaele Scientific Institute, Milan (A.C.); Prism Health North Texas (G.I.S.) and North Texas Infectious Diseases Consultants (M.B.) - both in Dallas; Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand (K.S.); Ruane Clinical Research Group, Los Angeles (P.J.R.), and Gilead Sciences, Foster City (H.W., N.A.M., H.D.-S., R.H.H., D.M.B., M.S.R., J.M.B.) - both in California; the University of Paris and the Department of Infectious Diseases, St. Louis-Lariboisière Hospitals, Assistance Publique-Hôpitaux de Paris, Paris (J.-M.M.); and AlloVir, Cambridge, MA (D.M.B.).
Edwin DeJesusFrom NewYork-Presbyterian Queens, Flushing, NY (S.S.-M.); Orlando Immunology Center, Orlando (E.D.), and Fort Lauderdale (G.J.R.) - both in Florida; Infektionsmedizinisches Centrum Hamburg, Hamburg, Germany (H.-J.S.); Vita-Salute University, San Raffaele Scientific Institute, Milan (A.C.); Prism Health North Texas (G.I.S.) and North Texas Infectious Diseases Consultants (M.B.) - both in Dallas; Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand (K.S.); Ruane Clinical Research Group, Los Angeles (P.J.R.), and Gilead Sciences, Foster City (H.W., N.A.M., H.D.-S., R.H.H., D.M.B., M.S.R., J.M.B.) - both in California; the University of Paris and the Department of Infectious Diseases, St. Louis-Lariboisière Hospitals, Assistance Publique-Hôpitaux de Paris, Paris (J.-M.M.); and AlloVir, Cambridge, MA (D.M.B.).
Hans-Jurgen StellbrinkFrom NewYork-Presbyterian Queens, Flushing, NY (S.S.-M.); Orlando Immunology Center, Orlando (E.D.), and Fort Lauderdale (G.J.R.) - both in Florida; Infektionsmedizinisches Centrum Hamburg, Hamburg, Germany (H.-J.S.); Vita-Salute University, San Raffaele Scientific Institute, Milan (A.C.); Prism Health North Texas (G.I.S.) and North Texas Infectious Diseases Consultants (M.B.) - both in Dallas; Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand (K.S.); Ruane Clinical Research Group, Los Angeles (P.J.R.), and Gilead Sciences, Foster City (H.W., N.A.M., H.D.-S., R.H.H., D.M.B., M.S.R., J.M.B.) - both in California; the University of Paris and the Department of Infectious Diseases, St. Louis-Lariboisière Hospitals, Assistance Publique-Hôpitaux de Paris, Paris (J.-M.M.); and AlloVir, Cambridge, MA (D.M.B.).
Antonella CastagnaFrom NewYork-Presbyterian Queens, Flushing, NY (S.S.-M.); Orlando Immunology Center, Orlando (E.D.), and Fort Lauderdale (G.J.R.) - both in Florida; Infektionsmedizinisches Centrum Hamburg, Hamburg, Germany (H.-J.S.); Vita-Salute University, San Raffaele Scientific Institute, Milan (A.C.); Prism Health North Texas (G.I.S.) and North Texas Infectious Diseases Consultants (M.B.) - both in Dallas; Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand (K.S.); Ruane Clinical Research Group, Los Angeles (P.J.R.), and Gilead Sciences, Foster City (H.W., N.A.M., H.D.-S., R.H.H., D.M.B., M.S.R., J.M.B.) - both in California; the University of Paris and the Department of Infectious Diseases, St. Louis-Lariboisière Hospitals, Assistance Publique-Hôpitaux de Paris, Paris (J.-M.M.); and AlloVir, Cambridge, MA (D.M.B.).
Gary J RichmondFrom NewYork-Presbyterian Queens, Flushing, NY (S.S.-M.); Orlando Immunology Center, Orlando (E.D.), and Fort Lauderdale (G.J.R.) - both in Florida; Infektionsmedizinisches Centrum Hamburg, Hamburg, Germany (H.-J.S.); Vita-Salute University, San Raffaele Scientific Institute, Milan (A.C.); Prism Health North Texas (G.I.S.) and North Texas Infectious Diseases Consultants (M.B.) - both in Dallas; Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand (K.S.); Ruane Clinical Research Group, Los Angeles (P.J.R.), and Gilead Sciences, Foster City (H.W., N.A.M., H.D.-S., R.H.H., D.M.B., M.S.R., J.M.B.) - both in California; the University of Paris and the Department of Infectious Diseases, St. Louis-Lariboisière Hospitals, Assistance Publique-Hôpitaux de Paris, Paris (J.-M.M.); and AlloVir, Cambridge, MA (D.M.B.).
Gary I SinclairFrom NewYork-Presbyterian Queens, Flushing, NY (S.S.-M.); Orlando Immunology Center, Orlando (E.D.), and Fort Lauderdale (G.J.R.) - both in Florida; Infektionsmedizinisches Centrum Hamburg, Hamburg, Germany (H.-J.S.); Vita-Salute University, San Raffaele Scientific Institute, Milan (A.C.); Prism Health North Texas (G.I.S.) and North Texas Infectious Diseases Consultants (M.B.) - both in Dallas; Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand (K.S.); Ruane Clinical Research Group, Los Angeles (P.J.R.), and Gilead Sciences, Foster City (H.W., N.A.M., H.D.-S., R.H.H., D.M.B., M.S.R., J.M.B.) - both in California; the University of Paris and the Department of Infectious Diseases, St. Louis-Lariboisière Hospitals, Assistance Publique-Hôpitaux de Paris, Paris (J.-M.M.); and AlloVir, Cambridge, MA (D.M.B.).
Krittaecho SiripassornFrom NewYork-Presbyterian Queens, Flushing, NY (S.S.-M.); Orlando Immunology Center, Orlando (E.D.), and Fort Lauderdale (G.J.R.) - both in Florida; Infektionsmedizinisches Centrum Hamburg, Hamburg, Germany (H.-J.S.); Vita-Salute University, San Raffaele Scientific Institute, Milan (A.C.); Prism Health North Texas (G.I.S.) and North Texas Infectious Diseases Consultants (M.B.) - both in Dallas; Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand (K.S.); Ruane Clinical Research Group, Los Angeles (P.J.R.), and Gilead Sciences, Foster City (H.W., N.A.M., H.D.-S., R.H.H., D.M.B., M.S.R., J.M.B.) - both in California; the University of Paris and the Department of Infectious Diseases, St. Louis-Lariboisière Hospitals, Assistance Publique-Hôpitaux de Paris, Paris (J.-M.M.); and AlloVir, Cambridge, MA (D.M.B.).
Peter J RuaneFrom NewYork-Presbyterian Queens, Flushing, NY (S.S.-M.); Orlando Immunology Center, Orlando (E.D.), and Fort Lauderdale (G.J.R.) - both in Florida; Infektionsmedizinisches Centrum Hamburg, Hamburg, Germany (H.-J.S.); Vita-Salute University, San Raffaele Scientific Institute, Milan (A.C.); Prism Health North Texas (G.I.S.) and North Texas Infectious Diseases Consultants (M.B.) - both in Dallas; Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand (K.S.); Ruane Clinical Research Group, Los Angeles (P.J.R.), and Gilead Sciences, Foster City (H.W., N.A.M., H.D.-S., R.H.H., D.M.B., M.S.R., J.M.B.) - both in California; the University of Paris and the Department of Infectious Diseases, St. Louis-Lariboisière Hospitals, Assistance Publique-Hôpitaux de Paris, Paris (J.-M.M.); and AlloVir, Cambridge, MA (D.M.B.).
Mezgebe BerheFrom NewYork-Presbyterian Queens, Flushing, NY (S.S.-M.); Orlando Immunology Center, Orlando (E.D.), and Fort Lauderdale (G.J.R.) - both in Florida; Infektionsmedizinisches Centrum Hamburg, Hamburg, Germany (H.-J.S.); Vita-Salute University, San Raffaele Scientific Institute, Milan (A.C.); Prism Health North Texas (G.I.S.) and North Texas Infectious Diseases Consultants (M.B.) - both in Dallas; Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand (K.S.); Ruane Clinical Research Group, Los Angeles (P.J.R.), and Gilead Sciences, Foster City (H.W., N.A.M., H.D.-S., R.H.H., D.M.B., M.S.R., J.M.B.) - both in California; the University of Paris and the Department of Infectious Diseases, St. Louis-Lariboisière Hospitals, Assistance Publique-Hôpitaux de Paris, Paris (J.-M.M.); and AlloVir, Cambridge, MA (D.M.B.).
Hui WangFrom NewYork-Presbyterian Queens, Flushing, NY (S.S.-M.); Orlando Immunology Center, Orlando (E.D.), and Fort Lauderdale (G.J.R.) - both in Florida; Infektionsmedizinisches Centrum Hamburg, Hamburg, Germany (H.-J.S.); Vita-Salute University, San Raffaele Scientific Institute, Milan (A.C.); Prism Health North Texas (G.I.S.) and North Texas Infectious Diseases Consultants (M.B.) - both in Dallas; Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand (K.S.); Ruane Clinical Research Group, Los Angeles (P.J.R.), and Gilead Sciences, Foster City (H.W., N.A.M., H.D.-S., R.H.H., D.M.B., M.S.R., J.M.B.) - both in California; the University of Paris and the Department of Infectious Diseases, St. Louis-Lariboisière Hospitals, Assistance Publique-Hôpitaux de Paris, Paris (J.-M.M.); and AlloVir, Cambridge, MA (D.M.B.).
Nicolas A MargotFrom NewYork-Presbyterian Queens, Flushing, NY (S.S.-M.); Orlando Immunology Center, Orlando (E.D.), and Fort Lauderdale (G.J.R.) - both in Florida; Infektionsmedizinisches Centrum Hamburg, Hamburg, Germany (H.-J.S.); Vita-Salute University, San Raffaele Scientific Institute, Milan (A.C.); Prism Health North Texas (G.I.S.) and North Texas Infectious Diseases Consultants (M.B.) - both in Dallas; Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand (K.S.); Ruane Clinical Research Group, Los Angeles (P.J.R.), and Gilead Sciences, Foster City (H.W., N.A.M., H.D.-S., R.H.H., D.M.B., M.S.R., J.M.B.) - both in California; the University of Paris and the Department of Infectious Diseases, St. Louis-Lariboisière Hospitals, Assistance Publique-Hôpitaux de Paris, Paris (J.-M.M.); and AlloVir, Cambridge, MA (D.M.B.).
Hadas Dvory-SobolFrom NewYork-Presbyterian Queens, Flushing, NY (S.S.-M.); Orlando Immunology Center, Orlando (E.D.), and Fort Lauderdale (G.J.R.) - both in Florida; Infektionsmedizinisches Centrum Hamburg, Hamburg, Germany (H.-J.S.); Vita-Salute University, San Raffaele Scientific Institute, Milan (A.C.); Prism Health North Texas (G.I.S.) and North Texas Infectious Diseases Consultants (M.B.) - both in Dallas; Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand (K.S.); Ruane Clinical Research Group, Los Angeles (P.J.R.), and Gilead Sciences, Foster City (H.W., N.A.M., H.D.-S., R.H.H., D.M.B., M.S.R., J.M.B.) - both in California; the University of Paris and the Department of Infectious Diseases, St. Louis-Lariboisière Hospitals, Assistance Publique-Hôpitaux de Paris, Paris (J.-M.M.); and AlloVir, Cambridge, MA (D.M.B.).
Robert H HylandFrom NewYork-Presbyterian Queens, Flushing, NY (S.S.-M.); Orlando Immunology Center, Orlando (E.D.), and Fort Lauderdale (G.J.R.) - both in Florida; Infektionsmedizinisches Centrum Hamburg, Hamburg, Germany (H.-J.S.); Vita-Salute University, San Raffaele Scientific Institute, Milan (A.C.); Prism Health North Texas (G.I.S.) and North Texas Infectious Diseases Consultants (M.B.) - both in Dallas; Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand (K.S.); Ruane Clinical Research Group, Los Angeles (P.J.R.), and Gilead Sciences, Foster City (H.W., N.A.M., H.D.-S., R.H.H., D.M.B., M.S.R., J.M.B.) - both in California; the University of Paris and the Department of Infectious Diseases, St. Louis-Lariboisière Hospitals, Assistance Publique-Hôpitaux de Paris, Paris (J.-M.M.); and AlloVir, Cambridge, MA (D.M.B.).
Diana M BrainardFrom NewYork-Presbyterian Queens, Flushing, NY (S.S.-M.); Orlando Immunology Center, Orlando (E.D.), and Fort Lauderdale (G.J.R.) - both in Florida; Infektionsmedizinisches Centrum Hamburg, Hamburg, Germany (H.-J.S.); Vita-Salute University, San Raffaele Scientific Institute, Milan (A.C.); Prism Health North Texas (G.I.S.) and North Texas Infectious Diseases Consultants (M.B.) - both in Dallas; Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand (K.S.); Ruane Clinical Research Group, Los Angeles (P.J.R.), and Gilead Sciences, Foster City (H.W., N.A.M., H.D.-S., R.H.H., D.M.B., M.S.R., J.M.B.) - both in California; the University of Paris and the Department of Infectious Diseases, St. Louis-Lariboisière Hospitals, Assistance Publique-Hôpitaux de Paris, Paris (J.-M.M.); and AlloVir, Cambridge, MA (D.M.B.).
Martin S RheeFrom NewYork-Presbyterian Queens, Flushing, NY (S.S.-M.); Orlando Immunology Center, Orlando (E.D.), and Fort Lauderdale (G.J.R.) - both in Florida; Infektionsmedizinisches Centrum Hamburg, Hamburg, Germany (H.-J.S.); Vita-Salute University, San Raffaele Scientific Institute, Milan (A.C.); Prism Health North Texas (G.I.S.) and North Texas Infectious Diseases Consultants (M.B.) - both in Dallas; Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand (K.S.); Ruane Clinical Research Group, Los Angeles (P.J.R.), and Gilead Sciences, Foster City (H.W., N.A.M., H.D.-S., R.H.H., D.M.B., M.S.R., J.M.B.) - both in California; the University of Paris and the Department of Infectious Diseases, St. Louis-Lariboisière Hospitals, Assistance Publique-Hôpitaux de Paris, Paris (J.-M.M.); and AlloVir, Cambridge, MA (D.M.B.).
Jared M BaetenFrom NewYork-Presbyterian Queens, Flushing, NY (S.S.-M.); Orlando Immunology Center, Orlando (E.D.), and Fort Lauderdale (G.J.R.) - both in Florida; Infektionsmedizinisches Centrum Hamburg, Hamburg, Germany (H.-J.S.); Vita-Salute University, San Raffaele Scientific Institute, Milan (A.C.); Prism Health North Texas (G.I.S.) and North Texas Infectious Diseases Consultants (M.B.) - both in Dallas; Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand (K.S.); Ruane Clinical Research Group, Los Angeles (P.J.R.), and Gilead Sciences, Foster City (H.W., N.A.M., H.D.-S., R.H.H., D.M.B., M.S.R., J.M.B.) - both in California; the University of Paris and the Department of Infectious Diseases, St. Louis-Lariboisière Hospitals, Assistance Publique-Hôpitaux de Paris, Paris (J.-M.M.); and AlloVir, Cambridge, MA (D.M.B.).
Jean-Michel MolinaFrom NewYork-Presbyterian Queens, Flushing, NY (S.S.-M.); Orlando Immunology Center, Orlando (E.D.), and Fort Lauderdale (G.J.R.) - both in Florida; Infektionsmedizinisches Centrum Hamburg, Hamburg, Germany (H.-J.S.); Vita-Salute University, San Raffaele Scientific Institute, Milan (A.C.); Prism Health North Texas (G.I.S.) and North Texas Infectious Diseases Consultants (M.B.) - both in Dallas; Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand (K.S.); Ruane Clinical Research Group, Los Angeles (P.J.R.), and Gilead Sciences, Foster City (H.W., N.A.M., H.D.-S., R.H.H., D.M.B., M.S.R., J.M.B.) - both in California; the University of Paris and the Department of Infectious Diseases, St. Louis-Lariboisière Hospitals, Assistance Publique-Hôpitaux de Paris, Paris (J.-M.M.); and AlloVir, Cambridge, MA (D.M.B.).
CAPELLA Study Investigators
Gilead Sciences (United States) · USBamrasnaradura Infectious Diseases Institute · THInfectious Disease Consultants · USInfektionsmedizinisches Centrum Hamburg · DEMylan (South Africa) · ZANew York Hospital Queens · USOrlando Immunology Center · USProteogenomics Research Institute for Systems Medicine · USRuane Medical · USUniversité Paris Cité · FRUniversity of Fort Lauderdale · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with multidrug-resistant human immunodeficiency virus type 1 (HIV-1) infection have limited treatment options. Lenacapavir is a first-in-class capsid inhibitor that showed substantial antiviral activity in a phase 1b study.

methodsIn this phase 3 trial, we enrolled patients with multidrug-resistant HIV-1 infection in two cohorts, according to the change in the plasma HIV-1 RNA level between the screening and cohort-selection visits. In cohort 1, patients were first randomly assigned in a 2:1 ratio to receive oral lenacapavir or placebo in addition to their failing therapy for 14 days; during the maintenance period, starting on day 15, patients in the lenacapavir group received subcutaneous lenacapavir once every 6 months, and those in the placebo group received oral lenacapavir, followed by subcutaneous lenacapavir; both groups also received optimized background therapy. In cohort 2, all the patients received open-label oral lenacapavir with optimized background therapy on days 1 through 14; subcutaneous lenacapavir was then administered once every 6 months starting on day 15. The primary end point was the percentage of patients in cohort 1 who had a decrease of at least 0.5 log

resultsA total of 72 patients were enrolled, with 36 in each cohort. In cohort 1, a decrease of at least 0.5 log

conclusionsIn patients with multidrug-resistant HIV-1 infection, those who received lenacapavir had a greater reduction from baseline in viral load than those who received placebo. (Funded by Gilead Sciences; CAPELLA ClinicalTrials.gov number, NCT04150068.).

Indexed as

Anti-HIV AgentsDrug Resistance, Multiple, ViralHIV-1HIV InfectionsCapsidCD4 Lymphocyte CountDrug Therapy, CombinationHumansRNA, ViralViral LoadAnti-HIV AgentsRNA, Viral

Identifiers

PMID35544387
OpenAlexW4280564133

What OpenQuestion holds

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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.