Evidence map›Paper›PMID 27232579›Full record

Trial reportLiver international : official journal of the International Association for the Study of the Liver2016

Simtuzumab treatment of advanced liver fibrosis in HIV and HCV-infected adults: results of a 6-month open-label safety trial.

Eric G Meissner, Mary McLaughlin, Lindsay Matthews, Ahmed M Gharib, Bradford J Wood, Elliot Levy, Ralph Sinkus, Kimmo Virtaneva, Dan Sturdevant, Craig Martens and 12 more

Open access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Liver international : official journal of the International Association for the Study of the Liver, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 1 pooled it
9.1field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 1 synthesis or guideline pooled it, 97 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
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  5. Article
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  8. Article
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  10. Challenges ofFrontiers in cell and developmental biology · 2025
    Review
  11. Article
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  13. Article
  14. Review
  15. Mechanobiology of portal hypertension.JHEP reports : innovation in hepatology · 2023
    Review
  16. LOXL2 in Cancer: A Two-Decade Perspective.International journal of molecular sciences · 2023
    Review
  17. Lysyl oxidase like-2 in fibrosis and cardiovascular disease.American journal of physiology. Cell physiology · 2023
    Review
  18. Review
  19. Review
  20. Article
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

22 authors at 9 institutions in 2 countries.

Eric G MeissnerLaboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
Mary McLaughlinLaboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
Lindsay MatthewsCritical Care Medicine Department, AIDS Section, NIH Clinical Center, Bethesda, MD, USA.
Ahmed M GharibBiomedical and Metabolic Imaging Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.
Bradford J WoodRadiology and Imaging Sciences, NIH Clinical Center, Bethesda, MD, USA.
Elliot LevyRadiology and Imaging Sciences, NIH Clinical Center, Bethesda, MD, USA.
Ralph SinkusBiomedical Engineering, Imaging Sciences and Biomedical Engineering Division, Kings College, London, UK.
Kimmo VirtanevaGenomics Unit, Research Technology Section, Rocky Mountain Laboratories, National Institute of Allergy and Infectious Diseases, Hamilton, MT, USA.
Dan SturdevantGenomics Unit, Research Technology Section, Rocky Mountain Laboratories, National Institute of Allergy and Infectious Diseases, Hamilton, MT, USA.
Craig MartensGenomics Unit, Research Technology Section, Rocky Mountain Laboratories, National Institute of Allergy and Infectious Diseases, Hamilton, MT, USA.
Stephen F PorcellaGenomics Unit, Research Technology Section, Rocky Mountain Laboratories, National Institute of Allergy and Infectious Diseases, Hamilton, MT, USA.
Zachary D GoodmanCenter for Liver Diseases, Inova Fairfax Hospital, Falls Church, VA, USA.
Bittoo KanwarGilead Sciences Inc., Foster City, CA, USA.
Robert P MyersGilead Sciences Inc., Foster City, CA, USA.
Mani SubramanianGilead Sciences Inc., Foster City, CA, USA.
Colleen HadiganLaboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
Henry MasurCritical Care Medicine Department, AIDS Section, NIH Clinical Center, Bethesda, MD, USA.
David E KleinerLaboratory of Pathology, National Cancer Institute, Bethesda, MD, USA.
Theo HellerLiver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.
Shyam KottililLaboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
Joseph A KovacsCritical Care Medicine Department, AIDS Section, NIH Clinical Center, Bethesda, MD, USA.
Caryn G MorseCritical Care Medicine Department, AIDS Section, NIH Clinical Center, Bethesda, MD, USA.
National Institute of Allergy and Infectious Diseases · USOffice of AIDS Research · USGilead Sciences (United States) · USNational Institute of Diabetes and Digestive and Kidney Diseases · USNational Institutes of Health Clinical Center · USInova Fairfax Hospital · USKing's College - North Carolina · USMedical University of South Carolina · USNational Cancer Institute · US

Funding

Infectious Diseases Research Technologies Core - RMLZICAI001052 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI CHERRY, JAMES · 2009 to 2025
$133.3M
Investigation of management and disease manifestations of viral hepatitisZIADK054514 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI HELLER, THEO · 2009 to 2025
$12.9M
Evaluation of HIV-related ComplicationsZIACL008075 · CLC · CLINICAL CENTER · PI KOVACS, JOSEPH A · 2009 to 2025
$0k
DC Partnership for HIV/AIDS Progress (DC PFAP)ZIACL009010 · CLC · CLINICAL CENTER · PI MASUR, HENRY · 2010 to 2025
$0k
Interventional OncologyZIACL040015 · CLC · CLINICAL CENTER · PI WOOD, BRADFORD · 2009 to 2025
$0k
CCR NIH HHS HHSN261200800001CIntramural NIH HHS Z99 AI999999Intramural NIH HHS Z99 CL999999NCI NIH HHS HHSN261200800001E
6 · The paper itself

Abstract

backgroundChronic liver injury can result in fibrosis that may progress over years to end-stage liver disease. The most effective anti-fibrotic therapy is treatment of the underlying disease, however when not possible, interventions to reverse or slow fibrosis progression are needed.

aimThe aim of this study was to study the safety and tolerability of simtuzumab, a monoclonal antibody directed against lysyl oxidase-like 2 (LOXL2) enzyme, in subjects with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or HCV-HIV co-infection and advanced liver disease.

methodsEighteen subjects with advanced liver fibrosis received simtuzumab 700 mg intravenously every 2 weeks for 22 weeks. Transjugular liver biopsies were performed during screening and at the end of treatment to measure hepatic venous pressure gradient (HVPG) and to stage fibrosis.

resultsTreatment was well-tolerated with no discontinuations due to adverse events. No significant changes were seen in HVPG or liver biopsy fibrosis score after treatment. Exploratory transcriptional and protein profiling using paired pre- and post-treatment liver biopsy and serum samples suggested up-regulation of TGF-β3 and IL-10 pathways with treatment.

conclusionIn this open-label, pilot clinical trial, simtuzumab treatment was well-tolerated in HCV- and HIV-infected subjects with advanced liver disease. Putative modulation of TGF-β3 and IL-10 pathways during simtuzumab treatment merits investigation in future trials.

Indexed as

Administration, IntravenousAdultAntibodies, Monoclonal, HumanizedCoinfectionDisease ProgressionFemaleHepatitis C, ChronicHIV InfectionsHumansInterleukin-10LiverLiver CirrhosisMaleMarylandMiddle AgedPortal PressureAntibodies, Monoclonal, HumanizedIL10 protein, humanInterleukin-10simtuzumabTGFB3 protein, humanTransforming Growth Factor beta3hepatic venous pressure gradientlysyl oxidasesmagnetic resonance elastographytransforming growth factor beta-3

Identifiers

PMID27232579
PMCPMC5116256
OpenAlexW2408729117

What OpenQuestion holds

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LicenceTDM
Read underepoch 390

Registered trials

None linked

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.