Evidence map›Paper›PMID 36045503›Full record

Trial reportJournal of medical virology2023

A Phase 2 open label study of ledipasvir/sofosbuvir for 12 weeks in subjects with hepatitis B virus infection.

Angie S Price, Amy K Nelson, Alip Ghosh, Shyamasundaran Kottilil, Joel V Chua

Open access · hybridAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of medical virology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.8field-weighted citation impact, top 28% 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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Review
  3. Hepatitis B: Model Systems and Therapeutic Approaches.Journal of immunology research · 2024
    Review
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

5 authors at 1 institution in 1 country.

Angie S PriceInstitute of Human Virology, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Amy K NelsonInstitute of Human Virology, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Alip GhoshInstitute of Human Virology, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Shyamasundaran KottililInstitute of Human Virology, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Joel V ChuaInstitute of Human Virology, University of Maryland School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-7579-4672
University of Maryland, Baltimore · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Retrospective data showed that when we administered ledipasvir/sofosbuvir (LDV/SOF) to patients with hepatitis B and C coinfection, there was a modest reduction in hepatitis B surface antigen (HBsAg). Therefore, we hypothesize that similar HBsAg reduction can be seen in hepatitis B virus (HBV) monoinfected subjects. Primary and secondary efficacy endpoints are the decline in HBsAg and HBV DNA at Week 12 from baseline, respectively. We conducted an open-label Phase 2 pilot study to evaluate the safety, tolerability, and antiviral activity of LDV and/or SOF for HBV. Eligible subjects were either suppressed on antivirals (Group B) or inactive chronic HBV (Group A, C, D). Group A and B received LDV/SOF. Group C and D received SOF 400 mg and LDV 90 mg, respectively. All subjects completed the study, and all related adverse events (AEs) were mild. No discontinuations due to AEs or hepatitis flare occurred. At Week 12, HBsAg decline (log

Indexed as

Hepatitis BHepatitis B, ChronicAntiviral AgentsBenzimidazolesDNA, ViralFluorenesHepacivirusHepatitis B Surface AntigensHepatitis B virusHumansPilot ProjectsRetrospective StudiesSofosbuvirSymptom Flare UpAntiviral AgentsBenzimidazolesDNA, ViralFluorenesHepatitis B Surface Antigensledipasvirledipasvir, sofosbuvir drug combinationSofosbuvirantiviral effectchronic hepatitis BHBV DNAHBV infectionhepatitis B surface antigenledipasvirnucleos(t)ide analoguesquantitative HBV surface antigensofosbuvirviral hepatitis B

Identifiers

PMID36045503
PMCPMC10087219
OpenAlexW4294123170

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.