Evidence map›Paper›PMID 37896803›Full record

ArticleViruses2023

Efficacy and Safety of Sofosbuvir/Velpatasvir Plus Ribavirin in Patients with Hepatitis C Virus-Related Decompensated Cirrhosis.

Steven Flamm, Eric Lawitz, Brian Borg, Michael Charlton, Charles Landis, K Rajender Reddy, Mitchell Shiffman, Angel Alsina, Charissa Chang, Natarajan Ravendhran and 5 more

Open access · goldAbstract read
In one paragraph

Article in Viruses, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.8field-weighted citation impact, top 14% 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

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Review
  5. SASLT guidelines: Update in treatment of hepatitis C virus infection, 2024.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 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

15 authors at 12 institutions in 2 countries.

Steven FlammDepartment of Internal Medicine, Division of Digestive Diseases and Nutrition, Rush University Medical Center, Chicago, IL 60612, USA.
Eric LawitzTexas Liver Institute, University of Texas Health San Antonio, San Antonio, TX 78215, USA.
Brian BorgSouthern Therapy and Advanced Research LLC, Jackson, MS 39216, USA.
Michael CharltonIntermountain Medical Center, Murray, UT 84107, USA.
Charles LandisDivision of Gastroenterology and Hepatology, University of Washington, Seattle, WA 98101, USA.
K Rajender ReddyDepartment of Medicine, Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA 19104, USA.
Mitchell ShiffmanBon Secours Mercy Health, Liver Institute of Virginia, Richmond, VA 23226, USA.
Angel AlsinaTampa General Medical Group, Tampa, FL 33609, USA.
Charissa ChangIcahn School of Medicine at Mount Sinai, New York, NY 10029, USA.
Natarajan RavendhranDigestive Disease Associates, Catonsville, MD 21228, USA.
Candido HernandezGilead Sciences, Inc., Foster City, CA 94404, USA.
Christophe HézodeGilead Sciences, Inc., Foster City, CA 94404, USA.
Stacey ScherbakovskyGilead Sciences, Inc., Foster City, CA 94404, USA.
Renee-Claude MercierGilead Sciences, Inc., Foster City, CA 94404, USA.ORCID 0000-0001-5983-6732
Didier SamuelCentre Hépatobiliaire, Hôpital Paul-Brousse, Inserm Research Unit 1193, Université Paris-Saclay, 94800 Villejuif, France.
Gilead Sciences (United States) · USBon Secours Mercy Health · USDigestive Care (United States) · USIcahn School of Medicine at Mount Sinai · USInserm · FRIntermountain Medical Center · USRush University Medical Center · USSouthern Research Institute · USTampa General Hospital · USThe University of Texas Health Science Center at San Antonio · USUniversity of Pennsylvania · USUniversity of Washington · US

Funding

Microwave-Enhanced Luminescence to Detect Growth FactorsR43CA094404 · NCI · MIRARI BIOSCIENCES, INC. · PI MARTIN, MARK T · 2002 to 2003
$270k
NCI NIH HHS R43 CA094404
6 · The paper itself

Abstract

A fixed-dose combination of sofosbuvir/velpatasvir (SOF/VEL) plus weight-based ribavirin (RBV) for 12 weeks is recommended for the treatment of patients with hepatitis C virus (HCV)-associated decompensated cirrhosis. However, large global studies, while confirming the effectiveness of SOF/VEL in a broad range of patients, often exclude these patients. This Phase 2, single-arm, open-label study in adult patients with HCV-associated decompensated cirrhosis in France and the USA aimed to provide further data on the safety and efficacy of SOF/VEL plus RBV for 12 weeks in this population. Patients were treated with a fixed-dose combination of SOF 400 mg/VEL 100 mg plus weight-based RBV once daily for 12 weeks. The inclusion criteria were chronic HCV infection (≥6 months), quantifiable HCV RNA at screening, Child-Turcotte-Pugh class B or C cirrhosis, and liver imaging within 6 months of Day 1 to exclude hepatocellular carcinoma. Among 32 patients who initiated treatment, 78.1% achieved sustained virologic response 12 weeks after the end of treatment (SVR12). Failure to achieve SVR12 was due to non-virologic reasons (investigator discretion,

Indexed as

Hepatitis CHepatitis C, ChronicAdultAntiviral AgentsBenzimidazolesBenzopyransCarbamatesDrug Therapy, CombinationGenotypeHepacivirusHeterocyclic Compounds, 4 or More RingsHumansRibavirinSofosbuvirTreatment OutcomeAntiviral AgentsBenzimidazolesBenzopyransCarbamatesHeterocyclic Compounds, 4 or More RingsRibavirinSofosbuvirvelpatasvirdecompensated cirrhosisHCVribavirinsofosbuvir/velpatasvirsustained virologic response

Identifiers

PMID37896803
PMCPMC10611233
OpenAlexW4387187616

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.