Evidence map›Paper›PMID 30987413›Full record

Trial reportCells2019

SVR12 Higher than 97% in GT3 Cirrhotic Patients with Evidence of Portal Hypertension Treated with SOF/VEL without Ribavirin: A Nation-Wide Cohort Study.

Alessandra Mangia, Giovanni Cenderello, Massimiliano Copetti, Gabriella Verucchi, Valeria Piazzolla, Celeste Lorusso, Rosanna Santoro, Maria Maddalena Squillante, Alessandra Orlandini, Rosalba Minisini and 1 more

Abstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Cells, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Global real-world evidence of sofosbuvir/velpatasvir as simple, effective HCV treatment: Analysis of 5552 patients from 12 cohorts.Liver international : official journal of the International Association for the Study of the Liver · 2020
    Article
  12. Article
  13. 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

11 authors.

Alessandra MangiaLiver Unit, Fondazione IRCCS "Casa Sollievo della Sofferenza", 71013 San Giovanni Rotondo, Italy. a.mangia@tin.it.
Giovanni CenderelloInfectious Disease Unit, Ospedale "Galliera", 16128 Genova, Italy. giovanni.cenderello@galliera.it.
Massimiliano CopettiBiostatistics Unit, Fondazione IRCCS "Casa Sollievo della Sofferenza", 71013 San Giovanni Rotondo, Italy. lorusso.celeste590@gmail.com.
Gabriella VerucchiInfectious Disease Unit, Università di Bologna,40126 Bologna, Italy. gabriella.verrucchi@libero.it.
Valeria PiazzollaLiver Unit, Fondazione IRCCS "Casa Sollievo della Sofferenza", 71013 San Giovanni Rotondo, Italy. squillante.ma@tiscali.it.
Celeste LorussoLiver Unit, Fondazione IRCCS "Casa Sollievo della Sofferenza", 71013 San Giovanni Rotondo, Italy. giovanni.cenderello@galliera.it.
Rosanna SantoroLiver Unit, Fondazione IRCCS "Casa Sollievo della Sofferenza", 71013 San Giovanni Rotondo, Italy. r.santoro@operapadrepio.it.
Maria Maddalena SquillanteLiver Unit, Fondazione IRCCS "Casa Sollievo della Sofferenza", 71013 San Giovanni Rotondo, Italy. gabriella.verrucchi@libero.it.
Alessandra OrlandiniInfectious Disease Unit, University of Parma, 43125 Parma, Italy. aorlandini@ao.pr.it.
Rosalba MinisiniInternal Medicine, Università del Piemonte Orientale, 28100,Novara, Italy. rosalba.minisini@med.unipo.it.
Alessia CiancioGastroenterology Unit, Università di Torino, 10124Torino, Italy. alessiaciancio@libero.it.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In clinical trials, a sofosbuvir/velpatasvir (SOF/VEL) pangenotypic single-tablet regimen was associated with high sustained virological response (SVR) rates at 12 weeks (SVR12) after the end of treatment, regardless of genotype and fibrosis stage. No real-life data on genotype 3 (GT3) cirrhotic patients with portal hypertension are available. The aim of this study was to assess the effectiveness of SOF/VEL in GT3 cirrhotics with portal hypertension. Patients with GT3 and advanced cirrhosis were treated for 12 weeks with SOF/VEL without ribavirin at five different centers in Italy from June 2017 to August 2018 and their SVR12 was assessed. Of the 227 GT3 cirrhotics evaluated, 205 met the inclusion criteria and 111 had transient elastography results ≥20 KPa. SVR12 was 97.6% (95% CI 94.4-98.9), rates were 99.1% (95% CI 95.7-99.8) in patients with ≥20 KPa and 95.8% (95% CI 89.5-98.3) in those with <20 KPa (p = 0.18). Analyzed by presence of esophageal varices, the SVR12 rates were 98.4% (95% CI 91.4-99.7) and 97.1% (95% CI 92.9-98.9) in patients without and with varices, respectively (p = 1.0). In real life, SOF/VEL GT3 cirrhotic patients with evidence of portal hypertension can achieve SVR12 levels comparable to those of patients without portal hypertension. These SVR12 rates are similar to what is reported in compensated cirrhosis treated within clinical trials.

Indexed as

Sustained Virologic ResponseAdultAgedBenzimidazolesBenzopyransCarbamatesCohort StudiesComorbidityFemaleHepacivirusHeterocyclic Compounds, 4 or More RingsHumansHypertension, PortalLiver CirrhosisMaleMiddle AgedBenzimidazolesBenzopyransCarbamatesHeterocyclic Compounds, 4 or More RingsRibavirinSofosbuvirvelpatasvircirrhosisgenotype 3HCVportal hypertensionSOF/VEL

Identifiers

PMID30987413
PMCPMC6523403

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Registered trials

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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.