Evidence map›Paper›PMID 36730135›Full record

ArticlePloS one2023

Safety and effectiveness of 8 weeks of Glecaprevir/Pibrentasvir in challenging HCV patients: Italian data from the CREST study.

Alessio Aghemo, Marcello Persico, Roberta D'Ambrosio, Massimo Andreoni, Erica Villa, Abhi Bhagat, Valentina Gallinaro, Giuliana Gualberti, Rocco Cosimo Damiano Merolla, Antonio Gasbarrini

Open access · goldAbstract read
In one paragraph

Article in PloS one, 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
1.0field-weighted citation impact, top 25% 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. Article
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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

10 authors at 7 institutions in 2 countries.

Alessio AghemoDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy.ORCID 0000-0003-0941-3226
Marcello PersicoDipartimento di Medicina Clinica Medica, Epatologica e Lungodegenza, AOU OO. RR. San Giovanni di Dio Ruggi e D'Aragona, Salerno, Italy.
Roberta D'AmbrosioDivision of Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Massimo AndreoniUniversity of Tor Vergata, Rome, Italy.
Erica VillaUC Gastroenterologia, Dipartimento di Specialità Mediche, Azienda Ospedaliera Universitaria di Modena, Modena, Italy.
Abhi BhagatAbbVie Inc., North Chicago, Illinois, United States of America.
Valentina GallinaroAbbVie srl, Campoverde, Latina, Italy.
Giuliana GualbertiAbbVie srl, Campoverde, Latina, Italy.
Rocco Cosimo Damiano MerollaAbbVie srl, Campoverde, Latina, Italy.
Antonio GasbarriniMedicina Interna e Gastroenterologia, Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario Gemelli IRCCS, Roma, Italy.
AbbVie (United States) · USAzienda Ospedaliero-Universitaria di Modena · ITFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITHumanitas University · ITOspedali Riuniti San Giovanni di Dio e Ruggi d'Aragona · ITUniversità Cattolica del Sacro Cuore · ITUniversity of Rome Tor Vergata · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGlecaprevir/pibrentasvir (G/P) has demonstrated high rates (>95%) of sustained virologic response at posttreatment Week 12 (SVR12) in treatment-naïve (TN) patients with hepatitis C virus (HCV) infection and compensated cirrhosis (CC). Here, in a key real-world subset of TN Italian patients with CC, we evaluated the effectiveness and safety of 8-week G/P treatment, including subgroups of interest such as those with genotype 3 (GT3) infection, elderly patients, and those with more advanced liver disease.

methodsSubanalysis of Italian patients enrolled in the CREST study. The full analysis set (FAS) included all patients enrolled in the study; the modified analysis set (MAS) excluded patients who discontinued G/P for nonvirologic failure or who had missing SVR12 results. Primary and secondary endpoints included SVR12 and safety, respectively.

resultsOf 42 patients included in the FAS, 1 discontinued for unknown reasons, and 2 had missing SVR12 data, leaving 39 patients included in the MAS. At treatment initiation, 74% of patients had ≥1 comorbidity, and 62% were receiving concomitant medications, including some that may potentially interact with G/P. SVR12 was achieved in 100% of patients in the MAS, and in 95% in the FAS. In subgroups of interest, the proportion of patients achieving SVR12 in the MAS (and FAS) was: 100% (94%) for patients ≥65 years, 100% (86%) for GT3, and 100% (100%) for patients with platelet count <150 × 109/L and FibroScan® >20 kPa. Overall, 2 (5%) patients had an adverse event and neither were serious.

conclusionResults from this real-world Italian cohort demonstrated the safety and effectiveness of 8-week G/P, with SVR12 rate >95%, even in elderly patients. These findings further support real-world evidence of the use of short-course G/P treatment in all patients with CC, including those with GT3, and those with advanced liver disease.

Indexed as

Hepatitis CHepatitis C, ChronicAgedAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesGenotypeHepacivirusHumansLactams, MacrocyclicLeucineLiver CirrhosisProlinePyrrolidinesQuinoxalinesAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesglecaprevirLactams, MacrocyclicLeucinepibrentasvirProlinePyrrolidinesQuinoxalinesSulfonamides

Identifiers

PMID36730135
PMCPMC9894491
OpenAlexW4318916996

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.