Evidence map›Paper›PMID 30063745›Full record

Observational studyPloS one2018

Real life rates of sustained virological response (SVR) and predictors of relapse following DAA treatment in genotype 3 (GT3) patients with advanced fibrosis/cirrhosis.

Alessandra Mangia, Ruggero Losappio, Giovanni Cenderello, Domenico Potenza, Michele Mazzola, Giulio De Stefano, Natalia Terreni, Massimiliano Copetti, Nicola Minerva, Valeria Piazzola and 4 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03923595 (The Puglia HCV Micro-elimination in People With Substance Use Disorders), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.9field-weighted citation impact, top 24% 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.

NCT03923595 completednot on this mapstarted 2019, after this paper: background citation

The Puglia HCV Micro-elimination in People With Substance Use Disorders

TypeobservationalSponsorAlessandra MangiaRan2019 to 2021Enrolled231ConditionsHepatitis CArmsAdherence intervention research
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Article
  3. Observational
  4. 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

14 authors at 7 institutions in 1 country.

Alessandra MangiaLiver Unit, "Casa Sollievo della Sofferenza", IRCCS, San Giovanni Rotondo, Italy.ORCID 0000-0002-2600-3555
Ruggero LosappioInfectious Disease Unit "Vittorio Emanuele II" Hospital, Bisceglie, Italy.
Giovanni CenderelloInfectious Disease Division "Galliera" Hospital, Genova, Italy.
Domenico PotenzaInfectious Disease Unit "A.Perrino" Hospital, Brindisi, Italy.
Michele MazzolaInfectious Disease Unit "Vittorio Emanuele II" Hospital, Bisceglie, Italy.
Giulio De StefanoInfectious Disease Unit "Madonna delle Grazie" Hospital, Matera, Italy.
Natalia TerreniGastroenterology Unit," Valduce" Hospital, Como, Italy.
Massimiliano CopettiBiostatistic Unit,"Casa Sollievo della Sofferenza", IRCCS, San Giovanni Rotondo, Italy.
Nicola MinervaInternal Medicine Unit "Caduti di Guerra" Hospital, Canosa, Italy.
Valeria PiazzolaLiver Unit, "Casa Sollievo della Sofferenza", IRCCS, San Giovanni Rotondo, Italy.
Donato BaccaGastroenterology and Hepatology Outpatients clinic, Casarano, Italy.
Vincenzo PalmieriInternal Medicine "A Murri" Pavillion, University of Bari, Bari, Italy.
Fernando SogariInternal Medicine "Santissima Annunziata" Hospital, Taranto, Italy.
Rosanna SantoroLiver Unit, "Casa Sollievo della Sofferenza", IRCCS, San Giovanni Rotondo, Italy.
Casa Sollievo della Sofferenza · ITEnte Ospedaliero Ospedali Galliera · ITOspedale A. Perrino · ITOspedale D. Cotugno · ITOspedale Madonna Delle Grazie · ITOspedale Valduce · ITUniversity of Bari Aldo Moro · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment of GT3 remains challenging compared to other genotypes.

aimsTo explore real life SVR rates and to identify predictors of virological failure across the most recently used Direct acting antiviral (DAA) regimens in a large cohort of Italian patients with cirrhosis or advanced fibrosis (F3 or F4).

methodsBetween May 2015 and June 2017, the combinations of sofosbuvir (SOF) plus daclatasvir (DCV) ± RBV and SOF plus velpatasvir (VEL) ± RBV become available in our Country. Patients were treated following Italian guidelines within a protocol implemented by 11 centers working together on genetics.

resultsOf 336 patients, 38.1% were Peg/IFN-experienced. SOF/DCV was used in 65.1%, SOF/VEL in the remaining. Overall SVR12 was 90.2% ranging from 87.2% after SOF/DCV to 95.7% after SOF/VEL (p = 0.012). No additional benefits of RBV use were observed for both regimens. 155 patients (46.1%) had cirrhosis. SVR12 was 87.1% (135/155) for cirrhotic patients and 92.8% (169/182) for non-cirrhotic (p = 0.09). NS5A-RASs were present at baseline in 6.4% of patients, PNPLA3GG and IL28BCC genotypes in 7.3% and 33.0%, respectively. No association between favorable genetics and SVR12 was observed. Predictors of relapse were: history of Peg/IFN/RBV failure (OR = 6.34, 95% CI 2.04-19.66, P = .001), baseline NS5A-RASs (OR = 8.7, 95% CI 1.58-47.92, P = 0.013) and treatment regimen (OR = 5.57 95% CI 1.64-18.95.96, P = 0.006).

conclusionsOur real-world results validate the efficacy of current GT3 IFN-free regimens suggesting that, among patients with severe disease, Peg/IFN/RBV experience and NS5A associated RASs are predictors of relapse. Their relevance can be expected to decline with the use of SOF/VEL. (250).

Indexed as

Sustained Virologic ResponseAntiviral AgentsCarbamatesDrug Therapy, CombinationGenotypeHepacivirusHepatitis C, ChronicHumansImidazolesItalyLiver CirrhosisPolymorphism, GeneticProspective StudiesPyrrolidinesRecurrenceRibavirinAntiviral AgentsCarbamatesdaclatasvirImidazolesPyrrolidinesRibavirinSofosbuvirValine

Identifiers

PMID30063745
PMCPMC6067691
OpenAlexW2887637544

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.