Evidence map›Paper›PMID 30970444›Full record

Observational studyGut and liver2020

High Efficacy and Safety of Flat-Dose Ribavirin Plus Sofosbuvir/Daclatasvir in Genotype 3 Cirrhotic Patients.

Adriano Pellicelli, Vincenzo Messina, Valerio Giannelli, Marco Distefano, Valeria Pace Palitti, Pascal Vignally, Pierluigi Tarquini, Antonio Izzi, Alessandra Moretti, Sergio Babudieri and 12 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Gut and liver, 2020. 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
–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

5 citing papers in PubMed.

  1. SASLT guidelines: Update in treatment of hepatitis C virus infection, 2024.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2024
    Review
  2. Article
  3. Article
  4. Viral hepatitis C treatment shortening - what is the limit?Clinical and experimental hepatology · 2019
    Review
  5. 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

22 authors.

Adriano PellicelliLiver and Transplant Unit, San Camillo Forlanini Hospital, Rome, Italy.ORCID 0000-0001-5845-6703
Vincenzo MessinaDepartment of Infectious Disease, Sant'Anna and San Sebastiano Hospital, Caserta, Italy.ORCID 0000-0003-1323-5127
Valerio GiannelliLiver and Transplant Unit, San Camillo Forlanini Hospital, Rome, Italy.ORCID 0000-0003-3392-3752
Marco DistefanoLiver Unit, Azienda Umberto I Hospital, Siracusa, Italy.
Valeria Pace PalittiLiver Unit, Department of Medicine, ASL Pescara, Pescara, Italy.
Pascal VignallyDepartment of Emergency, Galliera Hospital, Genoa, Italy.ORCID 0000-0003-1021-1648
Pierluigi TarquiniDepartment of Infectious Disease, Giuseppe Mazzini Hospital, Teramo, Italy.
Antonio IzziDepartment of Infectious Disease and Emergency Infectious Disease, Cotugno Hospital, Napoli, Italy.
Alessandra MorettiDepartment of Gastroenterology, San Filippo Neri Hospital, Rome, Italy.
Sergio BabudieriDepartment of Infectious Disease, University of Sassari, Sassari, Italy.ORCID 0000-0001-7291-8687
Serena Dell'Isola
Massimo MarignaniDigestive and Liver Disease Unit, Sant'Andrea Hospital, Rome, Italy.ORCID 0000-0002-8912-9972
Gaetano ScifoLiver Unit, Azienda Umberto I Hospital, Siracusa, Italy.
Vincenzo IovinellaDepartment of Internal Medicine, San Paolo Hospital, Naples, Italy.
Giuseppe CaritiInfectious Disease, Department of Medical Science, University of Turin, Turin, Italy.
Maurizio PompiliDepartment of Internal Medicine, Catholic University, Rome, Italy.ORCID 0000-0001-6699-7980
Francesco Di CandiloDepartment of Infectious Disease, Perugia Hospital, Perugia, Italy.
Luca FontanellaCenter for Liver Disease, Fatebenefratelli Hospital, Napoli, Italy.ORCID 0000-0002-2357-2293
Giuseppe M EttorreDivision of General Surgery and Liver Transplantation, San Camillo Forlanini Hospital, Rome, Italy.ORCID 0000-0002-7501-5472
Giovanni VennarecciDivision of General Surgery and Liver Transplantation, San Camillo Forlanini Hospital, Rome, Italy.ORCID 0000-0001-9727-4304
Antonio Massimo IppolitoDivision of Gastroenterology, Casa Sollievo Sofferenza Hospital IRCCS, San Giovanni Rotondo, Pavia, Italy.ORCID 0000-0003-2135-5209
Giorgio BarbariniDepartment of Infectious Disease, IRCCS San Matteo, Pavia, Italy.ORCID 0000-0003-2712-0259

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background/Aims: Patients with genotype 3 hepatitis C virus (G3-HCV) cirrhosis are very difficult to treat compared to patients with other HCV genotypes. The optimal treatment duration and drug regimen associated with ribavirin (RBV) remain unclear. To evaluate the efficacy and safety of daclatasvir (DCV)/sofosbuvir (SOF) plus a flat dose of 800 mg RBV (flat dose) compared to DCV/SOF without RBV or DCV/SOF plus an RBV dose based on body weight (weight-based) in G3-HCV patients with compensated or decompensated cirrhosis. Methods: We analyzed data for 233 G3 cirrhotic patients. Of these, 70 (30%), 87(37%) and 76 (33%) received SOF/DCV, SOF/DCV/RBV flat dose, and SOF/DCV/RBV weight-based dose, respectively. Treatment duration was 24 weeks. Sustained virological response (SVR) was evaluated at week 12 posttreatment (SVR12). Results: Overall, SVR12 was achieved in 220 out of 233 patients (94.4%). The SVR12 rate was lower in the DCV/SOF group than in the DCV/SOF/RBV flat-dose group and the DCV/SOF/RBV weight-based group (87.1% vs 97.7% and 97.4%, respectively, p=0.007). A higher incidence of anemia occurred in the DCV/SOF/RBV weight-based group compared to those in the other two groups (p<0.007). Conclusions: We found that the DCV/SOF/RBV flat-dose regimen is an effective treatment in terms of efficacy and safety in patients with G3-HCV compensated or decompensated cirrhosis. Therefore, antiviral regimens without RBV should be restricted only to naïve patients with G3-HCV compensated cirrhosis who have a clear contraindication for RBV.

Indexed as

Antiviral AgentsCarbamatesDrug Therapy, CombinationFemaleGenotypeHepacivirusHepatitis C, ChronicHumansImidazolesLiver CirrhosisMaleMiddle AgedPyrrolidinesRetrospective StudiesRibavirinSofosbuvirAntiviral AgentsCarbamatesdaclatasvirImidazolesPyrrolidinesRibavirinSofosbuvirValineCirrhosisDaclatasvirDrug therapyGenotypes 3Hepatitis CliverRibavirin

Identifiers

PMID30970444
PMCPMC7234881

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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.