Evidence map›Paper›PMID 33408749›Full record

ArticleDrugs in context2020

Sustained virological response in patients with HCV treated with daclatasvir plus sofosbuvir, with or without ribavirin: a large, field-practice study.

Rodolfo Sacco, Vincenzo Messina, Umberto Vespasiani Gentilucci, Luigi Elio Adinolfi, Antonio Ascione, Giorgio Barbarini, Angelo Barlattani, Giuseppe Cariti, Raffaele Cozzolongo, Basilio Fimiani and 17 more

Abstract read
In one paragraph

Article in Drugs in context, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

27 authors.

Rodolfo SaccoGastroenterology and Metabolic Diseases Unit - Pisa University Hospital, Pisa, Italy.
Vincenzo MessinaInfectious Disease Unit Sant'Anna e San Sebastiano Hospital Caserta, Italy.
Umberto Vespasiani GentilucciInternal Medicine Unit Policlinico Campus Biomedico Rome, Italy.
Luigi Elio AdinolfiInternal Medicine Unit "L Vanvitelli" University, Naples, Italy.
Antonio AscioneCenter for Liver Diseases "Buon Consiglio-Fatebenefratelli" Hospital, Naples, Italy.
Giorgio BarbariniInfectious Diseases Unit IRCCS San Matteo, Pavia, Italy.
Angelo BarlattaniCenter for Liver Diseases, Rome, Italy.
Giuseppe CaritiUnit of Infectious Diseases, University of Turin, Amedeo di Savoia Hospital, Turin, Italy.
Raffaele CozzolongoDivision of Gastroenterology, IRCCS "S De Bellis Hospital", Castellana Grotte, Italy.
Basilio FimianiInternal Medicine Unit, "Umberto I" Hospital, Nocera Inferiore, Italy.
Ruggiero FrancavillaCenter for Liver Diseases Bisceglie, Italy.
Caterina FurlanInfectious and Tropical Diseases Policlinico "Umberto I", Rome, Italy.
Giovanni GarrucciuMedical Pathology Unit University of Sassari Sassari, Italy.
Vincenzo IovinellaInternal Medicine Unit "San Paolo" Hospital Naples, Italy.
Luca RinaldiInternal Medicine Unit "L Vanvitelli" University, Naples, Italy.
Massimo MarignaniDigestive and Liver Diseases "S. Andrea" Hospital Rome, Italy.
Paola BeginiDigestive and Liver Diseases "S. Andrea" Hospital Rome, Italy.
Valeria Pace PalittiHepatology Department of Medicine ASL Pescara, Pescara, Italy.
Adriano M PellicelliLiver Disease unit Department of Liver Transplantation "San Camillo" Hospital Rome, Italy.
Gaetano ScifoInfectious Disease Unit "Umberto I" Hospital, Siracusa, Italy.
Antonio FacciorussoOspedali Riuniti di Foggia, Foggia, Italy.
Luca GiacomelliDepartment of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy.
Aashni ShahPolistudium srl, Milan, Italy.
Gaetano BertinoHepatology Unit, Catania University, Italy.
Serena PerazzoDepartment of Infectious Diseases and Emergency Infectious Diseases "D. Cotugno" Hospital Naples, Italy.
Giampaolo BresciGastroenterology and Metabolic Diseases Unit - Pisa University Hospital, Pisa, Italy.
Antonio IzziDepartment of Infectious Diseases and Emergency Infectious Diseases "D. Cotugno" Hospital Naples, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe once-daily oral combination of daclatasvir (DCV) and sofosbuvir (SOF), with or without ribavirin (RBV), is effective and well tolerated in patients with hepatitis C virus (HCV). However, further field-practice studies are necessary to investigate the effectiveness and safety of the DCV+SOF combination in diverse subpopulations of patients with HCV, including those who are more challenging to treat such as patients with a genotype 3 (G3) infection. The aim of this retrospective, multicenter, field-practice study was to investigate the therapeutic efficacy and safety of the oral combination of DCV and SOF, with or without RBV (DCV+SOF±RBV), in a large unselected cohort of patients with chronic HCV infection (CHC). PATIENTS AND

methodsConsecutive patients received DCV+SOF±RBV for 12 or 24 weeks. The efficacy endpoint was sustained virological response at 12 weeks after the end of treatment (SVR12). Safety factors were also considered.

resultsA total of 620 patients were included in this study; the predominant genotype was G3 (55.3%). Of the total sample, 248 (40%) patients were treated with DCV+SOF+RBV and 372 (60%) did not receive RBV. The majority of patients assessed at week 12 (98%, 596/608) achieved SVR12. Among G3 patients, 98.8% (335/339) achieved SVR12. The most common adverse event was elevated bilirubin (30.6%), recorded in 4.9% of cases as a grade 3-4 adverse event.

conclusionThis study shows the high pan-genotypic effectiveness and safety of the DCV+SOF±RBV combination in a large, unselected sample of CHC patients with G1-4, including a wide proportion of G3 CHC patients.

Indexed as

daclatasvirdirect-acting antiviralsHCV NS5A inhibitorsHCV replication complexribavirinsofosbuvir

Identifiers

PMID33408749
PMCPMC7747789

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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.