Evidence map›Paper›PMID 32245397›Full record

Trial reportBMC infectious diseases2020

Ombitasvir/paritaprevir/ritonavir & dasabuvir ± ribavirin following protease inhibitors failure - a prospective multi-centre trial.

Liat Deutsch, Inbal Houri, Ziv Ben-Ari, Amir Shlomai, Ella Veitsman, Oranit Cohen-Ezra, Assaf Issachar, Orna Mor, Yael Gozlan, Rafael Bruck and 4 more

Registry-linked trialOpen access · goldAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in BMC infectious diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02646111 (An Open-label, Multi-center Study to Evaluate Sustained Virologic Response With Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With and Without Ribavirin in Genotype 1 Chronic Hepatitis C Virus Infected Patients With Past PI Failure), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 33% 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.

NCT02646111 phase3unknown statusnot on this map

An Open-label, Multi-center Study to Evaluate Sustained Virologic Response With Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With and Without Ribavirin in Genotype 1 Chronic Hepatitis C Virus Infected Patients With Past PI Failure

TypeinterventionalSponsorTel-Aviv Sourasky Medical CenterRan2016 to 2019Enrolled120ConditionsHepatitis CArms12 weeks without Ribavirin, 12 weeks with Ribavirin, 24 weeks with Ribavirin
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. 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 5 institutions in 1 country.

Liat DeutschDepartment of Gastroenterology and Liver diseases, Tel Aviv Sourasky Medical Centre and Tel-Aviv University, 6 Weizmann St, 64239, Tel-Aviv, Israel.
Inbal HouriDepartment of Gastroenterology and Liver diseases, Tel Aviv Sourasky Medical Centre and Tel-Aviv University, 6 Weizmann St, 64239, Tel-Aviv, Israel.
Ziv Ben-AriSackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
Amir ShlomaiSackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
Ella VeitsmanSackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
Oranit Cohen-EzraSackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
Assaf IssacharSackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
Orna MorCentral Virology Laboratory, Ministry of Health, Chaim Sheba Medical Centre, Ramat-Gan, Israel.
Yael GozlanCentral Virology Laboratory, Ministry of Health, Chaim Sheba Medical Centre, Ramat-Gan, Israel.
Rafael BruckDepartment of Gastroenterology and Liver diseases, Tel Aviv Sourasky Medical Centre and Tel-Aviv University, 6 Weizmann St, 64239, Tel-Aviv, Israel.
Yoram MenachemDepartment of Gastroenterology and Liver diseases, Tel Aviv Sourasky Medical Centre and Tel-Aviv University, 6 Weizmann St, 64239, Tel-Aviv, Israel.
Shira Zelber-SagiDepartment of Gastroenterology and Liver diseases, Tel Aviv Sourasky Medical Centre and Tel-Aviv University, 6 Weizmann St, 64239, Tel-Aviv, Israel.
Helena KatchmanDepartment of Gastroenterology and Liver diseases, Tel Aviv Sourasky Medical Centre and Tel-Aviv University, 6 Weizmann St, 64239, Tel-Aviv, Israel.
Oren ShiboletDepartment of Gastroenterology and Liver diseases, Tel Aviv Sourasky Medical Centre and Tel-Aviv University, 6 Weizmann St, 64239, Tel-Aviv, Israel. orensh@tlvmc.gov.il.
Tel Aviv University · ILTel Aviv Sourasky Medical Center · ILRabin Medical Center · ILSheba Medical Center · ILIsrael Ministry of Health · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHepatitis C virus (HCV) infection is a leading cause of chronic liver disease and hepatocellular carcinoma. Treatment with first generation protease inhibitors (PI) + peg-interferon (pegIFN) and ribavirin (RBV) achieved sustained virologic response (SVR) rates of 65-75% but was associated with multiple side effects. The aim of this study was to evaluate safety and efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir (3D) ± RBV in HCV genotype 1 patients that failed previous treatment with first generation PIs.

methodsAn investigator-initiated, open-label, multi-centre clinical trial. HCV Genotype 1 patients who were previously null/partial responders or relapsers to telaprevir, boceprevir or simepravir+pegIFN/RBV and met eligibility criteria were included. 3D ± RBV were administrated for 12 or 24 weeks according to label. The primary outcome was antiviral response (SVR12); Secondary outcomes were patient reported outcomes, adverse events and resistance associated variants.

resultsThirty-nine patients initiated treatment according to study protocol (59% men, age 54.0 ± 8.7 years, BMI 28.7 ± 4.5 kg/m

conclusion3D ± RBV is safe and effective in achieving SVR among patients with HCV genotype 1 who failed previous first-generation PI treatment.

trial registrationNCT02646111 (submitted to ClinicalTrials.gov, December 28, 2015).

Indexed as

2-NaphthylamineAnilidesAntiviral AgentsCarbamatesCyclopropanesDrug Therapy, CombinationFemaleGenotypeHepatitis CHumansLactams, MacrocyclicMacrocyclic CompoundsMaleMiddle AgedProlineProspective Studies2-NaphthylamineAnilidesAntiviral AgentsCarbamatesCyclopropanesdasabuvirLactams, MacrocyclicMacrocyclic CompoundsombitasvirparitaprevirProlineProtease InhibitorsRibavirinRitonavirSulfonamidesUracilValineAbbVie 3DDirect acting anti-viral agentsHCVProtease inhibitors failure

Identifiers

PMID32245397
PMCPMC7126165
OpenAlexW3014613688

What OpenQuestion holds

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LicenceCC BY
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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.