Evidence map›Paper›PMID 29546644›Full record

Trial reportDigestive diseases and sciences2018

Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients.

Adel Abdel-Moneim, Alaa Aboud, Mohamed Abdel-Gabbar, Mohamed Zanaty, Mohamed Ramadan

2 registry-linked trialsAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Digestive diseases and sciences, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.7field-weighted citation impact, top 15% 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.

NCT04378608 phase1 / phase2completednot on this map

Efficacy of Ombitasvir With Paritaprevir/Ritonavir Plus Ribavirin on the Treatment naïve Patients With Chronic Hepatitis C Virus Genotype 4

TypeinterventionalSponsorBeni-Suef UniversityRan2017 to 2017Enrolled100ConditionsHepatitis C Virus InfectionArmsOBV/PTV/r) ± ribavirin (RBV)
NCT04391985 phase1 / phase2completednot on this map

Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients

TypeinterventionalSponsorBeni-Suef UniversityRan2017 to 2017Enrolled113ConditionsChronic Hepatitis C Virus InfectionArmsSOF plus (OBV/PTV/r) plus RBV
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Article
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  4. An Overview of the Randomized Placebo-Controlled Trials of Chinese Herbal Medicine Formula Granules.Evidence-based complementary and alternative medicine : eCAM · 2019
    Review
  5. Review
  6. 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

5 authors at 1 institution in 1 country.

Adel Abdel-MoneimMolecular Physiology Division, Faculty of Science, Beni-Suef University, Salah Salim St., Beni Suef, 62511, Egypt. adel_men2020@yahoo.com.ORCID http://orcid.org/0000-0002-5221-4823
Alaa AboudTropical Medicine Department, Faculty of Medicine, Beni-Suef University, Beni Suef, Egypt.
Mohamed Abdel-GabbarBiochemistry Division, Chemistry Department, Faculty of Science, Beni-Suef University, Beni Suef, Egypt.
Mohamed ZanatyBiotechnology Department, Postgraduate Studies for Advanced Science, Beni-Suef University, Beni Suef, Egypt.
Mohamed RamadanBiochemistry Division, Chemistry Department, Faculty of Science, Beni-Suef University, Beni Suef, Egypt.
Beni-Suef University · EG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe current standard of care for patients with chronic hepatitis C virus (HCV) infection is a combination of direct-acting antiviral agents (DAAs). However, rare clinical trials have been reported on the combination regimen of sofosbuvir (SOF) with ombitasvir, paritaprevir, and ritonavir (OBV/PTV/r) plus ribavirin (RBV) for treated patients with HCV genotype 4 (GT4) infection.

aimsTo clarify the retreatment efficacy and safety of the recent regimen, SOF with OBV/PTV/r + RBV, for chronic HCV GT4-experienced patients who failed treatment with DAA-based regimens.

methodsA total of 113 treatment-experienced patients were allocated for the completion of their treatment period. The enrolled patients were treated orally with SOF plus a fixed dose combination of OBV/PTV/r + RBV, which was administered orally based on the patients' tolerability. The primary end point was a sustained virological response (HCV RNA < 15 IU/mL), observed 12 weeks after the end of the treatment (SVR12).

resultsAmong all patients, the treatment-experienced patients with SOF plus OBV/PTV/r + RBV had a higher SVR12 rate (97%; 109/113). Further, SVR12 was achieved by 98% (81/83) of non-cirrhotic patients and 93% (28/30) of cirrhotic patients. Additionally, the most common adverse events reported included fatigue, headache, insomnia, nausea, and dyspnea.

conclusionsThe recent multi-targeted regimen of SOF plus OBV/PTV/r + RBV was well tolerated and achieved excellent SVR rates among retreatment-experienced Egyptian patients with prior DAA treatments failure, thus providing an alternative regimen for the retreatment of difficult-to-cure HCV GT4 patients.

Indexed as

AdolescentAdultAgedAged, 80 and overAnilidesAntiviral AgentsCarbamatesCyclopropanesDrug Therapy, CombinationFemaleFollow-Up StudiesGenotypeHepacivirusHepatitis C, ChronicHumansLactams, MacrocyclicAnilidesAntiviral AgentsCarbamatesCyclopropanesLactams, MacrocyclicMacrocyclic CompoundsombitasvirparitaprevirProlineRibavirinRitonavirSofosbuvirSulfonamidesValineEgyptian patientsOmbitasvirParitaprevirRibavirinRitonavirSofosbuvir

Identifiers

PMID29546644
OpenAlexW2792996680

What OpenQuestion holds

Textmetadata
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.