Evidence map›Paper›PMID 26628861›Full record

Trial reportDrug design, development and therapy2015

The very-rapid and the ultra-rapid virologic response to two treatment options in patients with chronic hepatitis C: an interim report of a prospective randomized comparative effectiveness study.

Mostafa Yakoot, Alaa M Abdo, Ahmed Yousry, Sherine Helmy

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2015. 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. Trial
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

4 authors.

Mostafa YakootGreen Clinic and Research Center, Alexandria University, Alexandria, Egypt ; Abbas Helmy Clinics, Alexandria University, Alexandria, Egypt.
Alaa M AbdoTropical Medicine and Hepatology Department, Alexandria Faculty of Medicine, Alexandria University, Alexandria, Egypt.
Ahmed YousryMicrobiology Department, High Institute of Public Health, Alexandria University, Alexandria, Egypt ; Mabarat El Asafra Labs, Alexandria, Egypt.
Sherine HelmyPharco Corporation, Alexandria, Egypt.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe aimed in this interim report to compare two registered generic sofosbuvir products for the degree and speed of virologic response to a dual antiviral treatment protocol within the first 2 weeks of treatment.

methodsData collected during the period of this interim report from the first 25 patients randomized to either one of two generic sofosbuvir products (Grateziano or Gratisovir) at a daily dose of one 400 mg tablet plus a weight-based ribavirin dose were analyzed for both the degree and speed of virus load reduction at the end of 1 and 2 weeks from starting treatment.

resultsThe baseline Log10 transformed virus load (Log polymerase chain reaction) showed a fairly similar marked and significant reduction in both groups by more than 4 and 5 Logs at the end of week 1 and 2 of starting treatment, respectively. The differences between the two treatment groups at both analysis points were not statistically significant (P>0.05) by repeated measures factorial analysis of variance test. The differences in proportions of patients with ultra-rapid virologic response at the end of week 1 and very-rapid virologic response at the end of week 2 in both groups were also not statistically significant (P>0.05).

conclusionWe can conclude from this interim report that the two generic products Gratisovir and Grateziano are almost equally fast and efficacious in reducing the hepatitis C virus load in our study setting.

Indexed as

AdultAntiviral AgentsComparative Effectiveness ResearchDrugs, GenericEgyptFemaleHepacivirusHepatitis C, ChronicHumansMaleMiddle AgedProspective StudiesRNA, ViralSofosbuvirTherapeutic EquivalencyTime FactorsAntiviral AgentsDrugs, GenericRNA, ViralSofosbuvirchronic hepatitis Cdirect acting antiviral agentsdual antiviral therapyultra-rapid virologic responsevery-rapid virologic response

Identifiers

PMID26628861
PMCPMC4651553

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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.