Evidence map›Paper›PMID 27601883›Full record

Trial reportDrug design, development and therapy2016

Very rapid virologic response and early HCV response kinetics, as quick measures to compare efficacy and guide a personalized response-guided therapy.

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

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Drug design, development and therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03480269 (Very Rapid and Rapid Virological Response as Predictors of Response to Sofosbuvir / Daclatasvir Treatment of HCV Related Liver Disease), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–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.

NCT03480269 unknown statusnot on this mapstarted 2018, after this paper: background citation

Very Rapid and Rapid Virological Response as Predictors of Response to Sofosbuvir / Daclatasvir Treatment of HCV Related Liver Disease

TypeobservationalSponsorAssiut UniversityRan2018 to 2020Enrolled100ConditionsPredictors of Response to HCV Tretment
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Chronic Hepatitis C: Do Generics Work as Well as Branded Drugs?Journal of clinical and experimental hepatology · 2017
    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

4 authors.

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

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis is the second and final report for our study designed to compare two generic sofosbuvir products for the degree and speed of virologic response to a dual anti-hepatitis C virus (HCV) treatment protocol. We aimed to test the applicability of the early virus response kinetics and the very rapid virologic response (vRVR) rate as quick outcome measures for accelerated comparative efficacy studies and as a foundation for a personalized response-guided therapy.

methodsFifty eligible chronic HCV patients were randomized to either one of two generic sofosbuvir products (Gratisovir or Grateziano) at a daily dose of one 400 mg tablet plus a weight-based ribavirin dose. Data were compared between the groups for early virus response kinetics and vRVR rates in relation to the rates of final sustained virologic response at week 12 posttreatment (SVR12).

resultsThe Log10 transformed virus load (Log polymerase chain reaction) curves showed fairly similar rapid decline during the first 2 weeks, with no significant difference between the groups at four analysis points throughout the study by repeated-measures factorial analysis of variance test (P=0.48). The SVR12 rates were 96% (95% confidence interval, 79.6%-99.9%) in Gratisovir group (24/25) and 95.7% (95% confidence interval, 78%-99.9%) in Grateziano group (22/23). There was no statistically significant difference found by exact test (P>0.999). There was a significant association between the vRVR and the SVR12, with 100% positive predictive value (38/38 of those who had vRVR, achieved a final SVR12) and 82.6% sensitivity (among the total 46 with SVR12, 38 were having vRVR).

conclusionWe can conclude from our study that the early HCV response kinetics and the vRVR rates could be used as sensitive quick markers for efficacy (with a very high positive predictive value for SVR12), based on our accelerated comparative efficacy research model. This might open the way for new models of accelerated equivalence efficacy studies along with the bioequivalence kinetics studies to test a generic drug against a reference. Also, the early response kinetics and the vRVR might be used as qualifiers for a personalized course of treatment. This could shorten unnecessarily long treatment courses in rapid responders and might help to avoid relapses in slow responders.

Indexed as

Precision MedicineAntiviral AgentsDose-Response Relationship, DrugFemaleHepacivirusHepatitis C, ChronicHumansKineticsMaleMiddle AgedRibavirinStructure-Activity RelationshipTabletsViral LoadAntiviral AgentsRibavirinTabletschronic hepatitis Cdirect-acting antiviral agentsdual therapyHCV response kineticsribavirinsofosbuvirvery rapid virologic responsevRVR

Identifiers

PMID27601883
PMCPMC5003574

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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.