Evidence map›Paper›PMID 36011057›Full record

ArticleHealthcare (Basel, Switzerland)2022

Evaluating Post-Market Adverse Events of The New Hepatitis C Therapies Using FEARS Data.

Majed A Algarni

Open access · goldAbstract read
In one paragraph

Article in Healthcare (Basel, Switzerland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the 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 36% 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.

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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  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

1 author at 1 institution in 1 country.

Majed A AlgarniDepartment of Clinical Pharmacy, College of Pharmacy, Taif University, P.O. Box 11099, Taif 21944, Saudi Arabia.ORCID 0000-0002-4192-1653
Taif University · SA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Little is known regarding the safety of direct-acting antivirals (DAA), even though they are widely used. This study aims to evaluate the adverse events of DAA using post-market data. Methods: FDA Adverse Events Reporting System (FAERS) data from January 2019 through December 2019 were analyzed. FERAS reports in which the suspected drug contained the DAA drugs were extracted and included in the analysis. Univariable and bivariable analyses were performed in this study. Results: Most of the reported side effects were non-serious (62%). The number of times the drug was reported as ineffective was significantly higher while using Harvoni vs. Mavyret (32.14% vs. 1.05%) (p-value < 0.0001). On the other hand, hospitalization was significantly more reported while using Mavyret compared to Harvoni (52.02% vs. 22.45%) (p-value < 0.0001). Liver cancer was significantly more reported while using Harvoni vs. Mavyret (7.65% vs. 1.20%) (p-value < 0.0001). No significant difference in death cases was reported while using both drugs. Conclusion: Depending on the FDA Adverse Events Reporting System (FAERS) database, most of the non-serious adverse effects were headache and fatigue. There was no significant difference in cases of death reported while using both drugs. Liver cancer was more reported while using Harvoni. Hospitalization was more reported while using Mavyret.

Indexed as

direct-acting antiviralsFEARS dataHarvonihepatitis CMavyretpharmacovigilance

Identifiers

PMID36011057
PMCPMC9408496
OpenAlexW4288067924

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.