Evidence map›Paper›PMID 35484503›Full record

ArticleBMC gastroenterology2022

Efficacy and safety of glecaprevir and pibrentasvir in Japanese patients with hepatitis C virus infection aged 75 years or older.

Yuri Komaki, Yoshinori Ozono, Kenichi Nakamura, Hisayoshi Iwakiri, Satoru Hasuike, Mitsue Sueta, Tadashi Miike, Shojiro Yamamoto, Hirofumi Uto, Kazunori Kusumoto and 9 more

Open access · goldAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC gastroenterology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 27% 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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. 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

19 authors at 4 institutions in 1 country.

Yuri KomakiDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Yoshinori OzonoDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Kenichi NakamuraDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Hisayoshi IwakiriDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Satoru HasuikeDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Mitsue SuetaDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Tadashi MiikeDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Shojiro YamamotoDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Hirofumi UtoDepartment of Gastroenterology, Miyazaki Medical Center Hospital, Miyazaki, Japan.
Kazunori KusumotoDepartment of Internal Medicine, Koga General Hospital, Miyazaki, Japan.
Toshimasa OchiaiDepartment of Internal Medicine, Koga General Hospital, Miyazaki, Japan.
Junya KatoDepartment of Internal Medicine, National Hospital Organization Miyakonojo Medical Center, Miyazaki, Japan.
Naoto KomadaDepartment of Internal Medicine, National Hospital Organization Miyakonojo Medical Center, Miyazaki, Japan.
Kazuo KurokiDepartment of Internal Medicine, Kushima Municipal Hospital, Miyazaki, Japan.
Toshiharu EtoDepartment of Internal Medicine, Kushima Municipal Hospital, Miyazaki, Japan.
Masafumi ShigehiraDepartment of Internal Medicine, Shigehira Clinic, Miyazaki, Japan.
Shuichi HironoDepartment of Internal Medicine, Hirono Naika Clinic, Miyazaki, Japan.
Kenji NagataDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Hiroshi KawakamiDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan. hiropon@med.miyazaki-u.ac.jp.
University of Miyazaki · JPKoga Hospital · JPNational Hospital Organization Miyazaki Higashi Hospital · JPUniversity of Miyazaki Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIt is estimated that approximately 50% of patients with hepatitis C virus (HCV) infection in Japan are currently over 75 years old. However, patients aged ≥ 75 years are typically underrepresented in clinical trials of direct-acting antivirals. This study aimed to evaluate the efficacy and safety of glecaprevir and pibrentasvir (G/P) treatment in Japanese patients with HCV infection aged ≥ 75 years.

methodsThis multicenter, retrospective study included 271 Japanese patients with HCV infection from 12 centers in Miyazaki Prefecture, Japan. Demographic, clinical, virological, and adverse events (AEs) data obtained during and after G/P treatment were collected from medical records. The patients were divided into two groups: younger (n = 199, aged < 75 years) and older (n = 72, aged ≥ 75 years). Virological data and AEs were analyzed according to the age group.

resultsIn intention-to-treat (ITT) and per-protocol analyses, the overall sustained virological response 12 (SVR12) rates were 93% and 98.8%, respectively. Two patients in the older group and 14 patients in the younger group dropped out before SVR12 assessment. Although patients in the older group tended to have liver cirrhosis, 95.8% in the older group and 92% in the younger group achieved SVR12 in the ITT analysis (P = 0.404). In total, 48 (17.7%) patients experienced treatment-related AEs. Common AEs during treatment included pruritus, headache, and fatigue. The AEs were not significantly different between the two groups.

conclusionsCompared with younger patients, older patients showed similar virological response and tolerance to G/P treatment.

Indexed as

HepacivirusHepatitis C, ChronicAgedAntiviral AgentsBenzimidazolesDrug CombinationsGenotypeHumansJapanPyrrolidinesQuinoxalinesRetrospective StudiesSulfonamidesAntiviral AgentsBenzimidazolesDrug Combinationsglecaprevir and pibrentasvirPyrrolidinesQuinoxalinesSulfonamidesChronic hepatitis CDirect-acting antiviralsGlecaprevirPibrentasvirSustained virological response

Identifiers

PMID35484503
PMCPMC9052496
OpenAlexW4225142645

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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.