Evidence map›Paper›PMID 35024454›Full record

ArticleHealth science reports2022

Safety and efficacy of glecaprevir and pibrentasvir in north Tohoku Japanese patients with genotype 1/2 hepatitis C virus infection.

Akio Miyasaka, Yuichi Yoshida, Akihiko Murakami, Takao Hoshino, Kei Sawara, Hiroshi Numao, Yasuhiro Takikawa

Open access · goldAbstract read
In one paragraph

Article in Health science reports, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Virus-Associated Nephropathies: A Narrative Review.International journal of molecular sciences · 2022
    Review
  6. Article
  7. Observational
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

7 authors at 3 institutions in 1 country.

Akio MiyasakaDivision of Hepatology, Department of Internal Medicine Iwate Medical University School of Medicine Shiwa-gun Japan.ORCID https://orcid.org/0000-0001-7747-5977
Yuichi YoshidaDivision of Hepatology, Department of Internal Medicine Iwate Medical University School of Medicine Shiwa-gun Japan.ORCID https://orcid.org/0000-0001-8855-4099
Akihiko MurakamiDepartment of Gastroenterology Iwate Prefectural Miyako hospital Miyako Japan.ORCID https://orcid.org/0000-0001-9231-5234
Takao HoshinoDepartment of Gastroenterology Akita Kosei Medical Center Akita Japan.ORCID https://orcid.org/0000-0001-7697-4379
Kei SawaraDivision of Hepatology, Department of Internal Medicine Iwate Medical University School of Medicine Shiwa-gun Japan.ORCID https://orcid.org/0000-0003-4608-277X
Hiroshi NumaoDepartment of Gastroenterology Aomori Prefectural Central Hospital Aomori Japan.ORCID https://orcid.org/0000-0002-6476-7038
Yasuhiro TakikawaDivision of Hepatology, Department of Internal Medicine Iwate Medical University School of Medicine Shiwa-gun Japan.ORCID https://orcid.org/0000-0002-1729-1540
Iwate Medical University · JPAomori Prefectural Central Hospital · JPIwate Prefectural Central Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsTo assess the efficacy and safety of treatment with glecaprevir/pibrentasvir in Japanese patients with genotype (GT) 1/2 hepatitis C virus (HCV) infection in a real-world clinical setting.

methodsA total of 230 patients from 12 centers in northern Tohoku Japan with chronic hepatitis (CH) or compensated liver cirrhosis (LC) and GT1/2 HCV infection were treated with glecaprevir/pibrentasvir and followed up for 12 weeks after treatment completion. Those patients were evaluated by dividing them into the following three groups: CH GT1/2 HCV-infected, direct-acting antiviral agents (DAA)-naive patients received 8 weeks of treatment (8-week initial treatment group), compensated LC GT1/2 HCV-infected, DAA-naive patients received 12 weeks of treatment (12-week initial treatment group), and GT1/2 HCV-infected patients with previous failed DAA treatment were assigned to 12-week treatment (12-week re-treatment group).

resultsThe overall sustained virologic response (SVR) rate in the modified intention-to-treat population was 99% (222/225). The SVR rate in 8-week initial treatment group, 12-week initial treatment group, and 12-week re-treatment group were 99% (118/119), 98% (104/106), and 97% (56/58), respectively. SVR rates based on chronic kidney disease (CKD) stage were 99% in stage 1/2, 96% in stage 3, and 100% in stage 4/5 patients. SVR rate among the three treatment groups was not influenced by CKD stage. Furthermore, all 18 patients (six in the 8-week initial treatment group, 12 in 12-week initial treatment group) who underwent hemodialysis attained SVR. Serious treatment-associated adverse events (grade ≥ 3) occurred in 12 patients (5.2%). Five patients (2.2%) discontinued treatment because of adverse events; however, three of these patients achieved SVR.

conclusionPrimary treatment and re-treatment with glecaprevir/pibrentasvir are effective and safe for patients without decompensated LC and GT1/2 HCV infection in a real-world clinical setting. Furthermore, the SVR rate was not influenced by CKD stage.

Indexed as

antiviral agentchronic kidney diseasehepatitis C virussustained virologic response

Identifiers

PMID35024454
PMCPMC8733835
OpenAlexW4205886576

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.