Evidence map›Paper›PMID 35229326›Full record

ArticleJournal of clinical pharmacy and therapeutics2022

Retrospective multicentre study on the effectiveness of first-line direct-acting antivirals against hepatitis C virus genotype-1.

Michihiro Kaya, Kazuyo Nakamura, Kyohei Sugiyama, Ayumi Kinae, Hiromi Yamaguchi, Hirotoshi Ukita, Keiichi Odagiri, Chika Ujiie, Jun Kato, Fujito Kageyama and 6 more

Open access · hybridAbstract readMulticenter Study
In one paragraph

Article in Journal of clinical pharmacy and therapeutics, 2022. 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
0.3field-weighted citation impact, top 48% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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

16 authors at 11 institutions in 3 countries.

Michihiro KayaDepartment of Pharmacy, Shizuoka General Hospital, Shizuoka City, Shizuoka, Japan.ORCID https://orcid.org/0000-0002-9341-1487
Kazuyo NakamuraDepartment of Pharmacy, Shizuoka General Hospital, Shizuoka City, Shizuoka, Japan.
Kyohei SugiyamaDepartment of Pharmacy, Shizuoka General Hospital, Shizuoka City, Shizuoka, Japan.
Ayumi KinaeDepartment of Pharmacy, Shizuoka General Hospital, Shizuoka City, Shizuoka, Japan.
Hiromi YamaguchiDepartment of Pharmacy, Shizuoka City Shimizu Hospital, Shizuoka City, Shizuoka, Japan.
Hirotoshi UkitaClinical Study Management Office, Iwata City Hospital, Iwata City, Shizuoka, Japan.
Keiichi OdagiriCenter for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu City, Shizuoka, Japan.
Chika UjiieDepartment of Pharmacy, Seirei Mikatahara General Hospital, Hamamatsu City, Shizuoka, Japan.
Jun KatoDepartment of Pharmacy, Yaizu City Hospital, Yaizu City, Shizuoka, Japan.
Fujito KageyamaDepartment of Gastroenterology and Hepatology, Hamamatsu Medical Center, Hamamatsu City, Shizuoka, Japan.
Mariko NaguraClinical Research Center, Chutoen General Medical Center, Kakegawa City, Shizuoka, Japan.
Kumi MatsushitaDepartment of Pharmacy, Kikugawa General Hospital, Kikugawa City, Shizuoka, Japan.
Kaori SugiueDepartment of Pharmacy, Japan Japanese Red Cross Shizuoka Hospital, Shizuoka City, Shizuoka, Japan.
Hiroki IshidaDepartment of Pharmacy, JA Shizuoka Kohseiren Enshu Hospital, Hamamatsu City, Shizuoka, Japan.
Shinya EndoDepartment of Gastroenterology, Shizuoka General Hospital, Shizuoka City, Shizuoka, Japan.
Takaya SuzukiDepartment of Pharmacy, Shizuoka General Hospital, Shizuoka City, Shizuoka, Japan.
Shizuoka City Hospital · JPHamamatsu Medical Center · JPHamamatsu University · JPInstitute for Development and Economic Analysis · IDIwata City Hospital · JPJA Shizuoka Koseiren ENSHU hospital · JPSeirei Mikatabara General Hospital · JPShizuoka City Shimizu Hospital · JPShizuoka Medical Center · JPShizuoka Red Cross Hospital · JPShizuoka University of Welfare · JP

Funding

Mt. Fuji Foundation for Healthcare Innovation and Cluster Development, and the Shizuoka General Hospital
6 · The paper itself

Abstract

WHAT IS KNOWN AND

objectiveIn Japan, ledipasvir/sofosbuvir, elbasvir/grazoprevir and glecaprevir/pibrentasvir are recommended as first-line treatments for patients with untreated hepatitis C virus genotype 1. Although they have demonstrated a high efficacy in clinical trials, there are no direct comparative studies. Clarification of their effectiveness and safety in real-world clinical practice is required. Therefore, we conducted a retrospective multicentre study on the effectiveness of these direct-acting antivirals in real-world clinical practice.

methodsWe retrospectively evaluated the clinical data of untreated patients with persistent HCV genotype 1 infection who started first-line treatment with ledipasvir/sofosbuvir, elbasvir/grazoprevir or glecaprevir/pibrentasvir between September 2015 and January 2019 at 11 medical institutions in Japan. The primary efficacy endpoint was a sustained virologic response after 12 weeks of treatment. The secondary endpoints included sustained virologic response after 24 weeks of treatment and end of treatment response. The safety endpoint was treatment completion rate. RESULTS AND DISCUSSION: During the study, 420 patients (median age, 70 years; 181 males) received ledipasvir/sofosbuvir, 48 (median age 72, years; 29 males) received elbasvir/grazoprevir and 63 (median age 66, years; 35 males) received glecaprevir/pibrentasvir. For ledipasvir/sofosbuvir, elbasvir/grazoprevir and glecaprevir/pibrentasvir, the sustained virologic response after 12 weeks of treatment was 98.6%, 97.9% and 100%; the sustained virologic response after 24 weeks of treatment was 99.0%, 97.7% and 100%; the end of treatment response was 99.8%, 97.9% and 98.4%; and the treatment completion rate was 98.3%, 91.7% and 100% respectively. WHAT IS NEW AND

conclusionIn real-world clinical practice, hepatitis C virus treatment with ledipasvir/sofosbuvir, elbasvir/grazoprevir and glecaprevir/pibrentasvir was effective with safety.

Indexed as

HepacivirusHepatitis C, ChronicAgedAntiviral AgentsCyclopropanesDrug Therapy, CombinationGenotypeHumansMaleRetrospective StudiesSofosbuvirAntiviral AgentsCyclopropanesSofosbuvirDAAhepatitis C virusliverreal worldvirologic response

Identifiers

PMID35229326
PMCPMC9543670
OpenAlexW4214540961

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.