Evidence map›Paper›PMID 32128704›Full record

ArticleHepatology international2020

The effectiveness and safety of glecaprevir/pibrentasvir in chronic hepatitis C patients with refractory factors in the real world: a comprehensive analysis of a prospective multicenter study.

Akito Nozaki, Masanori Atsukawa, Chisa Kondo, Hidenori Toyoda, Makoto Chuma, Makoto Nakamuta, Haruki Uojima, Koichi Takaguchi, Hiroki Ikeda, Tsunamasa Watanabe and 29 more

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Hepatology international, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 3 pooled it
3.2field-weighted citation impact, top 7% 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

20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 35 citations in OpenAlex.

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  19. Selection dynamics of HCV genotype 3 resistance-associated substitutions under direct-acting antiviral therapy pressure.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases
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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

39 authors at 20 institutions in 1 country.

Akito NozakiGastroenterological Center, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan. akino@yokohama-cu.ac.jp.ORCID http://orcid.org/0000-0002-3310-6632
Masanori AtsukawaDepartment of Internal Medicine, Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan.
Chisa KondoDepartment of Internal Medicine, Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan.
Hidenori ToyodaDepartment of Gastroenterology, Ogaki Municipal Hospital, Ogaki, Japan.
Makoto ChumaGastroenterological Center, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.
Makoto NakamutaNational Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
Haruki UojimaDepartment of Gastroenterology, Internal Medicine, Kitasato University School of Medicine, Sagamihara, Japan.
Koichi TakaguchiDepartment of Hepatology, Kagawa Prefectural Central Hospital, Takamatsu, Japan.
Hiroki IkedaDepartment of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan.
Tsunamasa WatanabeDepartment of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan.
Shintaro OgawaDepartment of Virology and Liver Unit, Nagoya City University, Graduate School of Medical Sciences, Aichi, Japan.
Norio ItokawaDivision of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Japan.
Taeang AraiDivision of Gastroenterology, Department of Internal Medicine, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.
Atsushi HiraokaGastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan.
Toru AsanoDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan.
Shinichi FujiokaDepartment of Gastroenterology, Okayama Saiseikai General Hospital, Okayama, Japan.
Tadashi IkegamiTokyo Medical University Ibaraki Medical Center, Ibaraki, Japan.
Toshihide ShimaDepartment of Gastroenterology and Hepatology, Saiseikai Suita Hospital, Suita, Japan.
Chikara OgawaDepartment of Gastroenterology and Hepatology, Takamatsu Red Cross Hospital, Takamatsu, Japan.
Takehiro AkahaneDepartment of Gastroenterology, Japanese Red Cross Ishinomaki Hospital, Ishinomaki, Japan.
Noritomo ShimadaDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Otakanomori Hospital, Kashiwa, Japan.
Shinya FukunishiSecond Department of Internal Medicine, Osaka Medical College, Osaka, Japan.
Hiroshi AbeDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Shinmatsudo Central General Hospital, Matsudo, Japan.
Akihito TsubotaCore Research Facilities for Basic Science, The Jikei University School of Medicine, Tokyo, Japan.
Takuya GendaDepartment of Gastroenterology, Juntendo Shizuoka University Hospital, Shizuoka, Japan.
Hironao OkuboDepartment of Gastroenterology, Juntendo Nerima University Hospital, Tokyo, Japan.
Shigeru MikamiDivision of Gastroenterology, Department of Internal Medicine, Kikkoman General Hospital, Noda, Japan.
Asahiro MorishitaDepartment of Gastroenterology, Kagawa University Graduate School of Medicine, Kagawa, Japan.
Akio MoriyaDepartment of Gastroenterology, Mitoyo General Hospital, Kannonji, Japan.
Joji TaniDepartment of Internal Medicine, Yashima General Hospital, Takamatsu, Japan.
Yoshihiko TachiBantane Hospital, Fujita Health University School of Medicine, Nagoya, Japan.
Naoki HottaDivision of Hepatology, Department of Internal Medicine, Masuko Memorial Hospital, Nagoya, Japan.
Toru IshikawaDepartment of Hepatology, Saiseikai Niigata Daini Hospital, Niigata, Japan.
Takeshi OkanoueDepartment of Gastroenterology and Hepatology, Saiseikai Suita Hospital, Suita, Japan.
Yasuhito TanakaDepartment of Virology and Liver Unit, Nagoya City University, Graduate School of Medical Sciences, Aichi, Japan.
Takashi KumadaDepartment of Gastroenterology, Ogaki Municipal Hospital, Ogaki, Japan.
Katsuhiko IwakiriDepartment of Internal Medicine, Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan.
Shin MaedaGastroenterological Center, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.
KTK49 Liver Study Group
Yokohama City University Medical Center · JPNagoya City University · JPSt. Marianna University School of Medicine · JPFujita Health University · JPJikei University School of Medicine · JPKikkoman (Japan) · JPNippon Medical School · JPOgaki Municipal Hospital · JPOsaka Medical and Pharmaceutical University · JPTakamatsu Red Cross Hospital · JPTokyo Metropolitan Bokutoh Hospital · JPChiba Hokusou Hospital · JPEhime Prefectural Central Hospital · JPKagawa Prefectural Central Hospital · JPKagawa University · JPMito Saiseikai General Hospital · JPNagoya Memorial Hospital · JPNational Kyushu Medical Center · JPOtemae Hospital · JPSaiseikai Niigata Daini Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDirect-acting anti-virals (DAAs) have markedly improved the effectiveness of anti-viral therapy for chronic hepatitis C (CHC) patients. In a phase III trial in Japan, treatment with the NS3/4A protease inhibitor glecaprevir and the NS5A inhibitor pibrentasvir (G/P) resulted in a small number of patients with refractory factors. We aimed to evaluate the effectiveness and safety of G/P, especially among patients with these refractory factors, and the influence of these factors on treatment.

methodsIn a prospective, multicenter study involving 33 medical institutions, 1439 patients were treated with G/P, and their efficacy, safety, and most frequent adverse effects (AEs) were analyzed.

resultsOverall SVR12 rates were 99.1% (1397/1410) in the per-protocol-analysis, and genotype sustained virologic response SVR12 rates were: genotype 1, 99.4% (707/711); genotype 2, 99.4% (670/674); genotype 3, 80.0% (16/20). DAA-naïve patients (p = 0.008) with HCV genotype except 3 (genotype 1 vs. 3, p = 2.68 × 10

conclusionsG/P regimen is highly effective and safe to treat CHC patients even with refractory factors such as CKD and advanced liver fibrosis. However, patients with past experience of IFN-free DAA treatment and genotype 3, CKD stage 4 or 5, and advanced liver fibrosis should be more closely observed.

Indexed as

AdolescentAdultAgedAged, 80 and overAntiviral AgentsBenzimidazolesDrug Administration ScheduleDrug CombinationsFemaleHepatitis C, ChronicHumansJapanMaleMiddle AgedProspective StudiesPyrrolidinesAntiviral AgentsBenzimidazolesDrug Combinationsglecaprevir and pibrentasvirPyrrolidinesQuinoxalinesSulfonamidesChronic hepatitis CGlecaprevirMulticenter studyPibrentasvirRefractory factors

Identifiers

PMID32128704
OpenAlexW3009290908

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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.