Evidence map›Paper›PMID 29626296›Full record

ArticleJournal of gastroenterology2018

Real-world efficacy and safety of ledipasvir and sofosbuvir in patients with hepatitis C virus genotype 1 infection: a nationwide multicenter study by the Japanese Red Cross Liver Study Group.

Keiji Tsuji, Masayuki Kurosaki, Jun Itakura, Nami Mori, Shintaro Takaki, Chitomi Hasebe, Takehiro Akahane, Kouji Joko, Hitoshi Yagisawa, Jirou Takezawa and 13 more

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Journal of gastroenterology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
–field-weighted citation impact
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

23 citing papers in PubMed.

  1. Trial
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  7. Change in Fibrosis 4 Index as Predictor of High Risk of Incident Hepatocellular Carcinoma After Eradication of Hepatitis C Virus.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
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  20. Observational
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors.

Keiji TsujiDepartment of Gastroenterology, Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima, Hiroshima, Japan.ORCID http://orcid.org/0000-0003-4000-835X
Masayuki KurosakiDepartment of Gastroenterology and Hepatology, Musashino Red Cross Hospital, 1-26-1 Kyonan-cho, Musashino-shi, Tokyo, 180-8610, Japan.
Jun ItakuraDepartment of Gastroenterology and Hepatology, Musashino Red Cross Hospital, 1-26-1 Kyonan-cho, Musashino-shi, Tokyo, 180-8610, Japan.
Nami MoriDepartment of Gastroenterology, Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima, Hiroshima, Japan.
Shintaro TakakiDepartment of Gastroenterology, Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima, Hiroshima, Japan.
Chitomi HasebeDepartment of Gastroenterology, Japanese Red Cross Asahikawa Hospital, Asahikawa, Hokkaido, Japan.
Takehiro AkahaneDepartment of Gastroenterology, Japanese Red Cross Ishinomaki Hospital, Ishinomaki, Miyagi, Japan.
Kouji JokoCenter for Liver-Biliary-Pancreatic Disease, Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan.
Hitoshi YagisawaDepartment of Gastroenterology, Japanese Red Cross Akita Hospital, Akita, Akita, Japan.
Jirou TakezawaDepartment of Internal Medicine, Japanese Red Cross Haramachi Hospital, Haramachi, Gunma, Japan.
Ryou NakataDepartment of Gastroenterology, Japanese Red Cross Medical Center, Shibuya-ku, Tokyo, Japan.
Atsunori KusakabeDepartment of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Aichi, Japan.
Yuji KojimaDepartment of Hepatology, Japanese Red Cross Ise Hospital, Ise, Mie, Japan.
Hiroyuki KimuraDepartment of Gastroenterology, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan.
Takashi TamadaDepartment of Gastroenterology, Takatsuki Red Cross Hospital, Takatsuki, Osaka, Japan.
Haruhiko KobashiDepartment of Gastroenterology, Japanese Red Cross Okayama Hospital, Okayama, Okayama, Japan.
Akeri MitsudaDepartment of Gastroenterology, Japanese Red Cross Tottori Hospital, Tottori, Tottori, Japan.
Masahiko KondouDepartment of Gastroenterology, Japanese Red Cross Otsu Hospital, Otsu, Shiga, Japan.
Chikara OgawaDepartment of Gastroenterology, Takamatsu Red Cross Hospital, Takamatsu, Kagawa, Japan.
Yasushi UchidaDepartment of Gastroenterology, Matsue Red Cross Hospital, Matsue, Shimane, Japan.
Tetsuro SohdaDepartment of Hepatology, Japanese Red Cross Fukuoka Hospital, Fukuoka, Fukuoka, Japan.
Ryouichi NaritaDepartment of Gastroenterology, Oita Red Cross Hospital, Oita, Oita, Japan.
Namiki IzumiDepartment of Gastroenterology and Hepatology, Musashino Red Cross Hospital, 1-26-1 Kyonan-cho, Musashino-shi, Tokyo, 180-8610, Japan. izumi012@musashino.jrc.or.jp.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe aimed to describe the real-world efficacy and safety of combination therapy with ledipasvir and sofosbuvir (LDV/SOF) for chronic hepatitis C virus (HCV) genotype 1 (GT1) infection.

methodsThis retrospective analysis of a prospective, nationwide, multicenter registry included GT1-infected patients treated with LDV/SOF for 12 weeks. We assessed the rate of sustained virological response at 12 weeks post-treatment (SVR12), incidence of adverse events, and serum markers of hepatocellular carcinoma (HCC).

resultsAmong the 1461 patients included (mean age, 69 years; 29.5% aged > 75 years; cirrhosis, 23.8%; history of treatment for HCC, 10.9%), the overall SVR12 rate was 98.4% (1438/1461). Factors associated with treatment failure were cirrhosis (odds ratio, 4.19; p = 0.014) and resistance-associated substitutions (RASs) in NS5A at baseline (odds ratio, 7.78; p = 0.0004). The SVR12 rate in patients with cirrhosis and NS5A RASs was 93.0% compared to 100% in patients without cirrhosis or NS5A RASs. In patients with SVR, the levels of alpha-fetoprotein (AFP), AFP-L3, and Mac-2 binding protein glycosylation isomer (M2BPGi) decreased from baseline to end of treatment (from 13.4 ± 37.6 to 6.0 ± 10.6 ng/mL, p < 0.0001; from 2.2 ± 4.9 to 1.5 ± 6.3%, p < 0.005; and from 3.6 ± 3.7 to 2.0 ± 3.5 cut-off index, p < 0.0001; respectively). Adverse events were rare and not associated with age. No decrease in estimated glomerular filtration rate was observed in patients with baseline chronic kidney disease stage 3.

conclusionsLDV/SOF therapy is highly effective and safe in elderly Japanese patients with HCV GT1, even in the presence of cirrhosis or NS5A RASs. Patients with SVR may have a lower risk of HCC.

Indexed as

AdultAgedAged, 80 and overalpha-FetoproteinsAntiviral AgentsBenzimidazolesCarcinoma, HepatocellularDrug Therapy, CombinationFemaleFluorenesHepacivirusHepatitis C, ChronicHumansJapanLiver CirrhosisLiver Neoplasmsalpha-FetoproteinsAntiviral AgentsBenzimidazolesFluorenesledipasvirNS-5 protein, hepatitis C virusRNA-Dependent RNA PolymeraseSofosbuvirViral Nonstructural ProteinsAlpha-fetoproteinChronic hepatitis CLedipasvirSofosbuvir

Identifiers

PMID29626296

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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.