Evidence map›Paper›PMID 33001338›Full record

Trial reportJournal of gastroenterology2021

Sofosbuvir plus velpatasvir treatment for hepatitis C virus in patients with decompensated cirrhosis: a Japanese real-world multicenter study.

Yuki Tahata, Hayato Hikita, Satoshi Mochida, Norifumi Kawada, Nobuyuki Enomoto, Akio Ido, Hitoshi Yoshiji, Daiki Miki, Yoichi Hiasa, Yasuhiro Takikawa and 23 more

Abstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Journal of gastroenterology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
5.0field-weighted citation impact, top 3% 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

33 citing papers in PubMed, 54 citations in OpenAlex.

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  12. [Research progress of direct-acting antiviral drugs in the treatment of chronic hepatitis C-related cirrhosis].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2024
    Review
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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

33 authors at 20 institutions in 1 country.

Yuki TahataDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Hayato HikitaDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Satoshi MochidaDepartment of Gastroenterology and Hepatology, Saitama Medical University, Saitama, Japan.
Norifumi KawadaDepartment of Hepatology, Graduate School of Medicine, Osaka City University, Osaka, Japan.
Nobuyuki EnomotoFirst Department of Internal Medicine, Faculty of Medicine, University of Yamanashi, Yamanashi, Japan.
Akio IdoDigestive and Lifestyle Diseases, Department of Human and Environmental Sciences, Kagoshima University Graduate School of Medicine and Dental Sciences, Kagoshima, Japan.
Hitoshi YoshijiDepartment of Gastroenterology, Nara Medical University, Nara, Japan.
Daiki MikiDepartment of Gastroenterology and Metabolism, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Yoichi HiasaDepartment of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Ehime, Japan.
Yasuhiro TakikawaDivision of Hepatology, Department of Internal Medicine, Iwate Medical University, Iwate, Japan.
Ryotaro SakamoriDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Masayuki KurosakiDepartment of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan.
Hiroshi YatsuhashiClinical Research Center, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan.
Ryosuke TateishiDepartment of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Yoshiyuki UenoDepartment of Gastroenterology, Faculty of Medicine, Yamagata University, Yamagata, Japan.
Yoshito ItohDepartment of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Taro YamashitaDepartment of General Medicine, Kanazawa University Hospital, Kanazawa, Japan.
Tatsuya KantoThe Research Center for Hepatitis and Immunology, National Center for Global Health and Medicine, Chiba, Japan.
Goki SudaDepartment of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.
Yasunari NakamotoSecond Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.
Naoya KatoDepartment of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba, Japan.
Yasuhiro AsahinaDepartment of Gastroenterology and Hepatology, Department of Liver Disease Control, Tokyo Medical and Dental University, Tokyo, Japan.
Kentaro MatsuuraDepartment of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Shuji TeraiDivision of Gastroenterology and Hepatology, Graduate School of Medicine and Dental Sciences, Niigata University, Niigata, Japan.
Kazuhiko NakaoDepartment of Gastroenterology and Hepatology, Nagasaki University of Graduate School of Biomedical Sciences, Nagasaki, Japan.
Masahito ShimizuDepartment of Gastroenterology/Internal Medicine, Gifu University Graduate School of Medicine, Gifu, Japan.
Taro TakamiDepartment of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi, Japan.
Norio AkutaDepartment of Hepatology, Toranomon Hospital, Tokyo, Japan.
Ryoko YamadaDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Takahiro KodamaDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Tomohide TatsumiDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Tomomi YamadaDepartment of Medical Innovation, Osaka University Hospital, Suita, Osaka, Japan.
Tetsuo TakeharaDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. takehara@gh.med.osaka-u.ac.jp.ORCID http://orcid.org/0000-0001-5036-3457
The University of Osaka · JPChiba University · JPEhime University · JPGifu University · JPHiroshima University · JPHokkaido University · JPIwate Medical University · JPKagoshima University · JPKanazawa University Hospital · JPKyoto Prefectural University of Medicine · JPMusashino Red Cross Hospital · JPNagasaki Medical Center · JPNagasaki University · JPNagoya City University · JPNara Medical University · JPNational Center for Global Health and Medicine · JPNiigata University · JPOsaka City University · JPOsaka University Hospital · JPSaitama Medical University · JP

Funding

Japan Agency for Medical Research and Development JP20fk0210058
6 · The paper itself

Abstract

backgroundReal-world data on the efficacy and safety of sofosbuvir plus velpatasvir (SOF/VEL) treatment for patients with hepatitis C virus (HCV)-related decompensated cirrhosis are limited in Japan.

methodsA total of 190 patients with compensated (108) or decompensated (82) cirrhosis who initiated direct-acting antiviral (DAA) treatment between February 2019 and August 2019 were enrolled. Sustained virologic response (SVR) was defined as undetectable serum HCV-RNA at 12 weeks after the end of treatment (EOT).

resultsThe SVR12 rates were 92.6% in patients with compensated cirrhosis and 90.2% in patients with decompensated cirrhosis (p = 0.564), and the treatment completion rates were 98.1% and 96.3%, respectively (p = 0.372). In patients with decompensated cirrhosis, 3 patients discontinued treatment and 2 patients died because of liver-related events. In patients with decompensated cirrhosis with SVR12, 50% of patients with Child-Pugh class B at baseline showed improvement to class A at SVR12, and 27% and 9% of patients with Child-Pugh class C at baseline showed improvement to class B and class A at SVR12, respectively. Patients who achieved SVR12 showed elevated serum albumin levels at the EOT, which were further elevated at SVR12, but no elevated serum albumin levels after the EOT were observed in patients with baseline serum albumin levels less than 2.8 g/dl.

conclusionsReal-world efficacy of SOF/VEL treatment for patients with decompensated cirrhosis was similar to Japanese phase 3 study, although treatment discontinuation and death related to liver disease occurred. In patients with poor hepatic reserve, whether it improves continuously after viral clearance requires further evaluation.

Indexed as

AdultAgedAged, 80 and overAntiviral AgentsCarbamatesDrug Administration ScheduleDrug CombinationsFemaleFollow-Up StudiesHepatitis C, ChronicHeterocyclic Compounds, 4 or More RingsHumansJapanLiver CirrhosisMaleMiddle AgedAntiviral AgentsCarbamatesDrug CombinationsHeterocyclic Compounds, 4 or More RingsSofosbuvirsofosbuvir-velpatasvir drug combinationAlbuminDirect-acting antiviralLiver cirrhosisLiver functionSustained virologic response

Identifiers

PMID33001338
OpenAlexW3091165809

What OpenQuestion holds

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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.