Evidence map›Paper›PMID 26872889›Full record

ArticleJournal of gastroenterology2016

Safety and efficacy of dual direct-acting antiviral therapy (daclatasvir and asunaprevir) for chronic hepatitis C virus genotype 1 infection in patients on hemodialysis.

Hidenori Toyoda, Takashi Kumada, Toshifumi Tada, Koichi Takaguchi, Toru Ishikawa, Kunihiko Tsuji, Mikio Zeniya, Etsuko Iio, Yasuhito Tanaka

Erratum issuedAbstract readControlled Clinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Article in Journal of gastroenterology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 30 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 3 pooled it
11.2field-weighted citation impact, top 1% 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

30 citing papers in PubMed, 3 syntheses or guidelines pooled it, 76 citations in OpenAlex.

  1. Pooled it
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  4. Trial
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  17. Treatment of hepatitis C in special populations.Journal of gastroenterology · 2018
    Review
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  20. Observational
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 1 country.

Hidenori ToyodaDepartment of Gastroenterology, Ogaki Municipal Hospital, 4-86 Minaminokawa, Ogaki, Gifu, 503-8502, Japan. hmtoyoda@spice.ocn.ne.jp.
Takashi KumadaDepartment of Gastroenterology, Ogaki Municipal Hospital, 4-86 Minaminokawa, Ogaki, Gifu, 503-8502, Japan.
Toshifumi TadaDepartment of Gastroenterology, Ogaki Municipal Hospital, 4-86 Minaminokawa, Ogaki, Gifu, 503-8502, Japan.
Koichi TakaguchiDepartment of Hepatology, Kagawa Prefectural Central Hospital, Takamatsu, Japan.
Toru IshikawaDepartment of Hepatology, Saiseikai Niigata Daini Hospital, Niigata, Japan.
Kunihiko TsujiCenter for Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan.
Mikio ZeniyaDepartment of Gastroenterology, Sanno Hospital, International University of Health and Welfare, Tokyo, Japan.
Etsuko IioDepartment of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Science, Nagoya, Japan.
Yasuhito TanakaDepartment of Virology and Liver Unit, Nagoya City University Graduate School of Medical Science, Nagoya, Japan.
Ogaki Municipal Hospital · JPNagoya City University · JPInternational University of Health and Welfare · JPKagawa Prefectural Central Hospital · JPSaiseikai Niigata Daini Hospital · JPTeine Keijinkai Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHepatitis C virus (HCV) infection is a major comorbidity in patients receiving hemodialysis. Interferon-based antiviral therapy to eradicate HCV is less effective in patients receiving hemodialysis than patients without renal dysfunction. Recently reported combination therapy with two oral direct-acting antiviral drugs, daclatasvir and asunaprevir, both of which are metabolized in the liver and excreted into the bile ducts, reportedly showed a high rate of HCV eradication. We evaluated the safety and efficacy of this therapy in patients receiving hemodialysis.

methodsThe safety and viral responses were compared among patients infected with HCV genotype 1, between 28 patients receiving hemodialysis, and propensity score-matched 56 patients without renal dysfunction.

resultsThe reduction in serum HCV RNA levels 1 day after the start of therapy was significantly larger (p = 0.0329) and the disappearance of serum HCV RNA occurred significantly earlier (p = 0.0017) in patients receiving hemodialysis than those without renal dysfunction. The rates of sustained virologic response, i.e., the eradication of HCV, were comparable between two groups; the rate of SVR12 was 100 % in patients receiving hemodialysis and 94.6 % in patients without renal dysfunction. No adverse constitutional events were observed in either of the groups. The elevation of serum alanine aminotransferase levels, a known adverse effect of these drugs, was observed in comparable rate of patients between the two groups.

conclusionsThe therapy with daclatasvir and asunaprevir has high antiviral efficacy in patients receiving hemodialysis with a comparable safety profile to patients without renal dysfunction.

Indexed as

Renal DialysisAgedAntiviral AgentsCarbamatesDrug Therapy, CombinationFemaleHepacivirusHepatitis C, ChronicHumansImidazolesIsoquinolinesKidney Failure, ChronicMaleMiddle AgedPyrrolidinesSulfonamidesAntiviral AgentsasunaprevirCarbamatesdaclatasvirImidazolesIsoquinolinesPyrrolidinesSulfonamidesValineChronic hepatitis CDirect-acting antiviral drugsHemodialysisSafetyViral response

Identifiers

PMID26872889
OpenAlexW4242579539

What OpenQuestion holds

Textmetadata
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.