Evidence map›Paper›PMID 29600429›Full record

ArticleHepatology international2018

Efficacy and safety of ledipasvir/sofosbuvir for genotype 1b chronic hepatitis C patients with moderate renal impairment.

Tomomi Okubo, Masanori Atsukawa, Akihito Tsubota, Hidenori Toyoda, Noritomo Shimada, Hiroshi Abe, Keizo Kato, Korenobu Hayama, Taeang Arai, Ai Nakagawa-Iwashita and 7 more

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Hepatology international, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 11% 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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Guideline
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  13. Real-world safety and efficacy of sofosbuvir and ledipasvir for elderly patients.JGH open : an open access journal of gastroenterology and hepatology · 2018
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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

17 authors at 7 institutions in 1 country.

Tomomi OkuboDivision of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan.
Masanori AtsukawaDivision of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan. momogachi@yahoo.co.jp.
Akihito TsubotaCore Research Facilities for Basic Science, Research Center for Medical Sciences, Jikei University School of Medicine, 3-19-18 Nishishinbashi, Minato-ku, Tokyo, 105-8471, Japan.
Hidenori ToyodaDivision of Gastroenterology, Department of Internal Medicine, Ogaki Municipal Hospital, 4-86 Minaminokawachou, 503-0864, Ogaki, Gifu, Japan.
Noritomo ShimadaDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Otakanomori Hospital, 113 Toyoshiki, Kashiwa, Chiba, 277-0863, Japan.
Hiroshi AbeDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Shinmatsudo Central General Hospital, 1-380 Shinmatsudo, Matsudo, Chiba, 270-0034, Japan.
Keizo KatoDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Shinmatsudo Central General Hospital, 1-380 Shinmatsudo, Matsudo, Chiba, 270-0034, Japan.
Korenobu HayamaDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan.
Taeang AraiDivision of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan.
Ai Nakagawa-IwashitaDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan.
Norio ItokawaDivision of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan.
Chisa KondoDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan.
Chiaki KawamotoDivision of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan.
Etsuko IioDepartment of Virology and Liver Unit, Graduate School of Medical Sciences, Nagoya City University, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 487-0001, Japan.
Yasuhito TanakaDepartment of Virology and Liver Unit, Graduate School of Medical Sciences, Nagoya City University, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 487-0001, Japan.
Takashi KumadaDivision of Gastroenterology, Department of Internal Medicine, Ogaki Municipal Hospital, 4-86 Minaminokawachou, 503-0864, Ogaki, Gifu, Japan.
Katsuhiko IwakiriDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan.
Chiba Hokusou Hospital · JPNippon Medical School · JPNagoya City University · JPOgaki Municipal Hospital · JPShinmatsudo Central General Hospital · JPJikei University School of Medicine · JPOtemae Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimTo evaluate the efficacy and safety of ledipasvir and sofosbuvir therapy for genotype 1b in chronic hepatitis C patients with chronic kidney disease (CKD) stage 3.

methodsIn a multicenter collaborative retrospective study, 706 patients who have received ledipasvir which is NS5A inhibitor, and sofosbuvir 400 mg which is NS5B nucleoside polymerase inhibitor daily for 12 weeks between September 2015 and January 2017 were subjected to this analysis. Virologic response and adverse events in patients with CKD stage 3 were compared with those in patients with CKD stages 1 and 2.

resultsThe rates of sustained virologic response (SVR) were 97.0% in patients with CKD stage 1, 97.1% in patients with CKD stage 2, and 94.7% in patients with CKD stage 3, respectively. There were no significant differences in the SVR rates between CKD stages 1 and 2, and CKD stage 1 and stage 3. The incidence of adverse events over than grade 2 was 0% in patients with CKD stage 1, 0.5% in patients with CKD stage 2, and 3.0% in patients with CKD stage 3, respectively. For treatment and follow-up period, eGFR levels in the patients with CKD stage 3 were not worsened compared to those at baseline.

conclusionThis study suggested that the virologic response of ledipasvir and sofosbuvir in patients with CKD stage 3 was not inferior to those with CKD stages 1 and 2. In addition, administration of ledipasvir and sofosbuvir did not affect eGFR levels in the patients with CKD stage 3.

Indexed as

AdultAgedAged, 80 and overAge DistributionAntiviral AgentsBenzimidazolesCreatinineDrug Resistance, ViralFluorenesGenotypeGlomerular Filtration RateHepatitis B virusHepatitis C, ChronicHumansMaleMiddle AgedAntiviral AgentsBenzimidazolesCreatinineFluorenesledipasvir, sofosbuvir drug combinationSofosbuvirUridine MonophosphateChronic hepatitis CChronic kidney diseaseLedipasvirSofosbuvir

Identifiers

PMID29600429
OpenAlexW2795267652

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.