Evidence map›Paper›PMID 28798288›Full record

ArticleGut and liver2018

The Real-World Safety and Efficacy of Daclatasvir and Asunaprevir for Elderly Patients.

Shinya Taki, Hideyuki Tamai, Yoshiyuki Ida, Naoki Shingaki, Akira Kawashima, Ryo Shimizu, Kosaku Moribata, Takao Maekita, Mikitaka Iguchi, Jun Kato and 2 more

Abstract read
In one paragraph

Article in Gut and liver, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

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

12 authors.

Shinya TakiSecond Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
Hideyuki TamaiSecond Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
Yoshiyuki IdaSecond Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
Naoki ShingakiSecond Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
Akira KawashimaDepartment of Internal Medicine, Naga Municipal Hospital, Wakayama, Japan.
Ryo ShimizuSecond Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
Kosaku MoribataSecond Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
Takao MaekitaSecond Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
Mikitaka IguchiSecond Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
Jun KatoSecond Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
Taisei NakaoDepartment of Internal Medicine, Naga Municipal Hospital, Wakayama, Japan.
Masayuki KitanoSecond Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsAlthough daclatasvir with asunaprevir was approved in Japan for interferon ineligible or intolerant patients, patients aged ≥75 years were excluded in the phase III trial. The present study aimed to evaluate the safety and efficacy of this therapy for elderly patients aged ≥75 years and to clarify whether an extremely high sustained virological response (SVR) rate can be achieved, even in a real-world setting when patients with resistance-associated substitutions (RASs) to nonstructural protein 5A (NS5A) inhibitors or prior simeprevir failure are excluded.

methodsDaclatasvir (60 mg) and asunaprevir (100 mg) were orally administered daily for 24 weeks. Patients without pre-existing NS5A RASs and simeprevir failure were enrolled in this study.

resultsOverall, 110 patients were treated. The median age was 73 years old. The SVR rates of total patients, those aged ≥75 years, and those aged <75 years were 97% (107/110), 98% (46/47), and 97% (61/63), respectively. The treatment of two patients (2%) was discontinued because of adverse events.

conclusionsDaclatasvir with asunaprevir was a safe treatment, even in patients aged ≥75 years. When patients without pre-existing NS5A RASs and prior simeprevir failure were selected, an extremely high SVR rate could be achieved irrespective of age.

Indexed as

AgedAged, 80 and overAntiviral AgentsCarbamatesDrug Resistance, ViralDrug Therapy, CombinationFemaleHepacivirusHepatitis C, ChronicHumansImidazolesIsoquinolinesJapanMalePyrrolidinesRNA-Dependent RNA PolymeraseAntiviral AgentsasunaprevirCarbamatesdaclatasvirImidazolesIsoquinolinesNS-5 protein, hepatitis C virusPyrrolidinesRNA-Dependent RNA PolymeraseSulfonamidesValineViral Nonstructural ProteinsAsunaprevirDaclatasvirGenotype 1bHepacivirus

Identifiers

PMID28798288
PMCPMC5753689

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.