Evidence map›Paper›PMID 29792020›Full record

ArticleThe Korean journal of internal medicine2019

Daclatasvir and asunaprevir combination therapy for patients with chronic hepatitis C virus genotype 1b infection in real world.

Jae Young Oh, Byung Seok Kim, Chang Hyeong Lee, Jeong Eun Song, Heon Ju Lee, Jung Gil Park, Jae Seok Hwang, Woo Jin Chung, Byoung Kuk Jang, Young Oh Kweon and 5 more

Abstract readMulticenter Study
In one paragraph

Article in The Korean journal of internal medicine, 2019. 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. Observational
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

15 authors.

Jae Young OhDepartment of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea.
Byung Seok KimDepartment of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea.
Chang Hyeong LeeDepartment of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea.
Jeong Eun SongDepartment of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea.
Heon Ju LeeDepartment of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
Jung Gil ParkDepartment of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
Jae Seok HwangDepartment of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.
Woo Jin ChungDepartment of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.
Byoung Kuk JangDepartment of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.
Young Oh KweonDepartment of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea.
Won Young TakDepartment of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea.
Soo Young ParkDepartment of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea.
Se Young JangDepartment of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea.
Jeong Ill SuhDepartment of Internal Medicine, Dongguk University College of Medicine, Gyeongju, Korea.
Sang Gyu KwakDepartment of Medical Statistics, Catholic University of Daegu School of Medicine, Daegu, Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsPrevious studies have reported a high rate of sustained virologic response (SVR) and a low rate of serious adverse events with the use of daclatasvir (DCV) and asunaprevir (ASV) combination therapy. We evaluated the efficacy and safety of DCV and ASV combination therapy for patients with chronic hepatitis C virus (HCV) genotype 1b infection in real world.

methodsWe enrolled 278 patients (184 treatment-naïve patients) from five hospitals in Daegu and Gyeongsangbuk-do. We evaluated the rates of rapid virologic response (RVR), end-of-treatment response (ETR), and SVR at 12 weeks after completion of treatment (SVR12). Furthermore, we investigated the rate of adverse events and predictive factors of SVR12 failure.

resultsThe mean age of patients was 59.5 ± 10.6 years, and 140 patients (50.2%) were men. Seventy-seven patients had cirrhosis. Baseline information regarding nonstructural protein 5A (NS5A) sequences was available in 268 patients. Six patients presented with pretreatment NS5A resistance-associated variants. The RVR and the ETR rates were 96.6% (258/267) and 95.2% (223/232), respectively. The overall SVR12 rate was 91.6% (197/215). Adverse events occurred in 17 patients (7.9%). Six patients discontinued treatment because of liver enzyme elevation (n = 4) and severe nausea (n = 2). Among these, four achieved SVR12. Other adverse events observed were fatigue, headache, diarrhea, dizziness, loss of appetite, skin rash, and dyspnea. Univariate analysis did not show significant predictive factors of SVR12 failure.

conclusionDCV and ASV combination therapy showed high rates of RVR, ETR, and SVR12 in chronic HCV genotype 1b-infected patients in real world and was well tolerated without serious adverse events.

Indexed as

AgedAntiviral AgentsCarbamatesDrug CombinationsFemaleGenotypeHepacivirusHepatitis C, ChronicHumansImidazolesIsoquinolinesMaleMiddle AgedPyrrolidinesRepublic of KoreaRetrospective StudiesAntiviral AgentsasunaprevirCarbamatesdaclatasvirDrug CombinationsImidazolesIsoquinolinesPyrrolidinesSulfonamidesValineAsunaprevirDaclatasvirGenotype 1bHepatitis C, chronicReal world

Identifiers

PMID29792020
PMCPMC6610199

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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.