Evidence map›Paper›PMID 29599611›Full record

Trial reportWorld journal of gastroenterology2018

Daclatasvir plus asunaprevir in treatment-naïve patients with hepatitis C virus genotype 1b infection.

Lai Wei, Fu-Sheng Wang, Ming-Xiang Zhang, Ji-Dong Jia, Alexey A Yakovlev, Wen Xie, Eduard Burnevich, Jun-Qi Niu, Yong Jin Jung, Xiang-Jun Jiang and 14 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in World journal of gastroenterology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. [Guidelines for the prevention and treatment of hepatitis C (2019 version)].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2019
    Article
  5. Review
  6. [Real-world study of daclatasvir and asunaprevir combination in Chinese patients with HCV genotype 1b infection].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2018
    Article
  7. [Safety and efficacy of DCV-based DAAs therapy for chronic HCV infection in China].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of 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

24 authors.

Lai WeiPeking University People's Hospital and Peking University Hepatology Institute, Beijing 100044, China.
Fu-Sheng Wang302 Military Hospital of China, Beijing 100039, China.
Ming-Xiang Zhangthe Sixth People's Hospital of Shenyang, Shenyang 110006, Liaoning Province, China.
Ji-Dong JiaBeijing Friendship Hospital, Capital Medical University, Beijing 100050, China.
Alexey A YakovlevSaint-Petersburg State Healthcare Institution 'Clinical Infectious Hospital n.a. S.P. Botkin', Saint-Petersburg 191167, Russia.
Wen XieBeijing Ditan Hospital, Capital Medical University, Beijing 100015, China.
Eduard BurnevichI.M. Sechenov First Moscow State Medical University, Moscow 119991, Russia.
Jun-Qi NiuThe First Hospital of Jilin University, Jilin 1300021, Jilin Province, China.
Yong Jin JungSMG-SNU Boramae Medical Center, Seoul 07061, South Korea.
Xiang-Jun JiangQingdao Municipal Hospital, Qingdao 266011, Shandong Province, China.
Min XuGuangzhou No. 8 People's Hospital, Guangzhou 510060, Guangdong Province, China.
Xin-Yue ChenBeijing Youan Hospital, Capital Medical University, Beijing 100069, China.
Qing XieShanghai Ruijin Hospital, Jiaotong University School of Medicine, Shenyang 200025, Liaoning Province, China.
Jun LiTheFirst Affiliated Hospital with Nanjing Medical University, Nanjing 210029, Jiangsu Province, China.
Jin-Lin HouHepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou 510515, Guangdong Province, China.
Hong TangWest China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China.
Xiao-Guang DouChina Medical University, Shengjing Hospital, Shenyang 110004, Liaoning Province, China.
Yash GandhiBristol-Myers Squibb, Princeton, NJ 08540, United States.
Wen-Hua HuBristol-Myers Squibb, Princeton, NJ 08540, United States.
Fiona McPheeBristol-Myers Squibb, Wallingford, CT 06492, United States.
Stephanie NovielloBristol-Myers Squibb, Princeton, NJ 08540, United States.
Michelle TreitelBristol-Myers Squibb, Princeton, NJ 08540, United States.
Ling MoBristol-Myers Squibb, Shanghai 200040, China.
Jun DengBristol-Myers Squibb, Shanghai 200040, China. daniel.deng@bms.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo assess daclatasvir plus asunaprevir (DUAL) in treatment-naïve patients from mainland China, Russia and South Korea with hepatitis C virus (HCV) genotype 1b infection.

methodsPatients were randomly assigned (3:1) to receive 24 wk of treatment with DUAL (daclatasvir 60 mg once daily and asunaprevir 100 mg twice daily) beginning on day 1 of the treatment period (immediate treatment arm) or following 12 wk of matching placebo (placebo-deferred treatment arm). The primary endpoint was a comparison of sustained virologic response at posttreatment week 12 (SVR12) compared with the historical SVR rate for peg-interferon plus ribavirin (70%) among patients in the immediate treatment arm. The first 12 wk of the study were blinded. Safety was assessed in DUAL-treated patients compared with placebo patients during the first 12 wk (double-blind phase), and during 24 wk of DUAL in both arms combined.

resultsIn total, 207 patients were randomly assigned to immediate (

conclusionDUAL was well-tolerated during this phase 3 study, and SVR12 with DUAL treatment (92%) exceeded the historical SVR rate for peg-interferon plus ribavirin of 70%.

Indexed as

AdultAgedAntiviral AgentsCarbamatesChinaDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleGenotypeHepacivirusHepatitis C, ChronicHumansImidazolesIsoquinolinesLiver Function TestsAntiviral AgentsasunaprevirCarbamatesdaclatasvirImidazolesIsoquinolinesPlacebosPyrrolidinesSulfonamidesValineAsunaprevirChronic hepatitis CDaclatasvirDirect-acting antiviralGenotype 1bLiver diseaseNS3NS5A

Identifiers

PMID29599611
PMCPMC5871831

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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.