Evidence map›Paper›PMID 31132846›Full record

ArticleClinical and molecular hepatology2019

An integrated analysis of elbasvir/grazoprevir in Korean patients with hepatitis C virus genotype 1b infection.

Youn Jae Lee, Jeong Heo, Do Young Kim, Woo Jin Chung, Won Young Tak, Yoon Jun Kim, Seung Woon Paik, Eungeol Sim, Susila Kulasingam, Rohit Talwani and 2 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical and molecular hepatology, 2019. 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. Article
  2. Observational
  3. Article
  4. Article
  5. Article
  6. Article
  7. 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.

Youn Jae LeeDepartment of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.
Jeong HeoDepartment of Internal Medicine, College of Medicine, Pusan National University, Busan, Korea.
Do Young KimDepartment of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
Woo Jin ChungDepartment of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.
Won Young TakDepartment of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea.
Yoon Jun KimDepartment of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Seung Woon PaikDepartment of Medicine, Samsung Medical Center, School of Medicine, Sungkyunkwan University, Seoul, Korea.
Eungeol SimMerck & Co., Inc., Kenilworth, NJ, USA.
Susila KulasingamMerck & Co., Inc., Kenilworth, NJ, USA.
Rohit TalwaniMerck & Co., Inc., Kenilworth, NJ, USA.
Barbara HaberMerck & Co., Inc., Kenilworth, NJ, USA.
Peggy HwangMerck & Co., Inc., Kenilworth, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsIn the Republic of Korea, an estimated 231,000 individuals have chronic hepatitis C virus (HCV) infection. The aim of the present analysis was to evaluate the safety and efficacy of elbasvir/grazoprevir (EBR/GZR) administered for 12 weeks in Korean patients who were enrolled in international clinical trial phase 3 studies.

methodsThis was a retrospective, integrated analysis of data from patients with HCV genotype (GT) 1b infection enrolled at Korean study sites in four EBR/GZR phase 3 clinical trials. Patients were treatment-naive or had previously failed interferon-based HCV therapy, and included those with human immunodeficiency virus coinfection or ChildPugh class A cirrhosis. All patients received EBR 50 mg/GZR 100 mg once daily for 12 weeks. The primary endpoint was sustained virologic response at 12 weeks after completion of therapy (SVR12, HCV RNA <15 IU/mL).

resultsSVR12 was achieved by 73 of 74 (98.6%) patients. No patients had virologic failure and one discontinued from the study after withdrawing consent. SVR12 rates were uniformly high across all patient subgroups. A total of 16 patients had nonstructural protein 5A resistance-associated substitutions at baseline (16/73, 22%), all of whom achieved SVR12. Adverse events (AEs) reported in >5% of patients were fatigue (6.8%), upper respiratory tract infection (5.4%), headache (5.4%), and nausea (5.4%). Thirteen patients (17.6%) reported drug-related AEs, two serious AEs occurred, and two patients discontinued treatment owing to an AEs.

conclusionIn this retrospective analysis, EBR/GZR administered for 12 weeks was well-tolerated and highly effective in Korean patients with HCV GT1b infection.

Indexed as

AdultAgedAmidesAntiviral AgentsBenzofuransCarbamatesClinical Trials, Phase III as TopicCyclopropanesDrug Resistance, ViralFatigueFemaleGenotypeHepacivirusHepatitis CHumansImidazolesAmidesAntiviral AgentsBenzofuransCarbamatesCyclopropaneselbasvirgrazoprevirImidazolesLactams, MacrocyclicNS-5 protein, hepatitis C virusQuinoxalinesRNA-Dependent RNA PolymeraseSulfonamidesViral Nonstructural ProteinsAntiviral agentsHepatitis C, ChronicSustained virologic response

Identifiers

PMID31132846
PMCPMC6933128

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.