Evidence map›Paper›PMID 31356562›Full record

ArticleJournal of the Chinese Medical Association : JCMA2019

Daclatasvir plus sofosbuvir, with or without ribavirin, is highly effective for all kinds of genotype-2 chronic hepatitis-C infection in Taiwan.

Sih-Hsien Wu, Chi-Jen Chu, Chien-Wei Su, Chung-Chi Lin, Shou-Dong Lee, Yuan-Jen Wang, Fa-Yauh Lee, Yi-Hsiang Huang, Ming-Chih Hou

Abstract read
In one paragraph

Article in Journal of the Chinese Medical Association : JCMA, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

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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

9 authors.

Sih-Hsien WuDivision of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.
Chi-Jen ChuDivision of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.
Chien-Wei SuDivision of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.
Chung-Chi LinFaculty of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.
Shou-Dong LeeFaculty of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.
Yuan-Jen WangFaculty of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.
Fa-Yauh LeeDivision of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.
Yi-Hsiang HuangDivision of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.
Ming-Chih HouDivision of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBased on the previously published results, 12 weeks of sofosbuvir (SOF) 400 mg/day plus ribavirin (RBV), the current direct antiviral agent regimen reimbursed by Bureau-of National-Health-Insurance (BNHI) of Taiwan for genotype-2 chronic hepatitis C (CHC), is suboptimal in efficacy, especially for difficult-to-treat subpopulations such as liver cirrhosis, previous interferon (IFN) treatment failure, and high viral-load. This study aimed to evaluate the efficacy and safety of SOF plus daclatasvir (DCV) for Taiwanese genotype-2 CHC patients.

methodsBetween March 2017 and December 2018, a total of 50 consecutive genotype-2 CHC patients who completed 12 weeks combination of SOF (400 mg/day) plus DCV (60 mg/day) with or without RBV by investigators were enrolled for analyses. When RBV was added, weight-based (800-1200 mg/day) approach was applied. Sustained virological response (SVR12) was defined by undetectable HCV RNA (<15 IU/mL) at the end and 12 weeks after completion of therapy.

resultsThe mean age was 62.0 ± 11.4 years, 16 (32.0%) of them were males and 20 (40.0%) of them failed to previous IFN. Severity of liver diseases was as follows: ≤F2 fibrosis: 24.0%; F3 fibrosis: 40.0%, Child-Pugh A cirrhosis: 30.0%; and Child-Pugh B-C cirrhosis: 6.0%. The mean baseline HCV RNA level was 6.19 ± 0.91 log10 IU/mL and 30 (60.0%) had baseline HCV RNA ≥ 2 million IU/mL. The rates of undetectable HCV RNA (<15 IU/mL) at weeks 2, 4, and end-of-treatment were 40%, 94%, and 100%, respectively. Majority (66.7%) of patients with detectable HCV RNA at week 2 belonged to low-level viremia (<50 IU/mL). Subjective adverse events (AEs) and laboratory abnormalities were more common for patients combining RBV. Grades of AEs were generally mild and all patients finished therapy without interruption. After post-treatment follow-up, all 50 patients (100%) achieved SVR12.

conclusionOur real-world cohort of Taiwan showed that a 12-week SOF/DCV-based treatment was well-tolerated and highly effective for genotype-2 CHC patients with or without liver cirrhosis.

Indexed as

AdultAgedAntiviral AgentsCarbamatesDrug Therapy, CombinationFemaleGenotypeHepacivirusHepatitis C, ChronicHumansImidazolesMaleMiddle AgedPyrrolidinesRetrospective StudiesRibavirinAntiviral AgentsCarbamatesdaclatasvirImidazolesPyrrolidinesRibavirinRNA, ViralSofosbuvirValine

Identifiers

PMID31356562
PMCPMC13048212

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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.