Evidence map›Paper›PMID 26155891›Full record

ArticleAdvances in therapy2015

High Sustained Virologic Response to Daclatasvir Plus Asunaprevir in Elderly and Cirrhotic Patients with Hepatitis C Virus Genotype 1b Without Baseline NS5A Polymorphisms.

Fiona McPhee, Yoshiyuki Suzuki, Joji Toyota, Yoshiyasu Karino, Kasuaki Chayama, Yoshiiku Kawakami, Min Lung Yu, Sang Hoon Ahn, Hiroki Ishikawa, Rafia Bhore and 4 more

Open access · hybridAbstract read
In one paragraph

Article in Advances in therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 4 pooled it
8.9field-weighted citation impact, top 1% of its field
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

29 citing papers in PubMed, 4 syntheses or guidelines pooled it, 70 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Guideline
  4. KASL clinical practice guidelines: management of hepatitis C.Clinical and molecular hepatology · 2016
    Guideline
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  19. Interferon-Free Therapy in Elderly Patients With Advanced Liver Disease.The American journal of gastroenterology · 2017
    Article
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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

14 authors at 6 institutions in 5 countries.

Fiona McPheeBristol-Myers Squibb Research and Development, Wallingford, CT, USA, fiona.mcphee@BMS.com.
Yoshiyuki Suzuki
Joji Toyota
Yoshiyasu Karino
Kasuaki Chayama
Yoshiiku Kawakami
Min Lung Yu
Sang Hoon Ahn
Hiroki Ishikawa
Rafia Bhore
Nannan Zhou
Dennis Hernandez
Patricia Mendez
Hiromitsu Kumada
Bristol-Myers Squibb (Germany) · DEHiroshima University · JPSapporo Kosei General Hospital · JPToranomon Hospital · JPKaohsiung Medical University Chung-Ho Memorial Hospital · TWYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOral daclatasvir (DCV; pangenotypic NS5A inhibitor) plus asunaprevir (ASV; NS3 protease inhibitor) is approved in Japan and Korea for treatment of chronic hepatitis C virus (HCV) genotype 1. Response to DCV + ASV is affected by DCV resistance-associated polymorphisms (RAPs) in HCV NS5A. The prevalence and influence of these RAPs on 12-week sustained virologic response (SVR12) to DCV + ASV was evaluated in Asian and non-Asian patients.

methodsData were pooled from 5 national and international studies of patients with HCV genotype 1b (GT-1b) receiving DCV + ASV at their recommended doses. Baseline NS5A RAPs and their effect on SVR12 were assessed overall, in older (≥65 years) patients, patients with cirrhosis, and in patients stratified by baseline HCV RNA or prior treatment experience with interferon-based therapy.

resultsBaseline NS5A sequences were available from 988 patients (374 Japanese; 125 Korean/Taiwanese; 489 from non-Asian countries), 979 of whom were assessed for SVR12. Pretreatment NS5A-L31F/I/M/V and/or NS5A-Y93H polymorphisms were present in 18% of Japanese and 12-13% of non-Japanese patients; these RAPs reduced SVR12 by 54.9% overall (93.9% [787/838] SVR12 when absent, 39.0% [55/141] SVR12 when present), with comparable reductions observed in Asians and non-Asians and across all categories of treatment experience, age, and cirrhosis. RAP-associated SVR12 rates declined with increasing baseline HCV RNA (SVR12 with RAPs: 64.7% [11/17] at 5-6 log10 IU/mL, 29.8% [14/47] at 7-8 log10). Without baseline RAPs, very high SVR12 rates (92-100%) were observed in older patients and patients with cirrhosis irrespective of national origin, with similarly high rates observed among treatment-naïve and interferon-experienced patients and those with high baseline HCV RNA.

conclusionsFollowing DCV + ASV treatment, the SVR12 rates in GT-1b patients without baseline NS5A-L31F/I/M/V and/or NS5A-Y93H polymorphisms were very high (approximately 90-100%), irrespective of age, cirrhosis, prior interferon treatment, or baseline HCV RNA.

fundingBristol-Myers Squibb.

Indexed as

AdultAgedAntiviral AgentsAsian PeopleCarbamatesDrug Resistance, ViralDrug Therapy, CombinationGenotypeHepacivirusHepatitis C, ChronicHumansImidazolesIsoquinolinesJapanLiver CirrhosisMiddle AgedAntiviral AgentsasunaprevirCarbamatesdaclatasvirImidazolesIsoquinolinesnonstructural phosphoprotein 5A, GB virus type CPhosphoproteinsPyrrolidinesSulfonamidesValineViral Nonstructural Proteins

Identifiers

PMID26155891
PMCPMC4522028
OpenAlexW1954015314

What OpenQuestion holds

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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.