Evidence map›Paper›PMID 24604476›Full record

Trial reportHepatology (Baltimore, Md.)2014

Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection.

Hiromitsu Kumada, Yoshiyuki Suzuki, Kenji Ikeda, Joji Toyota, Yoshiyasu Karino, Kazuaki Chayama, Yoshiiku Kawakami, Akio Ido, Kazuhide Yamamoto, Koichi Takaguchi and 11 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Hepatology (Baltimore, Md.), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01497834 (A Phase 3 Japanese Study of BMS-790052 Plus BMS-650032 Combination Therapy in Chronic Hepatitis C Genotype 1b Infected Subjects Who Are Non Response to Interferon Plus Ribavirin and Interferon Based Therapy Ineligible Naive/Intolerant), which is not on this map. Cited by 211 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
211citing papers in PubMed, 3 pooled it
–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.

NCT01497834 phase3completednot on this map

A Phase 3 Japanese Study of BMS-790052 Plus BMS-650032 Combination Therapy in Chronic Hepatitis C Genotype 1b Infected Subjects Who Are Non Response to Interferon Plus Ribavirin and Interferon Based Therapy Ineligible Naive/Intolerant

TypeinterventionalSponsorBristol-Myers SquibbRan2012 to 2013Enrolled224ConditionsHepatitis CArmsBMS-790052 (Daclatasvir), BMS-650032 (Asunaprevir)
3 · Its place in the literature

Who cites it

211 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  3. KASL clinical practice guidelines: management of hepatitis C.Clinical and molecular hepatology · 2016
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151 more citing papers are in PubMed but not listed here.

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

21 authors.

Hiromitsu KumadaToranomon Hospital, Tokyo, Japan.
Yoshiyuki Suzuki
Kenji Ikeda
Joji Toyota
Yoshiyasu Karino
Kazuaki Chayama
Yoshiiku Kawakami
Akio Ido
Kazuhide Yamamoto
Koichi Takaguchi
Namiki Izumi
Kazuhiko Koike
Tetsuo Takehara
Norifumi Kawada
Michio Sata
Hidetaka Miyagoshi
Timothy Eley
Fiona McPhee
Andrew Damokosh
Hiroki Ishikawa
Eric Hughes

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledAll-oral combinations of direct-acting antivirals may improve efficacy and safety outcomes for patients with hepatitis C virus (HCV) infection, particularly those who are poor candidates for current interferon/ribavirin-based regimens. In this open-label, phase 3 study, 135 interferon-ineligible/intolerant and 87 nonresponder patients with chronic HCV genotype 1b infection were enrolled at 24 centers in Japan. Patients received daclatasvir 60 mg once daily plus asunaprevir 100 mg twice daily for 24 weeks. The primary endpoint was sustained virologic response 24 weeks after treatment (SVR24 ). This study is registered with ClinicalTrials.gov (NCT01497834). SVR24 was achieved by 87.4% of interferon-ineligible/intolerant patients and 80.5% of nonresponder (null and partial) patients; rates were similar in cirrhosis (90.9%) and noncirrhosis (84.0%) patients, and in patients with IL28B CC (84.5%) or non-CC (84.8%) genotypes. Fourteen patients in each group (12.6%) discontinued dual therapy, mainly due to adverse events or lack of efficacy. Nine nonresponder patients received additional treatment with peginterferon/ribavirin per protocol-defined criteria. The rate of serious adverse events was low (5.9%) and varied among patients. The most common adverse events were nasopharyngitis, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST), headache, diarrhea, and pyrexia.

conclusionInterferon-free, ribavirin-free all-oral therapy with daclatasvir and asunaprevir for 24 weeks is well tolerated and can achieve a high rate of SVR in patients with HCV genotype 1b who were ineligible, intolerant, or had not responded to prior interferon-based therapy. (Hepatology 2014;59:2083-2091).

Indexed as

AdultAgedCarbamatesDrug Therapy, CombinationFemaleHepacivirusHepatitis C, ChronicHumansImidazolesIsoquinolinesMaleMiddle AgedPyrrolidinesRNA, ViralSulfonamidesTreatment FailureasunaprevirCarbamatesdaclatasvirImidazolesIsoquinolinesPyrrolidinesRNA, ViralSulfonamidesValine

Identifiers

PMID24604476
PMCPMC4315868

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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.