Evidence map›Paper›PMID 27502287›Full record

Trial reportJournal of gastroenterology2017

Daclatasvir/asunaprevir/beclabuvir fixed-dose combination in Japanese patients with HCV genotype 1 infection.

Joji Toyota, Yoshiyasu Karino, Fumitaka Suzuki, Fusao Ikeda, Akio Ido, Katsuaki Tanaka, Koichi Takaguchi, Atsushi Naganuma, Eiichi Tomita, Kazuaki Chayama and 11 more

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

Trial report in Journal of gastroenterology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
6.5field-weighted citation impact, top 3% 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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.

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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

21 authors at 13 institutions in 2 countries.

Joji ToyotaDepartment of Gastroenterology, Sapporo-Kosei General Hospital, 8-5 Higashi Kita-3-jo Chuo-ku, Sapporo-shi, Hokkaido, Japan. joji.toyota@ja-hokkaidoukouseiren.or.jp.
Yoshiyasu KarinoDepartment of Gastroenterology, Sapporo-Kosei General Hospital, 8-5 Higashi Kita-3-jo Chuo-ku, Sapporo-shi, Hokkaido, Japan.
Fumitaka SuzukiToranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo, Japan.
Fusao IkedaOkayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama, Japan.
Akio IdoKagoshima University, 8-35-1 Sakuragoka, Kagoshima-shi, Kagoshima, Japan.
Katsuaki TanakaYokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, Kanagawa, Japan.
Koichi TakaguchiKagawa Prefectural Central Hospital, 1-2-1 Asahimachi, Takamatsu-shi, Kagawa, Japan.
Atsushi NaganumaTakasaki General Medical Center, 36 Takamatsu-cho, Takasaki-shi, Gunma, Japan.
Eiichi TomitaGifu Municipal Hospital, 7-1 Kashima-cho, Gifu-shi, Gifu, Japan.
Kazuaki ChayamaHiroshima University, 1-2-3 Kasumi, Minami-Ku, Hiroshima-shi, Hiroshima, Japan.
Shigetoshi FujiyamaKumamoto Shinto General Hospital, 1-17-27 Shinyashiki, Chuo-ku, Kumamoto, Kumamoto, Japan.
Yukiko InadaMiyazaki Medical Center Hospital, 2-16 Takamatsu-cho, Miyazaki-shi, Miyazaki, Japan.
Hitoshi YoshijiNara Medical University, 840 Shijocho, Kashihara-shi, Nara, Japan.
Hideaki WatanabeBristol-Myers Squibb K.K., 5-1 Nishi-Shinjuku 6-chome, Shinjuku-ku, Tokyo, Japan.
Hiroki IshikawaBristol-Myers Squibb K.K., 5-1 Nishi-Shinjuku 6-chome, Shinjuku-ku, Tokyo, Japan.
Wenhua HuBristol-Myers Squibb, 5 Research Parkway, Wallingford, CT, USA.
Fiona McPheeBristol-Myers Squibb, 5 Research Parkway, Wallingford, CT, USA.
Misti LinaberryBristol-Myers Squibb, 100 Nassau Park Blvd, Princeton, NJ, USA.
Philip D YinBristol-Myers Squibb, 5 Research Parkway, Wallingford, CT, USA.
Eugene Scott SwensonBristol-Myers Squibb, 5 Research Parkway, Wallingford, CT, USA.
Hiromitsu KumadaToranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo, Japan.
Bristol-Myers Squibb (United States) · USBristol-Myers Squibb (Japan) · JPSapporo Kosei General Hospital · JPToranomon Hospital · JPGifu Municipal Hospital · JPHiroshima University · JPKagawa Prefectural Central Hospital · JPKagoshima University · JPNara Medical University · JPNational Hospital Organization Takasaki Medical Center · JPOkayama University · JPUniversity of Miyazaki Hospital · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDCV-TRIO, a fixed-dose combination of daclatasvir (pangenotypic NS5A inhibitor), asunaprevir (NS3/4A protease inhibitor), and beclabuvir (non-nucleoside NS5B inhibitor), has achieved high rates of sustained virologic response at post-treatment Week 12 (SVR12) in phase 3 studies.

methodsIn this phase 3 study, DCV-TRIO for 12 weeks and daclatasvir plus asunaprevir (DUAL) for 24 weeks were studied in Japanese patients infected with HCV genotype 1 (99 % genotype 1b).

resultsSVR12 rates ≥95 % were achieved in both treatment-naive (N = 152) and interferon-experienced (N = 65) cohorts treated with DCV-TRIO for 12 weeks and were comparable across patient subgroups, including patients aged ≥65 years and those with cirrhosis. DUAL recipients (N = 75) had an SVR12 rate of 87 %. In the absence of baseline resistance-associated polymorphisms at positions NS5A-Y93H or -L31, SVR12 rates were 98 % with DCV-TRIO or DUAL. Among genotype 1b-infected patients with baseline Y93H or L31 polymorphisms, 35/38 (92 %) DCV-TRIO recipients, and 7/16 (44 %) DUAL recipients achieved SVR12. Adverse events, mostly liver related, led to treatment discontinuation in 10 % of DCV-TRIO recipients. In this group, SVR12 was achieved by 3/9 patients who discontinued before Week 4 and by 12/12 patients who completed ≥4 weeks of DCV-TRIO. Treatment-related serious adverse events occurred in 4 and 3 % of DCV-TRIO and DUAL recipients, respectively. Seven patients (9 %) discontinued DUAL due to adverse events. No deaths occurred.

conclusionSVR12 was achieved by 96 % of Japanese patients with HCV genotype 1 infection after 12 weeks of treatment with the DCV-TRIO regimen. DCV-TRIO and DUAL exhibited comparable safety profiles.

Indexed as

AdultAgedAged, 80 and overAntiviral AgentsBenzazepinesCarbamatesDouble-Blind MethodDrug Administration ScheduleDrug CombinationsFemaleGenotypeHepacivirusHepatitis C, ChronicHumansImidazolesIndoles8-cyclohexyl-N-((dimethylamino)sulfonyl)-1,1a,2,12b-tetrahydro-11-methoxy-1a-((3-methyl-3,8-diazabicyclo(3.2.1)oct-8-yl)carbonyl)cycloprop(d)indolo(2,1-a)(2)benzazepine-5-carboxamideAntiviral AgentsasunaprevirBenzazepinesCarbamatesdaclatasvirDrug CombinationsImidazolesIndolesIsoquinolinesPyrrolidinesRNA, ViralSulfonamidesValineDirect-acting antiviralHCV therapyNS3/4A inhibitorNS5A inhibitorNS5B inhibitor

Identifiers

PMID27502287
OpenAlexW2478752051

What OpenQuestion holds

Textmetadata
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.