Evidence map›Paper›PMID 27873094›Full record

Trial reportJournal of gastroenterology2017

The combination of elbasvir and grazoprevir for the treatment of chronic HCV infection in Japanese patients: a randomized phase II/III study.

Hiromitsu Kumada, Yoshiyuki Suzuki, Yoshiyasu Karino, Kazuaki Chayama, Norifumi Kawada, Takeshi Okanoue, Yoshito Itoh, Satoshi Mochida, Hidenori Toyoda, Hitoshi Yoshiji and 9 more

Registry-linked trialAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC 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. It is linked to trial NCT02203149 (A Phase II, Randomized Clinical Trial to Study the Safety, Tolerability, and Efficacy of the Combination Regimen of MK-5172 and MK-8742 in Japanese Subjects With Chronic Hepatitis C and a Phase III, Randomized Placebo-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of the Combination Regimen of MK-5172 and MK-8742 in Japanese Subjects With Chronic Hepatitis C), which is not on this map. Cited by 39 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing 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.

NCT02203149 phase2 / phase3completednot on this map

A Phase II, Randomized Clinical Trial to Study the Safety, Tolerability, and Efficacy of the Combination Regimen of MK-5172 and MK-8742 in Japanese Subjects With Chronic Hepatitis C and a Phase III, Randomized Placebo-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of the Combination Regimen of MK-5172 and MK-8742 in Japanese Subjects With Chronic Hepatitis C

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2014 to 2016Enrolled399ConditionsHepatitis CArmsGrazoprevir, Elbasvir, Placebo to Grazoprevir, Placebo to Elbasvir
3 · Its place in the literature

Who cites it

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

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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

19 authors.

Hiromitsu KumadaDepartment of Hepatology, Toranomon Hospital, 1-3-1 Kajigaya, Takatsu-ku, Kawasaki, Kanagawa, 213-8587, Japan. kumahiro@toranomon.gr.jp.
Yoshiyuki SuzukiDepartment of Hepatology, Toranomon Hospital, 1-3-1 Kajigaya, Takatsu-ku, Kawasaki, Kanagawa, 213-8587, Japan.
Yoshiyasu KarinoDepartment of Gastroenterology, Sapporo Kosei General Hospital, North-3 East-8, Chuou-ku, Sapporo, Hokkaido, 060-0033, Japan.
Kazuaki ChayamaDepartment of Gastroenterology and Metabolism, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, Japan.
Norifumi KawadaDepartment of Hepatology, Osaka City University Medical School, 1-4-3 Asahimachi, Abeno-ku, Osaka, 545-8585, Japan.
Takeshi OkanoueDepartment of Gastroenterology and Hepatology, Saiseikai Suita Hospital, 1-2 Kawazono-cho, Suita-Shi, Osaka, 564-0013, Japan.
Yoshito ItohDepartment of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan.
Satoshi MochidaDepartment of Gastroenterology and Hepatology, Saitama Medical University, 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan.
Hidenori ToyodaDepartment of Gastroenterology, Ogaki Municipal Hospital, 4-86 Minaminokawa, Ogaki, 503-8502, Japan.
Hitoshi YoshijiThird Department of Internal Medicine, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.
Shintaro TakakiDepartment of Gastroenterology/Liver Center, Hiroshima Red Cross Hospital and Atomic-Bomb Survivors Hospital, 1-9-6, Senda-machi, Naka-ku, Hiroshima, 730-8619, Japan.
Naoyoshi YatsuzukaMSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan.
Etsuo YodoyaMSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan.
Takashi IwasaMSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan.
Go FujimotoMSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan.
Michael N RobertsonMerck & Co.Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA.
Stuart BlackMerck & Co.Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA.
Luzelena CaroMerck & Co.Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA.
Janice WahlMerck & Co.Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundElbasvir (EBR) in combination with grazoprevir (GZR) has demonstrated efficacy in patients with hepatitis C virus (HCV) infections in trials primarily conducted in the USA and Europe. We investigated the safety and efficacy of EBR in combination with GZR in Japanese patients with chronic HCV infection, with or without cirrhosis.

methodsThe study was conducted in two parts. In part 1, noncirrhotic patients were randomized 1:1 to receive EBR (50 mg) in combination with GZR (50 or 100 mg) once daily for 12 weeks. In part 2, noncirrhotic patients were randomized 3:1 to receive immediate or deferred treatment with EBR (50 mg) and GZR (100 mg, determined in part 1) for 12 weeks; cirrhotic patients received open-label immediate treatment. The primary efficacy end point was the rate of sustained virologic response 12 weeks after completion of the study treatment.

resultsIn part 1, 63 patients were randomized to receive EBR in combination with GZR at a dose of 50 mg (n = 31) or 100 mg (n = 32). The SVR12 rates were 100% with GZR at a dose of 50 mg and 96.8% with GZR at a dose of 100 mg. Tolerability was similar in both arms. In part 2, 301 noncirrhotic patients were randomized to receive immediate treatment (n = 227) or deferred treatment (n = 74), and 35 cirrhotic patients were enrolled. The SVR12 rates were 96.5% and 97.1% after immediate treatment in noncirrhotic and cirrhotic patients respectively. Safety was generally similar between immediate and deferred treatment.

conclusionTreatment with EBR in combination with GZR for 12 weeks is effective and well tolerated in Japanese patients with chronic HCV infection. CLINICALTRIALS. GOV IDENTIFIER: NCT02203149.

Indexed as

Administration, OralAdultAgedAged, 80 and overAmidesAntiviral AgentsBenzofuransCarbamatesCyclopropanesDouble-Blind MethodDrug Administration ScheduleDrug Resistance, ViralDrug Therapy, CombinationFemaleHepacivirusHepatitis C, ChronicAmidesAntiviral AgentsBenzofuransCarbamatesCyclopropaneselbasvirgrazoprevirImidazolesLactams, MacrocyclicQuinoxalinesRNA, ViralSulfonamidesClinical trialEfficacyGenotypeSustained virologic responseTherapy

Identifiers

PMID27873094
PMCPMC5357479

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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.