Trial reportJournal of gastroenterology2018
Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 1 hepatitis C virus infection with and without cirrhosis.
Trial report in Journal of gastroenterology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02707952 (A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection), which is not on this map. Cited by 66 papers, 5 of them syntheses that pooled 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.
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.
A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection (CERTAIN-1)
Who cites it
66 citing papers in PubMed, 5 syntheses or guidelines pooled it, 114 citations in OpenAlex.
- [Guideline for the prevention and treatment of hepatitis C (2022 version)].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2022Guideline
- Drug-induced liver injury by glecaprevir/pibrentasvir treatment for chronic hepatitis C infection: a systematic review and meta-analysis.Annals of medicine · 2022Pooled it
- Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases-Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection.Hepatology (Baltimore, Md.) · 2020Guideline
- Treatment optimisation for hepatitis C in the era of combination direct-acting antiviral therapy: a systematic review and meta-analysis.Wellcome open research · 2019Pooled it
- 2017 KASL clinical practice guidelines management of hepatitis C: Treatment of chronic hepatitis C.Clinical and molecular hepatology · 2018Guideline
- Integrated Resistance Analysis of CERTAIN-1 and CERTAIN-2 Studies in Hepatitis C Virus-Infected Patients Receiving Glecaprevir and Pibrentasvir in Japan.Antimicrobial agents and chemotherapy · 2018Trial
- Diagnostic accuracy of a clinically accessible iTACT-based HCV core antigen assay in a Japanese cohort.Clinical and molecular hepatology · 2026Article
- Safety and Drug-Drug Interaction Burden of Direct-Acting Antiviral Therapy for Hepatitis C: A Single-Center Community Hospital Analysis.International journal of hepatology · 2026Article
- The usefulness of a simultaneous immunoassay for hepatitis C virus antigen-antibody using the ELECSYS HCV Duo assay.Hepatology forum · 2026Article
- Clinical factors to predict changes of esophagogastric varices after sustained viral response with direct-acting antiviral therapy.Journal of gastroenterology · 2025Article
- Self-testing strategy to eliminate hepatitis C as per World Health Organization's goal: Analysis of disease burden and cost-effectiveness.Clinical and molecular hepatology · 2025Article
- Elimination of hepatitis C in the Middle East: a narrative review of the efficacy of direct-acting antiviral therapies.Translational gastroenterology and hepatology · 2025Review
- Analysis of the susceptibility of refractory hepatitis C virus resistant to nonstructural 5A inhibitors.Scientific reports · 2024Article
- Effect of treatment periods on efficacy of glecaprevir and pibrentasvir in chronic hepatitis C: A nationwide, prospective, multicenter study.JGH open : an open access journal of gastroenterology and hepatology · 2024Article
- SASLT guidelines: Update in treatment of hepatitis C virus infection, 2024.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2024Review
- Efficacy and safety of glecaprevir and pibrentasvir in Saudi patients with chronic hepatitis C virus infection at a major tertiary hospital.Saudi medical journal · 2024Article
- Hepatitis C Virus Infection in the Elderly in the Era of Direct-Acting Antivirals: Evidence from Clinical Trials and Real Life.Tropical medicine and infectious disease · 2023Review
- Ledipasvir/Sofosbuvir Is Effective for Relapsed Genotype 1b Hepatitis C Virus Patients after Achieving a Sustained Virological Response at Post-treatment Week 12 with Glecaprevir/Pibrentasvir.Internal medicine (Tokyo, Japan) · 2023Article
- Simple new clinical score to predict hepatocellular carcinoma after sustained viral response with direct-acting antivirals.Scientific reports · 2023Article
- Risk Factors of Glecaprevir/Pibrentasvir-Induced Liver Injury and Efficacy of Ursodeoxycholic Acid.Viruses · 2023Article
6 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 12 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe once-daily, all oral, RBV-free, pangenotypic direct-acting anti-viral regimen consisting of co-formulated NS3/4A protease inhibitor glecaprevir and NS5A inhibitor pibrentasvir (G/P), demonstrated high rates of sustained virologic response (SVR) in phase 2 and 3 studies outside Japan.
methodsCERTAIN-1 is a phase 3, open-label, multicenter study assessing the safety and efficacy of G/P (300/120 mg) once daily in Japanese patients with chronic HCV GT1 infection. Patients without cirrhosis received 8 weeks of G/P or 12 weeks of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r, 25/150/100 mg); patients with cirrhosis received G/P for 12 weeks. The primary efficacy endpoint was non-inferiority of G/P compared to OBV/PTV/r by assessing SVR at post-treatment week 12 (SVR12) among non-cirrhotic patients without the NS5A Y93H polymorphism.
resultsSVR12 was achieved by 128/129 (99.2%; one patient lost to follow-up) non-cirrhotic patients in the 8-week G/P Arm (including 23/23 patients with the NS5A Y93H polymorphism) and 52/52 (100%) patients in the 12-week OBV/PTV/r Arm. No patients from the G/P Arm prematurely discontinued the study drug or experienced a treatment-emergent serious adverse event (TESAE). Three patients from the OBV/PTV/r Arm experienced five TESAEs and one of these patients discontinued the study drug due to TESAEs. All 38 (100%) patients with compensated cirrhosis achieved SVR12; in this group, no TESAEs were reported and one patient discontinued treatment due to an AE.
conclusionsCERTAIN-1 study results demonstrate high efficacy and favorable tolerability of G/P in GT1-infected Japanese patients including those with the NS5A Y93H polymorphism, with no virologic failures observed.
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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.