Evidence map›Paper›PMID 27198664›Full record

Trial reportHepatology international2016

A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 hepatitis C virus.

Young-Suk Lim, Sang Hoon Ahn, Kwan Sik Lee, Seung Woon Paik, Youn-Jae Lee, Sook-Hyang Jeong, Ju-Hyun Kim, Seung Kew Yoon, Hyung Joon Yim, Won Young Tak and 12 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Hepatology international, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 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.

NCT02021656 phase3completednot on this map

A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naïve and Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection

TypeinterventionalSponsorGilead SciencesRan2013 to 2017Enrolled384ConditionsChronic HCV InfectionArmsLDV/SOF
NCT04498936 phase4completednot on this mapstarted 2020, after this paper: background citation

Efficacy of Adding Sofosbuvir/Ledipasvir Combination, or Nitazoxanide to the Standard of Care in Treatment of COVID-19: A Randomized Controlled Trial

TypeinterventionalSponsorAssiut UniversityRan2020 to 2020Enrolled240ConditionsCOVIDArmsSofosbuvir and Ledipasvir, Nitazoxanide
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Trial
  3. No Evidence of Reactivation of Hepatitis B Virus Among Patients Treated With Ledipasvir-Sofosbuvir for Hepatitis C Virus Infection.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016
    Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Review
  11. Observational
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

22 authors.

Young-Suk LimDepartment of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Sang Hoon AhnDepartment of Internal Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.
Kwan Sik LeeDepartment of Gastroenterology and Hepatology, Gangnam Severance Hospital, Yonsei University Health System, Seoul, South Korea.
Seung Woon PaikDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Youn-Jae LeeDepartment of Infectious Diseases, Gastroenterology, and Hepatology, Inje University, Pusan Paik Hospital, Busan, South Korea.
Sook-Hyang JeongDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.
Ju-Hyun KimDepartment of Internal Medicine, Gachon University Gil Hospital, Incheon, South Korea.
Seung Kew YoonDepartment of Gastroenterology, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, South Korea.
Hyung Joon YimDepartment of Internal Medicine, Korea University Ansan Hospital, Ansan-si, Gyeonggi-do, South Korea.
Won Young TakDepartment of Internal Medicine, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, South Korea.
Sang-Young HanDepartment of Internal Medicine, Dong-A University Medical Center, Busan, South Korea.
Jenny C YangGilead Sciences, Inc, Foster City, CA, USA.
Hongmei MoGilead Sciences, Inc, Foster City, CA, USA.
Kimberly L GarrisonGilead Sciences, Inc, Foster City, CA, USA.
Bing GaoGilead Sciences, Inc, Foster City, CA, USA.
Steven J KnoxGilead Sciences, Inc, Foster City, CA, USA.
Phillip S PangGilead Sciences, Inc, Foster City, CA, USA.
Yoon Jun KimDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine and Liver Research Institute, Seoul, South Korea.
Kwan-Soo ByunDepartment of Internal Medicine, Korea University Guro Hospital, Seoul, South Korea.
Young Seok KimDepartment of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, South Korea.
Jeong HeoDepartment of Internal Medicine, Pusan National University and Medical Research Institute, Pusan National University Hospital, Busan, South Korea.
Kwang-Hyub HanDepartment of Internal Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea. gihankhys@yuhs.ac.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe standard-of-care regimen for chronic hepatitis C virus (HCV) infection in Korea, pegylated-interferon-alpha plus ribavirin, is poorly tolerated. Ledipasvir/sofosbuvir is a two-drug, fixed-dose combination tablet approved in the USA, European Union, and Japan for chronic genotype 1 HCV infection.

methodsThis single-arm, phase IIIb study (NCT02021656) investigated the efficacy and safety of ledipasvir/sofosbuvir fixed-dose combination tablet for 12 weeks in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 HCV with or without compensated cirrhosis.

resultsThe proportion of patients with sustained virologic response 12 weeks after treatment discontinuation (SVR12) was 99 % (92/93), with rates of 100 % (46/46) and 98 % (46/47) in treatment-naïve and treatment-experienced patients, respectively. There were no on-treatment failures. One patient relapsed after the end of treatment. The most common treatment-emergent adverse events were headache (8 %, 7/93) and fatigue (6 %, 6/93). There were no grade 3 or 4 adverse events, seven grade 3 laboratory abnormalities, and one premature discontinuation of study treatment (due to nonserious mouth ulceration). None of the three reported serious adverse events were related to treatment.

conclusionsThese data suggest that 12 weeks of ledipasvir/sofosbuvir is effective and well tolerated in treatment-naïve and treatment-experienced Korean patients with chronic genotype 1 HCV infection.

Indexed as

AdultAgedAntiviral AgentsBenzimidazolesDrug Administration ScheduleFemaleFluorenesGenotypeHepacivirusHepatitis C, ChronicHumansMaleMiddle AgedRepublic of KoreaSofosbuvirSustained Virologic ResponseAntiviral AgentsBenzimidazolesFluorenesledipasvir, sofosbuvir drug combinationSofosbuvirTabletsUridine MonophosphateGenotype 1Hepatitis C virus (HCV)KoreaLedipasvirSofosbuvir

Identifiers

PMID27198664

What OpenQuestion holds

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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.