Evidence map›Paper›PMID 37424500›Full record

Trial reportThe Korean journal of internal medicine2023

Efficacy and safety of sofosbuvir-velpatasvir and sofosbuvir-velpatasvir-voxilaprevir for hepatitis C in Korea: a Phase 3b study.

Jeong Heo, Yoon Jun Kim, Sung Wook Lee, Youn-Jae Lee, Ki Tae Yoon, Kwan Soo Byun, Yong Jin Jung, Won Young Tak, Sook-Hyang Jeong, Kyung Min Kwon and 15 more

Open access · goldAbstract readMulticenter StudyClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Korean journal of internal medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.6field-weighted citation impact, top 16% 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

7 citing papers in PubMed, 8 citations in OpenAlex.

  1. Observational
  2. Observational
  3. Article
  4. Observational
  5. Observational
  6. Article
  7. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 19 institutions in 3 countries.

Jeong HeoDepartment of Internal Medicine, College of Medicine, Pusan National University and Biomedical Research Institute, Pusan National University Hospital, Busan, Korea.
Yoon Jun KimDepartment of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Sung Wook LeeDepartment of Internal Medicine, Dong-A University Hospital, Dong-A University College of Medicine, Busan, Korea.
Youn-Jae LeeDepartment of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.
Ki Tae YoonDepartment of Internal Medicine, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Yangsan, Korea.
Kwan Soo ByunDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
Yong Jin JungDivision of Gastroenterology, Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
Won Young TakDepartment of Internal Medicine, Kyungpook National University Hospital, School of Medicine, Kyungpook National University, Daegu, Korea.
Sook-Hyang JeongDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
Kyung Min KwonGilead Sciences, Inc., Foster City, CA, USA.
Vithika SuriGilead Sciences, Inc., Foster City, CA, USA.
Peiwen WuGilead Sciences, Inc., Foster City, CA, USA.
Byoung Kuk JangDepartment of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.
Byung Seok LeeDepartment of Internal Medicine, School of Medicine, Chungnam National University, Daejeon, Korea.
Ju-Yeon ChoDepartment of Internal Medicine, College of Medicine, Chosun University, Gwangju, Korea.
Jeong Won JangDivision of Hepatology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Soo Hyun YangDepartment of Internal Medicine, Veterans Health Service Medical Center, Seoul, Korea.
Seung Woon PaikDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Hyung Joon KimDepartment of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
Jung Hyun KwonDivision of Hepatology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Neung Hwa ParkDepartment of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
Ju Hyun KimDepartment of Internal Medicine, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.
In Hee KimDepartment of Internal Medicine, Jeonbuk National University Hospital, Jeonju, Korea.
Sang Hoon AhnDepartment of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
Young-Suk LimDepartment of Gastroenterology, Liver Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Gilead Sciences (United States) · USCatholic University of Korea · KRSeoul National University · KRUlsan College · KRYonsei University · KRChosun University · KRChung-Ang University · KRChungnam National University · KRDong-A University Hospital · KRGachon University Gil Medical Center · KRInje University Busan Paik Hospital · KRJeonbuk National University · KRKeimyung University · KRKorea University · KRKyungpook National University Hospital · KRPusan National University Yangsan Hospital · KRSamsung Medical Center · KRSeoul National University Bundang Hospital · KRVeterans Health Service Medical Center · KR

Funding

Gilead Sciences, Inc.
6 · The paper itself

Abstract

BACKGROUND/

aimsDespite the availability of direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) infection in Korea, need remains for pangenotypic regimens that can be used in the presence of hepatic impairment, comorbidities, or prior treatment failure. We investigated the efficacy and safety of sofosbuvir-velpatasvir and sofosbuvir-velpatasvir-voxilaprevir for 12 weeks in HCV-infected Korean adults.

methodsThis Phase 3b, multicenter, open-label study included 2 cohorts. In Cohort 1, participants with HCV genotype 1 or 2 and who were treatment-naive or treatment-experienced with interferon-based treatments, received sofosbuvir-velpatasvir 400/100 mg/day. In Cohort 2, HCV genotype 1 infected individuals who previously received an NS5A inhibitor-containing regimen ≥ 4 weeks received sofosbuvir-velpatasvir-voxilaprevir 400/100/100 mg/day. Decompensated cirrhosis was an exclusion criterion. The primary endpoint was SVR12, defined as HCV RNA < 15 IU/mL 12 weeks following treatment.

resultsOf 53 participants receiving sofosbuvir-velpatasvir, 52 (98.1%) achieved SVR12. The single participant who did not achieve SVR12 experienced an asymptomatic Grade 3 ASL/ALT elevation on day 15 and discontinued treatment. The event resolved without intervention. All 33 participants (100%) treated with sofosbuvir-velpatasvir-voxilaprevir achieved SVR 12. Overall, sofosbuvir-velpatasvir and sofosbuvir-velpatasvir-voxilaprevir were safe and well tolerated. Three participants (5.6%) in Cohort 1 and 1 participant (3.0%) in Cohort 2 had serious adverse events, but none were considered treatment-related. No deaths or grade 4 laboratory abnormalities were reported.

conclusionTreatment with sofosbuvir-velpatasvir or sofosbuvir-velpatasvir-voxilaprevir was safe and resulted in high SVR12 rates in Korean HCV patients.

Indexed as

Hepatitis CHepatitis C, ChronicAdultAminoisobutyric AcidsAntiviral AgentsBenzimidazolesBenzopyransCarbamatesCyclopropanesDrug Therapy, CombinationGenotypeHepacivirusHeterocyclic Compounds, 4 or More RingsHumansLactams, MacrocyclicLeucineAminoisobutyric AcidsAntiviral AgentsBenzimidazolesBenzopyransCarbamatesCyclopropanesHeterocyclic Compounds, 4 or More RingsLactams, MacrocyclicLeucineProlineQuinoxalinesSofosbuvirSulfonamidesvelpatasvirvoxilaprevirDecompensated cirrhosisDirect-acting antiviralNS5A inhibitorPolymerase inhibitorProtease inhibitor

Identifiers

PMID37424500
PMCPMC10338242
OpenAlexW4382789860

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.