Evidence map›Paper›PMID 34023350›Full record

ArticleJournal of hepatology2021

Sofosbuvir/velpatasvir for 12 vs. 6 weeks for the treatment of recently acquired hepatitis C infection.

Gail V Matthews, Sanjay Bhagani, Marc Van der Valk, Juergen Rockstroh, Jordan J Feld, Andri Rauch, Christine Thurnheer, Julie Bruneau, Arthur Kim, Margaret Hellard and 14 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter Study
In one paragraph

Article in Journal of hepatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02625909 (A Randomised Study of Interferon-free Treatment for Recently Acquired Hepatitis C in People Who Inject Drugs and People With HIV Coinfection.), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 4% 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.

NCT02625909 phase3completednot on this map

A Randomised Study of Interferon-free Treatment for Recently Acquired Hepatitis C in People Who Inject Drugs and People With HIV Coinfection.

TypeinterventionalSponsorKirby InstituteRan2017 to 2020Enrolled222ConditionsHepatitis CArmsSOF/VEL for 6 weeks, SOF/VEL for 12 weeks
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 47 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Short Course Therapy With Glecaprevir/Pibrentasvir for Early Hepatitis C Virus Infection: PURGE-C.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
  7. Article
  8. Article
  9. [Recent Advances in the Treatment of Chronic Hepatitis C].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2025
    Review
  10. Article
  11. Article
  12. Review
  13. SASLT guidelines: Update in treatment of hepatitis C virus infection, 2024.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2024
    Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. Article
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

24 authors at 20 institutions in 8 countries.

Gail V MatthewsKirby Institute, UNSW Sydney, Australia; St Vincent's Hospital, Sydney, Australia. Electronic address: gmatthews@kirby.unsw.edu.au.
Sanjay BhaganiRoyal Free Hospital, London, United Kingdom.
Marc Van der ValkAmsterdam University Medical Centers, Academic Medical Center, University of Amsterdam, Department of Infectious Diseases, Amsterdam Infection & Immunity Institute, Amsterdam, the Netherlands.
Juergen RockstrohUniversity Clinic Bonn, Bonn, Germany.
Jordan J FeldToronto Centre for Liver Diseases, Toronto General Hospital, Toronto, Canada.
Andri RauchDepartment of Infectious Diseases, Inselspital, Bern, Switzerland.
Christine ThurnheerDepartment of Infectious Diseases, Inselspital, Bern, Switzerland.
Julie BruneauCentre Hospitalier de l'Université de Montréal, Montréal, Canada.
Arthur KimDivision of Infectious Diseases, Massachusetts General Hospital, Boston, United States.
Margaret HellardThe Alfred Hospital, Melbourne, Australia; The Burnet Institute, Melbourne, Australia.
David ShawRoyal Adelaide Hospital, Adelaide, Australia.
Ed GaneAuckland City Hospital, Auckland, New Zealand.
Mark NelsonChelsea & Westminster Hospital, London, United Kingdom.
Patrick IngilizZentrum für Infektiologie Berlin-Prenzlauer Berg, Berlin, Germany.
Tanya L ApplegateKirby Institute, UNSW Sydney, Australia.
Jason GrebelyKirby Institute, UNSW Sydney, Australia.
Phillipa MarksKirby Institute, UNSW Sydney, Australia.
Marianne MartinelloKirby Institute, UNSW Sydney, Australia.
Kathy PetoumenosKirby Institute, UNSW Sydney, Australia.
Gregory J DoreKirby Institute, UNSW Sydney, Australia; St Vincent's Hospital, Sydney, Australia.
REACT study group
Protocol Steering Committee
Coordinating Centre
Site Principal Investigators
UNSW Sydney · AUUniversity Hospital of Bern · CHAmsterdam UMC Location University of Amsterdam · NLAuckland City Hospital · NZBurnet Institute · AUCentre Hospitalier de l’Université de Montréal · CAMassachusetts General Hospital · USThe Royal Free Hospital · GBToronto General Hospital · CAUniversity Hospital Bonn · DEChelsea and Westminster Hospital · GBRoyal Adelaide Hospital · AUSt Vincent's Hospital Sydney · AUZentrum für Pathologie und Zytodiagnostik · DEEpatocentro Ticino · CHJohns Hopkins University · USPennine Acute Hospitals NHS Trust · GBSt. Paul's Hospital · CASt Vincent’s Private Hospital Sydney · AUThe Royal Melbourne Hospital · AU

Funding

A randomised study of interferon-free treatment for recently acquired hepatitis C in people who inject drugs and people with HIV coinfection (the REACT Study)R01DA040506 · NIDA · UNIVERSITY OF NEW SOUTH WALES · PI MATTHEWS, GAIL · 2015 to 2019
$3.7M
NIDA NIH HHS R01 DA040506
6 · The paper itself

Abstract

BACKGROUND &

aimsShortened duration therapy for acute and recent HCV infection has been shown to be highly effective in several small non-randomised studies with direct-acting antiviral regimens; however, large randomised studies are lacking.

methodsREACT was an NIH-funded multicentre international, open-label, randomised, phase IV non-inferiority trial examining the efficacy of short course (6-week) vs. standard course (12-week) therapy with sofosbuvir-velpatasvir for recent HCV infection (estimated duration of infection ≤12 months). Randomisation occurred at week 6. The primary endpoint was sustained virological response 12 weeks after treatment end (SVR12) in the intention-to treat (ITT) population. A total of 250 participants were due to be enrolled, but on advice of the data safety and monitoring board the study was halted early.

resultsThe primary analysis population consisted of 188 randomised participants at termination of study enrolment; short arm (n = 93), standard arm (n = 95). Ninety-seven percent were male and 69% HIV positive. ITT SVR12 was 76/93, 81.7% (95% CI 72.4-89.0) in the short arm and 86/95, 90.5% (95% CI 82.7-95.6) in the standard arm. The difference between the arms was -8.8 (95% CI -18.6 to 1.0). In modified ITT analysis, wherein non-virological reasons for failure were excluded (death, reinfection, loss to follow-up), SVR12 was 76/85, 89.4% (95% CI 80.8-95.0) in the short arm and 86/88, 97.7% in the standard arm (95% CI 92.0-99.7; difference -8.3%, p = 0.025).

conclusionsIn this randomised study in recent HCV infection, a 6-week course of sofosbuvir-velpatasvir did not meet the criteria for non-inferiority to standard 12-week therapy. LAY SUMMARY: In this randomised trial, 188 people with recently acquired hepatitis C infection were randomly assigned to treatment using either a short 6-week course (93 people) or standard 12-week course (95 people) of the hepatitis C treatment sofosbuvir/velpatasvir. There were 9 cases of relapse after treatment with the short course and 2 following the standard course. A shortened course of 6-week therapy for hepatitis C infection appeared to be less effective than a standard 12-week course in people with recently acquired hepatitis C infection. CLINICALTRIALS. GOV IDENTIFIER: NCT02625909.

Indexed as

Time FactorsAdultAntiviral AgentsAustraliaCanadaCarbamatesDrug CombinationsFemaleGermanyHepatitis CHeterocyclic Compounds, 4 or More RingsHumansMaleMiddle AgedNetherlandsNew ZealandAntiviral AgentsCarbamatesDrug CombinationsHeterocyclic Compounds, 4 or More RingsSofosbuvirsofosbuvir-velpatasvir drug combinationacutedirect-acting antiviralsHCVrecently acquiredshort durationtreatment

Identifiers

PMID34023350
PMCPMC9831671
OpenAlexW3164979394

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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.