Evidence map›Paper›PMID 29091342›Full record

Trial reportLiver international : official journal of the International Association for the Study of the Liver2018

Ledipasvir/sofosbuvir for treatment of hepatitis C virus in sofosbuvir-experienced, NS5A treatment-naïve patients: Findings from two randomized trials.

Edward Tam, Anne F Luetkemeyer, Parvez S Mantry, Sanjaya K Satapathy, Peter Ghali, Minhee Kang, Richard Haubrich, Xianlin Shen, Liyun Ni, Gregory Camus and 5 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Liver international : official journal of the International Association for the Study of the Liver, 2018. 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 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
1.2field-weighted citation impact, top 22% 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.

NCT02600351 phase3terminatednot on this map

A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Subjects Who Have Failed Prior Treatment With Sofosbuvir-based Therapies

TypeinterventionalSponsorGilead SciencesRan2015 to 2017Enrolled87ConditionsHepatitis C Virus InfectionArmsLDV/SOF, RBV
NCT02605304 phase2terminatednot on this map

Phase II Trial of Retreatment Strategies for Difficult-to-Treat Hepatitis C Virus (HCV)-Infected Individuals Who Have Failed Prior Direct Acting Antiviral (DAA)-Based Regimens

TypeinterventionalSponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsRan2016 to 2017Enrolled7ConditionsHIV-1 Infection, Hepatitis CArmsLedipasvir/sofosbuvir, Ribavirin
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Review
  6. Article
  7. Review
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

15 authors at 8 institutions in 2 countries.

Edward TamLAIR Centre, Vancouver, BC, Canada.
Anne F LuetkemeyerDepartment of Medicine, University of California, San Francisco, CA, USA.
Parvez S MantryThe Liver Institute, Methodist Dallas Medical Center, Dallas, TX, USA.
Sanjaya K SatapathyMethodist University Hospital Transplant Institute, University of Tennessee Health Sciences Center, Memphis, TN, USA.
Peter GhaliMcGill University Health Centre, Royal Victoria Hospital, Montreal, QC, Canada.
Minhee KangHarvard T.H. Chan School of Public Health, Boston, MA, USA.
Richard HaubrichGilead Sciences, Foster City, CA, USA.
Xianlin ShenGilead Sciences, Foster City, CA, USA.
Liyun NiGilead Sciences, Foster City, CA, USA.
Gregory CamusGilead Sciences, Foster City, CA, USA.
Amanda CopansGilead Sciences, Foster City, CA, USA.
Lorenzo RossaroGilead Sciences, Foster City, CA, USA.
Bill GuyerGilead Sciences, Foster City, CA, USA.
Robert S BrownDivision of Gastroenterology and Hepatology, Weill Cornell Medical College, New York City, NY, USA.
RESCUE and ACTG A5348 study investigators
Gilead Sciences (United States) · USCanadian Society of Intestinal Research · CACornell University · USHarvard University · USMethodist Dallas Medical Center · USMethodist University Hospital · USRoyal Victoria Regional Health Centre · CAUniversity of California, San Francisco · US

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

BACKGROUND &

aimsWe report data from two similarly designed studies that evaluated the efficacy, safety, and optimal duration of ledipasvir/sofosbuvir (LDV/SOF) ± ribavirin (RBV) for retreatment of chronic hepatitis C virus (HCV) in individuals who failed to achieve sustained virological response (SVR) with prior SOF-based, non-NS5A inhibitor-containing regimens.

methodsThe RESCUE study enrolled HCV mono-infected adults with genotype (GT) 1 or 4. Non-cirrhotic participants were randomized to 12 weeks of LDV/SOF or LDV/SOF + RBV. Compensated cirrhotic participants were randomized to LDV/SOF + RBV (12 weeks) or LDV/SOF (24 weeks). The AIDS Clinical Trials Group A5348 study randomized genotype 1 adults with HCV/HIV co-infection to LDV/SOF + RBV (12 weeks) or LDV/SOF (24 weeks). Both studies used SVR at 12 weeks post-treatment (SVR12) as the primary endpoint.

resultsIn the RESCUE study, 82 participants were randomized and treated, and all completed treatment. Overall, SVR12 was 88% (72/82); 81-100% in non-cirrhotic participants treated with LDV/SOF or LDV/SOF + RBV for 12 weeks and 80-92% in cirrhotic participants treated with LDV/SOF + RBV for 12 weeks or LDV/SOF for 24 weeks. Adverse events (AEs), mostly mild-to-moderate in severity, were experienced by 78% of participants, with headache and fatigue most frequently reported. One serious AE, not related to treatment, was observed. No premature discontinuations of study drug, or deaths occurred. In the A5348 study, seven participants were randomized (cirrhotic n = 1; GT1a n = 5) and all attained SVR12, with no serious AEs or premature discontinuations.

conclusionsIn this SOF-experienced, NS5A inhibitor-naïve population, which included participants with cirrhosis or HCV/HIV co-infection, high SVR12 rates were achieved.

Indexed as

AdultAgedAntiviral AgentsBenzimidazolesCoinfectionFatigueFemaleFluorenesHeadacheHepacivirusHepatitis C, ChronicHIV InfectionsHumansLiver CirrhosisMaleMiddle AgedAntiviral AgentsBenzimidazolesFluorenesledipasvir, sofosbuvir drug combinationRibavirinSofosbuvirUridine MonophosphateHCVHIVledipasvirsofosbuvirtreatment-experienced

Identifiers

PMID29091342
PMCPMC5930158
OpenAlexW2766848478

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.