Evidence map›Paper›PMID 27444413›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2016

Ribavirin-Free Regimen With Sofosbuvir and Velpatasvir Is Associated With High Efficacy and Improvement of Patient-Reported Outcomes in Patients With Genotypes 2 and 3 Chronic Hepatitis C: Results From Astral-2 and -3 Clinical Trials.

Zobair M Younossi, Maria Stepanova, Mark Sulkowski, Graham R Foster, Nancy Reau, Alessandra Mangia, Keyur Patel, Norbert Bräu, Stuart K Roberts, Nezam Afdhal and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03801707 (An Open Label, Proof of Concept Study to Evaluate the Feasibility and Safety of Kidney Transplant From HCV Positive Donors Into HCV Negative Recipient), which is not on this map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 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.

NCT03801707 phase2 / phase3completednot on this mapstarted 2019, after this paper: background citation

An Open Label, Proof of Concept Study to Evaluate the Feasibility and Safety of Kidney Transplant From HCV Positive Donors Into HCV Negative Recipient

TypeinterventionalSponsorOhio State UniversityRan2019 to 2021Enrolled54ConditionsKidney Transplant, Hepatitis C, HCVArmsSofosbuvir / Velpatasvir Oral Tablet [Epclusa], Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET]
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  5. Observational
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  17. Health-Related Quality of Life in Chronic Hepatitis C.GE Portuguese journal of gastroenterology · 2017
    Article
  18. Observational
  19. Review
  20. 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

13 authors.

Zobair M YounossiCenter for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia.
Maria StepanovaCenter for Outcomes Research in Liver Disease, Washington D.C.
Mark SulkowskiJohns Hopkins University, Baltimore, Maryland.
Graham R FosterQueen Mary University London, United Kingdom.
Nancy ReauRush University Medical Center, Chicago, Illinois.
Alessandra MangiaCasa Sollievo della Sofferenza Hospital, San Giovanni Rotondo, Italy.
Keyur PatelUniversity of Toronto Health Network, Ontario, Canada.
Norbert BräuJames J. Peters Veterans Affairs Medical Center, Bronx, New York.
Stuart K RobertsAlfred Health and Monash University, Melbourne, Australia.
Nezam AfdhalBeth Israel Deaconess Medical Center, Boston, Massachusetts.
Fatema NaderCenter for Outcomes Research in Liver Disease, Washington D.C.
Linda HenryCenter for Outcomes Research in Liver Disease, Washington D.C.
Sharon HuntCenter for Outcomes Research in Liver Disease, Washington D.C.

Funding

Patient Oriented Research in Hepatitis C-infected Injection Drug UsersK24DA034621 · NIDA · JOHNS HOPKINS UNIVERSITY · PI SULKOWSKI, MARK SEBASTIAN · 2012 to 2022
$1.2M
NIDA NIH HHS K24 DA034621
6 · The paper itself

Abstract

backgroundUntil recently, the approved treatment regimens for patients with hepatitis C virus (HCV) genotypes (GTs) 2 and 3 contain sofosbuvir (SOF) and ribavirin (RBV) for 12 or 24 weeks. The impact of RBV-free pan-genotypic regimen with SOF and velpatasvir (SOF/VEL) on patient-reported outcomes (PROs) of patients with genotype 2 and 3 has not been described.

methodsPROs data were collected from participants of ASTRAL-2 and ASTRAL-3 studies before, during, and after treatment using 4 PRO instruments (Short Form-36, Chronic Liver Disease Questionnaire-HCV, Functional Assessment of Chronic Illness Therapy-Fatigue, and Work Productivity and Activity Index: Specific Health Problem), and compared between the SOF/VEL and SOF + RBV groups.

resultsA total of 818 HCV patients were included: 78% treatment naive, 25% cirrhosis. The rates of nearly all adverse events were lower in the RBV-free SOF/VEL group (all P < .03). The SOF/VEL group also experienced improvement of their PROs by treatment week 4 (+1.8% on average across all PROs), which continued throughout treatment (+4.1%) and post-treatment (+5.5%). In contrast, those in the SOF + RBV group had a modest decline in their PROs starting at treatment week 4 (up to -3.7%), which lasted until the end of treatment (up to -6.4%). In multiple regression analysis, the association of a treatment regimen with end-of-treatment PROs was significant for nearly all PROs; the average beta was +5.0% for the use of SOF/VEL (reference: SOF + RBV).

conclusionsPatients receiving ribavirin-free SOF/VEL reported significantly better PRO scores during treatment compared with those receiving the RBV-containing regimen. Furthermore, the interferon- and ribavirin-free SOF/VEL regimen resulted in a rapid improvement of PROs in HCV GTs 2 and 3 patients during treatment and after achieving sustained virologic response.

Indexed as

GenotypeAdultBenzimidazolesBenzopyransCarbamatesComorbidityDrug Therapy, CombinationFemaleHepacivirusHepatitis C, ChronicHeterocyclic Compounds, 4 or More RingsHumansMaleMiddle AgedPatient Reported Outcome MeasuresRibavirinBenzimidazolesBenzopyransCarbamatesHeterocyclic Compounds, 4 or More RingsRibavirinSofosbuvirvelpatasvirdirect-acting antiviralsfatiguehealth-related quality of lifehepatitis Cwork productivity

Identifiers

PMID27444413
PMCPMC6276885

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.