Evidence map›Paper›PMID 26202761›Full record

ArticleHepatology international2014

Favorable adverse event profile of sofosbuvir/ribavirin compared to boceprevir/interferon/ribavirin for treatment of hepatitis C.

Shivakumar Narayanan, Kerry Townsend, Thomas Macharia, Adrian Majid, Amy Nelson, Robert R Redfield, Shyam Kottilil, Rohit Talwani, Anu Osinusi

Abstract read
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In one paragraph

Article in Hepatology international, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.3field-weighted citation impact, top 20% 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

1 citing paper in PubMed, 11 citations in OpenAlex.

  1. 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

9 authors at 3 institutions in 1 country.

Shivakumar NarayananDivision of Infectious Diseases, Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD, USA.
Kerry TownsendLaboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 10/11N204, 9000 Rockville Pike, Bethesda, MD, 20892, USA.
Thomas MachariaDivision of Infectious Diseases, Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD, USA.
Adrian MajidDivision of Infectious Diseases, Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD, USA.
Amy NelsonLaboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 10/11N204, 9000 Rockville Pike, Bethesda, MD, 20892, USA.
Robert R RedfieldDivision of Infectious Diseases, Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD, USA.
Shyam KottililLaboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 10/11N204, 9000 Rockville Pike, Bethesda, MD, 20892, USA. skottilil@niaid.nih.gov.
Rohit TalwaniDivision of Infectious Diseases, Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD, USA.
Anu OsinusiDivision of Infectious Diseases, Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD, USA.
University of Maryland, Baltimore · USNational Institutes of Health · USNational Institute of Allergy and Infectious Diseases · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTriple therapy for the treatment of hepatitis C virus (HCV) with first-generation directly acting antiviral agents, the non-structural serine protease inhibitors boceprevir (BOC) and telaprevir have resulted in improved sustained virologic response (SVR) rates. However, a high incidence of adverse events (AEs), high pill burdens and drug interactions remain significant barriers to successful completion of therapy. The aim of this study was to evaluate the AEs observed with BOC triple therapy in comparison to IFN-free sofosbuvir/ribavirin (SOF/RBV) therapy in HCV monoinfected, genotype-1 (GT-1) individuals.

methodsWe retrospectively evaluated HCV monoinfected, treatment-naïve or -experienced, GT-1 individuals treated with either BOC/IFN/RBV at the Veterans Affairs Medical Center, Baltimore (n = 97) or SOF/RBV in the NIAID SPARE clinical trial (n = 60). AEs, namely hematologic (hemoglobin, neutrophil and platelet counts), hepatic (alanine transaminase or bilirubin) and renal (eGFR), were measured according to the DAIDS toxicity table (version 1.0).

resultsBOC/IFN/RBV was associated with significantly more AEs, most commonly neutropenia, anemia and thrombocytopenia. In the SOF/RBV cohort, five (8 %) patients discontinued treatment early, but none (0 %) were because of AEs, while 60 (62 %) patients on triple therapy discontinued treatment early, 34 (57 %) because of AEs. SVR24 rates were 68 versus 34 % with SOF/RBV versus BOC/IFN/RBV.

conclusionsSOF/RBV treatment was associated with fewer side effects than BOC-based triple therapy, appearing to be a safer and more tolerable alternative for HCV GT-1 subjects. These results show that emerging IFN-free therapies may enhance patient adherence, allowing treatment of larger number of patients with improved efficacy.

Indexed as

Adverse eventsHCV monoinfectionRibavirinSofosbuvir

Identifiers

PMID26202761
OpenAlexW1991635907

What OpenQuestion holds

Textmetadata
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.