Evidence map›Paper›PMID 29453451›Full record

Observational studyScientific reports2018

Prevalence and impact of baseline resistance-associated substitutions on the efficacy of ledipasvir/sofosbuvir or simeprevir/sofosbuvir against GT1 HCV infection.

Gary P Wang, Norah Terrault, Jacqueline D Reeves, Lin Liu, Eric Li, Lisa Zhao, Joseph K Lim, Giuseppe Morelli, Alexander Kuo, Josh Levitsky and 7 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Scientific reports, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–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.

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

9 citing papers in PubMed.

  1. A Bibliometric Analysis of the HCV Drug-Resistant Majority and Minority Variants.International journal of environmental research and public health · 2025
    Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. Article
  9. A real-life study of the positive response to DAA-based therapies for hepatitis C in Brazil.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases
    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

17 authors.

Gary P WangUniversity of Florida, Gainesville, USA. gary.wang@medicine.ufl.edu.
Norah TerraultUniversity of California, San Francisco, San Francisco, USA.
Jacqueline D ReevesMonogram Biosciences, South San Francisco, USA.
Lin LiuUniversity of Florida, Gainesville, USA.
Eric LiUniversity of Florida, Gainesville, USA.
Lisa ZhaoUniversity of Florida, Gainesville, USA.
Joseph K LimYale University School of Medicine, New Haven, USA.
Giuseppe MorelliUniversity of Florida, Gainesville, USA.
Alexander KuoVirginia Mason Medical Center, Seattle, USA.
Josh LevitskyNorthwestern University Feinberg School of Medicine, Chicago, USA.
Kenneth E ShermanUniversity of Cincinnati, Cincinnati, USA.
Lynn M FrazierLiver Wellness Center, Little Rock, USA.
Ananthakrishnan RamaniColumbia Memorial Hospital (Mountainview Medical Center), Hudson, USA.
Joy PeterUniversity of Florida, Gainesville, USA.
Lucy AkuskevichUniversity of North Carolina, Chapel Hill, United States.
Michael W FriedUniversity of North Carolina, Chapel Hill, United States.
David R NelsonUniversity of Florida, Gainesville, USA.

Funding

Virology Research Program (Program 4)P30CA016086 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI David Darr · 1985 to 2026
$201.5M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Using social networks to map and evaluate team science across CTSA hubsUL1TR001427 · NCATS · UNIVERSITY OF FLORIDA · PI MITCHELL, DUANE A. · 2015 to 2024
$37.2M
Stem Cell/Organoid and Genome Editing CoreP30DK078392 · NIDDK · CINCINNATI CHILDRENS HOSP MED CTR · PI Alexander Miethke · 2007 to 2026
$24.4M
Mentoring Junior Faculty: Viral hepatitis Clinical ResearchK24DK066144 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI FRIED, MICHAEL W · 2004 to 2014
$1.5M
NCATS NIH HHS UL1 TR001427NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA016086NIDDK NIH HHS K24 DK066144NIDDK NIH HHS P30 DK078392
6 · The paper itself

Abstract

Baseline resistance-associated substitutions (RASs) have variable impacts in clinical trials but their prevalence and impact in real-world patients remains unclear. We performed baseline resistance testing using a commercial assay (10% cutoff) for 486 patients treated with LDV/SOF or SMV/SOF, with or without ribavirin, in the multi-center, observational HCV-TARGET cohort. Linkage of RASs was evaluated in selected samples using a novel quantitative single variant sequencing assay. Our results showed that the prevalence of NS3, NS5A, NS5B RASs was 45%, 13%, and 8%, respectively, and 10% of patients harbored RASs in 2 or more drug classes. Baseline LDV RASs in GT1a, TE, and cirrhosis LDV/SOF subgroup was associated with 2-4% lower SVR12 rates. SMV RASs was associated with lower SVR12 rates in GT1a, treatment-experienced, cirrhotics SMV/SOF subgroup. Pooled analysis of all patients with baseline RASs revealed that SVR12 was 100% (19/19) in patients treated for longer than 98 days but was 87% (81/93) in patients treated for shorter than 98 days. These results demonstrate that RASs prevalence and their impact in real world practice are in general agreement with registration trials, and suggest that longer treatment duration may overcome the negative impact of baseline RASs on SVR12 rates in clinical practice.

Indexed as

AgedAntiviral AgentsBenzimidazolesClinical Trials as TopicDrug Resistance, ViralFemaleFluorenesGenotypeHepacivirusHepatitis C, ChronicHumansMaleMiddle AgedPrevalenceSimeprevirSofosbuvirAntiviral AgentsBenzimidazolesFluorenesledipasvirSimeprevirSofosbuvir

Identifiers

PMID29453451
PMCPMC5816647

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.