Evidence map›Paper›PMID 27021197›Full record

Trial reportThe American journal of gastroenterology2016

An In-Depth Analysis of Patient-Reported Outcomes in Patients With Chronic Hepatitis C Treated With Different Anti-Viral Regimens.

Zobair M Younossi, Maria Stepanova, Linda Henry, Fatema Nader, Sharon Hunt

Abstract readClinical Trial, Phase IIIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in The American journal of gastroenterology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing 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

27 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Hepatitis C direct-acting antiviral outcomes in patients 75 years and older.JGH open : an open access journal of gastroenterology and hepatology · 2021
    Article
  11. Article
  12. Review
  13. Health-related quality of life in hepatitis C patients who achieve sustained virological response to direct-acting antivirals: a comparison with the general population.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2019
    Article
  14. Review
  15. Hepatitis C Guidance 2018 Update: AASLD-IDSA Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018
    Article
  16. Article
  17. Review
  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

5 authors.

Zobair M YounossiCenter for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia, USA.
Maria StepanovaCenter for Outcomes Research in Liver Diseases, Washington DC, USA.
Linda HenryCenter for Outcomes Research in Liver Diseases, Washington DC, USA.
Fatema NaderCenter for Outcomes Research in Liver Diseases, Washington DC, USA.
Sharon HuntCenter for Outcomes Research in Liver Diseases, Washington DC, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesInterferon- and ribavirin (RBV)-containing regimens negatively impact patients' experience. The aim of this study was to quantify the impact of different anti-viral regimens for hepatitis C on patients' work productivity, fatigue, and other patient-reported outcomes (PROs).

methodsThe PRO data from multicenter multinational phase 3 clinical trials of sofosbuvir with and without interferon or RBV were retrospectively used. Treatment regimens were classified as interferon+RBV-containing, interferon-free RBV-containing, and interferon-free RBV-free. Four PRO instruments (SF-36, CLDQ-HCV, FACIT-F, and WPAI:SHP) were administered to subjects at baseline, during, and up to 24 weeks after treatment.

resultsWe included 3,425 subjects with chronic hepatitis C infection with PRO data. Patients were 62.8% male, 62.2% treatment naive, 18.1% with cirrhosis, and 72.9% with HCV genotype 1. Of the study participants, 546 received interferon+RBV+sofosbuvir, 1,721 received sofosbuvir+RBV, and 1,158 received interferon- and RBV-free ledipasvir+sofosbuvir. At baseline, there were no difference in PROs between treatment groups (all P>0.01). During treatment, the decrements in PROs were up to -23.6% for the interferon+RBV group, up to -7.0% in the sofosbuvir+RBV group, whereas there was an improvement of up to +11.6% in the interferon-free RBV-free group (all P<0.0001). In multivariate analysis, the use of interferon was independently associated with up to -26.0% worsening of the PRO scores during treatment and the use of RBV with up to -9.0% worsening. After 12 weeks post-treatment, in patients with sustained virologic response-12, improvements were observed regardless of the regimen, and these improvements continued to increase by week 24 of follow-up.

conclusionsThe use of interferon- and RBV-free regimens for HCV is associated with better patients' experience and work productivity during treatment.

Indexed as

Patient Reported Outcome MeasuresAntiviral AgentsBenzimidazolesDrug Therapy, CombinationFemaleFluorenesHepatitis C, ChronicHumansInterferonsMaleMiddle AgedRetrospective StudiesRibavirinSofosbuvirAntiviral AgentsBenzimidazolesFluorenesInterferonsledipasvirRibavirinSofosbuvir

Identifiers

PMID27021197

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.