Evidence map›Paper›PMID 26583882›Full record

Observational studyLiver international : official journal of the International Association for the Study of the Liver2016

Sofosbuvir and simeprevir in hepatitis C genotype 1-patients with end-stage renal disease on haemodialysis or GFR <30 ml/min.

Hector E Nazario, Milka Ndungu, Apurva A Modi

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Liver international : official journal of the International Association for the Study of the Liver, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 1 pooled it
12.6field-weighted citation impact, top 1% 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

38 citing papers in PubMed, 1 synthesis or guideline pooled it, 108 citations in OpenAlex.

  1. Pooled it
  2. Observational
  3. Article
  4. Hepatitis C virus infection and global kidney health: the consensus proceedings of the International Federation of Kidney Foundations.African journal of nephrology : official publication of the African Association of Nephrology. African Association of Nephrology · 2020
    Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Observational
  13. Treatment of hepatitis C in special populations.Journal of gastroenterology · 2018
    Review
  14. Review
  15. Article
  16. Review
  17. Expert opinion on the management of hepatitis C infection in Kuwait.Hepatic medicine : evidence and research · 2018
    Article
  18. Sofosbuvir: A Potential Treatment for Ebola.Frontiers in pharmacology · 2018
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 1 country.

Hector E NazarioDivision of Hepatology, The Liver Institute at Methodist Dallas Medical Center, Dallas, TX, USA.
Milka NdunguDivision of Hepatology, The Liver Institute at Methodist Dallas Medical Center, Dallas, TX, USA.
Apurva A ModiDivision of Hepatology, Liver Consultants of Texas, Baylor All Saints Medical Center, Fort Worth, TX, USA.
Methodist Dallas Medical Center · USBaylor Scott & White All Saints Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND &

aimsTreating chronic hepatitis C (CHC) in patients with end-stage renal disease (ESRD) has suboptimal tolerability and cure rates. Safety and efficacy of sofosbuvir plus simeprevir regimen in CHC-infected patients with ESRD on haemodialysis (HD) or glomerular filtration rate (GFR) <30 ml/min is unknown. We evaluated the safety and efficacy of sofosbuvir and simeprevir in this special patient population.

methodsAll (n = 17) patients in the analysis had ESRD on HD or GFR <30 ml/min. All received sofosbuvir 400 mg daily and simeprevir 150 mg daily, without ribavirin for 12 weeks. Safety and efficacy data were collected; including SVR4 and SVR12 data for all patients after completing therapy.

resultsIn this 17 patient cohort, eight (47%) were cirrhotic, four (24%) had stage three liver fibrosis and 13 (76%) were genotype 1A. All 17 have completed 12 weeks of therapy. Treatment was overall well tolerated with no treatment discontinuations reported. Four (24%) patients reported mild adverse events (AE). These AEs were insomnia (n = 2), headache (n = 1), nausea (n = 1) and worsening anaemia requiring blood transfusion (n = 1). All 17 patients reached post-treatment week-12 follow-up, and achieved SVR12 or virological cure (100% SVR12).

conclusionsDaily, full dose of sofosbuvir plus simeprevir for 12 weeks of therapy appears to be well tolerated in patients with ESRD on HD or GFR <30 ml/min. Most common AEs resembled those of healthier CHC patients without significant renal impairment. The cure rates obtained in this cohort treated with sofosbuvir and simeprevir are dramatically superior to any previous treatment regimen studied & published in this special patient population.

Indexed as

AgedAntiviral AgentsDrug Therapy, CombinationFemaleGlomerular Filtration RateHepacivirusHepatitis C, ChronicHumansKidney Failure, ChronicLiver CirrhosisMaleMiddle AgedRenal DialysisSimeprevirSofosbuvirSustained Virologic ResponseAntiviral AgentsSimeprevirSofosbuvirChronic hepatitis CCirrhosisend-stage renal diseasekidney transplantliver transplantationrenal failuresevere renal impairmentsimeprevirsofosbuvir

Identifiers

PMID26583882
OpenAlexW2178797117

What OpenQuestion holds

Textmetadata
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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.