Evidence map›Paper›PMID 26923436›Full record

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

Safety and efficacy of sofosbuvir-containing regimens in hepatitis C-infected patients with impaired renal function.

Varun Saxena, Farrukh M Koraishy, Meghan E Sise, Joseph K Lim, Monica Schmidt, Raymond T Chung, Annmarie Liapakis, David R Nelson, Michael W Fried, Norah A Terrault and 1 more

Open access · greenAbstract readMulticenter StudyObservational Study
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 106 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
106citing papers in PubMed, 9 pooled it
36.5field-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

106 citing papers in PubMed, 9 syntheses or guidelines pooled it, 298 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Guideline
  7. Guideline
  8. Guideline
  9. Guideline
  10. Trial
  11. Observational
  12. Article
  13. Renal Manifestations of Chronic Hepatitis C: A Review.Journal of clinical medicine · 2024
    Review
  14. SASLT guidelines: Update in treatment of hepatitis C virus infection, 2024.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2024
    Review
  15. Review
  16. Article
  17. Observational
  18. Review
  19. Article
  20. Breakthroughs in hepatitis C research: from discovery to cure.Nature reviews. Gastroenterology & hepatology · 2022
    Review

46 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 1 country.

Varun SaxenaUniversity of California San Francisco, San Francisco, CA, USA.
Farrukh M KoraishySaint Louis University School of Medicine, St Louis, MO, USA.
Meghan E SiseMassachusetts General Hospital, Boston, MA, USA.
Joseph K LimYale University School of Medicine, New Haven, CT, USA.
Monica SchmidtUniversity of North Carolina, Chapel Hill, NC, USA.
Raymond T ChungMassachusetts General Hospital, Boston, MA, USA.
Annmarie LiapakisYale University School of Medicine, New Haven, CT, USA.
David R NelsonUniversity of Florida, Gainesville, FL, USA.
Michael W FriedUniversity of North Carolina, Chapel Hill, NC, USA.
Norah A TerraultUniversity of California San Francisco, San Francisco, CA, USA.
HCV-TARGET
Massachusetts General Hospital · USUniversity of California, San Francisco · USUniversity of North Carolina at Chapel Hill · USYale University · USSaint Louis University · USUniversity of Florida · US

Funding

Yale Liver CenterP30DK034989 · NIDDK · YALE UNIVERSITY · PI WAJAHAT Zafar MEHAL · 1986 to 2026
$31.1M
UCSF Liver Core CenterP30DK026743 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JACQUELYN J. MAHER · 1986 to 2026
$30.7M
UF Clinical and Translational Science AwardUL1TR000064 · NCATS · UNIVERSITY OF FLORIDA · PI NELSON, DAVID R · 2012 to 2014
$12.2M
NRSA Hepatology Training GrantT32DK060414 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Mandana Khalili, JACQUELYN J. MAHER · 2002 to 2026
$6.8M
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 TR000064NIDDK NIH HHS K24 DK066144NIDDK NIH HHS P30 DK026743NIDDK NIH HHS P30 DK034989NIDDK NIH HHS T32 DK060414
6 · The paper itself

Abstract

BACKGROUND &

aimsRenal clearance is the major elimination pathway for sofosbuvir (SOF). We assessed the safety and efficacy of SOF-containing regimens in patients with varying baseline estimated glomerular filtration rate (eGFR).

methodsHCV-TARGET database is a multicentre, longitudinal 'real-world' treatment cohort.

resultsA total of 1789 patients [genotypes 1 (72%), 2 (17%) 3 (9%), 4-6 (2%)] had baseline eGFR determination: 73 with eGFR≤45 (18 with eGFR≤30, 5 on dialysis) were compared to 1716 with eGFR>45 ml/min/1.73 m(2) . Patients with baseline eGFR≤45 vs. >45 differed in being female (55% vs. 36%), age ≥65 years (24% vs. 16%), Black race (22% vs. 12%), having cirrhosis with decompensation (73% vs. 24%) and being post-transplant (49% vs. 10%), all P < 0.05. All patients with eGFR≤45 were treated with SOF 400 mg/day (including those on haemodialysis) and had median starting ribavirin (RBV) dose of 800 mg (IQR: 400-1200). Sustained virologic response (SVR) frequencies were similar across eGFR groups, ranging from 82-83%. Patients with eGFR ≤45 more frequently experienced anaemia, worsening renal function and serious AEs (all P < 0.05), and these associations persisted when limiting analysis to RBV-free regimens. Patients with baseline eGFR≤30 and eGFR 31-45 had similar frequencies of efficacy and safety outcomes.

conclusionsSustained viral clearance was achieved in 83% of patients with renal impairment (eGFR ≤45 ml/min/1.73 m(2) ) treated with SOF-containing regimens. However, these patients had higher rates of anaemia, worsening renal dysfunction and serious adverse events regardless of use of RBV. Patient with renal impairment require close monitoring and should be treated by providers extensively experienced with SOF-containing regimens.

Indexed as

AdolescentAdultAgedAged, 80 and overAntiviral AgentsDatabases, FactualDrug Therapy, CombinationEuropeFemaleGlomerular Filtration RateHepacivirusHepatitis C, ChronicHumansLiver CirrhosisLongitudinal StudiesMaleAntiviral AgentsSimeprevirSofosbuvirdecompensated cirrhosishaemodialysisliver transplantationsustained virologic response

Identifiers

PMID26923436
PMCPMC6453817
OpenAlexW2284028703

What OpenQuestion holds

Textmetadata
LicenceTDM
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.