Evidence map›Paper›PMID 26033798›Full record

ArticleHepatology (Baltimore, Md.)2015

Safety and Efficacy of Simeprevir/Sofosbuvir in Hepatitis C-Infected Patients With Compensated and Decompensated Cirrhosis.

Varun Saxena, Lisa Nyberg, Marypat Pauly, Aditi Dasgupta, Anders Nyberg, Barbara Piasecki, Bradley Winston, Jacquelyn Redd, Joanna Ready, Norah A Terrault

Open access · greenAbstract readComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Hepatology (Baltimore, Md.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing 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

39 citing papers in PubMed, 1 synthesis or guideline pooled it, 109 citations in OpenAlex.

  1. KASL clinical practice guidelines: management of hepatitis C.Clinical and molecular hepatology · 2016
    Guideline
  2. Efficacy and safety of sofosbuvir-based therapy for chronic hepatitis C infection in "real-life" cohort.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2016
    Trial
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Bioprinting for Liver Transplantation.Bioengineering (Basel, Switzerland) · 2019
    Review
  11. Monitoring liver transplant rates in persons diagnosed with hepatitis C: a data linkage study, England 2008 to 2017.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2019
    Observational
  12. Article
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Review
  19. Article
  20. 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

10 authors at 2 institutions in 1 country.

Varun SaxenaUniversity of California San Francisco, San Francisco, CA.
Lisa NybergKaiser Permanente Southern California, San Diego, CA.
Marypat PaulyKaiser Permanente Northern California, Oakland, CA.
Aditi DasguptaUniversity of California San Francisco, San Francisco, CA.
Anders NybergKaiser Permanente Southern California, San Diego, CA.
Barbara PiaseckiKaiser Permanente Colorado, Denver, CO.
Bradley WinstonKaiser Permanente Mid-Atlantic, Rockville, MD.
Jacquelyn ReddKaiser Permanente Mid-Atlantic, Rockville, MD.
Joanna ReadyKaiser Permanente Northern California, Oakland, CA.
Norah A TerraultUniversity of California San Francisco, San Francisco, CA.
Kaiser Permanente · USUniversity of California, San Francisco · US

Funding

UCSF Liver Core CenterP30DK026743 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Holger Willenbring · 1986 to 2026
$30.7M
NRSA Hepatology Training GrantT32DK060414 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Mandana Khalili, JACQUELYN J. MAHER · 2002 to 2026
$6.8M
NIDDK NIH HHS P30 DK 026743NIDDK NIH HHS P30 DK026743NIDDK NIH HHS T32 DK060414
6 · The paper itself

Abstract

unlabelledRisks and benefits of simeprevir plus sofosbuvir (SIM+SOF) in patients with advanced cirrhosis are unknown. We assessed the safety and sustained virological responses (SVR) of SIM+SOF with and without ribavirin (RBV) in patients with Child-Pugh (CP)-B/C versus CP-A cirrhosis and compared to matched untreated controls. This study was of a multicenter cohort of adults with hepatitis C virus genotype 1 and cirrhosis treated with SIM+SOF with/without RBV for 12 weeks. Controls were matched on treatment center, age, CP class, and Model for End-Stage Liver Disease (MELD) score. Of 160 patients treated with SIM+SOF with/without RBV, 35% had CP-B/C and 64% had CP-A, with median baseline MELD 9 (interquartile range, 8-11). Sustained virological response at week 12 (SVR12) was achieved by 73% of CP-B/C versus 91% of CP-A (P < 0.01). CP-B/C versus CP-A had more early treatment discontinuations (11% vs. 1%), adverse events (AEs) requiring hospitalization (22% vs. 2%), infections requiring antibiotics (20% vs. 1%), and hepatic decompensating events (20% vs. 3%; all P < 0.01). There were 2 deaths: 1 CP-B/C (liver related) and 1 CP-A (not liver related). In multivariate analysis, CP-B/C independently predicted lack of SVR12 (odds ratio, 0.27; 95% confidence interval: 0.08-0.92). In comparing SIM+SOF-treated patients versus matched untreated controls, AEs requiring hospitalization (9% vs. 13%; P = 0.55), infections (8% vs. 6%; P = 0.47), and events of decompensation (9% vs. 10%; P = 0.78) occurred at similar frequency.

conclusionsSIM+SOF with/without RBV has lower efficacy and higher rates of AEs in patients with CP-B/C cirrhosis, compared to CP-A. Frequency of adverse safety outcomes were similar to matched untreated controls, suggesting that safety events reflect the natural history of cirrhosis and are not related to treatment.

Indexed as

AgedAnalysis of VarianceAntiviral AgentsCase-Control StudiesDrug Therapy, CombinationFemaleFollow-Up StudiesHepacivirusHepatitis CHumansLiver CirrhosisLogistic ModelsMaleMiddle AgedMultivariate AnalysisPatient SafetyAntiviral AgentsRibavirinSimeprevirSofosbuvir

Identifiers

PMID26033798
PMCPMC4549204
OpenAlexW2145933460

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.