Evidence map›Paper›PMID 29147645›Full record

ArticleWorld journal of virology2017

Real-world cure rates for hepatitis C virus treatments that include simeprevir and/or sofosbuvir are comparable to clinical trial results.

Kian Bichoupan, Neeta Tandon, James F Crismale, Joshua Hartman, David Del Bello, Neal Patel, Sweta Chekuri, Alyson Harty, Michel Ng, Keith M Sigel and 13 more

Abstract read
In one paragraph

Article in World journal of virology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Observational
  3. Article
  4. 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

23 authors.

Kian BichoupanDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Neeta TandonJanssen Scientific Affairs, LLC, Titusville, NJ 08560, United States.
James F CrismaleDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Joshua HartmanDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
David Del BelloDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Neal PatelDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Sweta ChekuriDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Alyson HartyDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Michel NgDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Keith M SigelDivision of General Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Meena B BansalDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Priya GrewalDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Charissa Y ChangDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Jennifer LeongDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Gene Y ImDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Lawrence U LiuDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Joseph A OdinDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Nancy BachDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Scott L FriedmanDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Thomas D SchianoDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Ponni V PerumalswamiDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Douglas T DieterichDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Andrea D BranchDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States. andrea.branch@mssm.edu.

Funding

Translational Research CoreP30DK020541 · NIDDK · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI JEFFREY E. PESSIN · 2015 to 2026
$27.7M
Optimizing Vitamin D Treatment in HIV/AIDS: An RCTR01DA031095 · NIDA · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI BRANCH, ANDREA D., DIETERICH, DOUGLAS THOMAS · 2010 to 2014
$3.3M
Clinical Outcomes and the HCV Core GeneR01DK090317 · NIDDK · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI BRANCH, ANDREA D. · 2010 to 2014
$2.0M
NIDA NIH HHS R01 DA031095NIDDK NIH HHS P30 DK020541NIDDK NIH HHS R01 DK090317
6 · The paper itself

Abstract

aimTo assess the real-world effectiveness and cost of simeprevir (SMV), and/or sofosbuvir (SOF)-based therapy for chronic hepatitis C virus (HCV) infection.

methodsThe real-world performance of patients treated with SMV/SOF ± ribavirin (RBV), SOF/RBV, and SOF/RBV with pegylated-interferon (PEG) were analyzed in a consecutive series of 508 patients with chronic HCV infection treated at a single academic medical center. Patients with genotypes 1 through 4 were included. Rates of sustained virological response - the absence of a detectable serum HCV RNA 12 wk after the end of treatment [sustained virological response (SVR) 12] - were calculated on an intention-to-treat basis. Costs were calculated from the payer's perspective using Medicare/Medicaid fees and Redbook Wholesale Acquisition Costs. Patient-related factors associated with SVR12 were identified using multivariable logistic regression.

resultsSVR12 rates were as follows: 86% (95%CI: 80%-91%) among 178 patients on SMV/SOF ± RBV; 62% (95%CI: 55%-68%) among 234 patients on SOF/RBV; and 78% (95%CI: 68%-86%) among 96 patients on SOF/PEG/RBV. Mean costs-per-SVR12 were $174442 (standard deviation: ± $18588) for SMV/SOF ± RBV; $223003 (± $77946) for SOF/RBV; and $126496 (± $31052) for SOF/PEG/RBV. Among patients on SMV/SOF ± RBV, SVR12 was less likely in patients previously treated with a protease inhibitor [odds ratio (OR): 0.20, 95%CI: 0.06-0.56]. Higher bilirubin (OR: 0.47, 95%CI: 0.30-0.69) reduced the likelihood of SVR12 among patients on SOF/RBV, while FIB-4 score ≥ 3.25 reduced the likelihood of SVR12 (OR: 0.18, 95%CI: 0.05-0.59) among those on SOF/PEG/RBV.

conclusionSVR12 rates for SMV and/or SOF-based regimens in a diverse real-world population are comparable to those in clinical trials. Treatment failure accounts for 27% of costs.

Indexed as

CirrhosisCostPolymerase inhibitorProtease inhibitorSustained virological response

Identifiers

PMID29147645
PMCPMC5680347

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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.