Evidence map›Paper›PMID 28504842›Full record

Observational studyHepatology (Baltimore, Md.)2017

Safety and efficacy of current direct-acting antiviral regimens in kidney and liver transplant recipients with hepatitis C: Results from the HCV-TARGET study.

Varun Saxena, Vandana Khungar, Elizabeth C Verna, Josh Levitsky, Robert S Brown, Mohamed A Hassan, Mark S Sulkowski, Jacqueline G O'Leary, Farrukh Koraishy, Joseph S Galati and 7 more

Abstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Hepatology (Baltimore, Md.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 5 pooled it
–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

66 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
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  5. Pooled it
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6 more citing papers are in PubMed but not listed here.

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

17 authors.

Varun SaxenaDivision of Gastroenterology/Hepatology, University of California San Francisco, San Francisco, CA.
Vandana KhungarUniversity of Pennsylvania, Philadelphia, PA.
Elizabeth C VernaColumbia University, New York, NY.
Josh LevitskyNorthwestern University, Chicago, IL.
Robert S BrownWeill Cornell Medicine, New York, NY.
Mohamed A HassanUniversity of Minnesota, Minneapolis, MN.
Mark S SulkowskiJohns Hopkins University, Baltimore, MD.
Jacqueline G O'LearyBaylor University Medical Center, Dallas, TX.
Farrukh KoraishySaint Louis University, St. Louis, MO.
Joseph S GalatiResearch Specialists of Texas, Houston, TX.
Alexander A KuoUniversity of California, San Diego, San Diego, CA.
Monika VainoriusUniversity of North Carolina, Chapel Hill, NC.
Lucy AkushevichUniversity of North Carolina, Chapel Hill, NC.
David R NelsonUniversity of Florida, Gainesville, FL.
Michael W FriedUniversity of North Carolina, Chapel Hill, NC.
Norah TerraultDivision of Gastroenterology/Hepatology, University of California San Francisco, San Francisco, CA.
K Rajender ReddyUniversity of Pennsylvania, Philadelphia, PA.

Funding

Using social networks to map and evaluate team science across CTSA hubsUL1TR001427 · NCATS · UNIVERSITY OF FLORIDA · PI MITCHELL, DUANE A. · 2015 to 2024
$37.2M
University of Florida Older Americans Independence Center (OAIC)P30AG028740 · NIA · UNIVERSITY OF FLORIDA · PI CHRISTIAAN LEEUWENBURGH · 2007 to 2026
$22.8M
NRSA Hepatology Training GrantT32DK060414 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Mandana Khalili, JACQUELYN J. MAHER · 2002 to 2026
$6.8M
The North Carolina Hepatitis Beta Clinical Research NetworkU01DK082867 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI FRIED, MICHAEL W · 2008 to 2019
$3.4M
Mentoring Junior Faculty: Viral hepatitis Clinical ResearchK24DK066144 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI FRIED, MICHAEL W · 2004 to 2014
$1.5M
Patient Oriented Research in Hepatitis C-infected Injection Drug UsersK24DA034621 · NIDA · JOHNS HOPKINS UNIVERSITY · PI SULKOWSKI, MARK SEBASTIAN · 2012 to 2022
$1.2M
NCATS NIH HHS UL1 TR001427NIA NIH HHS P30 AG028740NIDA NIH HHS K24 DA034621NIDDK NIH HHS K24 DK066144NIDDK NIH HHS T32 DK060414NIDDK NIH HHS U01 DK082867
6 · The paper itself

Abstract

Data outside of clinical trials with direct-acting antiviral regimens with or without ribavirin as treatment of chronic hepatitis C virus in solid organ transplant recipients are limited. Liver transplant (LT), kidney transplant (KT), and dual liver kidney (DLK) transplant recipients from the Hepatitis C Therapeutic Registry and Research Network database, a multicenter, longitudinal clinical care treatment cohort, treated with direct-acting antiviral regimens between January 1, 2014, and February 15, 2016, were included to assess safety and efficacy. Included were 443 posttransplant patients (KT = 60, LT = 347, DLK = 36); 42% had cirrhosis, and 54% had failed prior antiviral therapy. Most had genotype (GT) 1 (87% with 52% GT1a, 27% GT1b, and 8% GT1 no subtype) and were treated with sofosbuvir (SOF)/ledipasvir ± ribavirin (85%) followed by SOF + daclatasvir ± ribavirin (9%) and ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin (6%). Rates of sustained virologic response (SVR) at 12 weeks were available on 412 patients, and 395 patients (95.9%) achieved SVR at 12 weeks: 96.6%, 94.5%, and 90.9% among LT, KT, and DLK transplant recipients, respectively. Ribavirin did not influence SVR rates and was more often used in those with higher BMI, higher estimated glomerular filtration rate and lower creatinine. Female gender, baseline albumin ≥3.5 g/dL, baseline total bilirubin ≤1.2 mg/dL, absence of cirrhosis, and hepatic decompensation predicted SVR at 12 weeks. Six episodes of acute rejection (n = 2 KT, 4 LT) occurred, during hepatitis C virus treatment in 4 and after cessation of treatment in 2.

conclusionIn a large prospective observational cohort study, direct-acting antiviral therapy with SOF/ledipasvir, ombitasvir/paritaprevir/ritonavir + dasabuvir, and SOF plus daclatasvir was efficacious and safe in LT, KT, and DLK transplant recipients; ribavirin did not influence SVR, and graft rejection was rare. (Hepatology 2017;66:1090-1101).

Indexed as

RegistriesAdultAgedAged, 80 and overAntiviral AgentsFemaleHepatitis C, ChronicHumansKidney TransplantationLiver TransplantationLongitudinal StudiesMaleMiddle AgedPostoperative ComplicationsProspective StudiesTreatment OutcomeAntiviral Agents

Identifiers

PMID28504842
PMCPMC5756478

What OpenQuestion holds

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Read underepoch 390

Registered trials

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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.