Evidence map›Paper›PMID 26604650›Full record

Observational studyWorld journal of gastroenterology2015

Re-re-treatment of hepatitis C virus: Eight patients who relapsed twice after direct-acting-antiviral drugs.

Joshua Hartman, Kian Bichoupan, Neal Patel, Sweta Chekuri, Alyson Harty, Douglas Dieterich, Ponni Perumalswami, Andrea D Branch

Open access · hybridAbstract readCase ReportsObservational Study
In one paragraph

Observational study in World journal of gastroenterology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 30% 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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Observational
  2. Hepatic steatosis in HCV-infected persons in the direct-acting antiviral era.Tropical diseases, travel medicine and vaccines · 2016
    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

8 authors at 1 institution in 2 countries.

Joshua HartmanJoshua Hartman, Department of Medicine, Icahn School of Medicine at the Mount Sinai Medical Center, New York, NY 10029, United States.
Kian BichoupanJoshua Hartman, Department of Medicine, Icahn School of Medicine at the Mount Sinai Medical Center, New York, NY 10029, United States.
Neal PatelJoshua Hartman, Department of Medicine, Icahn School of Medicine at the Mount Sinai Medical Center, New York, NY 10029, United States.
Sweta ChekuriJoshua Hartman, Department of Medicine, Icahn School of Medicine at the Mount Sinai Medical Center, New York, NY 10029, United States.
Alyson HartyJoshua Hartman, Department of Medicine, Icahn School of Medicine at the Mount Sinai Medical Center, New York, NY 10029, United States.
Douglas DieterichJoshua Hartman, Department of Medicine, Icahn School of Medicine at the Mount Sinai Medical Center, New York, NY 10029, United States.
Ponni PerumalswamiJoshua Hartman, Department of Medicine, Icahn School of Medicine at the Mount Sinai Medical Center, New York, NY 10029, United States.
Andrea D BranchJoshua Hartman, Department of Medicine, Icahn School of Medicine at the Mount Sinai Medical Center, New York, NY 10029, United States.
Bristol-Myers Squibb (Germany) · DE

Funding

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 R01 DK090317
6 · The paper itself

Abstract

aimTo determine risk factors associated with hepatitis C virus (HCV) treatment failure after direct acting antivirals in patients with complex treatment histories.

methodsAll HCV mono-infected patients who received treatment at our institution were queried. Analysis was restricted to patients who previously failed treatment with boceprevir (BOC) or telaprevir (TVR) and started simeprevir (SMV) and sofosbuvir (SOF) ± ribavirin (RBV) between December 2013 and June 2014. Patients with human immunodeficiency virus (HIV)/HCV co-infection or patients who received a liver transplant in the past were excluded. Viral loads were recorded while on treatment and after treatment. Data collection continued until December, 31(st) 2014 when data analysis was initiated. Patients missing virologic outcomes data were not included in the analysis. Analysis of 35 patients who had virologic outcome data available resulted in eight patients who were viral load negative at the end of treatment with SMF/SOF but later relapsed. Data related to patient demographics, HCV infection, and treatment history was collected in order to identify risk factors shared among patients who failed treatment with SMF/SOF.

resultsEight patients who were treated with the first generation HCV protease inhibitors BOC or TVR in combination with pegylated-interferon (PEG) and RBV who failed this triple therapy were subsequently re-treated with an off-label all-oral regimen of SMV and SOF for 12 wk, with RBV in seven cases. Treatment was initiated before the Food and Drug Administration approved a 24-wk SMV/SOF regimen for patients with liver cirrhosis. All eight patients had an end of treatment response, but later relapsed. Eight (100%) patients were male. Mean age was 56 (range, 49-64). Eight (100%) patients had previously failed PEG/RBV dual therapy at least once in addition to prior failure with triple therapy. Total number of times treated ranged from 3-6 (mean 3.8). Eight (100%) patients were male had liver cirrhosis as determined by Fibroscan or MRI. Seven (87.5%) patients had genotype 1a HCV. Seven (87.5%) patients had over 1 million IU/mL HCV RNA at the time of re-treatment.

conclusionThis study identifies factors associated with SMV/SOF treatment failure and provides evidence that twleve weeks of SMV/SOF/RBV is insufficient in cirrhotics with high-titer genotype 1a HCV.

Indexed as

Antiviral AgentsDrug Therapy, CombinationHepacivirusHepatitis CHumansMaleMiddle AgedRecurrenceRetreatmentRisk FactorsTime FactorsTreatment FailureVirus ActivationAntiviral AgentsHepatitis CProtease inhibitorRelapseSimeprevirSofosbuvirTreatment failure

Identifiers

PMID26604650
PMCPMC4649126
OpenAlexW2178339151

What OpenQuestion holds

Textmetadata
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.