Evidence map›Paper›PMID 25889921›Full record

ArticleVirology journal2015

First-generation protease inhibitor-triple therapy: SVR 24, safety, and predictors of response in a large single center cohort.

Christoph R Werner, Carolin Franz, Daniel P Egetemeyr, Robert Beck, Nisar P Malek, Ulrich M Lauer, Christoph P Berg

Abstract readClinical Study
In one paragraph

Article in Virology journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Trial
  2. Antimicrobial agents and chemotherapy · 2018
    Article
  3. Article
  4. Article
  5. Predictors of early treatment discontinuation and severe anemia in a Brazilian cohort of hepatitis C patients treated with first-generation protease inhibitors.Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica · 2016
    Article
  6. 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

7 authors.

Christoph R WernerDepartment of Gastroenterology, Hepatology, and Infectiology, University Hospital Tübingen, Tübingen, Germany. christoph.werner@med.uni-tuebingen.de.
Carolin FranzDepartment of Gastroenterology, Hepatology, and Infectiology, University Hospital Tübingen, Tübingen, Germany. caro-fra@web.de.
Daniel P EgetemeyrDepartment of Gastroenterology, Hepatology, and Infectiology, University Hospital Tübingen, Tübingen, Germany. daniel.egetemeyr@med.uni-tuebingen.de.
Robert BeckInstitute of Medical Virology, University Hospital Tübingen, Tübingen, Germany. robert.beck@med.uni-tuebingen.de.
Nisar P MalekDepartment of Gastroenterology, Hepatology, and Infectiology, University Hospital Tübingen, Tübingen, Germany. nisar.malek@med.uni-tuebingen.de.
Ulrich M LauerDepartment of Gastroenterology, Hepatology, and Infectiology, University Hospital Tübingen, Tübingen, Germany. ulrich.lauer@uni-tuebingen.de.
Christoph P BergDepartment of Gastroenterology, Hepatology, and Infectiology, University Hospital Tübingen, Tübingen, Germany. christoph.berg@med.uni-tuebingen.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsAim of this retrospective study was to analyze the efficacy, safety, and predictors of treatment success for first-generation-PI triple therapies, including either boceprevir or telaprevir, in a mono-centric "real-life" setting with respect to SVR 24. PATIENTS: 131 patients (102 patients telaprevir, 29 patients boceprevir) were treated. Of these, 33/131 patients were treatment naïve, 72/131 patients had been pretreated with PEG-IFN/RBV (PR) (thereof: 36 with non-response, 30 with relapse, 6 unknown), and 26/131 patients previously had received non-pegylated interferon. 96/131 patients were infected with HCV genotype 1b. 41/131 patients had liver cirrhosis.

results95/131 (73%) patients achieved SVR 24. SVR rates for subgroups were: 26/33 (79%) for treatment naïve, 25/30 (83%) for PR-relapse, 20/36 (56%) for PR-non-response, 21/26 (81%) for non-PR pretreated patients, (26/41) 63% for patients with liver cirrhosis, 23/35 (66%) genotype 1a, 72/96 (75%) genotype 1b. Predictors of SVR 24 were eRVR and a negative viral load at PI-treatment week 4 (p < 0.0001), negative predictors were quantifiable HCV viral load at PI-treatment week 4 (p < 0.0001), baseline platelet count < 100/nl (p < 0.0001), and previous PR-non-response (p = 0.006). 33/131 (25%) patients discontinued treatment prematurely, of those 14/131 (11%) patients due to virological failure. Side effects were frequent (anemia 59/131 [45%], severe infections 6/131 [5%]).

conclusionsAccording to our SVR 24 results, efficacy of PI-based triple therapy in our "real-life" cohort is comparable to the large multi-centric clinical trials. Pronounced side effects are frequent during therapy and often need complex therapeutic interventions. Since new DAA are available, it is open to discussion, if first-generation PI-triple therapy is no longer indicated at all.

Indexed as

AdultAntiviral AgentsDrug Therapy, CombinationFemaleHepacivirusHepatitis C, ChronicHumansMaleMiddle AgedOligopeptidesProlineProtease InhibitorsRetrospective StudiesAntiviral AgentsN-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamideOligopeptidesProlineProtease Inhibitorstelaprevir

Identifiers

PMID25889921
PMCPMC4355422

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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.