Evidence map›Paper›PMID 32155165›Full record

ArticlePloS one2020

Directly observed therapy for HCV with glecaprevir/pibrentasvir alongside opioid substitution in people who inject drugs-First real world data from Austria.

Caroline Schmidbauer, Raphael Schubert, Angelika Schütz, Cornelia Schwanke, Julian Luhn, Enisa Gutic, Roxana Pirker, Tobias Lang, Thomas Reiberger, Hans Haltmayer and 1 more

Open access · goldAbstract readComparative Study
In one paragraph

Article in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
4.2field-weighted citation impact, top 5% 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

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 39 citations in OpenAlex.

  1. Pooled it
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  4. A systematic PCR record-based re-call of HCV-RNA-positive people enables re-linkage to care and HCV elimination in Austria - The ELIMINATE project.Liver international : official journal of the International Association for the Study of the Liver · 2024
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  6. 'Canadian liver journal · 2024
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  18. Epidemiological trends of HBV and HDV coinfection among Viennese HIV+ patients.Liver international : official journal of the International Association for the Study of the Liver · 2021
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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

11 authors at 3 institutions in 1 country.

Caroline SchmidbauerDepartment of Internal Medicine IV, Wilhelminenspital, Vienna, Austria.ORCID 0000-0001-7762-7483
Raphael SchubertAmbulatorium Suchthilfe Wien, Suchthilfe Wien gGmbH, Vienna, Austria.
Angelika SchützAmbulatorium Suchthilfe Wien, Suchthilfe Wien gGmbH, Vienna, Austria.
Cornelia SchwankeAmbulatorium Suchthilfe Wien, Suchthilfe Wien gGmbH, Vienna, Austria.
Julian LuhnAmbulatorium Suchthilfe Wien, Suchthilfe Wien gGmbH, Vienna, Austria.
Enisa GuticDepartment of Internal Medicine IV, Wilhelminenspital, Vienna, Austria.
Roxana PirkerDepartment of Internal Medicine IV, Wilhelminenspital, Vienna, Austria.
Tobias LangDepartment of Internal Medicine IV, Wilhelminenspital, Vienna, Austria.
Thomas ReibergerDivision of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.ORCID 0000-0002-4590-3583
Hans HaltmayerAmbulatorium Suchthilfe Wien, Suchthilfe Wien gGmbH, Vienna, Austria.
Michael GschwantlerDepartment of Internal Medicine IV, Wilhelminenspital, Vienna, Austria.
Wilhelminen Hospital · ATAustrian Breast & Colorectal Cancer Study Group · ATSigmund Freud Privatuniversität Wien · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDirectly acting antivirals (DAA) against hepatitis C virus (HCV) infection have facilitated sustained virologic response (SVR) rates >90% in clinical studies. Yet, real life data regarding DAA treatment in people who inject drugs (PWIDs) are scarce. We evaluated the effectiveness of glecaprevir/pibrentasvir (G/P) in difficult-to-treat PWIDs with presumed high risk of non-adherence to DAA therapy using the concept of directly observed therapy involving their opioid substitution therapy (OST) facility.

methodsN = 145 patients (m/f: 91/54; median age: 41.1 (IQR 19.5) years; HCV-genotype (GT) 1/2/3/4: 82/1/56/5, GT3: 38.6%; cirrhosis: n = 6; 4.1%) treated with G/P were included. PWIDs at high risk for non-adherence to DAA therapy received HCV treatment together with their OST under the supervision of medical staff ("directly observed therapy", DOT). The effectiveness of G/P given as DOT in PWIDs with presumed high risk of non-adherence to DAA therapy was compared to patients with suspected "excellent compliance" in the "standard setting" (SS) of G/P prescription at a tertiary care center and self-managed G/P intake at home. Treatment duration was 8-16 weeks according to the G/P drug label.

resultsDOT-patients (n = 74/145; 51.0%) were younger than SS-patients (median 38.7, IQR 12.5 vs. median 50.6, IQR 20.3 years), all had psychiatric co-morbidities and most had a poor socioeconomic status. 50/74 (67.6%) reported ongoing intravenous drug use (IDU). SVR was achieved in n = 70/74 (94.6%) patients with n = 3 being lost to follow-up (FU) and n = 1 showing nonresponse to therapy. SS-patients achieved SVR in 97.2% (69/71) with n = 1 patient being lost to FU and n = 1 patient with GT3 showing HCV relapse.

conclusionG/P given as DOT along with OST in PWIDs with high risk of non-adherence to DAA therapy resulted in similarly high SVR rates (94.6%) as in patients with presumed "excellent compliance" under standard drug intake.

Indexed as

AdultAgedAustriaBenzimidazolesDirectly Observed TherapyDrug CombinationsFemaleHepatitis C, ChronicHumansMaleMedication AdherenceMiddle AgedOpiate Substitution TreatmentPatient CompliancePyrrolidinesQuinoxalinesBenzimidazolesDrug Combinationsglecaprevir and pibrentasvirPyrrolidinesQuinoxalinesSulfonamides

Identifiers

PMID32155165
PMCPMC7064180
OpenAlexW3010846870

What OpenQuestion holds

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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.