Evidence map›Paper›PMID 32352385›Full record

ArticleJournal of medical Internet research2020

Wirelessly Observed Therapy to Optimize Adherence and Target Interventions for Oral Hepatitis C Treatment: Observational Pilot Study.

Maurizio Bonacini, Yoona Kim, Caroline Pitney, Lee McKoin, Melody Tran, Charles Landis

Open access · goldAbstract read
In one paragraph

Article in Journal of medical Internet research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.7field-weighted citation impact, top 16% 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

11 citing papers in PubMed, 19 citations in OpenAlex.

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  9. Role of digital therapeutics and the changing future of healthcare.Journal of family medicine and primary care · 2020
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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

6 authors at 3 institutions in 1 country.

Maurizio BonaciniMission Gastroenterology and Hepatology, san francisco, CA, United States.ORCID 0000-0002-4460-2367
Yoona KimProteus Digital Health, Redwood City, CA, United States.ORCID 0000-0001-9078-6657
Caroline PitneyPaul G. Allen School of Computer Science and Engineering, University of Washington, Seattle, WA, United States.ORCID 0000-0002-3262-7751
Lee McKoinPaul G. Allen School of Computer Science and Engineering, University of Washington, Seattle, WA, United States.
Melody TranProteus Digital Health, Redwood City, CA, United States.ORCID 0000-0003-4490-2762
Charles LandisPaul G. Allen School of Computer Science and Engineering, University of Washington, Seattle, WA, United States.ORCID 0000-0002-1074-7760
University of Washington · USProteus Digital Health · USMission Bio (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA fixed-dose combination of ledipasvir/sofosbuvir (LDV/SOF) is efficacious in treating chronic hepatitis C virus (HCV) infection; however, objective adherence to prescribed regimens in real-world clinical settings has not been well studied.

objectiveThis study aimed to evaluate adherence and virologic outcomes in patients with chronic HCV infection treated with LDV/SOF using a novel digital medicine program that directly measures drug ingestion adherence.

methodsThis prospective, observational, open-label, single-arm pilot study was conducted at 2 clinical research sites and followed patients with HCV infection who were prescribed LDV/SOF along with an ingestible sensor. Patients were treated for 8 or 12 weeks. The main outcomes were ingestion adherence, medical interventions, virologic response, safety, and patient satisfaction.

resultsOf the 28 patients (mean 59 years, SD 7), 61% (17/28) were male, 61% (17/28) were non-Caucasian, and 93% (26/28) were treatment naïve. All 28 had genotype 1 HCV, and of these, 27 completed an 8- or 12-week treatment. Patients used the digital medicine program for 92% of the expected days; the overall mean ingestion adherence rate was 97%. Providers used the digital medicine program data for same-day medication therapy management in 39% (11/28) of patients. End-of-treatment response was achieved in all the available 21 of 28 patients. Sustained virologic response at 12 weeks or more was achieved in 26 of 28 patients; of the 2 patients who relapsed, one had less than 90% adherence and the other had greater than or equal to 95% adherence, lending insights into reasons for treatment failure. A total of 4 subjects reported nonserious adverse events, which were resolved.

conclusionsConclusions: The findings of this study suggest that digital medicines can be used for wirelessly observed therapy to support adherence to antiviral HCV therapy, reduce unnecessary medication wastage and retreatment costs, and potentially optimize sustained virologic response rates, especially in populations at high risk for nonadherence.

Indexed as

FemaleHepatitis C, ChronicHumansMaleMiddle AgedPilot ProjectsProspective StudiesSofosbuvirTreatment OutcomeSofosbuvirantiviralschronic hepatitis CcomplianceHCVsofosbuvirsustained virologic response

Identifiers

PMID32352385
PMCPMC7226036
OpenAlexW2980605841

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.