Evidence map›Paper›PMID 38169058›Full record

ArticleAdvances in therapy2024

Real-World Safety and Effectiveness of an 8-Week Regimen of Glecaprevir/Pibrentasvir in Patients with Hepatitis C and Cirrhosis.

Mei Lu, Loralee B Rupp, Christina Melkonian, Sheri Trudeau, Yihe G Daida, Mark A Schmidt, Stuart C Gordon

Erratum issuedOpen access · bronzeAbstract read
In one paragraph

Article in Advances in therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.5field-weighted citation impact, top 20% 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. Article
  2. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Mei LuDepartment of Public Health Sciences, Henry Ford Health, One Ford Place, Detroit, MI, 48202, USA. mlu1@hfhs.org.
Loralee B RuppDepartment of Health Policy and Health Services Research, Henry Ford Health, Detroit, MI, USA.
Christina MelkonianDepartment of Public Health Sciences, Henry Ford Health, One Ford Place, Detroit, MI, 48202, USA.
Sheri TrudeauDepartment of Public Health Sciences, Henry Ford Health, One Ford Place, Detroit, MI, 48202, USA.
Yihe G DaidaCenter for Integrated Health Care Research, Kaiser Permanente Hawaii, Honolulu, HI, USA.
Mark A SchmidtCenter for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.
Stuart C GordonDepartment of Gastroenterology and Hepatology, Henry Ford Health, Detroit, MI, USA.
Henry Ford Health System · USKaiser Permanente · USKaiser Permanente Center for Health Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn 2019, an 8-week regimen of glecaprevir/ pibrentasvir (GLE/PIB) was FDA-approved for treatment of chronic hepatitis C (HCV) in patients with cirrhosis. We used data from the Chronic Hepatitis Cohort Study (CHeCS) to evaluate treatment response and adverse events among patients with HCV and cirrhosis under routine clinical care.

methodsUsing an intention-to-treat (ITT)/modified ITT (mITT) approach, endpoints were (1) sustained virological response (SVR) at 12 weeks (SVR12) post-treatment; and (2) adverse events (AEs)/serious AEs during treatment. Patients with cirrhosis from two CHeCS sites were included if they were prescribed GLE/PIB from August 2017 to June 2020. Detailed treatment and clinical data were collected. Patient baseline characteristics were described with mean/standard deviation (std) for continuous variables, and proportions for categorical variables. Analyses were propensity score adjusted. The final model retained variables that were significant with p value < 0.05.

resultsThe ITT sample included 166 patients, with 43, 116, and 7 patients in the 8-week, 12-week, and > 12-week planned treatment groups. Among them, 159 had confirmed SVR (95.8%, LCL 93.2%). The mITT analysis included 160 patients after excluding 6 with unknown HCV RNA results; 159 achieved SVR (99.4%, LCL 98.3%). There were no significant differences in rates of SVR between the 8-week and 12-week regimens in either analysis, nor any association with patient characteristics. SAEs were experienced by 1 patient (2%) in the 8-week group, 7 (5%) in the 12-week group (including one death), and 2 (29%) in the > 12-week group; 4 patients (from the 12-week group) experienced serious AEs or hepatic events that were "likely attributable" to GLE/PIB treatment.

conclusionAn 8-week regimen of GLE/PIB is well tolerated and highly effective among US patients with HCV and cirrhosis receiving routine clinical care.

Indexed as

Aminoisobutyric AcidsBenzimidazolesCyclopropanesHepatitis C, ChronicLactams, MacrocyclicLiver CirrhosisSulfonamidesAntiviral AgentsCohort StudiesGenotypeHepacivirusHumansLeucineProlinePyrrolidinesQuinoxalinesAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesglecaprevirLactams, MacrocyclicLeucinepibrentasvirProlinePyrrolidinesQuinoxalinesSulfonamidesDecompensated cirrhosisDirect acting antiviralMavyretObservationalSafety

Identifiers

PMID38169058
PMCPMC11006752
OpenAlexW4390497981

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.