Updated Results from the Retrospective CREST Study on the Safety and Effectiveness of 8-Week Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis.

Compensated cirrhosis Direct-acting antivirals Hepatitis C virus Real world Treatment-naïve

Journal

Advances in therapy

ISSN: 1865-8652

Titre abrégé: Adv Ther

Pays: United States

ID NLM: 8611864

Informations de publication

Date de publication:
29 Oct 2024

Historique:

received: 21 05 2024

accepted: 10 09 2024

medline: 29 10 2024

pubmed: 29 10 2024

entrez: 29 10 2024

Statut: aheadofprint

Résumé

This brief report presents updated findings from the previously published CREST study evaluating the safety and effectiveness of 8-week glecaprevir/pibrentasvir (GLE/PIB) in treatment-naïve patients with chronic hepatitis C virus (HCV) infection and compensated cirrhosis. The current study includes an additional 51 patients, presents effectiveness data stratified by additional comorbidities and comedications, and offers insights into healthcare resource utilization. Analysis of treatment-naïve patients with HCV infection and compensated cirrhosis enrolled in the CREST study, a real-world, observational multicenter study. All enrolled patients were included in the full analysis set (FAS); the modified analysis set (MAS) excluded patients with missing SVR12 data, or who discontinued GLE/PIB for nonvirologic failure. The primary endpoint was sustained virologic response at posttreatment week 12 (SVR12) in the MAS. Safety and healthcare resource utilization were also assessed. The FAS included 437 patients, and the MAS 375. Overall, the results were consistent with the previously published study, with 98.9% of patients in the MAS achieving SVR12. Patients with comorbidities such as alcoholism, diabetes, and hyperlipidemia achieved SVR12 rates > 94%. High SVR12 rates were also achieved by patients receiving comedications such as anxiolytics, antidepressants, and opioid agonists. Of the 26.8% of patients with an adverse event, 1.1% had a serious adverse event, none of which were deemed related to GLE/PIB. Healthcare resource utilization varied by employment status and history of drug use. Active drug users had more physician and nurse visits than specialist visits compared with former drug users. This study provides further evidence on the safety and effectiveness of 8-week GLE/PIB, supporting the use of shorter treatment in treatment-naïve patients with Child-Pugh A cirrhosis including subgroups of interest, regardless of comorbidities and comedications observed in this population. The variable healthcare resource utilization in different patient types can help plan and resource linkage to care better, thus supporting HCV elimination efforts.

Identifiants

DOI: 10.1007/s12325-024-02996-6 PMID: 39470876

pubmed: 39470876

doi: 10.1007/s12325-024-02996-6

pii: 10.1007/s12325-024-02996-6

doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

Informations de copyright

Références

Blach S, Terrault NA, Tacke F, et al. Global change in hepatitis C virus prevalence and cascade of care between 2015 and 2020: a modelling study. Lancet Gastroenterol Hepatol. 2022;7:396–415.

doi: 10.1016/S2468-1253(21)00472-6

World Health Organization (WHO). Global progress report on HIV, viral hepatitis and sexually transmitted infections, 2021. Accountability for the global health sector strategies 2016–2021: actions for impact. 2021. https://www.who.int/publications/i/item/9789240027077 . Accessed October 2023.

European Association for the Study of the Liver, Clinical Practice Guidelines Panel Chair, EASL Governing Board representative, Panel members. EASL recommendations on treatment of hepatitis C: Final update of the series. J Hepatol. 2020;73:1170–218.

AbbVie. Maviret EU Summary of Product Characteristics; 2021. https://www.ema.europa.eu/en/documents/product-information/maviret-epar-product-information_en.pdf . Accessed October 2023.

AbbVie. Mavyret US Package Insert; 2021. https://www.rxabbvie.com/pdf/mavyret_pi.pdf . Accessed October 2023.

AbbVie. Maviret Product Monograph; 2022. https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/MAVIRET_PM_EN.pdf . Accessed October 2023.

Zuckerman E, Gutierrez JA, Dylla DE, et al. Eight weeks of treatment with glecaprevir/pibrentasvir is safe and efficacious in an integrated analysis of treatment-naïve patients with hepatitis C virus infection. Clin Gastroenterol Hepatol. 2020;18(2544–53):e6.

Brown RS Jr, Buti M, Rodrigues L, et al. Glecaprevir/pibrentasvir for 8 weeks in treatment-naive patients with chronic HCV genotypes 1–6 and compensated cirrhosis: the EXPEDITION-8 trial. J Hepatol. 2020;72:441–9.

doi: 10.1016/j.jhep.2019.10.020 pubmed: 31682879

Flamm SL, Kort J, Marx SE, et al. Effectiveness of 8-week glecaprevir/pibrentasvir for treatment-naive, compensated cirrhotic patients with chronic hepatitis C infection. Adv Ther. 2020;37:2267–74.

doi: 10.1007/s12325-020-01301-5 pubmed: 32279176 pmcid: 7467488

Lampertico P, Mauss S, Persico M, et al. Real-world clinical practice use of 8-week glecaprevir/pibrentasvir in treatment-naïve patients with compensated cirrhosis. Adv Ther. 2020;37:4033–42.

doi: 10.1007/s12325-020-01449-0 pubmed: 32754824 pmcid: 7444399

Klinker H, Naumann U, Rossle M, et al. Glecaprevir/pibrentasvir for 8 weeks in patients with compensated cirrhosis: safety and effectiveness data from the German Hepatitis C-Registry. Liver Int. 2021;41:1518–22.

doi: 10.1111/liv.14937 pubmed: 33966349

Aghemo A, Horsmans Y, Bourgeois S, et al. Real-world outcomes in historically underserved patients with chronic hepatitis C infection treated with glecaprevir/pibrentasvir. Infect Dis Ther. 2021;10:2203–22.

doi: 10.1007/s40121-021-00455-1 pubmed: 34125405 pmcid: 8572930

Lampertico P, Peck-Radosavljevic M, Bondin M, et al. Addressing barriers to hepatitis C virus (HCV) elimination: real-world outcomes in historically underserved patients with chronic HCV infection treated with glecaprevir/pibrentasvir. Hepatology. 2019;70:954A-A955.

D’Ambrosio R, Pasulo L, Puoti M, et al. Real-world effectiveness and safety of glecaprevir/pibrentasvir in 723 patients with chronic hepatitis C. J Hepatol. 2019;70:379–87.

doi: 10.1016/j.jhep.2018.11.011 pubmed: 30472321

Kinoshita A, Koike K, Mizuno Y, et al. Efficacy and safety of glecaprevir/pibrentasvir in patients with hepatitis C virus infection aged ≥75 years. Geriatr Gerontol Int. 2020;20:578–83.

doi: 10.1111/ggi.13919 pubmed: 32267087

Cornberg M, Ahumada A, Aghemo A, et al. Safety and effectiveness using 8 weeks of glecaprevir/pibrentasvir in HCV-infected treatment-naïve patients with compensated cirrhosis: the CREST Study. Adv Ther. 2022;39:3146–58.

doi: 10.1007/s12325-022-02158-6 pubmed: 35543964 pmcid: 9239949

Clopper C, Pearson E. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika. 1934;26:404–13.

doi: 10.1093/biomet/26.4.404

University of Liverpool. HEP drug interactions. 2019. https://www.hep-druginteractions.org/checker . Accessed October 2023.

Persico M, Aglitti A, Milella M, et al. Real-life glecaprevir/pibrentasvir in a large cohort of patients with hepatitis C virus infection: the MISTRAL study. Liver Int. 2019;39:1852–9.

doi: 10.1111/liv.14170 pubmed: 31175707

Brown RS Jr, Buti M, Rodrigues L, et al. Glecaprevir/pibrentasvir for 8 weeks in treatment-naïve patients with chronic HCV genotypes 1–6 and compensated cirrhosis: the EXPEDITION-8 trial. J Hepatol. 2020;72:441–9.

doi: 10.1016/j.jhep.2019.10.020 pubmed: 31682879

Brown RS Jr, Collins MA, Strasser SI, et al. Efficacy and safety of 8-or 12 weeks of glecaprevir/pibrentasvir in patients with evidence of portal hypertension. Infect Dis Ther. 2022;11:913–24.

doi: 10.1007/s40121-022-00599-8 pubmed: 35174470 pmcid: 8960502

Amoako A, Ortiz-Paredes D, Engler K, Lebouché B, Klein MB. Patient and provider perceived barriers and facilitators to direct acting antiviral hepatitis C treatment among priority populations in high income countries: a knowledge synthesis. Int J Drug Policy. 2021;96:103247.

doi: 10.1016/j.drugpo.2021.103247 pubmed: 33853727

Artenie AA, Jutras-Aswad D, Roy É, et al. Visits to primary care physicians among persons who inject drugs at high risk of hepatitis C virus infection: room for improvement. J Viral Hepat. 2015;22:792–9.

doi: 10.1111/jvh.12393 pubmed: 25586516

Papaluca T, McDonald L, Craigie A, et al. Outcomes of treatment for hepatitis C in prisoners using a nurse-led, statewide model of care. J Hepatol. 2019;70:839–46.

doi: 10.1016/j.jhep.2019.01.012 pubmed: 30654067

Andreoni M, Di Perri G, Persico M, et al. Addressing HCV elimination barriers in Italy: healthcare resource utilization and cost impact using 8 weeks’ glecaprevir/pibrentasvir therapy. Infect Dis Ther. 2021;10:763–74.

doi: 10.1007/s40121-021-00410-0 pubmed: 33655410 pmcid: 7925258

Huang C-F, Kuo H-T, Chang T-S, et al. Nationwide registry of glecaprevir plus pibrentasvir in the treatment of HCV in Taiwan. Sci Rep. 2021;11:23473.

doi: 10.1038/s41598-021-03006-3 pubmed: 34873250 pmcid: 8648748

Gane E, de Ledinghen V, Dylla DE, et al. Positive predictive value of sustained virologic response 4 weeks posttreatment for achieving sustained virologic response 12 weeks posttreatment in patients receiving glecaprevir/pibrentasvir in phase 2 and 3 clinical trials. J Viral Hepat. 2021;28:1635–42.

doi: 10.1111/jvh.13600 pubmed: 34448313 pmcid: 9292745

Brown J, Demou E, Tristram MA, Gilmour H, Sanati KA, Macdonald EB. Employment status and health: understanding the health of the economically inactive population in Scotland. BMC Public Health. 2012;12:1–9.

doi: 10.1186/1471-2458-12-327

Lueckmann SL, Hoebel J, Roick J, et al. Socioeconomic inequalities in primary-care and specialist physician visits: a systematic review. Int J Equity Health. 2021;20:1–19.

doi: 10.1186/s12939-020-01375-1

Chang TS, Huang CF, Kuo HT, et al. Effectiveness and safety of 8-week glecaprevir/pibrentasvir in HCV treatment-naïve patients with compensated cirrhosis: real-world experience from Taiwan nationwide HCV registry. Hepatol Int. 2023;17(3):550–61.

doi: 10.1007/s12072-023-10506-z pubmed: 36973633

Andreoni M, Coppola N, Craxì A, et al. Meet–test–treat for HCV management: patients’ and clinicians’ preferences in hospital and drug addiction services in Italy. BMC Infect Dis. 2022;22:1–14.

doi: 10.1186/s12879-021-06983-y