Effectiveness and safety of glecaprevir/pibrentasvir in chronic hepatitis C patients: Results of the Italian cohort of a post-marketing observational study

Aghemo, Alessio; Alberti, Alberto; Andreone, Pietro; Angélico, M.; Brunetto, M.R.; Chessa, Luchino; Ciancio, Alessia; Craxı̀, Antonio; Gaeta, Giovanni Battista; Galli, Massimo; Gasbarrini, Antonio; Giorgini, Alessia; Grilli, Elisabetta; Lampertico, Pietro; Lichtner, Miriam; Milella, Michele Stanislaw; Morisco, Filomena; Persico, Marcello; Pirisi, Mario; Puoti, Massimo; Raimondo, Giovanni; Romano, A.; Russello, Maurizio; Sangiovanni, Vincenzo; Schiavini, Monica; Serviddio, Gaetano; Villa, Erica; Vinci, M.; Michina, Antonella De; Gallinaro, Valentina; Gualberti, Giuliana; Roscini, Antonio Saverio; Zignego, Anna Linda

doi:10.1016/j.dld.2020.08.007

Cited by 6 publications

(7 citation statements)

References 35 publications

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“…We observed an overall SVR12 rate of 97.9% and two virological failures due to relapse (2.1%). This rate is slightly lower than that estimated from the multinational analysis of the same study (98.0%) 17 and from an Italian cohort (99.4%), 18 but is consistent with the results from a Swiss cohort (96.9%), 19 as well as with the pooled analysis of other real-world studies (96.7%). 11 Prospective data of the German Hepatitis C registry (n = 552 patients; 53% GT1, 33% GT3; mostly treatment-naïve, non-cirrhotic and receiving the 8-week GLE/PIB regimen) showed an overall SVR12 rate of 96.7%, with one documented relapse and two HCV reinfections.…”

Section: Discussionsupporting

confidence: 89%

Real-World Effectiveness and Safety of Glecaprevir/Pibrentasvir for the Treatment of Chronic Hepatitis C: A Prospective Cohort Study in Portugal

Vera,

Gomes,

Póvoas

et al. 2024

Acta Med Port

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Introduction: Information about pan-genotypic treatments for hepatitis in Portugal is scarce. We aimed to evaluate the effectiveness and safety of glecaprevir plus pibrentasvir (GLE/PIB) treatment for hepatitis C virus (HCV) infection in real-world clinical practice.Methods: An observational prospective study was implemented in six hospitals with 121 adult HCV patients who initiated treatment with GLE/PIB between October 2018 and April 2019, according to clinical practice. Eligible patients had confirmed HCV infection genotype (GT) 1 to 6 and were either treatment-naïve or had experience with interferon-, ribavirin- or sofosbuvir-based regimens, with or without compensated cirrhosis. Baseline sociodemographic and safety data are described for the total population (N = 115). Effectiveness [sustained virologic response 12 weeks after treatment (SVR12)] and patient-reported outcomes are presented for the core population with sufficient follow-up data (n = 97).Results: Most patients were male (83.5%), aged < 65 years (94.8%), with current or former alcohol consumption (77.3%), illicit drug use (72.6%), and HCV acquisition through intravenous drug use (62.0%). HIV co-infection occurred in 22.6% of patients. The prevalence of each GT was: GT1 51.3%, GT2 1.7%, GT3 30.4%, GT4 16.5%, and GT5.6 0%. Most patients were non-cirrhotic (80.9%) and treatment-naïve (93.8%). The SVR12 rates were 97.9% (95% CI: 92.8 - 99.4), and > 95% across cirrhosis status, GT, illicit drug use, alcohol consumption, and HCV treatment experience. The adverse event rate was 2.6%, and no patient discontinued treatment due to adverse events related to GLE/PIB.Conclusion: Consistent with other real-world studies and clinical trials, treatment with GLE/PIB showed high effectiveness and tolerability overall and in difficult-to-treat subgroups (ClinicalTrials.gov: NCT03303599).

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Section: Discussionsupporting

confidence: 89%

Real-World Effectiveness and Safety of Glecaprevir/Pibrentasvir for the Treatment of Chronic Hepatitis C: A Prospective Cohort Study in Portugal

Vera,

Gomes,

Póvoas

et al. 2024

Acta Med Port

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“…In contrast to the data reported in registration trials 10 , lower SVR rates were observed to be associated with males, high baseline HCV RNA levels, HCV GT3 and intravenous drug abuse in the current study. Other large-scaled real-world reports and post marketing observational studies for GLE/PIB have reported conflicting results of the predicting factors including the male gender 22 , 23 , HCV viral load at baseline 23 , 24 , GT3 24 , 25 and people who use drugs 22 , 25 . It is worth noting that the SVR12 rates remained high (> 95%) for all subgroups analyzed, excepting a numerically lower SVR12 rate of 90.2% for PWID, but it might have been affected by the small number of patients (41, 1.3%).…”

Section: Discussionmentioning

confidence: 97%

Nationwide registry of glecaprevir plus pibrentasvir in the treatment of HCV in Taiwan

Huang

Kuo

Chang

et al. 2021

Sci Rep

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The study evaluated the real-world treatment outcomes of Glecaprevir/pibrentasvir (GLE/PIB) including effectiveness, safety and healthcare resource utilization based on a nation-wide registry in Taiwan. The Taiwan HCV Registry (TACR) is a nation-wide platform organized and supervised by the Taiwan Association for the Study of the Liver. Data were analyzed for patients treated with GLE/PIB, including 3144 patients who had treatment outcome available. The primary endpoint was sustained virological response (SVR12, undetectable HCV RNA throughout 12 weeks of end-of-treatment). The overall SVR12 rate was 98.9% (3110/3144), with 98.8%, 99.4% and 100% in patients receiving 8 weeks, 12 weeks, and 16 weeks of GLE/PIB respectively. The SVR12 rate in the treatment-naïve cirrhotic patients receiving 8 weeks of GLE/PIB was 98.2% (108/110). The most common AEs were fatigue (7.5%), pruritus (6.7%) and dizziness (1.5%). The mean number of outpatient visits during the GLE/PIB was 5.94 visits for patients treated with 8 weeks, significantly different from the patients treated with 12 weeks of GLE/PIB (6.90 visits). The results support the effectiveness and safety of GLE/PIB treatment in real-world clinical practice, and provide further evidence that the shorter, 8-week GLE/PIB regimen is effective and cost-saving.

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“…Glecaprevir/pibrentasvir (G/P) is a fixed‐dose pangenotypic DAA combination approved for the treatment of HCV genotypes (GT) 1–6. 5 , 11 Data from clinical trials and real‐world studies have shown G/P to be highly effective and well tolerated in a broad range of patients without cirrhosis and those with compensated cirrhosis (CC), 12 , 13 , 14 , 15 , 16 over treatment durations as short as 8 weeks. 5 , 17 , 18 …”

Section: Introductionmentioning

confidence: 99%

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

Gane

Lédinghen

Dylla

et al. 2021

Journal of Viral Hepatitis

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Sustained virologic response at posttreatment Week 12 (SVR12) is the widely accepted efficacy endpoint for direct‐acting antiviral agents. Those with hepatitis C virus (HCV) are presenting younger with milder liver disease, potentially reducing need for long‐term liver posttreatment monitoring. This analysis aimed to determine the positive predictive value (PPV) of SVR at posttreatment Week 4 (SVR4) for achieving SVR12 in patients with HCV, without cirrhosis or with compensated cirrhosis, receiving glecaprevir/pibrentasvir (G/P) in clinical trials. An integrated dataset from 20 Phase 2 and 3 clinical trials of G/P was evaluated in patients with 8‐, 12‐ or 16‐week treatment duration consistent with the current label (label‐consistent group), and in all patients regardless of treatment duration consistency with the current label (overall group). Sensitivity analyses handled missing data either by backward imputation or were excluded. SVR4 PPV, negative predictive value (NPV), sensitivity and specificity were calculated for achieving SVR12 in both groups, and by treatment duration in the label‐consistent group. SVR was defined as HCV ribonucleic acid 99% in both groups regardless of treatment duration. Not achieving SVR4 had 100% NPV and sensitivity for all groups. SVR4 measure had 79.5% specificity for identifying patients who did not achieve SVR12. Across 20 Phase 2/3 clinical trials of G/P, SVR4 was highly predictive of SVR12. Long‐term follow‐up to confirm SVR may not be necessary for certain populations of patients with HCV.

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Effectiveness and safety of glecaprevir/pibrentasvir in chronic hepatitis C patients: Results of the Italian cohort of a post-marketing observational study

Cited by 6 publications

References 35 publications

Real-World Effectiveness and Safety of Glecaprevir/Pibrentasvir for the Treatment of Chronic Hepatitis C: A Prospective Cohort Study in Portugal

Real-World Effectiveness and Safety of Glecaprevir/Pibrentasvir for the Treatment of Chronic Hepatitis C: A Prospective Cohort Study in Portugal

Nationwide registry of glecaprevir plus pibrentasvir in the treatment of HCV in Taiwan

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

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