Safety analysis of glecaprevir/pibrentasvir in patients with markers of advanced liver disease in clinical and real‐world cohorts

Feld, Jordan J.; Forns, Xavier; Dylla, Douglas E.; Kumada, Hiromitsu; Lédinghen, Victor de; Wei, Lai; Brown, Robert S.; Flisiak, Robert; Lampertico, Pietro; Thabut, Dominique; Bondin, Mark; Tatsch, Fernando; Burroughs, Margaret; Marcinak, John; Zhang, Zhenzhen; Emmett, Amanda; Jacobson, Ira M.

doi:10.1111/jvh.13738

Cited by 2 publications

(1 citation statement)

References 39 publications

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“…A recent cohort study demonstrated that protease inhibitor (PI)-containing DAAs were as well tolerated as non-PI DAAs in terms of patient safety, even among patient with advanced cirrhosis [ 28 ]. Another study indicated the absence of specific safety signals in patients with compensated cirrhosis receiving GLE/PIB, even in cases where patients presented with overt thrombocytopenia or a Child‒Pugh score of A6 [ 29 ]. A pooled analysis of nine clinical trials revealed only three liver decompensation events among patients with portal hypertension, which were judged as non-investigational drug-related events [ 30 ].…”

Section: Discussionmentioning

confidence: 99%

Real-World Efficacy and Safety of Universal 8-Week Glecaprevir/Pibrentasvir for Treatment-Naïve Patients from a Nationwide HCV Registry in Taiwan

Yang,

Huang,

Chang

et al. 2024

Infect Dis Ther

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Introduction Eight-week glecaprevir/pibrentasvir (GLE/PIB) is indicated for treatment-naïve (TN) patients with chronic hepatitis C (CHC), with or without compensated cirrhosis. Given that the Taiwanese government is committed to eliminating hepatitis C virus (HCV) by 2025, this study aimed to measure real-world evidence for TN patients using 8-week GLE/PIB in the Taiwan HCV Registry (TACR). Methods The data of patients with CHC treated with 8-week GLE/PIB were retrieved from TACR, a nationwide registry program organized by the Taiwan Association for the Study of the Liver (TASL). Treatment efficacy, defined as a sustained virologic response at posttreatment week 12 (SVR12), was assessed in the modified intention-to-treat (mITT) population, which excluded patients who were lost to follow-up or lacked SVR12 data. The safety profile of the ITT population was assessed. Results A total of 7246 (6897 without cirrhosis; 349 with cirrhosis) patients received at least one dose of GLE/PIB (ITT), 7204 of whom had SVR12 data available (mITT). The overall SVR12 rate was 98.9% (7122/7204) among all patients, 98.9% (6780/6856) and 98.3% (342/348) among patients without and with cirrhosis, respectively. For the selected subgroups, which included patients with genotype 3 infection, diabetes, chronic kidney disease, people who injected drugs, and those with human immunodeficiency virus coinfection, the SVR12 rates were 95.1% (272/286), 98.9% (1084/1096), 99.0% (1171/1183), 97.4% (566/581), and 96.1% (248/258), respectively. Overall, 14.1% (1021/7246) of the patients experienced adverse events (AEs). Twenty-two patients (0.3%) experienced serious AEs, and 15 events (0.2%) resulted in permanent drug discontinuation. Only one event was considered treatment drug related. Conclusion Eight-week GLE/PIB therapy was effective and well tolerated in all TN patients, regardless of cirrhosis status. Supplementary Information The online version contains supplementary material available at 10.1007/s40121-024-00968-5.

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Section: Discussionmentioning

confidence: 99%

Real-World Efficacy and Safety of Universal 8-Week Glecaprevir/Pibrentasvir for Treatment-Naïve Patients from a Nationwide HCV Registry in Taiwan

Yang,

Huang,

Chang

et al. 2024

Infect Dis Ther

View full text Add to dashboard Cite

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Safety analysis of glecaprevir/pibrentasvir in patients with markers of advanced liver disease in clinical and real‐world cohorts

Feld

Forns

Dylla

et al. 2022

Journal of Viral Hepatitis

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Chronic hepatitis C virus (HCV) infection has the greatest health impact in patients with advanced liver disease. The direct-acting antiviral (DAA) regimen glecaprevir/ pibrentasvir (G/P) is approved for treatment of HCV-infected patients without cirrhosis and with compensated cirrhosis. However, events of liver decompensation/failure have been reported in patients treated with protease-inhibitor-containing DAA regimens, often in patients with advanced liver disease. This study examines the safety of | 1051 FELD et al. How to cite this article: Feld JJ, Forns X, Dylla DE, et al. Safety analysis of glecaprevir/pibrentasvir in patients with markers of advanced liver disease in clinical and real-world cohorts.

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Safety analysis of glecaprevir/pibrentasvir in patients with markers of advanced liver disease in clinical and real‐world cohorts

Cited by 2 publications

References 39 publications

Real-World Efficacy and Safety of Universal 8-Week Glecaprevir/Pibrentasvir for Treatment-Naïve Patients from a Nationwide HCV Registry in Taiwan

Real-World Efficacy and Safety of Universal 8-Week Glecaprevir/Pibrentasvir for Treatment-Naïve Patients from a Nationwide HCV Registry in Taiwan

Safety analysis of glecaprevir/pibrentasvir in patients with markers of advanced liver disease in clinical and real‐world cohorts

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